perrigo new york inc release - dailymed.nlm.nih.gov
TRANSCRIPT
SCOPOLAMINE TRANDERMAL SYSTEM- scolopamine transdermalsystem patch extended release Padagis Israel Pharmaceuticals Ltd----------
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use SCOPOLAMINETRANSDERMAL SYSTEM safely and effectively See full prescribing information for SCOPOLAMINE TRANSDERMAL SYSTEMSCOPOLAMINE transdermal system 1 mg3 daysInitial US Approval 1979
RECENT MAJOR CHANGESWarnings and Precautions (53) 032019
INDICATIONS AND USAGEScopolamine transdermal system is an anticholinergic indicated in adults for the prevention of
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DOSAGE AND ADMINISTRATIONApplication and Removal (21)
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Recommended Dosage
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DOSAGE FORMS AND STRENGTHSTransdermal system 1 mg3 days (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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nausea and vomiting associated with motion sickness (1)post-operative nausea and vomiting (PONV) associated with recovery from anesthesia andor opiateanalgesia and surgery (1)
Each scopolamine transdermal system delivers 1 mg of scopolamine over 3 daysOnly wear one transdermal system at a timeDo not cut the transdermal systemWash hands thoroughly after applicationUpon removal fold used transdermal system in half with sticky side together and discard to preventaccidental contact or ingestion
Motion Sickness Apply one transdermal system to the hairless area behind one ear at least 4 hoursbefore antiemetic effect is required for use up to 3 days If therapy for more than 3 days is requiredremove the first transdermal system and apply a new transdermal system behind the other ear (22)PONV For surgeries other than cesarean section apply one transdermal system behind the ear theevening before surgery and remove 24 hours following surgery (22)
Angle closure glaucoma (4 62)Hypersensitivity to scopolamine or to other belladonna alkaloids or to any ingredient or component ofthe formulation or delivery system (4 7)
Acute Angle Closure Glaucoma Monitor for increased intraocular pressure in patients with open-angleglaucoma and adjust glaucoma therapy as needed Discontinue if signs or symptoms of acute angleclosure glaucoma develop (51)Neuropsychiatric Adverse Reactions May cause psychiatric and cognitive effects seizures and impairmental andor physical abilities Monitor patients for new or worsening psychiatric symptoms duringtreatment and during concomitant treatment with other drugs that are associated with similarpsychiatric effects (52 71)Eclamptic Seizures in Pregnant Women Avoid use in patients with severe preeclampsia (53)Gastrointestinal and Urinary Disorders Consider more frequent monitoring during treatment inpatients suspected of having intestinal obstruction patients with pyloric obstruction urinary bladderneck obstruction or receiving other anticholinergic drugs Discontinue if patient develops difficulty inurination (54 72)Drug WithdrawalPost-Removal Symptoms Anticholinergic symptoms may occur 24 hours or more
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ADVERSE REACTIONSMost common adverse reactions are
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To report SUSPECTED ADVERSE REACTIONS contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or wwwfdagovmedwatch
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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See 17 for PATIENT COUNSELING INFORMATION and Medication GuideRevised 112021
FULL PRESCRIBING INFORMATION CONTENTS1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION
21 Important Application and Removal Instructions22 Recommended Adult Dosage
3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS
51 Acute Angle Closure Glaucoma52 Neuropsychiatric Adverse Reactions53 Eclamptic Seizures in Pregnant Women54 Gastrointestinal and Urinary Disorders55 Drug WithdrawalPost-Removal Symptoms56 Blurred Vision57 Magnetic Resonance Imaging (MRI) Skin Burns
6 ADVERSE REACTIONS61 Clinical Trials Experience62 Postmarketing Experience
7 DRUG INTERACTIONS
Drug WithdrawalPost-Removal Symptoms Anticholinergic symptoms may occur 24 hours or moreafter removal of the transdermal system (55)Blurred Vision Avoid contact with the eyes (21 56)Magnetic Resonance Imaging (MRI) Skin Burns Remove scopolamine transdermal system prior to MRIscan (57)
Motion Sickness (gt15) dry mouth drowsiness blurred vision and dilation of the pupils (61)PONV (ge 3) dry mouth dizziness somnolence agitation visual impairment confusion mydriasisand pharyngitis (61)
Drugs Causing Central Nervous System (CNS) Adverse Reactions Monitor patients for CNS adversereactions (drowsiness dizziness or disorientations) (71)Anticholinergic Drugs Consider more frequent monitoring during treatment in patients receiving otheranticholinergic drugs (72)Oral Drugs Absorbed in the Stomach Monitor for increased or decreased therapeutic effect of theoral drug (73)Interaction with Gastric Secretion Test Discontinue use of scopolamine transdermal system 10 daysprior to testing (74)
Geriatric Patients Consider more frequent monitoring during treatment due to increased risk of CNSadverse reactions (52 85)Renal or Hepatic Impairment Consider more frequent monitoring during treatment due to increasedrisk of CNS adverse reactions (52 86)
71 Drugs Causing Central Nervous System (CNS) Adverse Reactions72 Anticholinergic Drugs73 Oral Drugs Absorbed in the Stomach74 Interaction with Gastric Secretion Test
8 USE IN SPECIFIC POPULATIONS81 Pregnancy82 Lactation84 Pediatric Use85 Geriatric Use86 Renal or Hepatic Impairment
9 DRUG ABUSE AND DEPENDENCE91 Controlled Substance93 Dependence
10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY
121 Mechanism of Action123 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY131 Carcinogenesis Mutagenesis Impairment of Fertility
14 CLINICAL STUDIES141 Prevention of Motion Sickness142 Prevention of Post-Operative Nausea and Vomiting
16 HOW SUPPLIEDSTORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGEScopolamine transdermal system is indicated in adults for prevention of
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2 DOSAGE AND ADMINISTRATION
21 Important Application and Removal Instructions
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Sections or subsections omitted from the full prescribing information are not listed
nausea and vomiting associated with motion sicknesspost-operative nausea and vomiting (PONV) associated with recovery fromanesthesia andor opiate analgesia and surgery
Each scopolamine transdermal system is formulated to deliver in vivo approximately1 mg of scopolamine over 3 daysOnly wear one transdermal system at any timeDo not cut the transdermal systemApply the transdermal system to the skin in the postauricular area (hairless area
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22 Recommended Adult DosageMotion SicknessApply one scopolamine transdermal system to the hairless area behind one ear at least 4hours before the antiemetic effect is required ndash for use up to 3 days If therapy isrequired for longer than 3 days remove the first transdermal system and apply a newscopolamine transdermal system behind the other earPONVFor surgeries other than cesarean section Apply one scopolamine transdermal systemthe evening before scheduled surgery Remove the transdermal system 24 hoursfollowing surgery
3 DOSAGE FORMS AND STRENGTHSTransdermal system a circular flat tan-colored transdermal system imprinted withldquoSCOP 1 mg3 daysrdquo in a repeating pattern
4 CONTRAINDICATIONSScopolamine transdermal system is contraindicated in patients with
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5 WARNINGS AND PRECAUTIONS
51 Acute Angle Closure GlaucomaThe mydriatic effect of scopolamine may cause an increase in intraocular pressureresulting in acute angle closure glaucoma Monitor intraocular pressure in patients withopen angle glaucoma and adjust glaucoma therapy during scopolamine transdermalsystem use as needed Advise patients to immediately remove the transdermal systemand contact their healthcare provider if they experience symptoms of acute angleclosure glaucoma (eg eye pain or discomfort blurred vision visual halos or coloredimages in association with red eyes from conjunctival congestion and corneal edema)
behind one ear)After the transdermal system is applied on the dry skin behind the ear wash handsthoroughly with soap and water and dry hands [see Warnings and Precautions(56)]If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
angle closure glaucoma [see Warnings and Precautions (51)]hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient orcomponent in the formulation or delivery system Reactions have included rashgeneralized and erythema [see Adverse Reactions (62) Description (11)]
52 Neuropsychiatric Adverse ReactionsPsychiatric Adverse ReactionsScopolamine has been reported to exacerbate psychosis Other psychiatric reactionshave also been reported including acute toxic psychosis agitation speech disorderhallucinations paranoia and delusions [see Adverse Reactions (62)] Monitor patientsfor new or worsening psychiatric symptoms during treatment with scopolaminetransdermal system Also monitor patients for new or worsening psychiatric symptomsduring concomitant treatment with other drugs that are associated with similarpsychiatric effects [see Drug Interactions (71)]SeizuresSeizures and seizure-like activity have been reported in patients receiving scopolamineWeigh this potential risk against the benefits before prescribing scopolaminetransdermal system to patients with a history of seizures including those receiving anti-epileptic medication or who have risk factors that can lower the seizure thresholdCognitive Adverse ReactionsScopolamine can cause drowsiness disorientation and confusion Discontinuescopolamine transdermal system if signs or symptoms of cognitive impairment developElderly and pediatric patients may be more sensitive to the neurological and psychiatriceffects of scopolamine transdermal system Consider more frequent monitoring duringtreatment with scopolamine transdermal system in elderly patients [see Use in SpecificPopulations (85)] Scopolamine transdermal system is not approved for use in pediatricpatients [see Use in Specific Populations (84)]Hazardous ActivitiesScopolamine transdermal system may impair the mental andor physical abilities requiredfor the performance of hazardous tasks such as driving a motor vehicle operatingmachinery or participating in underwater sports Concomitant use of other drugs thatcause central nervous system (CNS) adverse reactions (eg alcohol sedativeshypnotics opiates and anxiolytics) or have anticholinergic properties (eg otherbelladonna alkaloids sedating antihistamines meclizine tricyclic antidepressants andmuscle relaxants) may increase this effect [see Drug Interactions (71)] Inform patientsnot to operate motor vehicles or other dangerous machinery or participate inunderwater sports until they are reasonably certain that scopolamine transdermalsystem does not affect them adversely
53 Eclamptic Seizures in Pregnant WomenEclamptic seizures have been reported in pregnant women with severe preeclampsiasoon after injection of intravenous and intramuscular scopolamine [see Use in SpecificPopulations (81)] Avoid use of scopolamine transdermal system in patients with severepreeclampsia
54 Gastrointestinal and Urinary DisordersScopolamine due to its anticholinergic properties can decrease gastrointestinal motilityand cause urinary retention Consider more frequent monitoring during treatment withscopolamine transdermal system in patients suspected of having intestinal obstructionpatients with pyloric obstruction or urinary bladder neck obstruction and patients
receiving other anticholinergic drugs [see Drug Interactions (72)] Discontinuescopolamine transdermal system in patients who develop difficulty in urination
55 Drug WithdrawalPost-Removal SymptomsDiscontinuation of scopolamine transdermal system usually after several days of usemay result in withdrawal symptoms such as disturbances of equilibrium dizzinessnausea vomiting abdominal cramps sweating headache mental confusion muscleweakness bradycardia and hypotension The onset of these symptoms is generally 24hours or more after the transdermal system has been removed Instruct patients toseek medical attention if they experience severe symptoms
56 Blurred VisionScopolamine can cause temporary dilation of the pupils resulting in blurred vision if itcomes in contact with the eyesAdvise patients to wash their hands thoroughly with soap and water and dry their handsimmediately after handling the transdermal system [see Dosage and Administration(21)]
57 Magnetic Resonance Imaging (MRI) Skin BurnsScopolamine transdermal system contains an aluminized membrane Skin burns havebeen reported at the application site in patients wearing an aluminized transdermalsystem during an MRI scan Remove scopolamine transdermal system beforeundergoing an MRI
6 ADVERSE REACTIONSThe following serious adverse reactions are described elsewhere in labeling
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61 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions adverse reactionrates observed in the clinical trials of a drug cannot be directly compared to rates in theclinical trials of another drug and may not reflect the rates observed in practiceMotion SicknessThe most common adverse reaction (approximately two thirds) was dry mouth Lesscommon adverse reactions included drowsiness (less than one sixth) blurred visionand dilation of the pupilsPONV
Acute Angle Closure Glaucoma [see Warnings and Precautions (51)]Neuropsychiatric Adverse Reactions [see Warnings and Precautions (52)]Eclamptic Seizures in Pregnant Women [see Warnings and Precautions (53)]Gastrointestinal and Urinary Disorders [see Warnings and Precautions (54)]Drug WithdrawalPost-Removal Symptoms [see Warnings and Precautions (55)]Blurred Vision [see Warnings and Precautions (56)]MRI Skin Burns [see Warnings and Precautions (57)]
Common adverse reactions occurring in at least 3 of patients in PONV clinical trialsare shown in Table 1
Scopolamine TransdermalSystem
(N = 461)
Placebo (N = 457)
Dry mouth 29 16Dizziness 12 7Somnolence 8 4Agitation 6 4Visual Impairment 5 3Confusion 4 3Mydriasis 4 0Pharyngitis 3 2
occurring in at least 3 of patients and at a rate higher than placebo
62 Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use ofscopolamine transdermal system Because these reactions are reported voluntarily froma population of uncertain size it is not always possible to reliably estimate theirfrequency or establish a causal relationship to drug exposurePsychiatric disorders acute psychosis including hallucinations disorientation andparanoiaNervous system disorders headache amnesia coordination abnormalities speechdisorder disturbance in attention restlessnessGeneral disorders and administration site conditions application site burningEye disorders dry eyes eye pruritus angle closure glaucoma amblyopia eyelid irritationSkin and subcutaneous tissue disorders rash generalized skin irritation erythemaRenal and urinary disorders dysuriaEar and labyrinth disorders vertigo
7 DRUG INTERACTIONS
71 Drugs Causing Central Nervous System (CNS) Adverse ReactionsThe concurrent use of scopolamine transdermal system with other drugs that causeCNS adverse reactions of drowsiness dizziness or disorientation (eg sedativeshypnotics opiates anxiolytics and alcohol) or have anticholinergic properties (eg otherbelladonna alkaloids sedating antihistamines meclizine tricyclic antidepressants andmuscle relaxants) may potentiate the effects of scopolamine transdermal system [seeWarnings and Precautions (52)] Either scopolamine transdermal system or theinteracting drug should be chosen depending on the importance of the drug to thepatient If the interacting drug cannot be avoided monitor patients for CNS adverse
reactions
72 Anticholinergic DrugsConcomitant use of scopolamine with other drugs having anticholinergic properties mayincrease the risk of CNS adverse reactions [see Drug Interactions (71)] intestinalobstruction andor urinary retention Consider more frequent monitoring duringtreatment with scopolamine transdermal system in patients receiving anticholinergicdrugs [see Warnings and Precautions (52 54)]
73 Oral Drugs Absorbed in the StomachScopolamine transdermal system as an anticholinergic may delay gastric and uppergastrointestinal motility and therefore the rate of absorption of other orallyadministered drugs Monitor patients for modified therapeutic effect of concomitantorally administered drugs with a narrow therapeutic index
74 Interaction with Gastric Secretion TestScopolamine will interfere with the gastric secretion test Discontinue scopolaminetransdermal system 10 days prior to testing
8 USE IN SPECIFIC POPULATIONS
81 PregnancyRisk SummaryAvailable data from observational studies and postmarketing reports with scopolamineuse in pregnant women have not identified a drug associated risk of major birth defectsmiscarriage or adverse fetal outcomes Avoid use of scopolamine transdermal systemin pregnant women with severe preeclampsia because eclamptic seizures have beenreported after exposure to scopolamine (see Data)
In animal studies there was no evidence of adverse developmental effects withintravenous administration of scopolamine hydrobromide revealed in ratsEmbryotoxicity was observed in rabbits at intravenous doses producing plasma levelsapproximately 100 times the levels achieved in humans using a transdermal systemThe estimated background risk of major birth defects and miscarriage for the indicatedpopulation is unknown All pregnancies have a background risk of birth defect loss orother adverse outcomes In the US general population the background risk of majorbirth defects and miscarriage in clinically recognized pregnancies is 2 to 4 and 15to 20 respectivelyDataHuman Data
Eclamptic Seizures In published case reports two pregnant patients with severe preeclampsia wereadministered intravenous and intramuscular scopolamine respectively and developedeclamptic seizures soon after scopolamine administration [see Warnings and Precautions(53)]
Animal Data
In animal reproduction studies when pregnant rats and rabbits received scopolaminehydrobromide by daily intravenous injection no adverse effects were observed in ratsAn embryotoxic effect was observed in rabbits at doses producing plasma levelsapproximately 100 times the levels achieved in humans using a transdermal systemScopolamine administered parenterally to rats and rabbits at doses higher than the dosedelivered by scopolamine transdermal system did not affect uterine contractions orincrease the duration of labor
82 LactationRisk SummaryScopolamine is present in human milk There are no available data on the effects ofscopolamine on the breastfed infant or the effects on milk production Because therehave been no consistent reports of adverse events in breastfed infants over decades ofuse the developmental and health benefits of breastfeeding should be considered alongwith the motherrsquos clinical need for scopolamine transdermal system and any potentialadverse effects on the breastfed child from scopolamine transdermal system or fromthe underlying maternal condition
84 Pediatric UseSafety and effectiveness in pediatric patients have not been established Pediatricpatients are particularly susceptible to the adverse reactions of scopolamine includingmydriasis hallucinations amblyopia and drug withdrawal syndrome Neurologic andpsychiatric adverse reactions such as hallucinations amblyopia and mydriasis have alsobeen reported
85 Geriatric UseClinical trials of scopolamine transdermal system did not include sufficient number ofsubjects aged 65 years and older to determine if they respond differently from youngersubjects In other clinical experience elderly patients had an increased risk of neurologicand psychiatric adverse reactions such as hallucinations confusion dizziness and drugwithdrawal syndrome [see Warnings and Precautions (52 55)] Consider morefrequent monitoring for CNS adverse reactions during treatment with scopolaminetransdermal system in elderly patients [see Warnings and Precautions (52)]
86 Renal or Hepatic ImpairmentScopolamine transdermal system has not been studied in patients with renal or hepaticimpairment Consider more frequent monitoring during treatment with scopolaminetransdermal system in patients with renal or hepatic impairment because of theincreased risk of CNS adverse reactions [see Warnings and Precautions (52)]
9 DRUG ABUSE AND DEPENDENCE
91 Controlled SubstanceScopolamine transdermal system contains scopolamine which is not a controlled
substance
93 DependenceTermination of scopolamine transdermal system usually after several days of use mayresult in withdrawal symptoms such as disturbances of equilibrium dizziness nauseavomiting abdominal cramps sweating headache mental confusion muscle weaknessbradycardia and hypotension These withdrawal symptoms indicate that scopolaminelike other anticholinergic drugs may produce physical dependence The onset of thesesymptoms generally 24 hours or more after the transdermal system has beenremoved can be severe and may require medical intervention [see Warnings andPrecautions (55)]
10 OVERDOSAGEThe signs and symptoms of anticholinergic toxicity include lethargy somnolence comaconfusion agitation hallucinations convulsion visual disturbance dry flushed skin drymouth decreased bowel sounds urinary retention tachycardia hypertension andsupraventricular arrhythmias These symptoms can be severe and may require medicalinterventionIn cases of toxicity remove the scopolamine transdermal system Serious symptomaticcases of overdosage involving multiple transdermal system applications andor ingestionmay be managed by initially ensuring the patient has an adequate airway and supportingrespiration and circulation This should be rapidly followed by removal of all transdermalsystems from the skin and the mouth If there is evidence of transdermal systemingestion endoscopic removal of swallowed transdermal systems or administration ofactivated charcoal should be considered as indicated by the clinical situation In anycase where there is serious overdosage or signs of evolving acute toxicity continuousmonitoring of vital signs and ECG establishment of intravenous access andadministration of oxygen are all recommendedThe signs and symptoms of overdosetoxicity due to scopolamine should be carefullydistinguished from the occasionally observed syndrome of withdrawal [see Warningsand Precautions (55)] Although mental confusion and dizziness may be observed withboth acute toxicity and withdrawal other characteristic findings differtachyarrhythmias dry skin and decreased bowel sounds suggest anticholinergictoxicity while bradycardia headache nausea and abdominal cramps and sweatingsuggest post-removal withdrawalIf over-exposure occurs call your Poison Control Center at 1-800-222-1222 for currentinformation on the management of poisoning or overdosage
11 DESCRIPTIONScopolamine transdermal system is designed for continuous release of scopolaminefollowing application to an area of intact skin on the head behind the ear Each systemcontains 13 mg of scopolamine base Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3310 ]nonan-7-yl) 3-hydroxy-2-phenylpropanoate The empirical formulais C H NO and its structural formula is
24
17 21 4
Scopolamine has a molecular weight of 30335 and a pKa of 755-781 The scopolaminetransdermal system is a circular 02 mm thick 25 cm film with four layers Proceedingfrom the visible surface towards the surface attached to the skin these layers are (1) abacking membrane of tan-colored aluminized polyester film (2) a drug layer ofscopolamine crospovidone isopropyl palmitate light mineral oil and polyisobutylene (3)an ethylene vinyl acetate copolymer membrane that controls the rate of delivery ofscopolamine from the system to the skin surface and (4) an contact layer formulationof crospovidone isopropyl palmitate light mineral oil polyisobutylene and scopolamineA release liner of siliconized polyester which covers the adhesive layer is removedbefore the system is usedCross section of the system
12 CLINICAL PHARMACOLOGY
121 Mechanism of ActionScopolamine a belladonna alkaloid is an anticholinergic Scopolamine acts i) as acompetitive inhibitor at postganglionic muscarinic receptor sites of the parasympatheticnervous system and ii) on smooth muscles that respond to acetylcholine but lackcholinergic innervation It has been suggested that scopolamine acts in the centralnervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei tohigher centers in the CNS and from the reticular formation to the vomiting centerScopolamine can inhibit the secretion of saliva and sweat decrease gastrointestinalsecretions and motility cause drowsiness dilate the pupils increase heart rate anddepress motor function
123 PharmacokineticsThe system is formulated to deliver approximately 1 mg of scopolamine to the systemiccirculation over 3 daysAbsorption
2
Following application to the skin behind the ear circulating plasma concentrations aredetected within 4 hours with peak concentrations being obtained on average within 24hours The average plasma concentration produced is 87 pgmL (028 nM) for freescopolamine and 354 pgmL for total scopolamine (free + conjugates) Followingremoval of the used transdermal system there is some degree of continued systemicabsorption of scopolamine bound in the skin layersDistribution The distribution of scopolamine is not well characterized It crosses the placenta and theblood brain barrier and may be reversibly bound to plasma proteinsEliminationMetabolism and Excretion Scopolamine is metabolized and conjugated with less than 5 of the total doseappearing unchanged in the urine The enzymes responsible for metabolizingscopolamine are unknown The exact elimination pattern of scopolamine has not beendetermined Following transdermal system removal plasma concentrations ofscopolamine decline in a log linear fashion with an observed half-life of 95 hours Lessthan 10 of the total dose is excreted in the urine as the parent drug and metabolitesover 108 hoursDrug Interaction StudiesAn in vitro study using human hepatocytes examined the induction of CYP1A2 andCYP3A4 by scopolamine Scopolamine did not induce CYP1A2 and CYP3A4 isoenzymesat the concentrations up to 10 nM In an in vitro study using human liver microsomeswhich evaluated the inhibition of CYP1A2 2C8 2C9 2C19 2D6 and 3A4 scopolaminedid not inhibit these cytochrome P450 isoenzymes at the concentrations up to 1micromolar No in vivo drug-drug interaction studies have been conducted
13 NONCLINICAL TOXICOLOGY
131 Carcinogenesis Mutagenesis Impairment of FertilityNo long-term studies in animals have been conducted to evaluate the carcinogenicpotential of scopolamine The mutagenic potential of scopolamine has not beenevaluatedFertility studies were performed in female rats and revealed no evidence of impairedfertility or harm to the fetus due to scopolamine hydrobromide administered by dailysubcutaneous injection Maternal body weights were reduced in the highest-dose group(plasma level approximately 500 times the level achieved in humans using a transdermalsystem) However fertility studies in male animals were not performed
14 CLINICAL STUDIES
141 Prevention of Motion SicknessIn 195 adult subjects of different racial origins who participated in clinical efficacy studiesat sea or in a controlled motion environment there was a 75 reduction in the incidenceof motion-induced nausea and vomiting Scopolamine transdermal system was applied
from 4 to 16 hours prior to the onset of motion in these studies
142 Prevention of Post-Operative Nausea and VomitingA clinical efficacy study evaluated 168 adult female patients undergoing gynecologicalsurgery with anesthesia and opiate analgesia Patients received scopolamine transdermalsystem or placebo applied approximately 11 hours before anesthesiaopiate analgesiaNo retchingvomiting during the 24-hour post-operative period was reported in 79 ofthose treated with scopolamine transdermal system compared to 72 of thosereceiving placebo When the need for additional antiemetic medication was assessedduring the same period there was no need for medication in 89 of patients treatedwith scopolamine transdermal system as compared to 72 of placebo-treated patients
16 HOW SUPPLIEDSTORAGE AND HANDLINGScopolamine Transdermal System 1 mg3 days is available as the following
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Store at 20degC to 25degC (68degF to 77degF) [see USP Controlled Room Temperature]Store pouch(es) in an upright positionDo not bend or roll pouch(es)Wash hands thoroughly with soap and water immediately after handling the transdermalsystem Upon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidental contactor ingestion by children pets or others [see Dosage and Administration (21) Warningsand Precautions (56)]
17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information andInstructions for Use)Administration InstructionsCounsel patients on how to apply and remove the transdermal system [see Dosage andAdministration (21)]
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Carton of 4 transdermal systems packaged into individual foil pouches NDC45802-580-84Carton of 10 transdermal systems packaged into individual foil pouches NDC45802-580-46Carton of 24 transdermal systems packaged into individual foil pouches NDC45802-580-62
Only wear one transdermal system at any timeDo not cut the transdermal systemApply the transdermal system to the skin in the postauricular (hairless area behindone ear) areaAfter the transdermal system is applied on the dry skin behind the ear wash handsthoroughly with soap and water and dry handsIf the transdermal system becomes displaced discard the transdermal system and
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Patients with Open-Angle GlaucomaAdvise patients with open-angle glaucoma to remove the scopolamine transdermalsystem immediately and contact their healthcare provider if they experience symptomsof acute angle closure glaucoma including pain and reddening of the eyes accompaniedby dilated pupils blurred vision andor seeing halos around lights [see Warnings andPrecautions (51)]Neuropsychiatric Adverse Reactions
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Decreased Gastrointestinal Motility and Urinary RetentionInstruct patients to remove the transdermal system if they develop symptoms ofintestinal obstruction (abdominal pain nausea or vomiting) or any difficulties in urinating[see Warnings and Precautions (54)]Drug WithdrawalPost-Removal SymptomsInform patients that if they remove the scopolamine transdermal system beforetreatment is complete withdrawal symptoms may occur and to seek immediate medicalcare if they develop severe symptoms after removing scopolamine transdermal system[see Warnings and Precautions (55)]Blurred VisionInform patients that temporary dilation of the pupils and blurred vision may occur ifscopolamine transdermal system comes in contact with the eyes Instruct patients towash their hands thoroughly with soap and water immediately after handling thetransdermal system [see Dosage and Administration (21) Warnings and Precautions(56)]MRI Skin BurnsInstruct patients to remove the scopolamine transdermal system before undergoing an
If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
Advise patients that psychiatric adverse reactions may occur especially in patientswith a past psychiatric history or in those receiving other drugs also associatedwith psychiatric effects and to report to their healthcare provider any new orworsening psychiatric symptomsAdvise patients to discontinue scopolamine transdermal system and contact ahealthcare provider immediately if they experience a seizureAdvise patients especially elderly patients that cognitive impairment may occurduring treatment with scopolamine transdermal system especially in thosereceiving other drugs also associated with CNS effects and to report to theirhealthcare provider if they develop signs or symptoms of cognitive impairmentsuch as hallucinations confusion or dizzinessInform patients not to operate motor vehicles or other dangerous machinery orparticipate in underwater sports until they are reasonably certain that scopolaminetransdermal system does not affect them adversely [see Warnings and Precautions(52)]
MRI [see Warnings and Precautions (57)]
Manufactured byAVEVA DRUG DELIVERY SYSTEMSAn APOTEX CompanyMiramar FL 33025Distributed ByPerrigoregAllegan MI 49010 wwwperrigocom5A800 RC BR7
Medication Guide
MEDICATION GUIDEScopolamine (skoe polrsquo a meen) Transdermal System
Read this Patient Information before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentWhat is scopolamine transdermal systemScopolamine transdermal system is a prescription medicine used for adults to helpprevent
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It is not known if scopolamine transdermal system is safe or effective in childrenWho should not use scopolamine transdermal systemDo not use Transderm Scōp if you
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What should I tell my doctor before using scopolamine transdermal systemBefore you use scopolamine transdermal system tell your doctor about all of yourmedical conditions including if you
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nausea and vomiting from motion sicknessnausea and vomiting from anesthesia or taking opioid pain medicines after surgery
have an eye problem called angle closure glaucomaare allergic to scopolamine belladonna alkaloids or any of the ingredients inscopolamine transdermal system See the end of this leaflet for a list of theingredients in scopolamine transdermal system Ask your doctor if you are notsure
have glaucoma (increased pressure in the eye)have a history of seizures or psychosishave problems with your stomach or intestineshave trouble urinatingare scheduled to have a gastric secretion testhave liver or kidney problemsare pregnant or plan to become pregnant It is not known if scopolamine
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Tell your doctor about all the medicines you take including prescription andover-the-counter medicines vitamins and herbal supplements Scopolamine transdermalsystem may affect the way other medicines work and other medicines may affect howscopolamine transdermal system works Medicines that you take by mouth may not beabsorbed well while you use scopolamine transdermal systemEspecially tell your doctor if you take
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Ask your doctor if you are not sure if your medicine is one that is listed aboveKnow the medicines you take Keep a list of them and show it to your doctor orpharmacist when you get a new medicineHow should I use scopolamine transdermal system
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What should I avoid while using scopolamine transdermal system
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What are the possible side effects of scopolamine transdermal systemScopolamine transdermal system may cause serious side effects including
transdermal system can harm your unborn babyare breastfeeding or plan to breastfeed Scopolamine can pass into your breastmilk and may harm your baby Talk to your doctor about the best way to feed yourbaby if you use scopolamine transdermal system
a sedative hypnotic opioid or anxiolytic (medicines that make you sleepy)an antidepressant medicinean anticholinergic medicine such as an allergy or cold medicine a medicine to treatbladder or bowel spasms certain asthma medicines or other medicines for motionsickness
See the detailed Instructions for Use for information about how to usescopolamine transdermal system at the end of this Patient Information leafletIt is important that you apply scopolamine transdermal system exactly as yourdoctor tells you toYour doctor may change your scopolamine transdermal system dose Do notchange your scopolamine transdermal system dose without talking to your doctorWear only one scopolamine transdermal system at any timeIf you use too much scopolamine transdermal system call your doctor or PoisonControl Center at 1-800-222-1222 or go to the nearest hospital emergency roomright away
You should not drink alcohol while using scopolamine transdermal system It canincrease your chances of having serious side effectsYou should not drive operate heavy machinery or do other dangerous activitiesuntil you know how scopolamine transdermal system affects youYou should not use scopolamine transdermal system during a Magnetic ResonanceImaging scan (MRI) Remove scopolamine transdermal system before undergoingan MRI It can cause your skin to burnYou should be careful if you use scopolamine transdermal system while youparticipate in watersports because you may feel lost or confused (disoriented)Limit contact with water while swimming and bathing because scopolaminetransdermal system may fall off If scopolamine transdermal system falls off throwit away and apply a new one on the hairless area behind your other ear
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The most common side effects of using scopolamine transdermal systeminclude
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Tell your doctor if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of scopolamine transdermal systemCall your doctor for medical advice about side effects You may report side effects toFDA at 1-800-FDA-1088General information about the safe and effective use of scopolaminetransdermal system
angle closure glaucoma If you have open angle glaucoma and use scopolaminetransdermal system remove scopolamine transdermal system and call a doctorright away if you feel pain or discomfort have blurred vision or see halos orcolored images around lights and reddening of your eyesworsening of seizures Tell your doctor about any worsening of seizures whileusing scopolamine transdermal systeman unusual reaction called acute psychosis Tell your doctor if you have anyof these symptoms
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confusionagitationrambling speechhallucinations (seeing or hearing things that are not there)paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy Some pregnant womenwith severe preeclampsia have had seizures after getting scopolamine by injectionin the muscle (intramuscular) or injection in the vein (intravenous)difficulty urinatingdifficulties in food passing from the stomach to the small intestineswhich may cause abdominal pain nausea or vomitingwithdrawal symptoms after removing scopolamine transdermal systemafter using it for several days Some people may have certain symptoms suchas difficulty with balance dizziness nausea vomiting stomach cramps sweatingconfusion muscle weakness low heart rate or low blood pressure that could start24 hours or more after removing scopolamine transdermal system Call yourdoctor right away if your symptoms become severetemporary increase in the size of your pupil and blurry vision especially ifscopolamine transdermal system comes in contact with your eyesskin burns at the site of scopolamine transdermal system This canhappen during a medical test called a Magnetic Resonance Imaging scan (MRI)Scopolamine transdermal system contains aluminum and should be removed fromyour skin before you have an MRI
dry mouth blurred vision oreye problems
feeling sleepy ordrowsy
disorientation(confusion)
dizziness feeling agitatedor irritable
pharyngitis(sore throat)
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
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To help prevent nausea and vomiting from motion sickness
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To help prevent nausea and vomiting after surgery
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How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
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Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
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ADVERSE REACTIONSMost common adverse reactions are
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To report SUSPECTED ADVERSE REACTIONS contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or wwwfdagovmedwatch
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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See 17 for PATIENT COUNSELING INFORMATION and Medication GuideRevised 112021
FULL PRESCRIBING INFORMATION CONTENTS1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION
21 Important Application and Removal Instructions22 Recommended Adult Dosage
3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS
51 Acute Angle Closure Glaucoma52 Neuropsychiatric Adverse Reactions53 Eclamptic Seizures in Pregnant Women54 Gastrointestinal and Urinary Disorders55 Drug WithdrawalPost-Removal Symptoms56 Blurred Vision57 Magnetic Resonance Imaging (MRI) Skin Burns
6 ADVERSE REACTIONS61 Clinical Trials Experience62 Postmarketing Experience
7 DRUG INTERACTIONS
Drug WithdrawalPost-Removal Symptoms Anticholinergic symptoms may occur 24 hours or moreafter removal of the transdermal system (55)Blurred Vision Avoid contact with the eyes (21 56)Magnetic Resonance Imaging (MRI) Skin Burns Remove scopolamine transdermal system prior to MRIscan (57)
Motion Sickness (gt15) dry mouth drowsiness blurred vision and dilation of the pupils (61)PONV (ge 3) dry mouth dizziness somnolence agitation visual impairment confusion mydriasisand pharyngitis (61)
Drugs Causing Central Nervous System (CNS) Adverse Reactions Monitor patients for CNS adversereactions (drowsiness dizziness or disorientations) (71)Anticholinergic Drugs Consider more frequent monitoring during treatment in patients receiving otheranticholinergic drugs (72)Oral Drugs Absorbed in the Stomach Monitor for increased or decreased therapeutic effect of theoral drug (73)Interaction with Gastric Secretion Test Discontinue use of scopolamine transdermal system 10 daysprior to testing (74)
Geriatric Patients Consider more frequent monitoring during treatment due to increased risk of CNSadverse reactions (52 85)Renal or Hepatic Impairment Consider more frequent monitoring during treatment due to increasedrisk of CNS adverse reactions (52 86)
71 Drugs Causing Central Nervous System (CNS) Adverse Reactions72 Anticholinergic Drugs73 Oral Drugs Absorbed in the Stomach74 Interaction with Gastric Secretion Test
8 USE IN SPECIFIC POPULATIONS81 Pregnancy82 Lactation84 Pediatric Use85 Geriatric Use86 Renal or Hepatic Impairment
9 DRUG ABUSE AND DEPENDENCE91 Controlled Substance93 Dependence
10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY
121 Mechanism of Action123 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY131 Carcinogenesis Mutagenesis Impairment of Fertility
14 CLINICAL STUDIES141 Prevention of Motion Sickness142 Prevention of Post-Operative Nausea and Vomiting
16 HOW SUPPLIEDSTORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGEScopolamine transdermal system is indicated in adults for prevention of
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2 DOSAGE AND ADMINISTRATION
21 Important Application and Removal Instructions
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Sections or subsections omitted from the full prescribing information are not listed
nausea and vomiting associated with motion sicknesspost-operative nausea and vomiting (PONV) associated with recovery fromanesthesia andor opiate analgesia and surgery
Each scopolamine transdermal system is formulated to deliver in vivo approximately1 mg of scopolamine over 3 daysOnly wear one transdermal system at any timeDo not cut the transdermal systemApply the transdermal system to the skin in the postauricular area (hairless area
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22 Recommended Adult DosageMotion SicknessApply one scopolamine transdermal system to the hairless area behind one ear at least 4hours before the antiemetic effect is required ndash for use up to 3 days If therapy isrequired for longer than 3 days remove the first transdermal system and apply a newscopolamine transdermal system behind the other earPONVFor surgeries other than cesarean section Apply one scopolamine transdermal systemthe evening before scheduled surgery Remove the transdermal system 24 hoursfollowing surgery
3 DOSAGE FORMS AND STRENGTHSTransdermal system a circular flat tan-colored transdermal system imprinted withldquoSCOP 1 mg3 daysrdquo in a repeating pattern
4 CONTRAINDICATIONSScopolamine transdermal system is contraindicated in patients with
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5 WARNINGS AND PRECAUTIONS
51 Acute Angle Closure GlaucomaThe mydriatic effect of scopolamine may cause an increase in intraocular pressureresulting in acute angle closure glaucoma Monitor intraocular pressure in patients withopen angle glaucoma and adjust glaucoma therapy during scopolamine transdermalsystem use as needed Advise patients to immediately remove the transdermal systemand contact their healthcare provider if they experience symptoms of acute angleclosure glaucoma (eg eye pain or discomfort blurred vision visual halos or coloredimages in association with red eyes from conjunctival congestion and corneal edema)
behind one ear)After the transdermal system is applied on the dry skin behind the ear wash handsthoroughly with soap and water and dry hands [see Warnings and Precautions(56)]If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
angle closure glaucoma [see Warnings and Precautions (51)]hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient orcomponent in the formulation or delivery system Reactions have included rashgeneralized and erythema [see Adverse Reactions (62) Description (11)]
52 Neuropsychiatric Adverse ReactionsPsychiatric Adverse ReactionsScopolamine has been reported to exacerbate psychosis Other psychiatric reactionshave also been reported including acute toxic psychosis agitation speech disorderhallucinations paranoia and delusions [see Adverse Reactions (62)] Monitor patientsfor new or worsening psychiatric symptoms during treatment with scopolaminetransdermal system Also monitor patients for new or worsening psychiatric symptomsduring concomitant treatment with other drugs that are associated with similarpsychiatric effects [see Drug Interactions (71)]SeizuresSeizures and seizure-like activity have been reported in patients receiving scopolamineWeigh this potential risk against the benefits before prescribing scopolaminetransdermal system to patients with a history of seizures including those receiving anti-epileptic medication or who have risk factors that can lower the seizure thresholdCognitive Adverse ReactionsScopolamine can cause drowsiness disorientation and confusion Discontinuescopolamine transdermal system if signs or symptoms of cognitive impairment developElderly and pediatric patients may be more sensitive to the neurological and psychiatriceffects of scopolamine transdermal system Consider more frequent monitoring duringtreatment with scopolamine transdermal system in elderly patients [see Use in SpecificPopulations (85)] Scopolamine transdermal system is not approved for use in pediatricpatients [see Use in Specific Populations (84)]Hazardous ActivitiesScopolamine transdermal system may impair the mental andor physical abilities requiredfor the performance of hazardous tasks such as driving a motor vehicle operatingmachinery or participating in underwater sports Concomitant use of other drugs thatcause central nervous system (CNS) adverse reactions (eg alcohol sedativeshypnotics opiates and anxiolytics) or have anticholinergic properties (eg otherbelladonna alkaloids sedating antihistamines meclizine tricyclic antidepressants andmuscle relaxants) may increase this effect [see Drug Interactions (71)] Inform patientsnot to operate motor vehicles or other dangerous machinery or participate inunderwater sports until they are reasonably certain that scopolamine transdermalsystem does not affect them adversely
53 Eclamptic Seizures in Pregnant WomenEclamptic seizures have been reported in pregnant women with severe preeclampsiasoon after injection of intravenous and intramuscular scopolamine [see Use in SpecificPopulations (81)] Avoid use of scopolamine transdermal system in patients with severepreeclampsia
54 Gastrointestinal and Urinary DisordersScopolamine due to its anticholinergic properties can decrease gastrointestinal motilityand cause urinary retention Consider more frequent monitoring during treatment withscopolamine transdermal system in patients suspected of having intestinal obstructionpatients with pyloric obstruction or urinary bladder neck obstruction and patients
receiving other anticholinergic drugs [see Drug Interactions (72)] Discontinuescopolamine transdermal system in patients who develop difficulty in urination
55 Drug WithdrawalPost-Removal SymptomsDiscontinuation of scopolamine transdermal system usually after several days of usemay result in withdrawal symptoms such as disturbances of equilibrium dizzinessnausea vomiting abdominal cramps sweating headache mental confusion muscleweakness bradycardia and hypotension The onset of these symptoms is generally 24hours or more after the transdermal system has been removed Instruct patients toseek medical attention if they experience severe symptoms
56 Blurred VisionScopolamine can cause temporary dilation of the pupils resulting in blurred vision if itcomes in contact with the eyesAdvise patients to wash their hands thoroughly with soap and water and dry their handsimmediately after handling the transdermal system [see Dosage and Administration(21)]
57 Magnetic Resonance Imaging (MRI) Skin BurnsScopolamine transdermal system contains an aluminized membrane Skin burns havebeen reported at the application site in patients wearing an aluminized transdermalsystem during an MRI scan Remove scopolamine transdermal system beforeundergoing an MRI
6 ADVERSE REACTIONSThe following serious adverse reactions are described elsewhere in labeling
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61 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions adverse reactionrates observed in the clinical trials of a drug cannot be directly compared to rates in theclinical trials of another drug and may not reflect the rates observed in practiceMotion SicknessThe most common adverse reaction (approximately two thirds) was dry mouth Lesscommon adverse reactions included drowsiness (less than one sixth) blurred visionand dilation of the pupilsPONV
Acute Angle Closure Glaucoma [see Warnings and Precautions (51)]Neuropsychiatric Adverse Reactions [see Warnings and Precautions (52)]Eclamptic Seizures in Pregnant Women [see Warnings and Precautions (53)]Gastrointestinal and Urinary Disorders [see Warnings and Precautions (54)]Drug WithdrawalPost-Removal Symptoms [see Warnings and Precautions (55)]Blurred Vision [see Warnings and Precautions (56)]MRI Skin Burns [see Warnings and Precautions (57)]
Common adverse reactions occurring in at least 3 of patients in PONV clinical trialsare shown in Table 1
Scopolamine TransdermalSystem
(N = 461)
Placebo (N = 457)
Dry mouth 29 16Dizziness 12 7Somnolence 8 4Agitation 6 4Visual Impairment 5 3Confusion 4 3Mydriasis 4 0Pharyngitis 3 2
occurring in at least 3 of patients and at a rate higher than placebo
62 Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use ofscopolamine transdermal system Because these reactions are reported voluntarily froma population of uncertain size it is not always possible to reliably estimate theirfrequency or establish a causal relationship to drug exposurePsychiatric disorders acute psychosis including hallucinations disorientation andparanoiaNervous system disorders headache amnesia coordination abnormalities speechdisorder disturbance in attention restlessnessGeneral disorders and administration site conditions application site burningEye disorders dry eyes eye pruritus angle closure glaucoma amblyopia eyelid irritationSkin and subcutaneous tissue disorders rash generalized skin irritation erythemaRenal and urinary disorders dysuriaEar and labyrinth disorders vertigo
7 DRUG INTERACTIONS
71 Drugs Causing Central Nervous System (CNS) Adverse ReactionsThe concurrent use of scopolamine transdermal system with other drugs that causeCNS adverse reactions of drowsiness dizziness or disorientation (eg sedativeshypnotics opiates anxiolytics and alcohol) or have anticholinergic properties (eg otherbelladonna alkaloids sedating antihistamines meclizine tricyclic antidepressants andmuscle relaxants) may potentiate the effects of scopolamine transdermal system [seeWarnings and Precautions (52)] Either scopolamine transdermal system or theinteracting drug should be chosen depending on the importance of the drug to thepatient If the interacting drug cannot be avoided monitor patients for CNS adverse
reactions
72 Anticholinergic DrugsConcomitant use of scopolamine with other drugs having anticholinergic properties mayincrease the risk of CNS adverse reactions [see Drug Interactions (71)] intestinalobstruction andor urinary retention Consider more frequent monitoring duringtreatment with scopolamine transdermal system in patients receiving anticholinergicdrugs [see Warnings and Precautions (52 54)]
73 Oral Drugs Absorbed in the StomachScopolamine transdermal system as an anticholinergic may delay gastric and uppergastrointestinal motility and therefore the rate of absorption of other orallyadministered drugs Monitor patients for modified therapeutic effect of concomitantorally administered drugs with a narrow therapeutic index
74 Interaction with Gastric Secretion TestScopolamine will interfere with the gastric secretion test Discontinue scopolaminetransdermal system 10 days prior to testing
8 USE IN SPECIFIC POPULATIONS
81 PregnancyRisk SummaryAvailable data from observational studies and postmarketing reports with scopolamineuse in pregnant women have not identified a drug associated risk of major birth defectsmiscarriage or adverse fetal outcomes Avoid use of scopolamine transdermal systemin pregnant women with severe preeclampsia because eclamptic seizures have beenreported after exposure to scopolamine (see Data)
In animal studies there was no evidence of adverse developmental effects withintravenous administration of scopolamine hydrobromide revealed in ratsEmbryotoxicity was observed in rabbits at intravenous doses producing plasma levelsapproximately 100 times the levels achieved in humans using a transdermal systemThe estimated background risk of major birth defects and miscarriage for the indicatedpopulation is unknown All pregnancies have a background risk of birth defect loss orother adverse outcomes In the US general population the background risk of majorbirth defects and miscarriage in clinically recognized pregnancies is 2 to 4 and 15to 20 respectivelyDataHuman Data
Eclamptic Seizures In published case reports two pregnant patients with severe preeclampsia wereadministered intravenous and intramuscular scopolamine respectively and developedeclamptic seizures soon after scopolamine administration [see Warnings and Precautions(53)]
Animal Data
In animal reproduction studies when pregnant rats and rabbits received scopolaminehydrobromide by daily intravenous injection no adverse effects were observed in ratsAn embryotoxic effect was observed in rabbits at doses producing plasma levelsapproximately 100 times the levels achieved in humans using a transdermal systemScopolamine administered parenterally to rats and rabbits at doses higher than the dosedelivered by scopolamine transdermal system did not affect uterine contractions orincrease the duration of labor
82 LactationRisk SummaryScopolamine is present in human milk There are no available data on the effects ofscopolamine on the breastfed infant or the effects on milk production Because therehave been no consistent reports of adverse events in breastfed infants over decades ofuse the developmental and health benefits of breastfeeding should be considered alongwith the motherrsquos clinical need for scopolamine transdermal system and any potentialadverse effects on the breastfed child from scopolamine transdermal system or fromthe underlying maternal condition
84 Pediatric UseSafety and effectiveness in pediatric patients have not been established Pediatricpatients are particularly susceptible to the adverse reactions of scopolamine includingmydriasis hallucinations amblyopia and drug withdrawal syndrome Neurologic andpsychiatric adverse reactions such as hallucinations amblyopia and mydriasis have alsobeen reported
85 Geriatric UseClinical trials of scopolamine transdermal system did not include sufficient number ofsubjects aged 65 years and older to determine if they respond differently from youngersubjects In other clinical experience elderly patients had an increased risk of neurologicand psychiatric adverse reactions such as hallucinations confusion dizziness and drugwithdrawal syndrome [see Warnings and Precautions (52 55)] Consider morefrequent monitoring for CNS adverse reactions during treatment with scopolaminetransdermal system in elderly patients [see Warnings and Precautions (52)]
86 Renal or Hepatic ImpairmentScopolamine transdermal system has not been studied in patients with renal or hepaticimpairment Consider more frequent monitoring during treatment with scopolaminetransdermal system in patients with renal or hepatic impairment because of theincreased risk of CNS adverse reactions [see Warnings and Precautions (52)]
9 DRUG ABUSE AND DEPENDENCE
91 Controlled SubstanceScopolamine transdermal system contains scopolamine which is not a controlled
substance
93 DependenceTermination of scopolamine transdermal system usually after several days of use mayresult in withdrawal symptoms such as disturbances of equilibrium dizziness nauseavomiting abdominal cramps sweating headache mental confusion muscle weaknessbradycardia and hypotension These withdrawal symptoms indicate that scopolaminelike other anticholinergic drugs may produce physical dependence The onset of thesesymptoms generally 24 hours or more after the transdermal system has beenremoved can be severe and may require medical intervention [see Warnings andPrecautions (55)]
10 OVERDOSAGEThe signs and symptoms of anticholinergic toxicity include lethargy somnolence comaconfusion agitation hallucinations convulsion visual disturbance dry flushed skin drymouth decreased bowel sounds urinary retention tachycardia hypertension andsupraventricular arrhythmias These symptoms can be severe and may require medicalinterventionIn cases of toxicity remove the scopolamine transdermal system Serious symptomaticcases of overdosage involving multiple transdermal system applications andor ingestionmay be managed by initially ensuring the patient has an adequate airway and supportingrespiration and circulation This should be rapidly followed by removal of all transdermalsystems from the skin and the mouth If there is evidence of transdermal systemingestion endoscopic removal of swallowed transdermal systems or administration ofactivated charcoal should be considered as indicated by the clinical situation In anycase where there is serious overdosage or signs of evolving acute toxicity continuousmonitoring of vital signs and ECG establishment of intravenous access andadministration of oxygen are all recommendedThe signs and symptoms of overdosetoxicity due to scopolamine should be carefullydistinguished from the occasionally observed syndrome of withdrawal [see Warningsand Precautions (55)] Although mental confusion and dizziness may be observed withboth acute toxicity and withdrawal other characteristic findings differtachyarrhythmias dry skin and decreased bowel sounds suggest anticholinergictoxicity while bradycardia headache nausea and abdominal cramps and sweatingsuggest post-removal withdrawalIf over-exposure occurs call your Poison Control Center at 1-800-222-1222 for currentinformation on the management of poisoning or overdosage
11 DESCRIPTIONScopolamine transdermal system is designed for continuous release of scopolaminefollowing application to an area of intact skin on the head behind the ear Each systemcontains 13 mg of scopolamine base Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3310 ]nonan-7-yl) 3-hydroxy-2-phenylpropanoate The empirical formulais C H NO and its structural formula is
24
17 21 4
Scopolamine has a molecular weight of 30335 and a pKa of 755-781 The scopolaminetransdermal system is a circular 02 mm thick 25 cm film with four layers Proceedingfrom the visible surface towards the surface attached to the skin these layers are (1) abacking membrane of tan-colored aluminized polyester film (2) a drug layer ofscopolamine crospovidone isopropyl palmitate light mineral oil and polyisobutylene (3)an ethylene vinyl acetate copolymer membrane that controls the rate of delivery ofscopolamine from the system to the skin surface and (4) an contact layer formulationof crospovidone isopropyl palmitate light mineral oil polyisobutylene and scopolamineA release liner of siliconized polyester which covers the adhesive layer is removedbefore the system is usedCross section of the system
12 CLINICAL PHARMACOLOGY
121 Mechanism of ActionScopolamine a belladonna alkaloid is an anticholinergic Scopolamine acts i) as acompetitive inhibitor at postganglionic muscarinic receptor sites of the parasympatheticnervous system and ii) on smooth muscles that respond to acetylcholine but lackcholinergic innervation It has been suggested that scopolamine acts in the centralnervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei tohigher centers in the CNS and from the reticular formation to the vomiting centerScopolamine can inhibit the secretion of saliva and sweat decrease gastrointestinalsecretions and motility cause drowsiness dilate the pupils increase heart rate anddepress motor function
123 PharmacokineticsThe system is formulated to deliver approximately 1 mg of scopolamine to the systemiccirculation over 3 daysAbsorption
2
Following application to the skin behind the ear circulating plasma concentrations aredetected within 4 hours with peak concentrations being obtained on average within 24hours The average plasma concentration produced is 87 pgmL (028 nM) for freescopolamine and 354 pgmL for total scopolamine (free + conjugates) Followingremoval of the used transdermal system there is some degree of continued systemicabsorption of scopolamine bound in the skin layersDistribution The distribution of scopolamine is not well characterized It crosses the placenta and theblood brain barrier and may be reversibly bound to plasma proteinsEliminationMetabolism and Excretion Scopolamine is metabolized and conjugated with less than 5 of the total doseappearing unchanged in the urine The enzymes responsible for metabolizingscopolamine are unknown The exact elimination pattern of scopolamine has not beendetermined Following transdermal system removal plasma concentrations ofscopolamine decline in a log linear fashion with an observed half-life of 95 hours Lessthan 10 of the total dose is excreted in the urine as the parent drug and metabolitesover 108 hoursDrug Interaction StudiesAn in vitro study using human hepatocytes examined the induction of CYP1A2 andCYP3A4 by scopolamine Scopolamine did not induce CYP1A2 and CYP3A4 isoenzymesat the concentrations up to 10 nM In an in vitro study using human liver microsomeswhich evaluated the inhibition of CYP1A2 2C8 2C9 2C19 2D6 and 3A4 scopolaminedid not inhibit these cytochrome P450 isoenzymes at the concentrations up to 1micromolar No in vivo drug-drug interaction studies have been conducted
13 NONCLINICAL TOXICOLOGY
131 Carcinogenesis Mutagenesis Impairment of FertilityNo long-term studies in animals have been conducted to evaluate the carcinogenicpotential of scopolamine The mutagenic potential of scopolamine has not beenevaluatedFertility studies were performed in female rats and revealed no evidence of impairedfertility or harm to the fetus due to scopolamine hydrobromide administered by dailysubcutaneous injection Maternal body weights were reduced in the highest-dose group(plasma level approximately 500 times the level achieved in humans using a transdermalsystem) However fertility studies in male animals were not performed
14 CLINICAL STUDIES
141 Prevention of Motion SicknessIn 195 adult subjects of different racial origins who participated in clinical efficacy studiesat sea or in a controlled motion environment there was a 75 reduction in the incidenceof motion-induced nausea and vomiting Scopolamine transdermal system was applied
from 4 to 16 hours prior to the onset of motion in these studies
142 Prevention of Post-Operative Nausea and VomitingA clinical efficacy study evaluated 168 adult female patients undergoing gynecologicalsurgery with anesthesia and opiate analgesia Patients received scopolamine transdermalsystem or placebo applied approximately 11 hours before anesthesiaopiate analgesiaNo retchingvomiting during the 24-hour post-operative period was reported in 79 ofthose treated with scopolamine transdermal system compared to 72 of thosereceiving placebo When the need for additional antiemetic medication was assessedduring the same period there was no need for medication in 89 of patients treatedwith scopolamine transdermal system as compared to 72 of placebo-treated patients
16 HOW SUPPLIEDSTORAGE AND HANDLINGScopolamine Transdermal System 1 mg3 days is available as the following
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Store at 20degC to 25degC (68degF to 77degF) [see USP Controlled Room Temperature]Store pouch(es) in an upright positionDo not bend or roll pouch(es)Wash hands thoroughly with soap and water immediately after handling the transdermalsystem Upon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidental contactor ingestion by children pets or others [see Dosage and Administration (21) Warningsand Precautions (56)]
17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information andInstructions for Use)Administration InstructionsCounsel patients on how to apply and remove the transdermal system [see Dosage andAdministration (21)]
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Carton of 4 transdermal systems packaged into individual foil pouches NDC45802-580-84Carton of 10 transdermal systems packaged into individual foil pouches NDC45802-580-46Carton of 24 transdermal systems packaged into individual foil pouches NDC45802-580-62
Only wear one transdermal system at any timeDo not cut the transdermal systemApply the transdermal system to the skin in the postauricular (hairless area behindone ear) areaAfter the transdermal system is applied on the dry skin behind the ear wash handsthoroughly with soap and water and dry handsIf the transdermal system becomes displaced discard the transdermal system and
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Patients with Open-Angle GlaucomaAdvise patients with open-angle glaucoma to remove the scopolamine transdermalsystem immediately and contact their healthcare provider if they experience symptomsof acute angle closure glaucoma including pain and reddening of the eyes accompaniedby dilated pupils blurred vision andor seeing halos around lights [see Warnings andPrecautions (51)]Neuropsychiatric Adverse Reactions
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Decreased Gastrointestinal Motility and Urinary RetentionInstruct patients to remove the transdermal system if they develop symptoms ofintestinal obstruction (abdominal pain nausea or vomiting) or any difficulties in urinating[see Warnings and Precautions (54)]Drug WithdrawalPost-Removal SymptomsInform patients that if they remove the scopolamine transdermal system beforetreatment is complete withdrawal symptoms may occur and to seek immediate medicalcare if they develop severe symptoms after removing scopolamine transdermal system[see Warnings and Precautions (55)]Blurred VisionInform patients that temporary dilation of the pupils and blurred vision may occur ifscopolamine transdermal system comes in contact with the eyes Instruct patients towash their hands thoroughly with soap and water immediately after handling thetransdermal system [see Dosage and Administration (21) Warnings and Precautions(56)]MRI Skin BurnsInstruct patients to remove the scopolamine transdermal system before undergoing an
If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
Advise patients that psychiatric adverse reactions may occur especially in patientswith a past psychiatric history or in those receiving other drugs also associatedwith psychiatric effects and to report to their healthcare provider any new orworsening psychiatric symptomsAdvise patients to discontinue scopolamine transdermal system and contact ahealthcare provider immediately if they experience a seizureAdvise patients especially elderly patients that cognitive impairment may occurduring treatment with scopolamine transdermal system especially in thosereceiving other drugs also associated with CNS effects and to report to theirhealthcare provider if they develop signs or symptoms of cognitive impairmentsuch as hallucinations confusion or dizzinessInform patients not to operate motor vehicles or other dangerous machinery orparticipate in underwater sports until they are reasonably certain that scopolaminetransdermal system does not affect them adversely [see Warnings and Precautions(52)]
MRI [see Warnings and Precautions (57)]
Manufactured byAVEVA DRUG DELIVERY SYSTEMSAn APOTEX CompanyMiramar FL 33025Distributed ByPerrigoregAllegan MI 49010 wwwperrigocom5A800 RC BR7
Medication Guide
MEDICATION GUIDEScopolamine (skoe polrsquo a meen) Transdermal System
Read this Patient Information before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentWhat is scopolamine transdermal systemScopolamine transdermal system is a prescription medicine used for adults to helpprevent
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It is not known if scopolamine transdermal system is safe or effective in childrenWho should not use scopolamine transdermal systemDo not use Transderm Scōp if you
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What should I tell my doctor before using scopolamine transdermal systemBefore you use scopolamine transdermal system tell your doctor about all of yourmedical conditions including if you
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nausea and vomiting from motion sicknessnausea and vomiting from anesthesia or taking opioid pain medicines after surgery
have an eye problem called angle closure glaucomaare allergic to scopolamine belladonna alkaloids or any of the ingredients inscopolamine transdermal system See the end of this leaflet for a list of theingredients in scopolamine transdermal system Ask your doctor if you are notsure
have glaucoma (increased pressure in the eye)have a history of seizures or psychosishave problems with your stomach or intestineshave trouble urinatingare scheduled to have a gastric secretion testhave liver or kidney problemsare pregnant or plan to become pregnant It is not known if scopolamine
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Tell your doctor about all the medicines you take including prescription andover-the-counter medicines vitamins and herbal supplements Scopolamine transdermalsystem may affect the way other medicines work and other medicines may affect howscopolamine transdermal system works Medicines that you take by mouth may not beabsorbed well while you use scopolamine transdermal systemEspecially tell your doctor if you take
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Ask your doctor if you are not sure if your medicine is one that is listed aboveKnow the medicines you take Keep a list of them and show it to your doctor orpharmacist when you get a new medicineHow should I use scopolamine transdermal system
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What should I avoid while using scopolamine transdermal system
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What are the possible side effects of scopolamine transdermal systemScopolamine transdermal system may cause serious side effects including
transdermal system can harm your unborn babyare breastfeeding or plan to breastfeed Scopolamine can pass into your breastmilk and may harm your baby Talk to your doctor about the best way to feed yourbaby if you use scopolamine transdermal system
a sedative hypnotic opioid or anxiolytic (medicines that make you sleepy)an antidepressant medicinean anticholinergic medicine such as an allergy or cold medicine a medicine to treatbladder or bowel spasms certain asthma medicines or other medicines for motionsickness
See the detailed Instructions for Use for information about how to usescopolamine transdermal system at the end of this Patient Information leafletIt is important that you apply scopolamine transdermal system exactly as yourdoctor tells you toYour doctor may change your scopolamine transdermal system dose Do notchange your scopolamine transdermal system dose without talking to your doctorWear only one scopolamine transdermal system at any timeIf you use too much scopolamine transdermal system call your doctor or PoisonControl Center at 1-800-222-1222 or go to the nearest hospital emergency roomright away
You should not drink alcohol while using scopolamine transdermal system It canincrease your chances of having serious side effectsYou should not drive operate heavy machinery or do other dangerous activitiesuntil you know how scopolamine transdermal system affects youYou should not use scopolamine transdermal system during a Magnetic ResonanceImaging scan (MRI) Remove scopolamine transdermal system before undergoingan MRI It can cause your skin to burnYou should be careful if you use scopolamine transdermal system while youparticipate in watersports because you may feel lost or confused (disoriented)Limit contact with water while swimming and bathing because scopolaminetransdermal system may fall off If scopolamine transdermal system falls off throwit away and apply a new one on the hairless area behind your other ear
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The most common side effects of using scopolamine transdermal systeminclude
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Tell your doctor if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of scopolamine transdermal systemCall your doctor for medical advice about side effects You may report side effects toFDA at 1-800-FDA-1088General information about the safe and effective use of scopolaminetransdermal system
angle closure glaucoma If you have open angle glaucoma and use scopolaminetransdermal system remove scopolamine transdermal system and call a doctorright away if you feel pain or discomfort have blurred vision or see halos orcolored images around lights and reddening of your eyesworsening of seizures Tell your doctor about any worsening of seizures whileusing scopolamine transdermal systeman unusual reaction called acute psychosis Tell your doctor if you have anyof these symptoms
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confusionagitationrambling speechhallucinations (seeing or hearing things that are not there)paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy Some pregnant womenwith severe preeclampsia have had seizures after getting scopolamine by injectionin the muscle (intramuscular) or injection in the vein (intravenous)difficulty urinatingdifficulties in food passing from the stomach to the small intestineswhich may cause abdominal pain nausea or vomitingwithdrawal symptoms after removing scopolamine transdermal systemafter using it for several days Some people may have certain symptoms suchas difficulty with balance dizziness nausea vomiting stomach cramps sweatingconfusion muscle weakness low heart rate or low blood pressure that could start24 hours or more after removing scopolamine transdermal system Call yourdoctor right away if your symptoms become severetemporary increase in the size of your pupil and blurry vision especially ifscopolamine transdermal system comes in contact with your eyesskin burns at the site of scopolamine transdermal system This canhappen during a medical test called a Magnetic Resonance Imaging scan (MRI)Scopolamine transdermal system contains aluminum and should be removed fromyour skin before you have an MRI
dry mouth blurred vision oreye problems
feeling sleepy ordrowsy
disorientation(confusion)
dizziness feeling agitatedor irritable
pharyngitis(sore throat)
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
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To help prevent nausea and vomiting from motion sickness
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To help prevent nausea and vomiting after surgery
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How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
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Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
71 Drugs Causing Central Nervous System (CNS) Adverse Reactions72 Anticholinergic Drugs73 Oral Drugs Absorbed in the Stomach74 Interaction with Gastric Secretion Test
8 USE IN SPECIFIC POPULATIONS81 Pregnancy82 Lactation84 Pediatric Use85 Geriatric Use86 Renal or Hepatic Impairment
9 DRUG ABUSE AND DEPENDENCE91 Controlled Substance93 Dependence
10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY
121 Mechanism of Action123 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY131 Carcinogenesis Mutagenesis Impairment of Fertility
14 CLINICAL STUDIES141 Prevention of Motion Sickness142 Prevention of Post-Operative Nausea and Vomiting
16 HOW SUPPLIEDSTORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGEScopolamine transdermal system is indicated in adults for prevention of
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2 DOSAGE AND ADMINISTRATION
21 Important Application and Removal Instructions
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Sections or subsections omitted from the full prescribing information are not listed
nausea and vomiting associated with motion sicknesspost-operative nausea and vomiting (PONV) associated with recovery fromanesthesia andor opiate analgesia and surgery
Each scopolamine transdermal system is formulated to deliver in vivo approximately1 mg of scopolamine over 3 daysOnly wear one transdermal system at any timeDo not cut the transdermal systemApply the transdermal system to the skin in the postauricular area (hairless area
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22 Recommended Adult DosageMotion SicknessApply one scopolamine transdermal system to the hairless area behind one ear at least 4hours before the antiemetic effect is required ndash for use up to 3 days If therapy isrequired for longer than 3 days remove the first transdermal system and apply a newscopolamine transdermal system behind the other earPONVFor surgeries other than cesarean section Apply one scopolamine transdermal systemthe evening before scheduled surgery Remove the transdermal system 24 hoursfollowing surgery
3 DOSAGE FORMS AND STRENGTHSTransdermal system a circular flat tan-colored transdermal system imprinted withldquoSCOP 1 mg3 daysrdquo in a repeating pattern
4 CONTRAINDICATIONSScopolamine transdermal system is contraindicated in patients with
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5 WARNINGS AND PRECAUTIONS
51 Acute Angle Closure GlaucomaThe mydriatic effect of scopolamine may cause an increase in intraocular pressureresulting in acute angle closure glaucoma Monitor intraocular pressure in patients withopen angle glaucoma and adjust glaucoma therapy during scopolamine transdermalsystem use as needed Advise patients to immediately remove the transdermal systemand contact their healthcare provider if they experience symptoms of acute angleclosure glaucoma (eg eye pain or discomfort blurred vision visual halos or coloredimages in association with red eyes from conjunctival congestion and corneal edema)
behind one ear)After the transdermal system is applied on the dry skin behind the ear wash handsthoroughly with soap and water and dry hands [see Warnings and Precautions(56)]If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
angle closure glaucoma [see Warnings and Precautions (51)]hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient orcomponent in the formulation or delivery system Reactions have included rashgeneralized and erythema [see Adverse Reactions (62) Description (11)]
52 Neuropsychiatric Adverse ReactionsPsychiatric Adverse ReactionsScopolamine has been reported to exacerbate psychosis Other psychiatric reactionshave also been reported including acute toxic psychosis agitation speech disorderhallucinations paranoia and delusions [see Adverse Reactions (62)] Monitor patientsfor new or worsening psychiatric symptoms during treatment with scopolaminetransdermal system Also monitor patients for new or worsening psychiatric symptomsduring concomitant treatment with other drugs that are associated with similarpsychiatric effects [see Drug Interactions (71)]SeizuresSeizures and seizure-like activity have been reported in patients receiving scopolamineWeigh this potential risk against the benefits before prescribing scopolaminetransdermal system to patients with a history of seizures including those receiving anti-epileptic medication or who have risk factors that can lower the seizure thresholdCognitive Adverse ReactionsScopolamine can cause drowsiness disorientation and confusion Discontinuescopolamine transdermal system if signs or symptoms of cognitive impairment developElderly and pediatric patients may be more sensitive to the neurological and psychiatriceffects of scopolamine transdermal system Consider more frequent monitoring duringtreatment with scopolamine transdermal system in elderly patients [see Use in SpecificPopulations (85)] Scopolamine transdermal system is not approved for use in pediatricpatients [see Use in Specific Populations (84)]Hazardous ActivitiesScopolamine transdermal system may impair the mental andor physical abilities requiredfor the performance of hazardous tasks such as driving a motor vehicle operatingmachinery or participating in underwater sports Concomitant use of other drugs thatcause central nervous system (CNS) adverse reactions (eg alcohol sedativeshypnotics opiates and anxiolytics) or have anticholinergic properties (eg otherbelladonna alkaloids sedating antihistamines meclizine tricyclic antidepressants andmuscle relaxants) may increase this effect [see Drug Interactions (71)] Inform patientsnot to operate motor vehicles or other dangerous machinery or participate inunderwater sports until they are reasonably certain that scopolamine transdermalsystem does not affect them adversely
53 Eclamptic Seizures in Pregnant WomenEclamptic seizures have been reported in pregnant women with severe preeclampsiasoon after injection of intravenous and intramuscular scopolamine [see Use in SpecificPopulations (81)] Avoid use of scopolamine transdermal system in patients with severepreeclampsia
54 Gastrointestinal and Urinary DisordersScopolamine due to its anticholinergic properties can decrease gastrointestinal motilityand cause urinary retention Consider more frequent monitoring during treatment withscopolamine transdermal system in patients suspected of having intestinal obstructionpatients with pyloric obstruction or urinary bladder neck obstruction and patients
receiving other anticholinergic drugs [see Drug Interactions (72)] Discontinuescopolamine transdermal system in patients who develop difficulty in urination
55 Drug WithdrawalPost-Removal SymptomsDiscontinuation of scopolamine transdermal system usually after several days of usemay result in withdrawal symptoms such as disturbances of equilibrium dizzinessnausea vomiting abdominal cramps sweating headache mental confusion muscleweakness bradycardia and hypotension The onset of these symptoms is generally 24hours or more after the transdermal system has been removed Instruct patients toseek medical attention if they experience severe symptoms
56 Blurred VisionScopolamine can cause temporary dilation of the pupils resulting in blurred vision if itcomes in contact with the eyesAdvise patients to wash their hands thoroughly with soap and water and dry their handsimmediately after handling the transdermal system [see Dosage and Administration(21)]
57 Magnetic Resonance Imaging (MRI) Skin BurnsScopolamine transdermal system contains an aluminized membrane Skin burns havebeen reported at the application site in patients wearing an aluminized transdermalsystem during an MRI scan Remove scopolamine transdermal system beforeundergoing an MRI
6 ADVERSE REACTIONSThe following serious adverse reactions are described elsewhere in labeling
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61 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions adverse reactionrates observed in the clinical trials of a drug cannot be directly compared to rates in theclinical trials of another drug and may not reflect the rates observed in practiceMotion SicknessThe most common adverse reaction (approximately two thirds) was dry mouth Lesscommon adverse reactions included drowsiness (less than one sixth) blurred visionand dilation of the pupilsPONV
Acute Angle Closure Glaucoma [see Warnings and Precautions (51)]Neuropsychiatric Adverse Reactions [see Warnings and Precautions (52)]Eclamptic Seizures in Pregnant Women [see Warnings and Precautions (53)]Gastrointestinal and Urinary Disorders [see Warnings and Precautions (54)]Drug WithdrawalPost-Removal Symptoms [see Warnings and Precautions (55)]Blurred Vision [see Warnings and Precautions (56)]MRI Skin Burns [see Warnings and Precautions (57)]
Common adverse reactions occurring in at least 3 of patients in PONV clinical trialsare shown in Table 1
Scopolamine TransdermalSystem
(N = 461)
Placebo (N = 457)
Dry mouth 29 16Dizziness 12 7Somnolence 8 4Agitation 6 4Visual Impairment 5 3Confusion 4 3Mydriasis 4 0Pharyngitis 3 2
occurring in at least 3 of patients and at a rate higher than placebo
62 Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use ofscopolamine transdermal system Because these reactions are reported voluntarily froma population of uncertain size it is not always possible to reliably estimate theirfrequency or establish a causal relationship to drug exposurePsychiatric disorders acute psychosis including hallucinations disorientation andparanoiaNervous system disorders headache amnesia coordination abnormalities speechdisorder disturbance in attention restlessnessGeneral disorders and administration site conditions application site burningEye disorders dry eyes eye pruritus angle closure glaucoma amblyopia eyelid irritationSkin and subcutaneous tissue disorders rash generalized skin irritation erythemaRenal and urinary disorders dysuriaEar and labyrinth disorders vertigo
7 DRUG INTERACTIONS
71 Drugs Causing Central Nervous System (CNS) Adverse ReactionsThe concurrent use of scopolamine transdermal system with other drugs that causeCNS adverse reactions of drowsiness dizziness or disorientation (eg sedativeshypnotics opiates anxiolytics and alcohol) or have anticholinergic properties (eg otherbelladonna alkaloids sedating antihistamines meclizine tricyclic antidepressants andmuscle relaxants) may potentiate the effects of scopolamine transdermal system [seeWarnings and Precautions (52)] Either scopolamine transdermal system or theinteracting drug should be chosen depending on the importance of the drug to thepatient If the interacting drug cannot be avoided monitor patients for CNS adverse
reactions
72 Anticholinergic DrugsConcomitant use of scopolamine with other drugs having anticholinergic properties mayincrease the risk of CNS adverse reactions [see Drug Interactions (71)] intestinalobstruction andor urinary retention Consider more frequent monitoring duringtreatment with scopolamine transdermal system in patients receiving anticholinergicdrugs [see Warnings and Precautions (52 54)]
73 Oral Drugs Absorbed in the StomachScopolamine transdermal system as an anticholinergic may delay gastric and uppergastrointestinal motility and therefore the rate of absorption of other orallyadministered drugs Monitor patients for modified therapeutic effect of concomitantorally administered drugs with a narrow therapeutic index
74 Interaction with Gastric Secretion TestScopolamine will interfere with the gastric secretion test Discontinue scopolaminetransdermal system 10 days prior to testing
8 USE IN SPECIFIC POPULATIONS
81 PregnancyRisk SummaryAvailable data from observational studies and postmarketing reports with scopolamineuse in pregnant women have not identified a drug associated risk of major birth defectsmiscarriage or adverse fetal outcomes Avoid use of scopolamine transdermal systemin pregnant women with severe preeclampsia because eclamptic seizures have beenreported after exposure to scopolamine (see Data)
In animal studies there was no evidence of adverse developmental effects withintravenous administration of scopolamine hydrobromide revealed in ratsEmbryotoxicity was observed in rabbits at intravenous doses producing plasma levelsapproximately 100 times the levels achieved in humans using a transdermal systemThe estimated background risk of major birth defects and miscarriage for the indicatedpopulation is unknown All pregnancies have a background risk of birth defect loss orother adverse outcomes In the US general population the background risk of majorbirth defects and miscarriage in clinically recognized pregnancies is 2 to 4 and 15to 20 respectivelyDataHuman Data
Eclamptic Seizures In published case reports two pregnant patients with severe preeclampsia wereadministered intravenous and intramuscular scopolamine respectively and developedeclamptic seizures soon after scopolamine administration [see Warnings and Precautions(53)]
Animal Data
In animal reproduction studies when pregnant rats and rabbits received scopolaminehydrobromide by daily intravenous injection no adverse effects were observed in ratsAn embryotoxic effect was observed in rabbits at doses producing plasma levelsapproximately 100 times the levels achieved in humans using a transdermal systemScopolamine administered parenterally to rats and rabbits at doses higher than the dosedelivered by scopolamine transdermal system did not affect uterine contractions orincrease the duration of labor
82 LactationRisk SummaryScopolamine is present in human milk There are no available data on the effects ofscopolamine on the breastfed infant or the effects on milk production Because therehave been no consistent reports of adverse events in breastfed infants over decades ofuse the developmental and health benefits of breastfeeding should be considered alongwith the motherrsquos clinical need for scopolamine transdermal system and any potentialadverse effects on the breastfed child from scopolamine transdermal system or fromthe underlying maternal condition
84 Pediatric UseSafety and effectiveness in pediatric patients have not been established Pediatricpatients are particularly susceptible to the adverse reactions of scopolamine includingmydriasis hallucinations amblyopia and drug withdrawal syndrome Neurologic andpsychiatric adverse reactions such as hallucinations amblyopia and mydriasis have alsobeen reported
85 Geriatric UseClinical trials of scopolamine transdermal system did not include sufficient number ofsubjects aged 65 years and older to determine if they respond differently from youngersubjects In other clinical experience elderly patients had an increased risk of neurologicand psychiatric adverse reactions such as hallucinations confusion dizziness and drugwithdrawal syndrome [see Warnings and Precautions (52 55)] Consider morefrequent monitoring for CNS adverse reactions during treatment with scopolaminetransdermal system in elderly patients [see Warnings and Precautions (52)]
86 Renal or Hepatic ImpairmentScopolamine transdermal system has not been studied in patients with renal or hepaticimpairment Consider more frequent monitoring during treatment with scopolaminetransdermal system in patients with renal or hepatic impairment because of theincreased risk of CNS adverse reactions [see Warnings and Precautions (52)]
9 DRUG ABUSE AND DEPENDENCE
91 Controlled SubstanceScopolamine transdermal system contains scopolamine which is not a controlled
substance
93 DependenceTermination of scopolamine transdermal system usually after several days of use mayresult in withdrawal symptoms such as disturbances of equilibrium dizziness nauseavomiting abdominal cramps sweating headache mental confusion muscle weaknessbradycardia and hypotension These withdrawal symptoms indicate that scopolaminelike other anticholinergic drugs may produce physical dependence The onset of thesesymptoms generally 24 hours or more after the transdermal system has beenremoved can be severe and may require medical intervention [see Warnings andPrecautions (55)]
10 OVERDOSAGEThe signs and symptoms of anticholinergic toxicity include lethargy somnolence comaconfusion agitation hallucinations convulsion visual disturbance dry flushed skin drymouth decreased bowel sounds urinary retention tachycardia hypertension andsupraventricular arrhythmias These symptoms can be severe and may require medicalinterventionIn cases of toxicity remove the scopolamine transdermal system Serious symptomaticcases of overdosage involving multiple transdermal system applications andor ingestionmay be managed by initially ensuring the patient has an adequate airway and supportingrespiration and circulation This should be rapidly followed by removal of all transdermalsystems from the skin and the mouth If there is evidence of transdermal systemingestion endoscopic removal of swallowed transdermal systems or administration ofactivated charcoal should be considered as indicated by the clinical situation In anycase where there is serious overdosage or signs of evolving acute toxicity continuousmonitoring of vital signs and ECG establishment of intravenous access andadministration of oxygen are all recommendedThe signs and symptoms of overdosetoxicity due to scopolamine should be carefullydistinguished from the occasionally observed syndrome of withdrawal [see Warningsand Precautions (55)] Although mental confusion and dizziness may be observed withboth acute toxicity and withdrawal other characteristic findings differtachyarrhythmias dry skin and decreased bowel sounds suggest anticholinergictoxicity while bradycardia headache nausea and abdominal cramps and sweatingsuggest post-removal withdrawalIf over-exposure occurs call your Poison Control Center at 1-800-222-1222 for currentinformation on the management of poisoning or overdosage
11 DESCRIPTIONScopolamine transdermal system is designed for continuous release of scopolaminefollowing application to an area of intact skin on the head behind the ear Each systemcontains 13 mg of scopolamine base Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3310 ]nonan-7-yl) 3-hydroxy-2-phenylpropanoate The empirical formulais C H NO and its structural formula is
24
17 21 4
Scopolamine has a molecular weight of 30335 and a pKa of 755-781 The scopolaminetransdermal system is a circular 02 mm thick 25 cm film with four layers Proceedingfrom the visible surface towards the surface attached to the skin these layers are (1) abacking membrane of tan-colored aluminized polyester film (2) a drug layer ofscopolamine crospovidone isopropyl palmitate light mineral oil and polyisobutylene (3)an ethylene vinyl acetate copolymer membrane that controls the rate of delivery ofscopolamine from the system to the skin surface and (4) an contact layer formulationof crospovidone isopropyl palmitate light mineral oil polyisobutylene and scopolamineA release liner of siliconized polyester which covers the adhesive layer is removedbefore the system is usedCross section of the system
12 CLINICAL PHARMACOLOGY
121 Mechanism of ActionScopolamine a belladonna alkaloid is an anticholinergic Scopolamine acts i) as acompetitive inhibitor at postganglionic muscarinic receptor sites of the parasympatheticnervous system and ii) on smooth muscles that respond to acetylcholine but lackcholinergic innervation It has been suggested that scopolamine acts in the centralnervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei tohigher centers in the CNS and from the reticular formation to the vomiting centerScopolamine can inhibit the secretion of saliva and sweat decrease gastrointestinalsecretions and motility cause drowsiness dilate the pupils increase heart rate anddepress motor function
123 PharmacokineticsThe system is formulated to deliver approximately 1 mg of scopolamine to the systemiccirculation over 3 daysAbsorption
2
Following application to the skin behind the ear circulating plasma concentrations aredetected within 4 hours with peak concentrations being obtained on average within 24hours The average plasma concentration produced is 87 pgmL (028 nM) for freescopolamine and 354 pgmL for total scopolamine (free + conjugates) Followingremoval of the used transdermal system there is some degree of continued systemicabsorption of scopolamine bound in the skin layersDistribution The distribution of scopolamine is not well characterized It crosses the placenta and theblood brain barrier and may be reversibly bound to plasma proteinsEliminationMetabolism and Excretion Scopolamine is metabolized and conjugated with less than 5 of the total doseappearing unchanged in the urine The enzymes responsible for metabolizingscopolamine are unknown The exact elimination pattern of scopolamine has not beendetermined Following transdermal system removal plasma concentrations ofscopolamine decline in a log linear fashion with an observed half-life of 95 hours Lessthan 10 of the total dose is excreted in the urine as the parent drug and metabolitesover 108 hoursDrug Interaction StudiesAn in vitro study using human hepatocytes examined the induction of CYP1A2 andCYP3A4 by scopolamine Scopolamine did not induce CYP1A2 and CYP3A4 isoenzymesat the concentrations up to 10 nM In an in vitro study using human liver microsomeswhich evaluated the inhibition of CYP1A2 2C8 2C9 2C19 2D6 and 3A4 scopolaminedid not inhibit these cytochrome P450 isoenzymes at the concentrations up to 1micromolar No in vivo drug-drug interaction studies have been conducted
13 NONCLINICAL TOXICOLOGY
131 Carcinogenesis Mutagenesis Impairment of FertilityNo long-term studies in animals have been conducted to evaluate the carcinogenicpotential of scopolamine The mutagenic potential of scopolamine has not beenevaluatedFertility studies were performed in female rats and revealed no evidence of impairedfertility or harm to the fetus due to scopolamine hydrobromide administered by dailysubcutaneous injection Maternal body weights were reduced in the highest-dose group(plasma level approximately 500 times the level achieved in humans using a transdermalsystem) However fertility studies in male animals were not performed
14 CLINICAL STUDIES
141 Prevention of Motion SicknessIn 195 adult subjects of different racial origins who participated in clinical efficacy studiesat sea or in a controlled motion environment there was a 75 reduction in the incidenceof motion-induced nausea and vomiting Scopolamine transdermal system was applied
from 4 to 16 hours prior to the onset of motion in these studies
142 Prevention of Post-Operative Nausea and VomitingA clinical efficacy study evaluated 168 adult female patients undergoing gynecologicalsurgery with anesthesia and opiate analgesia Patients received scopolamine transdermalsystem or placebo applied approximately 11 hours before anesthesiaopiate analgesiaNo retchingvomiting during the 24-hour post-operative period was reported in 79 ofthose treated with scopolamine transdermal system compared to 72 of thosereceiving placebo When the need for additional antiemetic medication was assessedduring the same period there was no need for medication in 89 of patients treatedwith scopolamine transdermal system as compared to 72 of placebo-treated patients
16 HOW SUPPLIEDSTORAGE AND HANDLINGScopolamine Transdermal System 1 mg3 days is available as the following
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Store at 20degC to 25degC (68degF to 77degF) [see USP Controlled Room Temperature]Store pouch(es) in an upright positionDo not bend or roll pouch(es)Wash hands thoroughly with soap and water immediately after handling the transdermalsystem Upon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidental contactor ingestion by children pets or others [see Dosage and Administration (21) Warningsand Precautions (56)]
17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information andInstructions for Use)Administration InstructionsCounsel patients on how to apply and remove the transdermal system [see Dosage andAdministration (21)]
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Carton of 4 transdermal systems packaged into individual foil pouches NDC45802-580-84Carton of 10 transdermal systems packaged into individual foil pouches NDC45802-580-46Carton of 24 transdermal systems packaged into individual foil pouches NDC45802-580-62
Only wear one transdermal system at any timeDo not cut the transdermal systemApply the transdermal system to the skin in the postauricular (hairless area behindone ear) areaAfter the transdermal system is applied on the dry skin behind the ear wash handsthoroughly with soap and water and dry handsIf the transdermal system becomes displaced discard the transdermal system and
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Patients with Open-Angle GlaucomaAdvise patients with open-angle glaucoma to remove the scopolamine transdermalsystem immediately and contact their healthcare provider if they experience symptomsof acute angle closure glaucoma including pain and reddening of the eyes accompaniedby dilated pupils blurred vision andor seeing halos around lights [see Warnings andPrecautions (51)]Neuropsychiatric Adverse Reactions
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Decreased Gastrointestinal Motility and Urinary RetentionInstruct patients to remove the transdermal system if they develop symptoms ofintestinal obstruction (abdominal pain nausea or vomiting) or any difficulties in urinating[see Warnings and Precautions (54)]Drug WithdrawalPost-Removal SymptomsInform patients that if they remove the scopolamine transdermal system beforetreatment is complete withdrawal symptoms may occur and to seek immediate medicalcare if they develop severe symptoms after removing scopolamine transdermal system[see Warnings and Precautions (55)]Blurred VisionInform patients that temporary dilation of the pupils and blurred vision may occur ifscopolamine transdermal system comes in contact with the eyes Instruct patients towash their hands thoroughly with soap and water immediately after handling thetransdermal system [see Dosage and Administration (21) Warnings and Precautions(56)]MRI Skin BurnsInstruct patients to remove the scopolamine transdermal system before undergoing an
If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
Advise patients that psychiatric adverse reactions may occur especially in patientswith a past psychiatric history or in those receiving other drugs also associatedwith psychiatric effects and to report to their healthcare provider any new orworsening psychiatric symptomsAdvise patients to discontinue scopolamine transdermal system and contact ahealthcare provider immediately if they experience a seizureAdvise patients especially elderly patients that cognitive impairment may occurduring treatment with scopolamine transdermal system especially in thosereceiving other drugs also associated with CNS effects and to report to theirhealthcare provider if they develop signs or symptoms of cognitive impairmentsuch as hallucinations confusion or dizzinessInform patients not to operate motor vehicles or other dangerous machinery orparticipate in underwater sports until they are reasonably certain that scopolaminetransdermal system does not affect them adversely [see Warnings and Precautions(52)]
MRI [see Warnings and Precautions (57)]
Manufactured byAVEVA DRUG DELIVERY SYSTEMSAn APOTEX CompanyMiramar FL 33025Distributed ByPerrigoregAllegan MI 49010 wwwperrigocom5A800 RC BR7
Medication Guide
MEDICATION GUIDEScopolamine (skoe polrsquo a meen) Transdermal System
Read this Patient Information before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentWhat is scopolamine transdermal systemScopolamine transdermal system is a prescription medicine used for adults to helpprevent
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It is not known if scopolamine transdermal system is safe or effective in childrenWho should not use scopolamine transdermal systemDo not use Transderm Scōp if you
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What should I tell my doctor before using scopolamine transdermal systemBefore you use scopolamine transdermal system tell your doctor about all of yourmedical conditions including if you
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nausea and vomiting from motion sicknessnausea and vomiting from anesthesia or taking opioid pain medicines after surgery
have an eye problem called angle closure glaucomaare allergic to scopolamine belladonna alkaloids or any of the ingredients inscopolamine transdermal system See the end of this leaflet for a list of theingredients in scopolamine transdermal system Ask your doctor if you are notsure
have glaucoma (increased pressure in the eye)have a history of seizures or psychosishave problems with your stomach or intestineshave trouble urinatingare scheduled to have a gastric secretion testhave liver or kidney problemsare pregnant or plan to become pregnant It is not known if scopolamine
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Tell your doctor about all the medicines you take including prescription andover-the-counter medicines vitamins and herbal supplements Scopolamine transdermalsystem may affect the way other medicines work and other medicines may affect howscopolamine transdermal system works Medicines that you take by mouth may not beabsorbed well while you use scopolamine transdermal systemEspecially tell your doctor if you take
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Ask your doctor if you are not sure if your medicine is one that is listed aboveKnow the medicines you take Keep a list of them and show it to your doctor orpharmacist when you get a new medicineHow should I use scopolamine transdermal system
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What should I avoid while using scopolamine transdermal system
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What are the possible side effects of scopolamine transdermal systemScopolamine transdermal system may cause serious side effects including
transdermal system can harm your unborn babyare breastfeeding or plan to breastfeed Scopolamine can pass into your breastmilk and may harm your baby Talk to your doctor about the best way to feed yourbaby if you use scopolamine transdermal system
a sedative hypnotic opioid or anxiolytic (medicines that make you sleepy)an antidepressant medicinean anticholinergic medicine such as an allergy or cold medicine a medicine to treatbladder or bowel spasms certain asthma medicines or other medicines for motionsickness
See the detailed Instructions for Use for information about how to usescopolamine transdermal system at the end of this Patient Information leafletIt is important that you apply scopolamine transdermal system exactly as yourdoctor tells you toYour doctor may change your scopolamine transdermal system dose Do notchange your scopolamine transdermal system dose without talking to your doctorWear only one scopolamine transdermal system at any timeIf you use too much scopolamine transdermal system call your doctor or PoisonControl Center at 1-800-222-1222 or go to the nearest hospital emergency roomright away
You should not drink alcohol while using scopolamine transdermal system It canincrease your chances of having serious side effectsYou should not drive operate heavy machinery or do other dangerous activitiesuntil you know how scopolamine transdermal system affects youYou should not use scopolamine transdermal system during a Magnetic ResonanceImaging scan (MRI) Remove scopolamine transdermal system before undergoingan MRI It can cause your skin to burnYou should be careful if you use scopolamine transdermal system while youparticipate in watersports because you may feel lost or confused (disoriented)Limit contact with water while swimming and bathing because scopolaminetransdermal system may fall off If scopolamine transdermal system falls off throwit away and apply a new one on the hairless area behind your other ear
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The most common side effects of using scopolamine transdermal systeminclude
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Tell your doctor if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of scopolamine transdermal systemCall your doctor for medical advice about side effects You may report side effects toFDA at 1-800-FDA-1088General information about the safe and effective use of scopolaminetransdermal system
angle closure glaucoma If you have open angle glaucoma and use scopolaminetransdermal system remove scopolamine transdermal system and call a doctorright away if you feel pain or discomfort have blurred vision or see halos orcolored images around lights and reddening of your eyesworsening of seizures Tell your doctor about any worsening of seizures whileusing scopolamine transdermal systeman unusual reaction called acute psychosis Tell your doctor if you have anyof these symptoms
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confusionagitationrambling speechhallucinations (seeing or hearing things that are not there)paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy Some pregnant womenwith severe preeclampsia have had seizures after getting scopolamine by injectionin the muscle (intramuscular) or injection in the vein (intravenous)difficulty urinatingdifficulties in food passing from the stomach to the small intestineswhich may cause abdominal pain nausea or vomitingwithdrawal symptoms after removing scopolamine transdermal systemafter using it for several days Some people may have certain symptoms suchas difficulty with balance dizziness nausea vomiting stomach cramps sweatingconfusion muscle weakness low heart rate or low blood pressure that could start24 hours or more after removing scopolamine transdermal system Call yourdoctor right away if your symptoms become severetemporary increase in the size of your pupil and blurry vision especially ifscopolamine transdermal system comes in contact with your eyesskin burns at the site of scopolamine transdermal system This canhappen during a medical test called a Magnetic Resonance Imaging scan (MRI)Scopolamine transdermal system contains aluminum and should be removed fromyour skin before you have an MRI
dry mouth blurred vision oreye problems
feeling sleepy ordrowsy
disorientation(confusion)
dizziness feeling agitatedor irritable
pharyngitis(sore throat)
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
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To help prevent nausea and vomiting from motion sickness
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To help prevent nausea and vomiting after surgery
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How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
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Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
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22 Recommended Adult DosageMotion SicknessApply one scopolamine transdermal system to the hairless area behind one ear at least 4hours before the antiemetic effect is required ndash for use up to 3 days If therapy isrequired for longer than 3 days remove the first transdermal system and apply a newscopolamine transdermal system behind the other earPONVFor surgeries other than cesarean section Apply one scopolamine transdermal systemthe evening before scheduled surgery Remove the transdermal system 24 hoursfollowing surgery
3 DOSAGE FORMS AND STRENGTHSTransdermal system a circular flat tan-colored transdermal system imprinted withldquoSCOP 1 mg3 daysrdquo in a repeating pattern
4 CONTRAINDICATIONSScopolamine transdermal system is contraindicated in patients with
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5 WARNINGS AND PRECAUTIONS
51 Acute Angle Closure GlaucomaThe mydriatic effect of scopolamine may cause an increase in intraocular pressureresulting in acute angle closure glaucoma Monitor intraocular pressure in patients withopen angle glaucoma and adjust glaucoma therapy during scopolamine transdermalsystem use as needed Advise patients to immediately remove the transdermal systemand contact their healthcare provider if they experience symptoms of acute angleclosure glaucoma (eg eye pain or discomfort blurred vision visual halos or coloredimages in association with red eyes from conjunctival congestion and corneal edema)
behind one ear)After the transdermal system is applied on the dry skin behind the ear wash handsthoroughly with soap and water and dry hands [see Warnings and Precautions(56)]If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
angle closure glaucoma [see Warnings and Precautions (51)]hypersensitivity to scopolamine or other belladonna alkaloids or to any ingredient orcomponent in the formulation or delivery system Reactions have included rashgeneralized and erythema [see Adverse Reactions (62) Description (11)]
52 Neuropsychiatric Adverse ReactionsPsychiatric Adverse ReactionsScopolamine has been reported to exacerbate psychosis Other psychiatric reactionshave also been reported including acute toxic psychosis agitation speech disorderhallucinations paranoia and delusions [see Adverse Reactions (62)] Monitor patientsfor new or worsening psychiatric symptoms during treatment with scopolaminetransdermal system Also monitor patients for new or worsening psychiatric symptomsduring concomitant treatment with other drugs that are associated with similarpsychiatric effects [see Drug Interactions (71)]SeizuresSeizures and seizure-like activity have been reported in patients receiving scopolamineWeigh this potential risk against the benefits before prescribing scopolaminetransdermal system to patients with a history of seizures including those receiving anti-epileptic medication or who have risk factors that can lower the seizure thresholdCognitive Adverse ReactionsScopolamine can cause drowsiness disorientation and confusion Discontinuescopolamine transdermal system if signs or symptoms of cognitive impairment developElderly and pediatric patients may be more sensitive to the neurological and psychiatriceffects of scopolamine transdermal system Consider more frequent monitoring duringtreatment with scopolamine transdermal system in elderly patients [see Use in SpecificPopulations (85)] Scopolamine transdermal system is not approved for use in pediatricpatients [see Use in Specific Populations (84)]Hazardous ActivitiesScopolamine transdermal system may impair the mental andor physical abilities requiredfor the performance of hazardous tasks such as driving a motor vehicle operatingmachinery or participating in underwater sports Concomitant use of other drugs thatcause central nervous system (CNS) adverse reactions (eg alcohol sedativeshypnotics opiates and anxiolytics) or have anticholinergic properties (eg otherbelladonna alkaloids sedating antihistamines meclizine tricyclic antidepressants andmuscle relaxants) may increase this effect [see Drug Interactions (71)] Inform patientsnot to operate motor vehicles or other dangerous machinery or participate inunderwater sports until they are reasonably certain that scopolamine transdermalsystem does not affect them adversely
53 Eclamptic Seizures in Pregnant WomenEclamptic seizures have been reported in pregnant women with severe preeclampsiasoon after injection of intravenous and intramuscular scopolamine [see Use in SpecificPopulations (81)] Avoid use of scopolamine transdermal system in patients with severepreeclampsia
54 Gastrointestinal and Urinary DisordersScopolamine due to its anticholinergic properties can decrease gastrointestinal motilityand cause urinary retention Consider more frequent monitoring during treatment withscopolamine transdermal system in patients suspected of having intestinal obstructionpatients with pyloric obstruction or urinary bladder neck obstruction and patients
receiving other anticholinergic drugs [see Drug Interactions (72)] Discontinuescopolamine transdermal system in patients who develop difficulty in urination
55 Drug WithdrawalPost-Removal SymptomsDiscontinuation of scopolamine transdermal system usually after several days of usemay result in withdrawal symptoms such as disturbances of equilibrium dizzinessnausea vomiting abdominal cramps sweating headache mental confusion muscleweakness bradycardia and hypotension The onset of these symptoms is generally 24hours or more after the transdermal system has been removed Instruct patients toseek medical attention if they experience severe symptoms
56 Blurred VisionScopolamine can cause temporary dilation of the pupils resulting in blurred vision if itcomes in contact with the eyesAdvise patients to wash their hands thoroughly with soap and water and dry their handsimmediately after handling the transdermal system [see Dosage and Administration(21)]
57 Magnetic Resonance Imaging (MRI) Skin BurnsScopolamine transdermal system contains an aluminized membrane Skin burns havebeen reported at the application site in patients wearing an aluminized transdermalsystem during an MRI scan Remove scopolamine transdermal system beforeundergoing an MRI
6 ADVERSE REACTIONSThe following serious adverse reactions are described elsewhere in labeling
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61 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions adverse reactionrates observed in the clinical trials of a drug cannot be directly compared to rates in theclinical trials of another drug and may not reflect the rates observed in practiceMotion SicknessThe most common adverse reaction (approximately two thirds) was dry mouth Lesscommon adverse reactions included drowsiness (less than one sixth) blurred visionand dilation of the pupilsPONV
Acute Angle Closure Glaucoma [see Warnings and Precautions (51)]Neuropsychiatric Adverse Reactions [see Warnings and Precautions (52)]Eclamptic Seizures in Pregnant Women [see Warnings and Precautions (53)]Gastrointestinal and Urinary Disorders [see Warnings and Precautions (54)]Drug WithdrawalPost-Removal Symptoms [see Warnings and Precautions (55)]Blurred Vision [see Warnings and Precautions (56)]MRI Skin Burns [see Warnings and Precautions (57)]
Common adverse reactions occurring in at least 3 of patients in PONV clinical trialsare shown in Table 1
Scopolamine TransdermalSystem
(N = 461)
Placebo (N = 457)
Dry mouth 29 16Dizziness 12 7Somnolence 8 4Agitation 6 4Visual Impairment 5 3Confusion 4 3Mydriasis 4 0Pharyngitis 3 2
occurring in at least 3 of patients and at a rate higher than placebo
62 Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use ofscopolamine transdermal system Because these reactions are reported voluntarily froma population of uncertain size it is not always possible to reliably estimate theirfrequency or establish a causal relationship to drug exposurePsychiatric disorders acute psychosis including hallucinations disorientation andparanoiaNervous system disorders headache amnesia coordination abnormalities speechdisorder disturbance in attention restlessnessGeneral disorders and administration site conditions application site burningEye disorders dry eyes eye pruritus angle closure glaucoma amblyopia eyelid irritationSkin and subcutaneous tissue disorders rash generalized skin irritation erythemaRenal and urinary disorders dysuriaEar and labyrinth disorders vertigo
7 DRUG INTERACTIONS
71 Drugs Causing Central Nervous System (CNS) Adverse ReactionsThe concurrent use of scopolamine transdermal system with other drugs that causeCNS adverse reactions of drowsiness dizziness or disorientation (eg sedativeshypnotics opiates anxiolytics and alcohol) or have anticholinergic properties (eg otherbelladonna alkaloids sedating antihistamines meclizine tricyclic antidepressants andmuscle relaxants) may potentiate the effects of scopolamine transdermal system [seeWarnings and Precautions (52)] Either scopolamine transdermal system or theinteracting drug should be chosen depending on the importance of the drug to thepatient If the interacting drug cannot be avoided monitor patients for CNS adverse
reactions
72 Anticholinergic DrugsConcomitant use of scopolamine with other drugs having anticholinergic properties mayincrease the risk of CNS adverse reactions [see Drug Interactions (71)] intestinalobstruction andor urinary retention Consider more frequent monitoring duringtreatment with scopolamine transdermal system in patients receiving anticholinergicdrugs [see Warnings and Precautions (52 54)]
73 Oral Drugs Absorbed in the StomachScopolamine transdermal system as an anticholinergic may delay gastric and uppergastrointestinal motility and therefore the rate of absorption of other orallyadministered drugs Monitor patients for modified therapeutic effect of concomitantorally administered drugs with a narrow therapeutic index
74 Interaction with Gastric Secretion TestScopolamine will interfere with the gastric secretion test Discontinue scopolaminetransdermal system 10 days prior to testing
8 USE IN SPECIFIC POPULATIONS
81 PregnancyRisk SummaryAvailable data from observational studies and postmarketing reports with scopolamineuse in pregnant women have not identified a drug associated risk of major birth defectsmiscarriage or adverse fetal outcomes Avoid use of scopolamine transdermal systemin pregnant women with severe preeclampsia because eclamptic seizures have beenreported after exposure to scopolamine (see Data)
In animal studies there was no evidence of adverse developmental effects withintravenous administration of scopolamine hydrobromide revealed in ratsEmbryotoxicity was observed in rabbits at intravenous doses producing plasma levelsapproximately 100 times the levels achieved in humans using a transdermal systemThe estimated background risk of major birth defects and miscarriage for the indicatedpopulation is unknown All pregnancies have a background risk of birth defect loss orother adverse outcomes In the US general population the background risk of majorbirth defects and miscarriage in clinically recognized pregnancies is 2 to 4 and 15to 20 respectivelyDataHuman Data
Eclamptic Seizures In published case reports two pregnant patients with severe preeclampsia wereadministered intravenous and intramuscular scopolamine respectively and developedeclamptic seizures soon after scopolamine administration [see Warnings and Precautions(53)]
Animal Data
In animal reproduction studies when pregnant rats and rabbits received scopolaminehydrobromide by daily intravenous injection no adverse effects were observed in ratsAn embryotoxic effect was observed in rabbits at doses producing plasma levelsapproximately 100 times the levels achieved in humans using a transdermal systemScopolamine administered parenterally to rats and rabbits at doses higher than the dosedelivered by scopolamine transdermal system did not affect uterine contractions orincrease the duration of labor
82 LactationRisk SummaryScopolamine is present in human milk There are no available data on the effects ofscopolamine on the breastfed infant or the effects on milk production Because therehave been no consistent reports of adverse events in breastfed infants over decades ofuse the developmental and health benefits of breastfeeding should be considered alongwith the motherrsquos clinical need for scopolamine transdermal system and any potentialadverse effects on the breastfed child from scopolamine transdermal system or fromthe underlying maternal condition
84 Pediatric UseSafety and effectiveness in pediatric patients have not been established Pediatricpatients are particularly susceptible to the adverse reactions of scopolamine includingmydriasis hallucinations amblyopia and drug withdrawal syndrome Neurologic andpsychiatric adverse reactions such as hallucinations amblyopia and mydriasis have alsobeen reported
85 Geriatric UseClinical trials of scopolamine transdermal system did not include sufficient number ofsubjects aged 65 years and older to determine if they respond differently from youngersubjects In other clinical experience elderly patients had an increased risk of neurologicand psychiatric adverse reactions such as hallucinations confusion dizziness and drugwithdrawal syndrome [see Warnings and Precautions (52 55)] Consider morefrequent monitoring for CNS adverse reactions during treatment with scopolaminetransdermal system in elderly patients [see Warnings and Precautions (52)]
86 Renal or Hepatic ImpairmentScopolamine transdermal system has not been studied in patients with renal or hepaticimpairment Consider more frequent monitoring during treatment with scopolaminetransdermal system in patients with renal or hepatic impairment because of theincreased risk of CNS adverse reactions [see Warnings and Precautions (52)]
9 DRUG ABUSE AND DEPENDENCE
91 Controlled SubstanceScopolamine transdermal system contains scopolamine which is not a controlled
substance
93 DependenceTermination of scopolamine transdermal system usually after several days of use mayresult in withdrawal symptoms such as disturbances of equilibrium dizziness nauseavomiting abdominal cramps sweating headache mental confusion muscle weaknessbradycardia and hypotension These withdrawal symptoms indicate that scopolaminelike other anticholinergic drugs may produce physical dependence The onset of thesesymptoms generally 24 hours or more after the transdermal system has beenremoved can be severe and may require medical intervention [see Warnings andPrecautions (55)]
10 OVERDOSAGEThe signs and symptoms of anticholinergic toxicity include lethargy somnolence comaconfusion agitation hallucinations convulsion visual disturbance dry flushed skin drymouth decreased bowel sounds urinary retention tachycardia hypertension andsupraventricular arrhythmias These symptoms can be severe and may require medicalinterventionIn cases of toxicity remove the scopolamine transdermal system Serious symptomaticcases of overdosage involving multiple transdermal system applications andor ingestionmay be managed by initially ensuring the patient has an adequate airway and supportingrespiration and circulation This should be rapidly followed by removal of all transdermalsystems from the skin and the mouth If there is evidence of transdermal systemingestion endoscopic removal of swallowed transdermal systems or administration ofactivated charcoal should be considered as indicated by the clinical situation In anycase where there is serious overdosage or signs of evolving acute toxicity continuousmonitoring of vital signs and ECG establishment of intravenous access andadministration of oxygen are all recommendedThe signs and symptoms of overdosetoxicity due to scopolamine should be carefullydistinguished from the occasionally observed syndrome of withdrawal [see Warningsand Precautions (55)] Although mental confusion and dizziness may be observed withboth acute toxicity and withdrawal other characteristic findings differtachyarrhythmias dry skin and decreased bowel sounds suggest anticholinergictoxicity while bradycardia headache nausea and abdominal cramps and sweatingsuggest post-removal withdrawalIf over-exposure occurs call your Poison Control Center at 1-800-222-1222 for currentinformation on the management of poisoning or overdosage
11 DESCRIPTIONScopolamine transdermal system is designed for continuous release of scopolaminefollowing application to an area of intact skin on the head behind the ear Each systemcontains 13 mg of scopolamine base Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3310 ]nonan-7-yl) 3-hydroxy-2-phenylpropanoate The empirical formulais C H NO and its structural formula is
24
17 21 4
Scopolamine has a molecular weight of 30335 and a pKa of 755-781 The scopolaminetransdermal system is a circular 02 mm thick 25 cm film with four layers Proceedingfrom the visible surface towards the surface attached to the skin these layers are (1) abacking membrane of tan-colored aluminized polyester film (2) a drug layer ofscopolamine crospovidone isopropyl palmitate light mineral oil and polyisobutylene (3)an ethylene vinyl acetate copolymer membrane that controls the rate of delivery ofscopolamine from the system to the skin surface and (4) an contact layer formulationof crospovidone isopropyl palmitate light mineral oil polyisobutylene and scopolamineA release liner of siliconized polyester which covers the adhesive layer is removedbefore the system is usedCross section of the system
12 CLINICAL PHARMACOLOGY
121 Mechanism of ActionScopolamine a belladonna alkaloid is an anticholinergic Scopolamine acts i) as acompetitive inhibitor at postganglionic muscarinic receptor sites of the parasympatheticnervous system and ii) on smooth muscles that respond to acetylcholine but lackcholinergic innervation It has been suggested that scopolamine acts in the centralnervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei tohigher centers in the CNS and from the reticular formation to the vomiting centerScopolamine can inhibit the secretion of saliva and sweat decrease gastrointestinalsecretions and motility cause drowsiness dilate the pupils increase heart rate anddepress motor function
123 PharmacokineticsThe system is formulated to deliver approximately 1 mg of scopolamine to the systemiccirculation over 3 daysAbsorption
2
Following application to the skin behind the ear circulating plasma concentrations aredetected within 4 hours with peak concentrations being obtained on average within 24hours The average plasma concentration produced is 87 pgmL (028 nM) for freescopolamine and 354 pgmL for total scopolamine (free + conjugates) Followingremoval of the used transdermal system there is some degree of continued systemicabsorption of scopolamine bound in the skin layersDistribution The distribution of scopolamine is not well characterized It crosses the placenta and theblood brain barrier and may be reversibly bound to plasma proteinsEliminationMetabolism and Excretion Scopolamine is metabolized and conjugated with less than 5 of the total doseappearing unchanged in the urine The enzymes responsible for metabolizingscopolamine are unknown The exact elimination pattern of scopolamine has not beendetermined Following transdermal system removal plasma concentrations ofscopolamine decline in a log linear fashion with an observed half-life of 95 hours Lessthan 10 of the total dose is excreted in the urine as the parent drug and metabolitesover 108 hoursDrug Interaction StudiesAn in vitro study using human hepatocytes examined the induction of CYP1A2 andCYP3A4 by scopolamine Scopolamine did not induce CYP1A2 and CYP3A4 isoenzymesat the concentrations up to 10 nM In an in vitro study using human liver microsomeswhich evaluated the inhibition of CYP1A2 2C8 2C9 2C19 2D6 and 3A4 scopolaminedid not inhibit these cytochrome P450 isoenzymes at the concentrations up to 1micromolar No in vivo drug-drug interaction studies have been conducted
13 NONCLINICAL TOXICOLOGY
131 Carcinogenesis Mutagenesis Impairment of FertilityNo long-term studies in animals have been conducted to evaluate the carcinogenicpotential of scopolamine The mutagenic potential of scopolamine has not beenevaluatedFertility studies were performed in female rats and revealed no evidence of impairedfertility or harm to the fetus due to scopolamine hydrobromide administered by dailysubcutaneous injection Maternal body weights were reduced in the highest-dose group(plasma level approximately 500 times the level achieved in humans using a transdermalsystem) However fertility studies in male animals were not performed
14 CLINICAL STUDIES
141 Prevention of Motion SicknessIn 195 adult subjects of different racial origins who participated in clinical efficacy studiesat sea or in a controlled motion environment there was a 75 reduction in the incidenceof motion-induced nausea and vomiting Scopolamine transdermal system was applied
from 4 to 16 hours prior to the onset of motion in these studies
142 Prevention of Post-Operative Nausea and VomitingA clinical efficacy study evaluated 168 adult female patients undergoing gynecologicalsurgery with anesthesia and opiate analgesia Patients received scopolamine transdermalsystem or placebo applied approximately 11 hours before anesthesiaopiate analgesiaNo retchingvomiting during the 24-hour post-operative period was reported in 79 ofthose treated with scopolamine transdermal system compared to 72 of thosereceiving placebo When the need for additional antiemetic medication was assessedduring the same period there was no need for medication in 89 of patients treatedwith scopolamine transdermal system as compared to 72 of placebo-treated patients
16 HOW SUPPLIEDSTORAGE AND HANDLINGScopolamine Transdermal System 1 mg3 days is available as the following
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Store at 20degC to 25degC (68degF to 77degF) [see USP Controlled Room Temperature]Store pouch(es) in an upright positionDo not bend or roll pouch(es)Wash hands thoroughly with soap and water immediately after handling the transdermalsystem Upon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidental contactor ingestion by children pets or others [see Dosage and Administration (21) Warningsand Precautions (56)]
17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information andInstructions for Use)Administration InstructionsCounsel patients on how to apply and remove the transdermal system [see Dosage andAdministration (21)]
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Carton of 4 transdermal systems packaged into individual foil pouches NDC45802-580-84Carton of 10 transdermal systems packaged into individual foil pouches NDC45802-580-46Carton of 24 transdermal systems packaged into individual foil pouches NDC45802-580-62
Only wear one transdermal system at any timeDo not cut the transdermal systemApply the transdermal system to the skin in the postauricular (hairless area behindone ear) areaAfter the transdermal system is applied on the dry skin behind the ear wash handsthoroughly with soap and water and dry handsIf the transdermal system becomes displaced discard the transdermal system and
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Patients with Open-Angle GlaucomaAdvise patients with open-angle glaucoma to remove the scopolamine transdermalsystem immediately and contact their healthcare provider if they experience symptomsof acute angle closure glaucoma including pain and reddening of the eyes accompaniedby dilated pupils blurred vision andor seeing halos around lights [see Warnings andPrecautions (51)]Neuropsychiatric Adverse Reactions
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Decreased Gastrointestinal Motility and Urinary RetentionInstruct patients to remove the transdermal system if they develop symptoms ofintestinal obstruction (abdominal pain nausea or vomiting) or any difficulties in urinating[see Warnings and Precautions (54)]Drug WithdrawalPost-Removal SymptomsInform patients that if they remove the scopolamine transdermal system beforetreatment is complete withdrawal symptoms may occur and to seek immediate medicalcare if they develop severe symptoms after removing scopolamine transdermal system[see Warnings and Precautions (55)]Blurred VisionInform patients that temporary dilation of the pupils and blurred vision may occur ifscopolamine transdermal system comes in contact with the eyes Instruct patients towash their hands thoroughly with soap and water immediately after handling thetransdermal system [see Dosage and Administration (21) Warnings and Precautions(56)]MRI Skin BurnsInstruct patients to remove the scopolamine transdermal system before undergoing an
If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
Advise patients that psychiatric adverse reactions may occur especially in patientswith a past psychiatric history or in those receiving other drugs also associatedwith psychiatric effects and to report to their healthcare provider any new orworsening psychiatric symptomsAdvise patients to discontinue scopolamine transdermal system and contact ahealthcare provider immediately if they experience a seizureAdvise patients especially elderly patients that cognitive impairment may occurduring treatment with scopolamine transdermal system especially in thosereceiving other drugs also associated with CNS effects and to report to theirhealthcare provider if they develop signs or symptoms of cognitive impairmentsuch as hallucinations confusion or dizzinessInform patients not to operate motor vehicles or other dangerous machinery orparticipate in underwater sports until they are reasonably certain that scopolaminetransdermal system does not affect them adversely [see Warnings and Precautions(52)]
MRI [see Warnings and Precautions (57)]
Manufactured byAVEVA DRUG DELIVERY SYSTEMSAn APOTEX CompanyMiramar FL 33025Distributed ByPerrigoregAllegan MI 49010 wwwperrigocom5A800 RC BR7
Medication Guide
MEDICATION GUIDEScopolamine (skoe polrsquo a meen) Transdermal System
Read this Patient Information before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentWhat is scopolamine transdermal systemScopolamine transdermal system is a prescription medicine used for adults to helpprevent
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It is not known if scopolamine transdermal system is safe or effective in childrenWho should not use scopolamine transdermal systemDo not use Transderm Scōp if you
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What should I tell my doctor before using scopolamine transdermal systemBefore you use scopolamine transdermal system tell your doctor about all of yourmedical conditions including if you
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nausea and vomiting from motion sicknessnausea and vomiting from anesthesia or taking opioid pain medicines after surgery
have an eye problem called angle closure glaucomaare allergic to scopolamine belladonna alkaloids or any of the ingredients inscopolamine transdermal system See the end of this leaflet for a list of theingredients in scopolamine transdermal system Ask your doctor if you are notsure
have glaucoma (increased pressure in the eye)have a history of seizures or psychosishave problems with your stomach or intestineshave trouble urinatingare scheduled to have a gastric secretion testhave liver or kidney problemsare pregnant or plan to become pregnant It is not known if scopolamine
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Tell your doctor about all the medicines you take including prescription andover-the-counter medicines vitamins and herbal supplements Scopolamine transdermalsystem may affect the way other medicines work and other medicines may affect howscopolamine transdermal system works Medicines that you take by mouth may not beabsorbed well while you use scopolamine transdermal systemEspecially tell your doctor if you take
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Ask your doctor if you are not sure if your medicine is one that is listed aboveKnow the medicines you take Keep a list of them and show it to your doctor orpharmacist when you get a new medicineHow should I use scopolamine transdermal system
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What should I avoid while using scopolamine transdermal system
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What are the possible side effects of scopolamine transdermal systemScopolamine transdermal system may cause serious side effects including
transdermal system can harm your unborn babyare breastfeeding or plan to breastfeed Scopolamine can pass into your breastmilk and may harm your baby Talk to your doctor about the best way to feed yourbaby if you use scopolamine transdermal system
a sedative hypnotic opioid or anxiolytic (medicines that make you sleepy)an antidepressant medicinean anticholinergic medicine such as an allergy or cold medicine a medicine to treatbladder or bowel spasms certain asthma medicines or other medicines for motionsickness
See the detailed Instructions for Use for information about how to usescopolamine transdermal system at the end of this Patient Information leafletIt is important that you apply scopolamine transdermal system exactly as yourdoctor tells you toYour doctor may change your scopolamine transdermal system dose Do notchange your scopolamine transdermal system dose without talking to your doctorWear only one scopolamine transdermal system at any timeIf you use too much scopolamine transdermal system call your doctor or PoisonControl Center at 1-800-222-1222 or go to the nearest hospital emergency roomright away
You should not drink alcohol while using scopolamine transdermal system It canincrease your chances of having serious side effectsYou should not drive operate heavy machinery or do other dangerous activitiesuntil you know how scopolamine transdermal system affects youYou should not use scopolamine transdermal system during a Magnetic ResonanceImaging scan (MRI) Remove scopolamine transdermal system before undergoingan MRI It can cause your skin to burnYou should be careful if you use scopolamine transdermal system while youparticipate in watersports because you may feel lost or confused (disoriented)Limit contact with water while swimming and bathing because scopolaminetransdermal system may fall off If scopolamine transdermal system falls off throwit away and apply a new one on the hairless area behind your other ear
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The most common side effects of using scopolamine transdermal systeminclude
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Tell your doctor if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of scopolamine transdermal systemCall your doctor for medical advice about side effects You may report side effects toFDA at 1-800-FDA-1088General information about the safe and effective use of scopolaminetransdermal system
angle closure glaucoma If you have open angle glaucoma and use scopolaminetransdermal system remove scopolamine transdermal system and call a doctorright away if you feel pain or discomfort have blurred vision or see halos orcolored images around lights and reddening of your eyesworsening of seizures Tell your doctor about any worsening of seizures whileusing scopolamine transdermal systeman unusual reaction called acute psychosis Tell your doctor if you have anyof these symptoms
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confusionagitationrambling speechhallucinations (seeing or hearing things that are not there)paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy Some pregnant womenwith severe preeclampsia have had seizures after getting scopolamine by injectionin the muscle (intramuscular) or injection in the vein (intravenous)difficulty urinatingdifficulties in food passing from the stomach to the small intestineswhich may cause abdominal pain nausea or vomitingwithdrawal symptoms after removing scopolamine transdermal systemafter using it for several days Some people may have certain symptoms suchas difficulty with balance dizziness nausea vomiting stomach cramps sweatingconfusion muscle weakness low heart rate or low blood pressure that could start24 hours or more after removing scopolamine transdermal system Call yourdoctor right away if your symptoms become severetemporary increase in the size of your pupil and blurry vision especially ifscopolamine transdermal system comes in contact with your eyesskin burns at the site of scopolamine transdermal system This canhappen during a medical test called a Magnetic Resonance Imaging scan (MRI)Scopolamine transdermal system contains aluminum and should be removed fromyour skin before you have an MRI
dry mouth blurred vision oreye problems
feeling sleepy ordrowsy
disorientation(confusion)
dizziness feeling agitatedor irritable
pharyngitis(sore throat)
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
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To help prevent nausea and vomiting from motion sickness
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To help prevent nausea and vomiting after surgery
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How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
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Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
52 Neuropsychiatric Adverse ReactionsPsychiatric Adverse ReactionsScopolamine has been reported to exacerbate psychosis Other psychiatric reactionshave also been reported including acute toxic psychosis agitation speech disorderhallucinations paranoia and delusions [see Adverse Reactions (62)] Monitor patientsfor new or worsening psychiatric symptoms during treatment with scopolaminetransdermal system Also monitor patients for new or worsening psychiatric symptomsduring concomitant treatment with other drugs that are associated with similarpsychiatric effects [see Drug Interactions (71)]SeizuresSeizures and seizure-like activity have been reported in patients receiving scopolamineWeigh this potential risk against the benefits before prescribing scopolaminetransdermal system to patients with a history of seizures including those receiving anti-epileptic medication or who have risk factors that can lower the seizure thresholdCognitive Adverse ReactionsScopolamine can cause drowsiness disorientation and confusion Discontinuescopolamine transdermal system if signs or symptoms of cognitive impairment developElderly and pediatric patients may be more sensitive to the neurological and psychiatriceffects of scopolamine transdermal system Consider more frequent monitoring duringtreatment with scopolamine transdermal system in elderly patients [see Use in SpecificPopulations (85)] Scopolamine transdermal system is not approved for use in pediatricpatients [see Use in Specific Populations (84)]Hazardous ActivitiesScopolamine transdermal system may impair the mental andor physical abilities requiredfor the performance of hazardous tasks such as driving a motor vehicle operatingmachinery or participating in underwater sports Concomitant use of other drugs thatcause central nervous system (CNS) adverse reactions (eg alcohol sedativeshypnotics opiates and anxiolytics) or have anticholinergic properties (eg otherbelladonna alkaloids sedating antihistamines meclizine tricyclic antidepressants andmuscle relaxants) may increase this effect [see Drug Interactions (71)] Inform patientsnot to operate motor vehicles or other dangerous machinery or participate inunderwater sports until they are reasonably certain that scopolamine transdermalsystem does not affect them adversely
53 Eclamptic Seizures in Pregnant WomenEclamptic seizures have been reported in pregnant women with severe preeclampsiasoon after injection of intravenous and intramuscular scopolamine [see Use in SpecificPopulations (81)] Avoid use of scopolamine transdermal system in patients with severepreeclampsia
54 Gastrointestinal and Urinary DisordersScopolamine due to its anticholinergic properties can decrease gastrointestinal motilityand cause urinary retention Consider more frequent monitoring during treatment withscopolamine transdermal system in patients suspected of having intestinal obstructionpatients with pyloric obstruction or urinary bladder neck obstruction and patients
receiving other anticholinergic drugs [see Drug Interactions (72)] Discontinuescopolamine transdermal system in patients who develop difficulty in urination
55 Drug WithdrawalPost-Removal SymptomsDiscontinuation of scopolamine transdermal system usually after several days of usemay result in withdrawal symptoms such as disturbances of equilibrium dizzinessnausea vomiting abdominal cramps sweating headache mental confusion muscleweakness bradycardia and hypotension The onset of these symptoms is generally 24hours or more after the transdermal system has been removed Instruct patients toseek medical attention if they experience severe symptoms
56 Blurred VisionScopolamine can cause temporary dilation of the pupils resulting in blurred vision if itcomes in contact with the eyesAdvise patients to wash their hands thoroughly with soap and water and dry their handsimmediately after handling the transdermal system [see Dosage and Administration(21)]
57 Magnetic Resonance Imaging (MRI) Skin BurnsScopolamine transdermal system contains an aluminized membrane Skin burns havebeen reported at the application site in patients wearing an aluminized transdermalsystem during an MRI scan Remove scopolamine transdermal system beforeundergoing an MRI
6 ADVERSE REACTIONSThe following serious adverse reactions are described elsewhere in labeling
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61 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions adverse reactionrates observed in the clinical trials of a drug cannot be directly compared to rates in theclinical trials of another drug and may not reflect the rates observed in practiceMotion SicknessThe most common adverse reaction (approximately two thirds) was dry mouth Lesscommon adverse reactions included drowsiness (less than one sixth) blurred visionand dilation of the pupilsPONV
Acute Angle Closure Glaucoma [see Warnings and Precautions (51)]Neuropsychiatric Adverse Reactions [see Warnings and Precautions (52)]Eclamptic Seizures in Pregnant Women [see Warnings and Precautions (53)]Gastrointestinal and Urinary Disorders [see Warnings and Precautions (54)]Drug WithdrawalPost-Removal Symptoms [see Warnings and Precautions (55)]Blurred Vision [see Warnings and Precautions (56)]MRI Skin Burns [see Warnings and Precautions (57)]
Common adverse reactions occurring in at least 3 of patients in PONV clinical trialsare shown in Table 1
Scopolamine TransdermalSystem
(N = 461)
Placebo (N = 457)
Dry mouth 29 16Dizziness 12 7Somnolence 8 4Agitation 6 4Visual Impairment 5 3Confusion 4 3Mydriasis 4 0Pharyngitis 3 2
occurring in at least 3 of patients and at a rate higher than placebo
62 Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use ofscopolamine transdermal system Because these reactions are reported voluntarily froma population of uncertain size it is not always possible to reliably estimate theirfrequency or establish a causal relationship to drug exposurePsychiatric disorders acute psychosis including hallucinations disorientation andparanoiaNervous system disorders headache amnesia coordination abnormalities speechdisorder disturbance in attention restlessnessGeneral disorders and administration site conditions application site burningEye disorders dry eyes eye pruritus angle closure glaucoma amblyopia eyelid irritationSkin and subcutaneous tissue disorders rash generalized skin irritation erythemaRenal and urinary disorders dysuriaEar and labyrinth disorders vertigo
7 DRUG INTERACTIONS
71 Drugs Causing Central Nervous System (CNS) Adverse ReactionsThe concurrent use of scopolamine transdermal system with other drugs that causeCNS adverse reactions of drowsiness dizziness or disorientation (eg sedativeshypnotics opiates anxiolytics and alcohol) or have anticholinergic properties (eg otherbelladonna alkaloids sedating antihistamines meclizine tricyclic antidepressants andmuscle relaxants) may potentiate the effects of scopolamine transdermal system [seeWarnings and Precautions (52)] Either scopolamine transdermal system or theinteracting drug should be chosen depending on the importance of the drug to thepatient If the interacting drug cannot be avoided monitor patients for CNS adverse
reactions
72 Anticholinergic DrugsConcomitant use of scopolamine with other drugs having anticholinergic properties mayincrease the risk of CNS adverse reactions [see Drug Interactions (71)] intestinalobstruction andor urinary retention Consider more frequent monitoring duringtreatment with scopolamine transdermal system in patients receiving anticholinergicdrugs [see Warnings and Precautions (52 54)]
73 Oral Drugs Absorbed in the StomachScopolamine transdermal system as an anticholinergic may delay gastric and uppergastrointestinal motility and therefore the rate of absorption of other orallyadministered drugs Monitor patients for modified therapeutic effect of concomitantorally administered drugs with a narrow therapeutic index
74 Interaction with Gastric Secretion TestScopolamine will interfere with the gastric secretion test Discontinue scopolaminetransdermal system 10 days prior to testing
8 USE IN SPECIFIC POPULATIONS
81 PregnancyRisk SummaryAvailable data from observational studies and postmarketing reports with scopolamineuse in pregnant women have not identified a drug associated risk of major birth defectsmiscarriage or adverse fetal outcomes Avoid use of scopolamine transdermal systemin pregnant women with severe preeclampsia because eclamptic seizures have beenreported after exposure to scopolamine (see Data)
In animal studies there was no evidence of adverse developmental effects withintravenous administration of scopolamine hydrobromide revealed in ratsEmbryotoxicity was observed in rabbits at intravenous doses producing plasma levelsapproximately 100 times the levels achieved in humans using a transdermal systemThe estimated background risk of major birth defects and miscarriage for the indicatedpopulation is unknown All pregnancies have a background risk of birth defect loss orother adverse outcomes In the US general population the background risk of majorbirth defects and miscarriage in clinically recognized pregnancies is 2 to 4 and 15to 20 respectivelyDataHuman Data
Eclamptic Seizures In published case reports two pregnant patients with severe preeclampsia wereadministered intravenous and intramuscular scopolamine respectively and developedeclamptic seizures soon after scopolamine administration [see Warnings and Precautions(53)]
Animal Data
In animal reproduction studies when pregnant rats and rabbits received scopolaminehydrobromide by daily intravenous injection no adverse effects were observed in ratsAn embryotoxic effect was observed in rabbits at doses producing plasma levelsapproximately 100 times the levels achieved in humans using a transdermal systemScopolamine administered parenterally to rats and rabbits at doses higher than the dosedelivered by scopolamine transdermal system did not affect uterine contractions orincrease the duration of labor
82 LactationRisk SummaryScopolamine is present in human milk There are no available data on the effects ofscopolamine on the breastfed infant or the effects on milk production Because therehave been no consistent reports of adverse events in breastfed infants over decades ofuse the developmental and health benefits of breastfeeding should be considered alongwith the motherrsquos clinical need for scopolamine transdermal system and any potentialadverse effects on the breastfed child from scopolamine transdermal system or fromthe underlying maternal condition
84 Pediatric UseSafety and effectiveness in pediatric patients have not been established Pediatricpatients are particularly susceptible to the adverse reactions of scopolamine includingmydriasis hallucinations amblyopia and drug withdrawal syndrome Neurologic andpsychiatric adverse reactions such as hallucinations amblyopia and mydriasis have alsobeen reported
85 Geriatric UseClinical trials of scopolamine transdermal system did not include sufficient number ofsubjects aged 65 years and older to determine if they respond differently from youngersubjects In other clinical experience elderly patients had an increased risk of neurologicand psychiatric adverse reactions such as hallucinations confusion dizziness and drugwithdrawal syndrome [see Warnings and Precautions (52 55)] Consider morefrequent monitoring for CNS adverse reactions during treatment with scopolaminetransdermal system in elderly patients [see Warnings and Precautions (52)]
86 Renal or Hepatic ImpairmentScopolamine transdermal system has not been studied in patients with renal or hepaticimpairment Consider more frequent monitoring during treatment with scopolaminetransdermal system in patients with renal or hepatic impairment because of theincreased risk of CNS adverse reactions [see Warnings and Precautions (52)]
9 DRUG ABUSE AND DEPENDENCE
91 Controlled SubstanceScopolamine transdermal system contains scopolamine which is not a controlled
substance
93 DependenceTermination of scopolamine transdermal system usually after several days of use mayresult in withdrawal symptoms such as disturbances of equilibrium dizziness nauseavomiting abdominal cramps sweating headache mental confusion muscle weaknessbradycardia and hypotension These withdrawal symptoms indicate that scopolaminelike other anticholinergic drugs may produce physical dependence The onset of thesesymptoms generally 24 hours or more after the transdermal system has beenremoved can be severe and may require medical intervention [see Warnings andPrecautions (55)]
10 OVERDOSAGEThe signs and symptoms of anticholinergic toxicity include lethargy somnolence comaconfusion agitation hallucinations convulsion visual disturbance dry flushed skin drymouth decreased bowel sounds urinary retention tachycardia hypertension andsupraventricular arrhythmias These symptoms can be severe and may require medicalinterventionIn cases of toxicity remove the scopolamine transdermal system Serious symptomaticcases of overdosage involving multiple transdermal system applications andor ingestionmay be managed by initially ensuring the patient has an adequate airway and supportingrespiration and circulation This should be rapidly followed by removal of all transdermalsystems from the skin and the mouth If there is evidence of transdermal systemingestion endoscopic removal of swallowed transdermal systems or administration ofactivated charcoal should be considered as indicated by the clinical situation In anycase where there is serious overdosage or signs of evolving acute toxicity continuousmonitoring of vital signs and ECG establishment of intravenous access andadministration of oxygen are all recommendedThe signs and symptoms of overdosetoxicity due to scopolamine should be carefullydistinguished from the occasionally observed syndrome of withdrawal [see Warningsand Precautions (55)] Although mental confusion and dizziness may be observed withboth acute toxicity and withdrawal other characteristic findings differtachyarrhythmias dry skin and decreased bowel sounds suggest anticholinergictoxicity while bradycardia headache nausea and abdominal cramps and sweatingsuggest post-removal withdrawalIf over-exposure occurs call your Poison Control Center at 1-800-222-1222 for currentinformation on the management of poisoning or overdosage
11 DESCRIPTIONScopolamine transdermal system is designed for continuous release of scopolaminefollowing application to an area of intact skin on the head behind the ear Each systemcontains 13 mg of scopolamine base Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3310 ]nonan-7-yl) 3-hydroxy-2-phenylpropanoate The empirical formulais C H NO and its structural formula is
24
17 21 4
Scopolamine has a molecular weight of 30335 and a pKa of 755-781 The scopolaminetransdermal system is a circular 02 mm thick 25 cm film with four layers Proceedingfrom the visible surface towards the surface attached to the skin these layers are (1) abacking membrane of tan-colored aluminized polyester film (2) a drug layer ofscopolamine crospovidone isopropyl palmitate light mineral oil and polyisobutylene (3)an ethylene vinyl acetate copolymer membrane that controls the rate of delivery ofscopolamine from the system to the skin surface and (4) an contact layer formulationof crospovidone isopropyl palmitate light mineral oil polyisobutylene and scopolamineA release liner of siliconized polyester which covers the adhesive layer is removedbefore the system is usedCross section of the system
12 CLINICAL PHARMACOLOGY
121 Mechanism of ActionScopolamine a belladonna alkaloid is an anticholinergic Scopolamine acts i) as acompetitive inhibitor at postganglionic muscarinic receptor sites of the parasympatheticnervous system and ii) on smooth muscles that respond to acetylcholine but lackcholinergic innervation It has been suggested that scopolamine acts in the centralnervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei tohigher centers in the CNS and from the reticular formation to the vomiting centerScopolamine can inhibit the secretion of saliva and sweat decrease gastrointestinalsecretions and motility cause drowsiness dilate the pupils increase heart rate anddepress motor function
123 PharmacokineticsThe system is formulated to deliver approximately 1 mg of scopolamine to the systemiccirculation over 3 daysAbsorption
2
Following application to the skin behind the ear circulating plasma concentrations aredetected within 4 hours with peak concentrations being obtained on average within 24hours The average plasma concentration produced is 87 pgmL (028 nM) for freescopolamine and 354 pgmL for total scopolamine (free + conjugates) Followingremoval of the used transdermal system there is some degree of continued systemicabsorption of scopolamine bound in the skin layersDistribution The distribution of scopolamine is not well characterized It crosses the placenta and theblood brain barrier and may be reversibly bound to plasma proteinsEliminationMetabolism and Excretion Scopolamine is metabolized and conjugated with less than 5 of the total doseappearing unchanged in the urine The enzymes responsible for metabolizingscopolamine are unknown The exact elimination pattern of scopolamine has not beendetermined Following transdermal system removal plasma concentrations ofscopolamine decline in a log linear fashion with an observed half-life of 95 hours Lessthan 10 of the total dose is excreted in the urine as the parent drug and metabolitesover 108 hoursDrug Interaction StudiesAn in vitro study using human hepatocytes examined the induction of CYP1A2 andCYP3A4 by scopolamine Scopolamine did not induce CYP1A2 and CYP3A4 isoenzymesat the concentrations up to 10 nM In an in vitro study using human liver microsomeswhich evaluated the inhibition of CYP1A2 2C8 2C9 2C19 2D6 and 3A4 scopolaminedid not inhibit these cytochrome P450 isoenzymes at the concentrations up to 1micromolar No in vivo drug-drug interaction studies have been conducted
13 NONCLINICAL TOXICOLOGY
131 Carcinogenesis Mutagenesis Impairment of FertilityNo long-term studies in animals have been conducted to evaluate the carcinogenicpotential of scopolamine The mutagenic potential of scopolamine has not beenevaluatedFertility studies were performed in female rats and revealed no evidence of impairedfertility or harm to the fetus due to scopolamine hydrobromide administered by dailysubcutaneous injection Maternal body weights were reduced in the highest-dose group(plasma level approximately 500 times the level achieved in humans using a transdermalsystem) However fertility studies in male animals were not performed
14 CLINICAL STUDIES
141 Prevention of Motion SicknessIn 195 adult subjects of different racial origins who participated in clinical efficacy studiesat sea or in a controlled motion environment there was a 75 reduction in the incidenceof motion-induced nausea and vomiting Scopolamine transdermal system was applied
from 4 to 16 hours prior to the onset of motion in these studies
142 Prevention of Post-Operative Nausea and VomitingA clinical efficacy study evaluated 168 adult female patients undergoing gynecologicalsurgery with anesthesia and opiate analgesia Patients received scopolamine transdermalsystem or placebo applied approximately 11 hours before anesthesiaopiate analgesiaNo retchingvomiting during the 24-hour post-operative period was reported in 79 ofthose treated with scopolamine transdermal system compared to 72 of thosereceiving placebo When the need for additional antiemetic medication was assessedduring the same period there was no need for medication in 89 of patients treatedwith scopolamine transdermal system as compared to 72 of placebo-treated patients
16 HOW SUPPLIEDSTORAGE AND HANDLINGScopolamine Transdermal System 1 mg3 days is available as the following
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Store at 20degC to 25degC (68degF to 77degF) [see USP Controlled Room Temperature]Store pouch(es) in an upright positionDo not bend or roll pouch(es)Wash hands thoroughly with soap and water immediately after handling the transdermalsystem Upon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidental contactor ingestion by children pets or others [see Dosage and Administration (21) Warningsand Precautions (56)]
17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information andInstructions for Use)Administration InstructionsCounsel patients on how to apply and remove the transdermal system [see Dosage andAdministration (21)]
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Carton of 4 transdermal systems packaged into individual foil pouches NDC45802-580-84Carton of 10 transdermal systems packaged into individual foil pouches NDC45802-580-46Carton of 24 transdermal systems packaged into individual foil pouches NDC45802-580-62
Only wear one transdermal system at any timeDo not cut the transdermal systemApply the transdermal system to the skin in the postauricular (hairless area behindone ear) areaAfter the transdermal system is applied on the dry skin behind the ear wash handsthoroughly with soap and water and dry handsIf the transdermal system becomes displaced discard the transdermal system and
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Patients with Open-Angle GlaucomaAdvise patients with open-angle glaucoma to remove the scopolamine transdermalsystem immediately and contact their healthcare provider if they experience symptomsof acute angle closure glaucoma including pain and reddening of the eyes accompaniedby dilated pupils blurred vision andor seeing halos around lights [see Warnings andPrecautions (51)]Neuropsychiatric Adverse Reactions
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Decreased Gastrointestinal Motility and Urinary RetentionInstruct patients to remove the transdermal system if they develop symptoms ofintestinal obstruction (abdominal pain nausea or vomiting) or any difficulties in urinating[see Warnings and Precautions (54)]Drug WithdrawalPost-Removal SymptomsInform patients that if they remove the scopolamine transdermal system beforetreatment is complete withdrawal symptoms may occur and to seek immediate medicalcare if they develop severe symptoms after removing scopolamine transdermal system[see Warnings and Precautions (55)]Blurred VisionInform patients that temporary dilation of the pupils and blurred vision may occur ifscopolamine transdermal system comes in contact with the eyes Instruct patients towash their hands thoroughly with soap and water immediately after handling thetransdermal system [see Dosage and Administration (21) Warnings and Precautions(56)]MRI Skin BurnsInstruct patients to remove the scopolamine transdermal system before undergoing an
If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
Advise patients that psychiatric adverse reactions may occur especially in patientswith a past psychiatric history or in those receiving other drugs also associatedwith psychiatric effects and to report to their healthcare provider any new orworsening psychiatric symptomsAdvise patients to discontinue scopolamine transdermal system and contact ahealthcare provider immediately if they experience a seizureAdvise patients especially elderly patients that cognitive impairment may occurduring treatment with scopolamine transdermal system especially in thosereceiving other drugs also associated with CNS effects and to report to theirhealthcare provider if they develop signs or symptoms of cognitive impairmentsuch as hallucinations confusion or dizzinessInform patients not to operate motor vehicles or other dangerous machinery orparticipate in underwater sports until they are reasonably certain that scopolaminetransdermal system does not affect them adversely [see Warnings and Precautions(52)]
MRI [see Warnings and Precautions (57)]
Manufactured byAVEVA DRUG DELIVERY SYSTEMSAn APOTEX CompanyMiramar FL 33025Distributed ByPerrigoregAllegan MI 49010 wwwperrigocom5A800 RC BR7
Medication Guide
MEDICATION GUIDEScopolamine (skoe polrsquo a meen) Transdermal System
Read this Patient Information before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentWhat is scopolamine transdermal systemScopolamine transdermal system is a prescription medicine used for adults to helpprevent
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It is not known if scopolamine transdermal system is safe or effective in childrenWho should not use scopolamine transdermal systemDo not use Transderm Scōp if you
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What should I tell my doctor before using scopolamine transdermal systemBefore you use scopolamine transdermal system tell your doctor about all of yourmedical conditions including if you
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nausea and vomiting from motion sicknessnausea and vomiting from anesthesia or taking opioid pain medicines after surgery
have an eye problem called angle closure glaucomaare allergic to scopolamine belladonna alkaloids or any of the ingredients inscopolamine transdermal system See the end of this leaflet for a list of theingredients in scopolamine transdermal system Ask your doctor if you are notsure
have glaucoma (increased pressure in the eye)have a history of seizures or psychosishave problems with your stomach or intestineshave trouble urinatingare scheduled to have a gastric secretion testhave liver or kidney problemsare pregnant or plan to become pregnant It is not known if scopolamine
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Tell your doctor about all the medicines you take including prescription andover-the-counter medicines vitamins and herbal supplements Scopolamine transdermalsystem may affect the way other medicines work and other medicines may affect howscopolamine transdermal system works Medicines that you take by mouth may not beabsorbed well while you use scopolamine transdermal systemEspecially tell your doctor if you take
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Ask your doctor if you are not sure if your medicine is one that is listed aboveKnow the medicines you take Keep a list of them and show it to your doctor orpharmacist when you get a new medicineHow should I use scopolamine transdermal system
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What should I avoid while using scopolamine transdermal system
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What are the possible side effects of scopolamine transdermal systemScopolamine transdermal system may cause serious side effects including
transdermal system can harm your unborn babyare breastfeeding or plan to breastfeed Scopolamine can pass into your breastmilk and may harm your baby Talk to your doctor about the best way to feed yourbaby if you use scopolamine transdermal system
a sedative hypnotic opioid or anxiolytic (medicines that make you sleepy)an antidepressant medicinean anticholinergic medicine such as an allergy or cold medicine a medicine to treatbladder or bowel spasms certain asthma medicines or other medicines for motionsickness
See the detailed Instructions for Use for information about how to usescopolamine transdermal system at the end of this Patient Information leafletIt is important that you apply scopolamine transdermal system exactly as yourdoctor tells you toYour doctor may change your scopolamine transdermal system dose Do notchange your scopolamine transdermal system dose without talking to your doctorWear only one scopolamine transdermal system at any timeIf you use too much scopolamine transdermal system call your doctor or PoisonControl Center at 1-800-222-1222 or go to the nearest hospital emergency roomright away
You should not drink alcohol while using scopolamine transdermal system It canincrease your chances of having serious side effectsYou should not drive operate heavy machinery or do other dangerous activitiesuntil you know how scopolamine transdermal system affects youYou should not use scopolamine transdermal system during a Magnetic ResonanceImaging scan (MRI) Remove scopolamine transdermal system before undergoingan MRI It can cause your skin to burnYou should be careful if you use scopolamine transdermal system while youparticipate in watersports because you may feel lost or confused (disoriented)Limit contact with water while swimming and bathing because scopolaminetransdermal system may fall off If scopolamine transdermal system falls off throwit away and apply a new one on the hairless area behind your other ear
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The most common side effects of using scopolamine transdermal systeminclude
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Tell your doctor if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of scopolamine transdermal systemCall your doctor for medical advice about side effects You may report side effects toFDA at 1-800-FDA-1088General information about the safe and effective use of scopolaminetransdermal system
angle closure glaucoma If you have open angle glaucoma and use scopolaminetransdermal system remove scopolamine transdermal system and call a doctorright away if you feel pain or discomfort have blurred vision or see halos orcolored images around lights and reddening of your eyesworsening of seizures Tell your doctor about any worsening of seizures whileusing scopolamine transdermal systeman unusual reaction called acute psychosis Tell your doctor if you have anyof these symptoms
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confusionagitationrambling speechhallucinations (seeing or hearing things that are not there)paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy Some pregnant womenwith severe preeclampsia have had seizures after getting scopolamine by injectionin the muscle (intramuscular) or injection in the vein (intravenous)difficulty urinatingdifficulties in food passing from the stomach to the small intestineswhich may cause abdominal pain nausea or vomitingwithdrawal symptoms after removing scopolamine transdermal systemafter using it for several days Some people may have certain symptoms suchas difficulty with balance dizziness nausea vomiting stomach cramps sweatingconfusion muscle weakness low heart rate or low blood pressure that could start24 hours or more after removing scopolamine transdermal system Call yourdoctor right away if your symptoms become severetemporary increase in the size of your pupil and blurry vision especially ifscopolamine transdermal system comes in contact with your eyesskin burns at the site of scopolamine transdermal system This canhappen during a medical test called a Magnetic Resonance Imaging scan (MRI)Scopolamine transdermal system contains aluminum and should be removed fromyour skin before you have an MRI
dry mouth blurred vision oreye problems
feeling sleepy ordrowsy
disorientation(confusion)
dizziness feeling agitatedor irritable
pharyngitis(sore throat)
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
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To help prevent nausea and vomiting from motion sickness
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To help prevent nausea and vomiting after surgery
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How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
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Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
receiving other anticholinergic drugs [see Drug Interactions (72)] Discontinuescopolamine transdermal system in patients who develop difficulty in urination
55 Drug WithdrawalPost-Removal SymptomsDiscontinuation of scopolamine transdermal system usually after several days of usemay result in withdrawal symptoms such as disturbances of equilibrium dizzinessnausea vomiting abdominal cramps sweating headache mental confusion muscleweakness bradycardia and hypotension The onset of these symptoms is generally 24hours or more after the transdermal system has been removed Instruct patients toseek medical attention if they experience severe symptoms
56 Blurred VisionScopolamine can cause temporary dilation of the pupils resulting in blurred vision if itcomes in contact with the eyesAdvise patients to wash their hands thoroughly with soap and water and dry their handsimmediately after handling the transdermal system [see Dosage and Administration(21)]
57 Magnetic Resonance Imaging (MRI) Skin BurnsScopolamine transdermal system contains an aluminized membrane Skin burns havebeen reported at the application site in patients wearing an aluminized transdermalsystem during an MRI scan Remove scopolamine transdermal system beforeundergoing an MRI
6 ADVERSE REACTIONSThe following serious adverse reactions are described elsewhere in labeling
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61 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions adverse reactionrates observed in the clinical trials of a drug cannot be directly compared to rates in theclinical trials of another drug and may not reflect the rates observed in practiceMotion SicknessThe most common adverse reaction (approximately two thirds) was dry mouth Lesscommon adverse reactions included drowsiness (less than one sixth) blurred visionand dilation of the pupilsPONV
Acute Angle Closure Glaucoma [see Warnings and Precautions (51)]Neuropsychiatric Adverse Reactions [see Warnings and Precautions (52)]Eclamptic Seizures in Pregnant Women [see Warnings and Precautions (53)]Gastrointestinal and Urinary Disorders [see Warnings and Precautions (54)]Drug WithdrawalPost-Removal Symptoms [see Warnings and Precautions (55)]Blurred Vision [see Warnings and Precautions (56)]MRI Skin Burns [see Warnings and Precautions (57)]
Common adverse reactions occurring in at least 3 of patients in PONV clinical trialsare shown in Table 1
Scopolamine TransdermalSystem
(N = 461)
Placebo (N = 457)
Dry mouth 29 16Dizziness 12 7Somnolence 8 4Agitation 6 4Visual Impairment 5 3Confusion 4 3Mydriasis 4 0Pharyngitis 3 2
occurring in at least 3 of patients and at a rate higher than placebo
62 Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use ofscopolamine transdermal system Because these reactions are reported voluntarily froma population of uncertain size it is not always possible to reliably estimate theirfrequency or establish a causal relationship to drug exposurePsychiatric disorders acute psychosis including hallucinations disorientation andparanoiaNervous system disorders headache amnesia coordination abnormalities speechdisorder disturbance in attention restlessnessGeneral disorders and administration site conditions application site burningEye disorders dry eyes eye pruritus angle closure glaucoma amblyopia eyelid irritationSkin and subcutaneous tissue disorders rash generalized skin irritation erythemaRenal and urinary disorders dysuriaEar and labyrinth disorders vertigo
7 DRUG INTERACTIONS
71 Drugs Causing Central Nervous System (CNS) Adverse ReactionsThe concurrent use of scopolamine transdermal system with other drugs that causeCNS adverse reactions of drowsiness dizziness or disorientation (eg sedativeshypnotics opiates anxiolytics and alcohol) or have anticholinergic properties (eg otherbelladonna alkaloids sedating antihistamines meclizine tricyclic antidepressants andmuscle relaxants) may potentiate the effects of scopolamine transdermal system [seeWarnings and Precautions (52)] Either scopolamine transdermal system or theinteracting drug should be chosen depending on the importance of the drug to thepatient If the interacting drug cannot be avoided monitor patients for CNS adverse
reactions
72 Anticholinergic DrugsConcomitant use of scopolamine with other drugs having anticholinergic properties mayincrease the risk of CNS adverse reactions [see Drug Interactions (71)] intestinalobstruction andor urinary retention Consider more frequent monitoring duringtreatment with scopolamine transdermal system in patients receiving anticholinergicdrugs [see Warnings and Precautions (52 54)]
73 Oral Drugs Absorbed in the StomachScopolamine transdermal system as an anticholinergic may delay gastric and uppergastrointestinal motility and therefore the rate of absorption of other orallyadministered drugs Monitor patients for modified therapeutic effect of concomitantorally administered drugs with a narrow therapeutic index
74 Interaction with Gastric Secretion TestScopolamine will interfere with the gastric secretion test Discontinue scopolaminetransdermal system 10 days prior to testing
8 USE IN SPECIFIC POPULATIONS
81 PregnancyRisk SummaryAvailable data from observational studies and postmarketing reports with scopolamineuse in pregnant women have not identified a drug associated risk of major birth defectsmiscarriage or adverse fetal outcomes Avoid use of scopolamine transdermal systemin pregnant women with severe preeclampsia because eclamptic seizures have beenreported after exposure to scopolamine (see Data)
In animal studies there was no evidence of adverse developmental effects withintravenous administration of scopolamine hydrobromide revealed in ratsEmbryotoxicity was observed in rabbits at intravenous doses producing plasma levelsapproximately 100 times the levels achieved in humans using a transdermal systemThe estimated background risk of major birth defects and miscarriage for the indicatedpopulation is unknown All pregnancies have a background risk of birth defect loss orother adverse outcomes In the US general population the background risk of majorbirth defects and miscarriage in clinically recognized pregnancies is 2 to 4 and 15to 20 respectivelyDataHuman Data
Eclamptic Seizures In published case reports two pregnant patients with severe preeclampsia wereadministered intravenous and intramuscular scopolamine respectively and developedeclamptic seizures soon after scopolamine administration [see Warnings and Precautions(53)]
Animal Data
In animal reproduction studies when pregnant rats and rabbits received scopolaminehydrobromide by daily intravenous injection no adverse effects were observed in ratsAn embryotoxic effect was observed in rabbits at doses producing plasma levelsapproximately 100 times the levels achieved in humans using a transdermal systemScopolamine administered parenterally to rats and rabbits at doses higher than the dosedelivered by scopolamine transdermal system did not affect uterine contractions orincrease the duration of labor
82 LactationRisk SummaryScopolamine is present in human milk There are no available data on the effects ofscopolamine on the breastfed infant or the effects on milk production Because therehave been no consistent reports of adverse events in breastfed infants over decades ofuse the developmental and health benefits of breastfeeding should be considered alongwith the motherrsquos clinical need for scopolamine transdermal system and any potentialadverse effects on the breastfed child from scopolamine transdermal system or fromthe underlying maternal condition
84 Pediatric UseSafety and effectiveness in pediatric patients have not been established Pediatricpatients are particularly susceptible to the adverse reactions of scopolamine includingmydriasis hallucinations amblyopia and drug withdrawal syndrome Neurologic andpsychiatric adverse reactions such as hallucinations amblyopia and mydriasis have alsobeen reported
85 Geriatric UseClinical trials of scopolamine transdermal system did not include sufficient number ofsubjects aged 65 years and older to determine if they respond differently from youngersubjects In other clinical experience elderly patients had an increased risk of neurologicand psychiatric adverse reactions such as hallucinations confusion dizziness and drugwithdrawal syndrome [see Warnings and Precautions (52 55)] Consider morefrequent monitoring for CNS adverse reactions during treatment with scopolaminetransdermal system in elderly patients [see Warnings and Precautions (52)]
86 Renal or Hepatic ImpairmentScopolamine transdermal system has not been studied in patients with renal or hepaticimpairment Consider more frequent monitoring during treatment with scopolaminetransdermal system in patients with renal or hepatic impairment because of theincreased risk of CNS adverse reactions [see Warnings and Precautions (52)]
9 DRUG ABUSE AND DEPENDENCE
91 Controlled SubstanceScopolamine transdermal system contains scopolamine which is not a controlled
substance
93 DependenceTermination of scopolamine transdermal system usually after several days of use mayresult in withdrawal symptoms such as disturbances of equilibrium dizziness nauseavomiting abdominal cramps sweating headache mental confusion muscle weaknessbradycardia and hypotension These withdrawal symptoms indicate that scopolaminelike other anticholinergic drugs may produce physical dependence The onset of thesesymptoms generally 24 hours or more after the transdermal system has beenremoved can be severe and may require medical intervention [see Warnings andPrecautions (55)]
10 OVERDOSAGEThe signs and symptoms of anticholinergic toxicity include lethargy somnolence comaconfusion agitation hallucinations convulsion visual disturbance dry flushed skin drymouth decreased bowel sounds urinary retention tachycardia hypertension andsupraventricular arrhythmias These symptoms can be severe and may require medicalinterventionIn cases of toxicity remove the scopolamine transdermal system Serious symptomaticcases of overdosage involving multiple transdermal system applications andor ingestionmay be managed by initially ensuring the patient has an adequate airway and supportingrespiration and circulation This should be rapidly followed by removal of all transdermalsystems from the skin and the mouth If there is evidence of transdermal systemingestion endoscopic removal of swallowed transdermal systems or administration ofactivated charcoal should be considered as indicated by the clinical situation In anycase where there is serious overdosage or signs of evolving acute toxicity continuousmonitoring of vital signs and ECG establishment of intravenous access andadministration of oxygen are all recommendedThe signs and symptoms of overdosetoxicity due to scopolamine should be carefullydistinguished from the occasionally observed syndrome of withdrawal [see Warningsand Precautions (55)] Although mental confusion and dizziness may be observed withboth acute toxicity and withdrawal other characteristic findings differtachyarrhythmias dry skin and decreased bowel sounds suggest anticholinergictoxicity while bradycardia headache nausea and abdominal cramps and sweatingsuggest post-removal withdrawalIf over-exposure occurs call your Poison Control Center at 1-800-222-1222 for currentinformation on the management of poisoning or overdosage
11 DESCRIPTIONScopolamine transdermal system is designed for continuous release of scopolaminefollowing application to an area of intact skin on the head behind the ear Each systemcontains 13 mg of scopolamine base Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3310 ]nonan-7-yl) 3-hydroxy-2-phenylpropanoate The empirical formulais C H NO and its structural formula is
24
17 21 4
Scopolamine has a molecular weight of 30335 and a pKa of 755-781 The scopolaminetransdermal system is a circular 02 mm thick 25 cm film with four layers Proceedingfrom the visible surface towards the surface attached to the skin these layers are (1) abacking membrane of tan-colored aluminized polyester film (2) a drug layer ofscopolamine crospovidone isopropyl palmitate light mineral oil and polyisobutylene (3)an ethylene vinyl acetate copolymer membrane that controls the rate of delivery ofscopolamine from the system to the skin surface and (4) an contact layer formulationof crospovidone isopropyl palmitate light mineral oil polyisobutylene and scopolamineA release liner of siliconized polyester which covers the adhesive layer is removedbefore the system is usedCross section of the system
12 CLINICAL PHARMACOLOGY
121 Mechanism of ActionScopolamine a belladonna alkaloid is an anticholinergic Scopolamine acts i) as acompetitive inhibitor at postganglionic muscarinic receptor sites of the parasympatheticnervous system and ii) on smooth muscles that respond to acetylcholine but lackcholinergic innervation It has been suggested that scopolamine acts in the centralnervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei tohigher centers in the CNS and from the reticular formation to the vomiting centerScopolamine can inhibit the secretion of saliva and sweat decrease gastrointestinalsecretions and motility cause drowsiness dilate the pupils increase heart rate anddepress motor function
123 PharmacokineticsThe system is formulated to deliver approximately 1 mg of scopolamine to the systemiccirculation over 3 daysAbsorption
2
Following application to the skin behind the ear circulating plasma concentrations aredetected within 4 hours with peak concentrations being obtained on average within 24hours The average plasma concentration produced is 87 pgmL (028 nM) for freescopolamine and 354 pgmL for total scopolamine (free + conjugates) Followingremoval of the used transdermal system there is some degree of continued systemicabsorption of scopolamine bound in the skin layersDistribution The distribution of scopolamine is not well characterized It crosses the placenta and theblood brain barrier and may be reversibly bound to plasma proteinsEliminationMetabolism and Excretion Scopolamine is metabolized and conjugated with less than 5 of the total doseappearing unchanged in the urine The enzymes responsible for metabolizingscopolamine are unknown The exact elimination pattern of scopolamine has not beendetermined Following transdermal system removal plasma concentrations ofscopolamine decline in a log linear fashion with an observed half-life of 95 hours Lessthan 10 of the total dose is excreted in the urine as the parent drug and metabolitesover 108 hoursDrug Interaction StudiesAn in vitro study using human hepatocytes examined the induction of CYP1A2 andCYP3A4 by scopolamine Scopolamine did not induce CYP1A2 and CYP3A4 isoenzymesat the concentrations up to 10 nM In an in vitro study using human liver microsomeswhich evaluated the inhibition of CYP1A2 2C8 2C9 2C19 2D6 and 3A4 scopolaminedid not inhibit these cytochrome P450 isoenzymes at the concentrations up to 1micromolar No in vivo drug-drug interaction studies have been conducted
13 NONCLINICAL TOXICOLOGY
131 Carcinogenesis Mutagenesis Impairment of FertilityNo long-term studies in animals have been conducted to evaluate the carcinogenicpotential of scopolamine The mutagenic potential of scopolamine has not beenevaluatedFertility studies were performed in female rats and revealed no evidence of impairedfertility or harm to the fetus due to scopolamine hydrobromide administered by dailysubcutaneous injection Maternal body weights were reduced in the highest-dose group(plasma level approximately 500 times the level achieved in humans using a transdermalsystem) However fertility studies in male animals were not performed
14 CLINICAL STUDIES
141 Prevention of Motion SicknessIn 195 adult subjects of different racial origins who participated in clinical efficacy studiesat sea or in a controlled motion environment there was a 75 reduction in the incidenceof motion-induced nausea and vomiting Scopolamine transdermal system was applied
from 4 to 16 hours prior to the onset of motion in these studies
142 Prevention of Post-Operative Nausea and VomitingA clinical efficacy study evaluated 168 adult female patients undergoing gynecologicalsurgery with anesthesia and opiate analgesia Patients received scopolamine transdermalsystem or placebo applied approximately 11 hours before anesthesiaopiate analgesiaNo retchingvomiting during the 24-hour post-operative period was reported in 79 ofthose treated with scopolamine transdermal system compared to 72 of thosereceiving placebo When the need for additional antiemetic medication was assessedduring the same period there was no need for medication in 89 of patients treatedwith scopolamine transdermal system as compared to 72 of placebo-treated patients
16 HOW SUPPLIEDSTORAGE AND HANDLINGScopolamine Transdermal System 1 mg3 days is available as the following
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Store at 20degC to 25degC (68degF to 77degF) [see USP Controlled Room Temperature]Store pouch(es) in an upright positionDo not bend or roll pouch(es)Wash hands thoroughly with soap and water immediately after handling the transdermalsystem Upon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidental contactor ingestion by children pets or others [see Dosage and Administration (21) Warningsand Precautions (56)]
17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information andInstructions for Use)Administration InstructionsCounsel patients on how to apply and remove the transdermal system [see Dosage andAdministration (21)]
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Carton of 4 transdermal systems packaged into individual foil pouches NDC45802-580-84Carton of 10 transdermal systems packaged into individual foil pouches NDC45802-580-46Carton of 24 transdermal systems packaged into individual foil pouches NDC45802-580-62
Only wear one transdermal system at any timeDo not cut the transdermal systemApply the transdermal system to the skin in the postauricular (hairless area behindone ear) areaAfter the transdermal system is applied on the dry skin behind the ear wash handsthoroughly with soap and water and dry handsIf the transdermal system becomes displaced discard the transdermal system and
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Patients with Open-Angle GlaucomaAdvise patients with open-angle glaucoma to remove the scopolamine transdermalsystem immediately and contact their healthcare provider if they experience symptomsof acute angle closure glaucoma including pain and reddening of the eyes accompaniedby dilated pupils blurred vision andor seeing halos around lights [see Warnings andPrecautions (51)]Neuropsychiatric Adverse Reactions
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Decreased Gastrointestinal Motility and Urinary RetentionInstruct patients to remove the transdermal system if they develop symptoms ofintestinal obstruction (abdominal pain nausea or vomiting) or any difficulties in urinating[see Warnings and Precautions (54)]Drug WithdrawalPost-Removal SymptomsInform patients that if they remove the scopolamine transdermal system beforetreatment is complete withdrawal symptoms may occur and to seek immediate medicalcare if they develop severe symptoms after removing scopolamine transdermal system[see Warnings and Precautions (55)]Blurred VisionInform patients that temporary dilation of the pupils and blurred vision may occur ifscopolamine transdermal system comes in contact with the eyes Instruct patients towash their hands thoroughly with soap and water immediately after handling thetransdermal system [see Dosage and Administration (21) Warnings and Precautions(56)]MRI Skin BurnsInstruct patients to remove the scopolamine transdermal system before undergoing an
If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
Advise patients that psychiatric adverse reactions may occur especially in patientswith a past psychiatric history or in those receiving other drugs also associatedwith psychiatric effects and to report to their healthcare provider any new orworsening psychiatric symptomsAdvise patients to discontinue scopolamine transdermal system and contact ahealthcare provider immediately if they experience a seizureAdvise patients especially elderly patients that cognitive impairment may occurduring treatment with scopolamine transdermal system especially in thosereceiving other drugs also associated with CNS effects and to report to theirhealthcare provider if they develop signs or symptoms of cognitive impairmentsuch as hallucinations confusion or dizzinessInform patients not to operate motor vehicles or other dangerous machinery orparticipate in underwater sports until they are reasonably certain that scopolaminetransdermal system does not affect them adversely [see Warnings and Precautions(52)]
MRI [see Warnings and Precautions (57)]
Manufactured byAVEVA DRUG DELIVERY SYSTEMSAn APOTEX CompanyMiramar FL 33025Distributed ByPerrigoregAllegan MI 49010 wwwperrigocom5A800 RC BR7
Medication Guide
MEDICATION GUIDEScopolamine (skoe polrsquo a meen) Transdermal System
Read this Patient Information before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentWhat is scopolamine transdermal systemScopolamine transdermal system is a prescription medicine used for adults to helpprevent
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It is not known if scopolamine transdermal system is safe or effective in childrenWho should not use scopolamine transdermal systemDo not use Transderm Scōp if you
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What should I tell my doctor before using scopolamine transdermal systemBefore you use scopolamine transdermal system tell your doctor about all of yourmedical conditions including if you
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nausea and vomiting from motion sicknessnausea and vomiting from anesthesia or taking opioid pain medicines after surgery
have an eye problem called angle closure glaucomaare allergic to scopolamine belladonna alkaloids or any of the ingredients inscopolamine transdermal system See the end of this leaflet for a list of theingredients in scopolamine transdermal system Ask your doctor if you are notsure
have glaucoma (increased pressure in the eye)have a history of seizures or psychosishave problems with your stomach or intestineshave trouble urinatingare scheduled to have a gastric secretion testhave liver or kidney problemsare pregnant or plan to become pregnant It is not known if scopolamine
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Tell your doctor about all the medicines you take including prescription andover-the-counter medicines vitamins and herbal supplements Scopolamine transdermalsystem may affect the way other medicines work and other medicines may affect howscopolamine transdermal system works Medicines that you take by mouth may not beabsorbed well while you use scopolamine transdermal systemEspecially tell your doctor if you take
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Ask your doctor if you are not sure if your medicine is one that is listed aboveKnow the medicines you take Keep a list of them and show it to your doctor orpharmacist when you get a new medicineHow should I use scopolamine transdermal system
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What should I avoid while using scopolamine transdermal system
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What are the possible side effects of scopolamine transdermal systemScopolamine transdermal system may cause serious side effects including
transdermal system can harm your unborn babyare breastfeeding or plan to breastfeed Scopolamine can pass into your breastmilk and may harm your baby Talk to your doctor about the best way to feed yourbaby if you use scopolamine transdermal system
a sedative hypnotic opioid or anxiolytic (medicines that make you sleepy)an antidepressant medicinean anticholinergic medicine such as an allergy or cold medicine a medicine to treatbladder or bowel spasms certain asthma medicines or other medicines for motionsickness
See the detailed Instructions for Use for information about how to usescopolamine transdermal system at the end of this Patient Information leafletIt is important that you apply scopolamine transdermal system exactly as yourdoctor tells you toYour doctor may change your scopolamine transdermal system dose Do notchange your scopolamine transdermal system dose without talking to your doctorWear only one scopolamine transdermal system at any timeIf you use too much scopolamine transdermal system call your doctor or PoisonControl Center at 1-800-222-1222 or go to the nearest hospital emergency roomright away
You should not drink alcohol while using scopolamine transdermal system It canincrease your chances of having serious side effectsYou should not drive operate heavy machinery or do other dangerous activitiesuntil you know how scopolamine transdermal system affects youYou should not use scopolamine transdermal system during a Magnetic ResonanceImaging scan (MRI) Remove scopolamine transdermal system before undergoingan MRI It can cause your skin to burnYou should be careful if you use scopolamine transdermal system while youparticipate in watersports because you may feel lost or confused (disoriented)Limit contact with water while swimming and bathing because scopolaminetransdermal system may fall off If scopolamine transdermal system falls off throwit away and apply a new one on the hairless area behind your other ear
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The most common side effects of using scopolamine transdermal systeminclude
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Tell your doctor if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of scopolamine transdermal systemCall your doctor for medical advice about side effects You may report side effects toFDA at 1-800-FDA-1088General information about the safe and effective use of scopolaminetransdermal system
angle closure glaucoma If you have open angle glaucoma and use scopolaminetransdermal system remove scopolamine transdermal system and call a doctorright away if you feel pain or discomfort have blurred vision or see halos orcolored images around lights and reddening of your eyesworsening of seizures Tell your doctor about any worsening of seizures whileusing scopolamine transdermal systeman unusual reaction called acute psychosis Tell your doctor if you have anyof these symptoms
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confusionagitationrambling speechhallucinations (seeing or hearing things that are not there)paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy Some pregnant womenwith severe preeclampsia have had seizures after getting scopolamine by injectionin the muscle (intramuscular) or injection in the vein (intravenous)difficulty urinatingdifficulties in food passing from the stomach to the small intestineswhich may cause abdominal pain nausea or vomitingwithdrawal symptoms after removing scopolamine transdermal systemafter using it for several days Some people may have certain symptoms suchas difficulty with balance dizziness nausea vomiting stomach cramps sweatingconfusion muscle weakness low heart rate or low blood pressure that could start24 hours or more after removing scopolamine transdermal system Call yourdoctor right away if your symptoms become severetemporary increase in the size of your pupil and blurry vision especially ifscopolamine transdermal system comes in contact with your eyesskin burns at the site of scopolamine transdermal system This canhappen during a medical test called a Magnetic Resonance Imaging scan (MRI)Scopolamine transdermal system contains aluminum and should be removed fromyour skin before you have an MRI
dry mouth blurred vision oreye problems
feeling sleepy ordrowsy
disorientation(confusion)
dizziness feeling agitatedor irritable
pharyngitis(sore throat)
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
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To help prevent nausea and vomiting from motion sickness
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To help prevent nausea and vomiting after surgery
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How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
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Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
Common adverse reactions occurring in at least 3 of patients in PONV clinical trialsare shown in Table 1
Scopolamine TransdermalSystem
(N = 461)
Placebo (N = 457)
Dry mouth 29 16Dizziness 12 7Somnolence 8 4Agitation 6 4Visual Impairment 5 3Confusion 4 3Mydriasis 4 0Pharyngitis 3 2
occurring in at least 3 of patients and at a rate higher than placebo
62 Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use ofscopolamine transdermal system Because these reactions are reported voluntarily froma population of uncertain size it is not always possible to reliably estimate theirfrequency or establish a causal relationship to drug exposurePsychiatric disorders acute psychosis including hallucinations disorientation andparanoiaNervous system disorders headache amnesia coordination abnormalities speechdisorder disturbance in attention restlessnessGeneral disorders and administration site conditions application site burningEye disorders dry eyes eye pruritus angle closure glaucoma amblyopia eyelid irritationSkin and subcutaneous tissue disorders rash generalized skin irritation erythemaRenal and urinary disorders dysuriaEar and labyrinth disorders vertigo
7 DRUG INTERACTIONS
71 Drugs Causing Central Nervous System (CNS) Adverse ReactionsThe concurrent use of scopolamine transdermal system with other drugs that causeCNS adverse reactions of drowsiness dizziness or disorientation (eg sedativeshypnotics opiates anxiolytics and alcohol) or have anticholinergic properties (eg otherbelladonna alkaloids sedating antihistamines meclizine tricyclic antidepressants andmuscle relaxants) may potentiate the effects of scopolamine transdermal system [seeWarnings and Precautions (52)] Either scopolamine transdermal system or theinteracting drug should be chosen depending on the importance of the drug to thepatient If the interacting drug cannot be avoided monitor patients for CNS adverse
reactions
72 Anticholinergic DrugsConcomitant use of scopolamine with other drugs having anticholinergic properties mayincrease the risk of CNS adverse reactions [see Drug Interactions (71)] intestinalobstruction andor urinary retention Consider more frequent monitoring duringtreatment with scopolamine transdermal system in patients receiving anticholinergicdrugs [see Warnings and Precautions (52 54)]
73 Oral Drugs Absorbed in the StomachScopolamine transdermal system as an anticholinergic may delay gastric and uppergastrointestinal motility and therefore the rate of absorption of other orallyadministered drugs Monitor patients for modified therapeutic effect of concomitantorally administered drugs with a narrow therapeutic index
74 Interaction with Gastric Secretion TestScopolamine will interfere with the gastric secretion test Discontinue scopolaminetransdermal system 10 days prior to testing
8 USE IN SPECIFIC POPULATIONS
81 PregnancyRisk SummaryAvailable data from observational studies and postmarketing reports with scopolamineuse in pregnant women have not identified a drug associated risk of major birth defectsmiscarriage or adverse fetal outcomes Avoid use of scopolamine transdermal systemin pregnant women with severe preeclampsia because eclamptic seizures have beenreported after exposure to scopolamine (see Data)
In animal studies there was no evidence of adverse developmental effects withintravenous administration of scopolamine hydrobromide revealed in ratsEmbryotoxicity was observed in rabbits at intravenous doses producing plasma levelsapproximately 100 times the levels achieved in humans using a transdermal systemThe estimated background risk of major birth defects and miscarriage for the indicatedpopulation is unknown All pregnancies have a background risk of birth defect loss orother adverse outcomes In the US general population the background risk of majorbirth defects and miscarriage in clinically recognized pregnancies is 2 to 4 and 15to 20 respectivelyDataHuman Data
Eclamptic Seizures In published case reports two pregnant patients with severe preeclampsia wereadministered intravenous and intramuscular scopolamine respectively and developedeclamptic seizures soon after scopolamine administration [see Warnings and Precautions(53)]
Animal Data
In animal reproduction studies when pregnant rats and rabbits received scopolaminehydrobromide by daily intravenous injection no adverse effects were observed in ratsAn embryotoxic effect was observed in rabbits at doses producing plasma levelsapproximately 100 times the levels achieved in humans using a transdermal systemScopolamine administered parenterally to rats and rabbits at doses higher than the dosedelivered by scopolamine transdermal system did not affect uterine contractions orincrease the duration of labor
82 LactationRisk SummaryScopolamine is present in human milk There are no available data on the effects ofscopolamine on the breastfed infant or the effects on milk production Because therehave been no consistent reports of adverse events in breastfed infants over decades ofuse the developmental and health benefits of breastfeeding should be considered alongwith the motherrsquos clinical need for scopolamine transdermal system and any potentialadverse effects on the breastfed child from scopolamine transdermal system or fromthe underlying maternal condition
84 Pediatric UseSafety and effectiveness in pediatric patients have not been established Pediatricpatients are particularly susceptible to the adverse reactions of scopolamine includingmydriasis hallucinations amblyopia and drug withdrawal syndrome Neurologic andpsychiatric adverse reactions such as hallucinations amblyopia and mydriasis have alsobeen reported
85 Geriatric UseClinical trials of scopolamine transdermal system did not include sufficient number ofsubjects aged 65 years and older to determine if they respond differently from youngersubjects In other clinical experience elderly patients had an increased risk of neurologicand psychiatric adverse reactions such as hallucinations confusion dizziness and drugwithdrawal syndrome [see Warnings and Precautions (52 55)] Consider morefrequent monitoring for CNS adverse reactions during treatment with scopolaminetransdermal system in elderly patients [see Warnings and Precautions (52)]
86 Renal or Hepatic ImpairmentScopolamine transdermal system has not been studied in patients with renal or hepaticimpairment Consider more frequent monitoring during treatment with scopolaminetransdermal system in patients with renal or hepatic impairment because of theincreased risk of CNS adverse reactions [see Warnings and Precautions (52)]
9 DRUG ABUSE AND DEPENDENCE
91 Controlled SubstanceScopolamine transdermal system contains scopolamine which is not a controlled
substance
93 DependenceTermination of scopolamine transdermal system usually after several days of use mayresult in withdrawal symptoms such as disturbances of equilibrium dizziness nauseavomiting abdominal cramps sweating headache mental confusion muscle weaknessbradycardia and hypotension These withdrawal symptoms indicate that scopolaminelike other anticholinergic drugs may produce physical dependence The onset of thesesymptoms generally 24 hours or more after the transdermal system has beenremoved can be severe and may require medical intervention [see Warnings andPrecautions (55)]
10 OVERDOSAGEThe signs and symptoms of anticholinergic toxicity include lethargy somnolence comaconfusion agitation hallucinations convulsion visual disturbance dry flushed skin drymouth decreased bowel sounds urinary retention tachycardia hypertension andsupraventricular arrhythmias These symptoms can be severe and may require medicalinterventionIn cases of toxicity remove the scopolamine transdermal system Serious symptomaticcases of overdosage involving multiple transdermal system applications andor ingestionmay be managed by initially ensuring the patient has an adequate airway and supportingrespiration and circulation This should be rapidly followed by removal of all transdermalsystems from the skin and the mouth If there is evidence of transdermal systemingestion endoscopic removal of swallowed transdermal systems or administration ofactivated charcoal should be considered as indicated by the clinical situation In anycase where there is serious overdosage or signs of evolving acute toxicity continuousmonitoring of vital signs and ECG establishment of intravenous access andadministration of oxygen are all recommendedThe signs and symptoms of overdosetoxicity due to scopolamine should be carefullydistinguished from the occasionally observed syndrome of withdrawal [see Warningsand Precautions (55)] Although mental confusion and dizziness may be observed withboth acute toxicity and withdrawal other characteristic findings differtachyarrhythmias dry skin and decreased bowel sounds suggest anticholinergictoxicity while bradycardia headache nausea and abdominal cramps and sweatingsuggest post-removal withdrawalIf over-exposure occurs call your Poison Control Center at 1-800-222-1222 for currentinformation on the management of poisoning or overdosage
11 DESCRIPTIONScopolamine transdermal system is designed for continuous release of scopolaminefollowing application to an area of intact skin on the head behind the ear Each systemcontains 13 mg of scopolamine base Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3310 ]nonan-7-yl) 3-hydroxy-2-phenylpropanoate The empirical formulais C H NO and its structural formula is
24
17 21 4
Scopolamine has a molecular weight of 30335 and a pKa of 755-781 The scopolaminetransdermal system is a circular 02 mm thick 25 cm film with four layers Proceedingfrom the visible surface towards the surface attached to the skin these layers are (1) abacking membrane of tan-colored aluminized polyester film (2) a drug layer ofscopolamine crospovidone isopropyl palmitate light mineral oil and polyisobutylene (3)an ethylene vinyl acetate copolymer membrane that controls the rate of delivery ofscopolamine from the system to the skin surface and (4) an contact layer formulationof crospovidone isopropyl palmitate light mineral oil polyisobutylene and scopolamineA release liner of siliconized polyester which covers the adhesive layer is removedbefore the system is usedCross section of the system
12 CLINICAL PHARMACOLOGY
121 Mechanism of ActionScopolamine a belladonna alkaloid is an anticholinergic Scopolamine acts i) as acompetitive inhibitor at postganglionic muscarinic receptor sites of the parasympatheticnervous system and ii) on smooth muscles that respond to acetylcholine but lackcholinergic innervation It has been suggested that scopolamine acts in the centralnervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei tohigher centers in the CNS and from the reticular formation to the vomiting centerScopolamine can inhibit the secretion of saliva and sweat decrease gastrointestinalsecretions and motility cause drowsiness dilate the pupils increase heart rate anddepress motor function
123 PharmacokineticsThe system is formulated to deliver approximately 1 mg of scopolamine to the systemiccirculation over 3 daysAbsorption
2
Following application to the skin behind the ear circulating plasma concentrations aredetected within 4 hours with peak concentrations being obtained on average within 24hours The average plasma concentration produced is 87 pgmL (028 nM) for freescopolamine and 354 pgmL for total scopolamine (free + conjugates) Followingremoval of the used transdermal system there is some degree of continued systemicabsorption of scopolamine bound in the skin layersDistribution The distribution of scopolamine is not well characterized It crosses the placenta and theblood brain barrier and may be reversibly bound to plasma proteinsEliminationMetabolism and Excretion Scopolamine is metabolized and conjugated with less than 5 of the total doseappearing unchanged in the urine The enzymes responsible for metabolizingscopolamine are unknown The exact elimination pattern of scopolamine has not beendetermined Following transdermal system removal plasma concentrations ofscopolamine decline in a log linear fashion with an observed half-life of 95 hours Lessthan 10 of the total dose is excreted in the urine as the parent drug and metabolitesover 108 hoursDrug Interaction StudiesAn in vitro study using human hepatocytes examined the induction of CYP1A2 andCYP3A4 by scopolamine Scopolamine did not induce CYP1A2 and CYP3A4 isoenzymesat the concentrations up to 10 nM In an in vitro study using human liver microsomeswhich evaluated the inhibition of CYP1A2 2C8 2C9 2C19 2D6 and 3A4 scopolaminedid not inhibit these cytochrome P450 isoenzymes at the concentrations up to 1micromolar No in vivo drug-drug interaction studies have been conducted
13 NONCLINICAL TOXICOLOGY
131 Carcinogenesis Mutagenesis Impairment of FertilityNo long-term studies in animals have been conducted to evaluate the carcinogenicpotential of scopolamine The mutagenic potential of scopolamine has not beenevaluatedFertility studies were performed in female rats and revealed no evidence of impairedfertility or harm to the fetus due to scopolamine hydrobromide administered by dailysubcutaneous injection Maternal body weights were reduced in the highest-dose group(plasma level approximately 500 times the level achieved in humans using a transdermalsystem) However fertility studies in male animals were not performed
14 CLINICAL STUDIES
141 Prevention of Motion SicknessIn 195 adult subjects of different racial origins who participated in clinical efficacy studiesat sea or in a controlled motion environment there was a 75 reduction in the incidenceof motion-induced nausea and vomiting Scopolamine transdermal system was applied
from 4 to 16 hours prior to the onset of motion in these studies
142 Prevention of Post-Operative Nausea and VomitingA clinical efficacy study evaluated 168 adult female patients undergoing gynecologicalsurgery with anesthesia and opiate analgesia Patients received scopolamine transdermalsystem or placebo applied approximately 11 hours before anesthesiaopiate analgesiaNo retchingvomiting during the 24-hour post-operative period was reported in 79 ofthose treated with scopolamine transdermal system compared to 72 of thosereceiving placebo When the need for additional antiemetic medication was assessedduring the same period there was no need for medication in 89 of patients treatedwith scopolamine transdermal system as compared to 72 of placebo-treated patients
16 HOW SUPPLIEDSTORAGE AND HANDLINGScopolamine Transdermal System 1 mg3 days is available as the following
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Store at 20degC to 25degC (68degF to 77degF) [see USP Controlled Room Temperature]Store pouch(es) in an upright positionDo not bend or roll pouch(es)Wash hands thoroughly with soap and water immediately after handling the transdermalsystem Upon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidental contactor ingestion by children pets or others [see Dosage and Administration (21) Warningsand Precautions (56)]
17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information andInstructions for Use)Administration InstructionsCounsel patients on how to apply and remove the transdermal system [see Dosage andAdministration (21)]
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Carton of 4 transdermal systems packaged into individual foil pouches NDC45802-580-84Carton of 10 transdermal systems packaged into individual foil pouches NDC45802-580-46Carton of 24 transdermal systems packaged into individual foil pouches NDC45802-580-62
Only wear one transdermal system at any timeDo not cut the transdermal systemApply the transdermal system to the skin in the postauricular (hairless area behindone ear) areaAfter the transdermal system is applied on the dry skin behind the ear wash handsthoroughly with soap and water and dry handsIf the transdermal system becomes displaced discard the transdermal system and
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Patients with Open-Angle GlaucomaAdvise patients with open-angle glaucoma to remove the scopolamine transdermalsystem immediately and contact their healthcare provider if they experience symptomsof acute angle closure glaucoma including pain and reddening of the eyes accompaniedby dilated pupils blurred vision andor seeing halos around lights [see Warnings andPrecautions (51)]Neuropsychiatric Adverse Reactions
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Decreased Gastrointestinal Motility and Urinary RetentionInstruct patients to remove the transdermal system if they develop symptoms ofintestinal obstruction (abdominal pain nausea or vomiting) or any difficulties in urinating[see Warnings and Precautions (54)]Drug WithdrawalPost-Removal SymptomsInform patients that if they remove the scopolamine transdermal system beforetreatment is complete withdrawal symptoms may occur and to seek immediate medicalcare if they develop severe symptoms after removing scopolamine transdermal system[see Warnings and Precautions (55)]Blurred VisionInform patients that temporary dilation of the pupils and blurred vision may occur ifscopolamine transdermal system comes in contact with the eyes Instruct patients towash their hands thoroughly with soap and water immediately after handling thetransdermal system [see Dosage and Administration (21) Warnings and Precautions(56)]MRI Skin BurnsInstruct patients to remove the scopolamine transdermal system before undergoing an
If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
Advise patients that psychiatric adverse reactions may occur especially in patientswith a past psychiatric history or in those receiving other drugs also associatedwith psychiatric effects and to report to their healthcare provider any new orworsening psychiatric symptomsAdvise patients to discontinue scopolamine transdermal system and contact ahealthcare provider immediately if they experience a seizureAdvise patients especially elderly patients that cognitive impairment may occurduring treatment with scopolamine transdermal system especially in thosereceiving other drugs also associated with CNS effects and to report to theirhealthcare provider if they develop signs or symptoms of cognitive impairmentsuch as hallucinations confusion or dizzinessInform patients not to operate motor vehicles or other dangerous machinery orparticipate in underwater sports until they are reasonably certain that scopolaminetransdermal system does not affect them adversely [see Warnings and Precautions(52)]
MRI [see Warnings and Precautions (57)]
Manufactured byAVEVA DRUG DELIVERY SYSTEMSAn APOTEX CompanyMiramar FL 33025Distributed ByPerrigoregAllegan MI 49010 wwwperrigocom5A800 RC BR7
Medication Guide
MEDICATION GUIDEScopolamine (skoe polrsquo a meen) Transdermal System
Read this Patient Information before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentWhat is scopolamine transdermal systemScopolamine transdermal system is a prescription medicine used for adults to helpprevent
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It is not known if scopolamine transdermal system is safe or effective in childrenWho should not use scopolamine transdermal systemDo not use Transderm Scōp if you
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What should I tell my doctor before using scopolamine transdermal systemBefore you use scopolamine transdermal system tell your doctor about all of yourmedical conditions including if you
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nausea and vomiting from motion sicknessnausea and vomiting from anesthesia or taking opioid pain medicines after surgery
have an eye problem called angle closure glaucomaare allergic to scopolamine belladonna alkaloids or any of the ingredients inscopolamine transdermal system See the end of this leaflet for a list of theingredients in scopolamine transdermal system Ask your doctor if you are notsure
have glaucoma (increased pressure in the eye)have a history of seizures or psychosishave problems with your stomach or intestineshave trouble urinatingare scheduled to have a gastric secretion testhave liver or kidney problemsare pregnant or plan to become pregnant It is not known if scopolamine
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Tell your doctor about all the medicines you take including prescription andover-the-counter medicines vitamins and herbal supplements Scopolamine transdermalsystem may affect the way other medicines work and other medicines may affect howscopolamine transdermal system works Medicines that you take by mouth may not beabsorbed well while you use scopolamine transdermal systemEspecially tell your doctor if you take
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Ask your doctor if you are not sure if your medicine is one that is listed aboveKnow the medicines you take Keep a list of them and show it to your doctor orpharmacist when you get a new medicineHow should I use scopolamine transdermal system
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What should I avoid while using scopolamine transdermal system
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What are the possible side effects of scopolamine transdermal systemScopolamine transdermal system may cause serious side effects including
transdermal system can harm your unborn babyare breastfeeding or plan to breastfeed Scopolamine can pass into your breastmilk and may harm your baby Talk to your doctor about the best way to feed yourbaby if you use scopolamine transdermal system
a sedative hypnotic opioid or anxiolytic (medicines that make you sleepy)an antidepressant medicinean anticholinergic medicine such as an allergy or cold medicine a medicine to treatbladder or bowel spasms certain asthma medicines or other medicines for motionsickness
See the detailed Instructions for Use for information about how to usescopolamine transdermal system at the end of this Patient Information leafletIt is important that you apply scopolamine transdermal system exactly as yourdoctor tells you toYour doctor may change your scopolamine transdermal system dose Do notchange your scopolamine transdermal system dose without talking to your doctorWear only one scopolamine transdermal system at any timeIf you use too much scopolamine transdermal system call your doctor or PoisonControl Center at 1-800-222-1222 or go to the nearest hospital emergency roomright away
You should not drink alcohol while using scopolamine transdermal system It canincrease your chances of having serious side effectsYou should not drive operate heavy machinery or do other dangerous activitiesuntil you know how scopolamine transdermal system affects youYou should not use scopolamine transdermal system during a Magnetic ResonanceImaging scan (MRI) Remove scopolamine transdermal system before undergoingan MRI It can cause your skin to burnYou should be careful if you use scopolamine transdermal system while youparticipate in watersports because you may feel lost or confused (disoriented)Limit contact with water while swimming and bathing because scopolaminetransdermal system may fall off If scopolamine transdermal system falls off throwit away and apply a new one on the hairless area behind your other ear
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The most common side effects of using scopolamine transdermal systeminclude
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Tell your doctor if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of scopolamine transdermal systemCall your doctor for medical advice about side effects You may report side effects toFDA at 1-800-FDA-1088General information about the safe and effective use of scopolaminetransdermal system
angle closure glaucoma If you have open angle glaucoma and use scopolaminetransdermal system remove scopolamine transdermal system and call a doctorright away if you feel pain or discomfort have blurred vision or see halos orcolored images around lights and reddening of your eyesworsening of seizures Tell your doctor about any worsening of seizures whileusing scopolamine transdermal systeman unusual reaction called acute psychosis Tell your doctor if you have anyof these symptoms
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confusionagitationrambling speechhallucinations (seeing or hearing things that are not there)paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy Some pregnant womenwith severe preeclampsia have had seizures after getting scopolamine by injectionin the muscle (intramuscular) or injection in the vein (intravenous)difficulty urinatingdifficulties in food passing from the stomach to the small intestineswhich may cause abdominal pain nausea or vomitingwithdrawal symptoms after removing scopolamine transdermal systemafter using it for several days Some people may have certain symptoms suchas difficulty with balance dizziness nausea vomiting stomach cramps sweatingconfusion muscle weakness low heart rate or low blood pressure that could start24 hours or more after removing scopolamine transdermal system Call yourdoctor right away if your symptoms become severetemporary increase in the size of your pupil and blurry vision especially ifscopolamine transdermal system comes in contact with your eyesskin burns at the site of scopolamine transdermal system This canhappen during a medical test called a Magnetic Resonance Imaging scan (MRI)Scopolamine transdermal system contains aluminum and should be removed fromyour skin before you have an MRI
dry mouth blurred vision oreye problems
feeling sleepy ordrowsy
disorientation(confusion)
dizziness feeling agitatedor irritable
pharyngitis(sore throat)
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
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To help prevent nausea and vomiting from motion sickness
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To help prevent nausea and vomiting after surgery
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How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
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Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
reactions
72 Anticholinergic DrugsConcomitant use of scopolamine with other drugs having anticholinergic properties mayincrease the risk of CNS adverse reactions [see Drug Interactions (71)] intestinalobstruction andor urinary retention Consider more frequent monitoring duringtreatment with scopolamine transdermal system in patients receiving anticholinergicdrugs [see Warnings and Precautions (52 54)]
73 Oral Drugs Absorbed in the StomachScopolamine transdermal system as an anticholinergic may delay gastric and uppergastrointestinal motility and therefore the rate of absorption of other orallyadministered drugs Monitor patients for modified therapeutic effect of concomitantorally administered drugs with a narrow therapeutic index
74 Interaction with Gastric Secretion TestScopolamine will interfere with the gastric secretion test Discontinue scopolaminetransdermal system 10 days prior to testing
8 USE IN SPECIFIC POPULATIONS
81 PregnancyRisk SummaryAvailable data from observational studies and postmarketing reports with scopolamineuse in pregnant women have not identified a drug associated risk of major birth defectsmiscarriage or adverse fetal outcomes Avoid use of scopolamine transdermal systemin pregnant women with severe preeclampsia because eclamptic seizures have beenreported after exposure to scopolamine (see Data)
In animal studies there was no evidence of adverse developmental effects withintravenous administration of scopolamine hydrobromide revealed in ratsEmbryotoxicity was observed in rabbits at intravenous doses producing plasma levelsapproximately 100 times the levels achieved in humans using a transdermal systemThe estimated background risk of major birth defects and miscarriage for the indicatedpopulation is unknown All pregnancies have a background risk of birth defect loss orother adverse outcomes In the US general population the background risk of majorbirth defects and miscarriage in clinically recognized pregnancies is 2 to 4 and 15to 20 respectivelyDataHuman Data
Eclamptic Seizures In published case reports two pregnant patients with severe preeclampsia wereadministered intravenous and intramuscular scopolamine respectively and developedeclamptic seizures soon after scopolamine administration [see Warnings and Precautions(53)]
Animal Data
In animal reproduction studies when pregnant rats and rabbits received scopolaminehydrobromide by daily intravenous injection no adverse effects were observed in ratsAn embryotoxic effect was observed in rabbits at doses producing plasma levelsapproximately 100 times the levels achieved in humans using a transdermal systemScopolamine administered parenterally to rats and rabbits at doses higher than the dosedelivered by scopolamine transdermal system did not affect uterine contractions orincrease the duration of labor
82 LactationRisk SummaryScopolamine is present in human milk There are no available data on the effects ofscopolamine on the breastfed infant or the effects on milk production Because therehave been no consistent reports of adverse events in breastfed infants over decades ofuse the developmental and health benefits of breastfeeding should be considered alongwith the motherrsquos clinical need for scopolamine transdermal system and any potentialadverse effects on the breastfed child from scopolamine transdermal system or fromthe underlying maternal condition
84 Pediatric UseSafety and effectiveness in pediatric patients have not been established Pediatricpatients are particularly susceptible to the adverse reactions of scopolamine includingmydriasis hallucinations amblyopia and drug withdrawal syndrome Neurologic andpsychiatric adverse reactions such as hallucinations amblyopia and mydriasis have alsobeen reported
85 Geriatric UseClinical trials of scopolamine transdermal system did not include sufficient number ofsubjects aged 65 years and older to determine if they respond differently from youngersubjects In other clinical experience elderly patients had an increased risk of neurologicand psychiatric adverse reactions such as hallucinations confusion dizziness and drugwithdrawal syndrome [see Warnings and Precautions (52 55)] Consider morefrequent monitoring for CNS adverse reactions during treatment with scopolaminetransdermal system in elderly patients [see Warnings and Precautions (52)]
86 Renal or Hepatic ImpairmentScopolamine transdermal system has not been studied in patients with renal or hepaticimpairment Consider more frequent monitoring during treatment with scopolaminetransdermal system in patients with renal or hepatic impairment because of theincreased risk of CNS adverse reactions [see Warnings and Precautions (52)]
9 DRUG ABUSE AND DEPENDENCE
91 Controlled SubstanceScopolamine transdermal system contains scopolamine which is not a controlled
substance
93 DependenceTermination of scopolamine transdermal system usually after several days of use mayresult in withdrawal symptoms such as disturbances of equilibrium dizziness nauseavomiting abdominal cramps sweating headache mental confusion muscle weaknessbradycardia and hypotension These withdrawal symptoms indicate that scopolaminelike other anticholinergic drugs may produce physical dependence The onset of thesesymptoms generally 24 hours or more after the transdermal system has beenremoved can be severe and may require medical intervention [see Warnings andPrecautions (55)]
10 OVERDOSAGEThe signs and symptoms of anticholinergic toxicity include lethargy somnolence comaconfusion agitation hallucinations convulsion visual disturbance dry flushed skin drymouth decreased bowel sounds urinary retention tachycardia hypertension andsupraventricular arrhythmias These symptoms can be severe and may require medicalinterventionIn cases of toxicity remove the scopolamine transdermal system Serious symptomaticcases of overdosage involving multiple transdermal system applications andor ingestionmay be managed by initially ensuring the patient has an adequate airway and supportingrespiration and circulation This should be rapidly followed by removal of all transdermalsystems from the skin and the mouth If there is evidence of transdermal systemingestion endoscopic removal of swallowed transdermal systems or administration ofactivated charcoal should be considered as indicated by the clinical situation In anycase where there is serious overdosage or signs of evolving acute toxicity continuousmonitoring of vital signs and ECG establishment of intravenous access andadministration of oxygen are all recommendedThe signs and symptoms of overdosetoxicity due to scopolamine should be carefullydistinguished from the occasionally observed syndrome of withdrawal [see Warningsand Precautions (55)] Although mental confusion and dizziness may be observed withboth acute toxicity and withdrawal other characteristic findings differtachyarrhythmias dry skin and decreased bowel sounds suggest anticholinergictoxicity while bradycardia headache nausea and abdominal cramps and sweatingsuggest post-removal withdrawalIf over-exposure occurs call your Poison Control Center at 1-800-222-1222 for currentinformation on the management of poisoning or overdosage
11 DESCRIPTIONScopolamine transdermal system is designed for continuous release of scopolaminefollowing application to an area of intact skin on the head behind the ear Each systemcontains 13 mg of scopolamine base Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3310 ]nonan-7-yl) 3-hydroxy-2-phenylpropanoate The empirical formulais C H NO and its structural formula is
24
17 21 4
Scopolamine has a molecular weight of 30335 and a pKa of 755-781 The scopolaminetransdermal system is a circular 02 mm thick 25 cm film with four layers Proceedingfrom the visible surface towards the surface attached to the skin these layers are (1) abacking membrane of tan-colored aluminized polyester film (2) a drug layer ofscopolamine crospovidone isopropyl palmitate light mineral oil and polyisobutylene (3)an ethylene vinyl acetate copolymer membrane that controls the rate of delivery ofscopolamine from the system to the skin surface and (4) an contact layer formulationof crospovidone isopropyl palmitate light mineral oil polyisobutylene and scopolamineA release liner of siliconized polyester which covers the adhesive layer is removedbefore the system is usedCross section of the system
12 CLINICAL PHARMACOLOGY
121 Mechanism of ActionScopolamine a belladonna alkaloid is an anticholinergic Scopolamine acts i) as acompetitive inhibitor at postganglionic muscarinic receptor sites of the parasympatheticnervous system and ii) on smooth muscles that respond to acetylcholine but lackcholinergic innervation It has been suggested that scopolamine acts in the centralnervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei tohigher centers in the CNS and from the reticular formation to the vomiting centerScopolamine can inhibit the secretion of saliva and sweat decrease gastrointestinalsecretions and motility cause drowsiness dilate the pupils increase heart rate anddepress motor function
123 PharmacokineticsThe system is formulated to deliver approximately 1 mg of scopolamine to the systemiccirculation over 3 daysAbsorption
2
Following application to the skin behind the ear circulating plasma concentrations aredetected within 4 hours with peak concentrations being obtained on average within 24hours The average plasma concentration produced is 87 pgmL (028 nM) for freescopolamine and 354 pgmL for total scopolamine (free + conjugates) Followingremoval of the used transdermal system there is some degree of continued systemicabsorption of scopolamine bound in the skin layersDistribution The distribution of scopolamine is not well characterized It crosses the placenta and theblood brain barrier and may be reversibly bound to plasma proteinsEliminationMetabolism and Excretion Scopolamine is metabolized and conjugated with less than 5 of the total doseappearing unchanged in the urine The enzymes responsible for metabolizingscopolamine are unknown The exact elimination pattern of scopolamine has not beendetermined Following transdermal system removal plasma concentrations ofscopolamine decline in a log linear fashion with an observed half-life of 95 hours Lessthan 10 of the total dose is excreted in the urine as the parent drug and metabolitesover 108 hoursDrug Interaction StudiesAn in vitro study using human hepatocytes examined the induction of CYP1A2 andCYP3A4 by scopolamine Scopolamine did not induce CYP1A2 and CYP3A4 isoenzymesat the concentrations up to 10 nM In an in vitro study using human liver microsomeswhich evaluated the inhibition of CYP1A2 2C8 2C9 2C19 2D6 and 3A4 scopolaminedid not inhibit these cytochrome P450 isoenzymes at the concentrations up to 1micromolar No in vivo drug-drug interaction studies have been conducted
13 NONCLINICAL TOXICOLOGY
131 Carcinogenesis Mutagenesis Impairment of FertilityNo long-term studies in animals have been conducted to evaluate the carcinogenicpotential of scopolamine The mutagenic potential of scopolamine has not beenevaluatedFertility studies were performed in female rats and revealed no evidence of impairedfertility or harm to the fetus due to scopolamine hydrobromide administered by dailysubcutaneous injection Maternal body weights were reduced in the highest-dose group(plasma level approximately 500 times the level achieved in humans using a transdermalsystem) However fertility studies in male animals were not performed
14 CLINICAL STUDIES
141 Prevention of Motion SicknessIn 195 adult subjects of different racial origins who participated in clinical efficacy studiesat sea or in a controlled motion environment there was a 75 reduction in the incidenceof motion-induced nausea and vomiting Scopolamine transdermal system was applied
from 4 to 16 hours prior to the onset of motion in these studies
142 Prevention of Post-Operative Nausea and VomitingA clinical efficacy study evaluated 168 adult female patients undergoing gynecologicalsurgery with anesthesia and opiate analgesia Patients received scopolamine transdermalsystem or placebo applied approximately 11 hours before anesthesiaopiate analgesiaNo retchingvomiting during the 24-hour post-operative period was reported in 79 ofthose treated with scopolamine transdermal system compared to 72 of thosereceiving placebo When the need for additional antiemetic medication was assessedduring the same period there was no need for medication in 89 of patients treatedwith scopolamine transdermal system as compared to 72 of placebo-treated patients
16 HOW SUPPLIEDSTORAGE AND HANDLINGScopolamine Transdermal System 1 mg3 days is available as the following
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Store at 20degC to 25degC (68degF to 77degF) [see USP Controlled Room Temperature]Store pouch(es) in an upright positionDo not bend or roll pouch(es)Wash hands thoroughly with soap and water immediately after handling the transdermalsystem Upon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidental contactor ingestion by children pets or others [see Dosage and Administration (21) Warningsand Precautions (56)]
17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information andInstructions for Use)Administration InstructionsCounsel patients on how to apply and remove the transdermal system [see Dosage andAdministration (21)]
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Carton of 4 transdermal systems packaged into individual foil pouches NDC45802-580-84Carton of 10 transdermal systems packaged into individual foil pouches NDC45802-580-46Carton of 24 transdermal systems packaged into individual foil pouches NDC45802-580-62
Only wear one transdermal system at any timeDo not cut the transdermal systemApply the transdermal system to the skin in the postauricular (hairless area behindone ear) areaAfter the transdermal system is applied on the dry skin behind the ear wash handsthoroughly with soap and water and dry handsIf the transdermal system becomes displaced discard the transdermal system and
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Patients with Open-Angle GlaucomaAdvise patients with open-angle glaucoma to remove the scopolamine transdermalsystem immediately and contact their healthcare provider if they experience symptomsof acute angle closure glaucoma including pain and reddening of the eyes accompaniedby dilated pupils blurred vision andor seeing halos around lights [see Warnings andPrecautions (51)]Neuropsychiatric Adverse Reactions
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Decreased Gastrointestinal Motility and Urinary RetentionInstruct patients to remove the transdermal system if they develop symptoms ofintestinal obstruction (abdominal pain nausea or vomiting) or any difficulties in urinating[see Warnings and Precautions (54)]Drug WithdrawalPost-Removal SymptomsInform patients that if they remove the scopolamine transdermal system beforetreatment is complete withdrawal symptoms may occur and to seek immediate medicalcare if they develop severe symptoms after removing scopolamine transdermal system[see Warnings and Precautions (55)]Blurred VisionInform patients that temporary dilation of the pupils and blurred vision may occur ifscopolamine transdermal system comes in contact with the eyes Instruct patients towash their hands thoroughly with soap and water immediately after handling thetransdermal system [see Dosage and Administration (21) Warnings and Precautions(56)]MRI Skin BurnsInstruct patients to remove the scopolamine transdermal system before undergoing an
If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
Advise patients that psychiatric adverse reactions may occur especially in patientswith a past psychiatric history or in those receiving other drugs also associatedwith psychiatric effects and to report to their healthcare provider any new orworsening psychiatric symptomsAdvise patients to discontinue scopolamine transdermal system and contact ahealthcare provider immediately if they experience a seizureAdvise patients especially elderly patients that cognitive impairment may occurduring treatment with scopolamine transdermal system especially in thosereceiving other drugs also associated with CNS effects and to report to theirhealthcare provider if they develop signs or symptoms of cognitive impairmentsuch as hallucinations confusion or dizzinessInform patients not to operate motor vehicles or other dangerous machinery orparticipate in underwater sports until they are reasonably certain that scopolaminetransdermal system does not affect them adversely [see Warnings and Precautions(52)]
MRI [see Warnings and Precautions (57)]
Manufactured byAVEVA DRUG DELIVERY SYSTEMSAn APOTEX CompanyMiramar FL 33025Distributed ByPerrigoregAllegan MI 49010 wwwperrigocom5A800 RC BR7
Medication Guide
MEDICATION GUIDEScopolamine (skoe polrsquo a meen) Transdermal System
Read this Patient Information before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentWhat is scopolamine transdermal systemScopolamine transdermal system is a prescription medicine used for adults to helpprevent
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It is not known if scopolamine transdermal system is safe or effective in childrenWho should not use scopolamine transdermal systemDo not use Transderm Scōp if you
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What should I tell my doctor before using scopolamine transdermal systemBefore you use scopolamine transdermal system tell your doctor about all of yourmedical conditions including if you
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nausea and vomiting from motion sicknessnausea and vomiting from anesthesia or taking opioid pain medicines after surgery
have an eye problem called angle closure glaucomaare allergic to scopolamine belladonna alkaloids or any of the ingredients inscopolamine transdermal system See the end of this leaflet for a list of theingredients in scopolamine transdermal system Ask your doctor if you are notsure
have glaucoma (increased pressure in the eye)have a history of seizures or psychosishave problems with your stomach or intestineshave trouble urinatingare scheduled to have a gastric secretion testhave liver or kidney problemsare pregnant or plan to become pregnant It is not known if scopolamine
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Tell your doctor about all the medicines you take including prescription andover-the-counter medicines vitamins and herbal supplements Scopolamine transdermalsystem may affect the way other medicines work and other medicines may affect howscopolamine transdermal system works Medicines that you take by mouth may not beabsorbed well while you use scopolamine transdermal systemEspecially tell your doctor if you take
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Ask your doctor if you are not sure if your medicine is one that is listed aboveKnow the medicines you take Keep a list of them and show it to your doctor orpharmacist when you get a new medicineHow should I use scopolamine transdermal system
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What should I avoid while using scopolamine transdermal system
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What are the possible side effects of scopolamine transdermal systemScopolamine transdermal system may cause serious side effects including
transdermal system can harm your unborn babyare breastfeeding or plan to breastfeed Scopolamine can pass into your breastmilk and may harm your baby Talk to your doctor about the best way to feed yourbaby if you use scopolamine transdermal system
a sedative hypnotic opioid or anxiolytic (medicines that make you sleepy)an antidepressant medicinean anticholinergic medicine such as an allergy or cold medicine a medicine to treatbladder or bowel spasms certain asthma medicines or other medicines for motionsickness
See the detailed Instructions for Use for information about how to usescopolamine transdermal system at the end of this Patient Information leafletIt is important that you apply scopolamine transdermal system exactly as yourdoctor tells you toYour doctor may change your scopolamine transdermal system dose Do notchange your scopolamine transdermal system dose without talking to your doctorWear only one scopolamine transdermal system at any timeIf you use too much scopolamine transdermal system call your doctor or PoisonControl Center at 1-800-222-1222 or go to the nearest hospital emergency roomright away
You should not drink alcohol while using scopolamine transdermal system It canincrease your chances of having serious side effectsYou should not drive operate heavy machinery or do other dangerous activitiesuntil you know how scopolamine transdermal system affects youYou should not use scopolamine transdermal system during a Magnetic ResonanceImaging scan (MRI) Remove scopolamine transdermal system before undergoingan MRI It can cause your skin to burnYou should be careful if you use scopolamine transdermal system while youparticipate in watersports because you may feel lost or confused (disoriented)Limit contact with water while swimming and bathing because scopolaminetransdermal system may fall off If scopolamine transdermal system falls off throwit away and apply a new one on the hairless area behind your other ear
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The most common side effects of using scopolamine transdermal systeminclude
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Tell your doctor if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of scopolamine transdermal systemCall your doctor for medical advice about side effects You may report side effects toFDA at 1-800-FDA-1088General information about the safe and effective use of scopolaminetransdermal system
angle closure glaucoma If you have open angle glaucoma and use scopolaminetransdermal system remove scopolamine transdermal system and call a doctorright away if you feel pain or discomfort have blurred vision or see halos orcolored images around lights and reddening of your eyesworsening of seizures Tell your doctor about any worsening of seizures whileusing scopolamine transdermal systeman unusual reaction called acute psychosis Tell your doctor if you have anyof these symptoms
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confusionagitationrambling speechhallucinations (seeing or hearing things that are not there)paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy Some pregnant womenwith severe preeclampsia have had seizures after getting scopolamine by injectionin the muscle (intramuscular) or injection in the vein (intravenous)difficulty urinatingdifficulties in food passing from the stomach to the small intestineswhich may cause abdominal pain nausea or vomitingwithdrawal symptoms after removing scopolamine transdermal systemafter using it for several days Some people may have certain symptoms suchas difficulty with balance dizziness nausea vomiting stomach cramps sweatingconfusion muscle weakness low heart rate or low blood pressure that could start24 hours or more after removing scopolamine transdermal system Call yourdoctor right away if your symptoms become severetemporary increase in the size of your pupil and blurry vision especially ifscopolamine transdermal system comes in contact with your eyesskin burns at the site of scopolamine transdermal system This canhappen during a medical test called a Magnetic Resonance Imaging scan (MRI)Scopolamine transdermal system contains aluminum and should be removed fromyour skin before you have an MRI
dry mouth blurred vision oreye problems
feeling sleepy ordrowsy
disorientation(confusion)
dizziness feeling agitatedor irritable
pharyngitis(sore throat)
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
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To help prevent nausea and vomiting from motion sickness
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To help prevent nausea and vomiting after surgery
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How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
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Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
Animal Data
In animal reproduction studies when pregnant rats and rabbits received scopolaminehydrobromide by daily intravenous injection no adverse effects were observed in ratsAn embryotoxic effect was observed in rabbits at doses producing plasma levelsapproximately 100 times the levels achieved in humans using a transdermal systemScopolamine administered parenterally to rats and rabbits at doses higher than the dosedelivered by scopolamine transdermal system did not affect uterine contractions orincrease the duration of labor
82 LactationRisk SummaryScopolamine is present in human milk There are no available data on the effects ofscopolamine on the breastfed infant or the effects on milk production Because therehave been no consistent reports of adverse events in breastfed infants over decades ofuse the developmental and health benefits of breastfeeding should be considered alongwith the motherrsquos clinical need for scopolamine transdermal system and any potentialadverse effects on the breastfed child from scopolamine transdermal system or fromthe underlying maternal condition
84 Pediatric UseSafety and effectiveness in pediatric patients have not been established Pediatricpatients are particularly susceptible to the adverse reactions of scopolamine includingmydriasis hallucinations amblyopia and drug withdrawal syndrome Neurologic andpsychiatric adverse reactions such as hallucinations amblyopia and mydriasis have alsobeen reported
85 Geriatric UseClinical trials of scopolamine transdermal system did not include sufficient number ofsubjects aged 65 years and older to determine if they respond differently from youngersubjects In other clinical experience elderly patients had an increased risk of neurologicand psychiatric adverse reactions such as hallucinations confusion dizziness and drugwithdrawal syndrome [see Warnings and Precautions (52 55)] Consider morefrequent monitoring for CNS adverse reactions during treatment with scopolaminetransdermal system in elderly patients [see Warnings and Precautions (52)]
86 Renal or Hepatic ImpairmentScopolamine transdermal system has not been studied in patients with renal or hepaticimpairment Consider more frequent monitoring during treatment with scopolaminetransdermal system in patients with renal or hepatic impairment because of theincreased risk of CNS adverse reactions [see Warnings and Precautions (52)]
9 DRUG ABUSE AND DEPENDENCE
91 Controlled SubstanceScopolamine transdermal system contains scopolamine which is not a controlled
substance
93 DependenceTermination of scopolamine transdermal system usually after several days of use mayresult in withdrawal symptoms such as disturbances of equilibrium dizziness nauseavomiting abdominal cramps sweating headache mental confusion muscle weaknessbradycardia and hypotension These withdrawal symptoms indicate that scopolaminelike other anticholinergic drugs may produce physical dependence The onset of thesesymptoms generally 24 hours or more after the transdermal system has beenremoved can be severe and may require medical intervention [see Warnings andPrecautions (55)]
10 OVERDOSAGEThe signs and symptoms of anticholinergic toxicity include lethargy somnolence comaconfusion agitation hallucinations convulsion visual disturbance dry flushed skin drymouth decreased bowel sounds urinary retention tachycardia hypertension andsupraventricular arrhythmias These symptoms can be severe and may require medicalinterventionIn cases of toxicity remove the scopolamine transdermal system Serious symptomaticcases of overdosage involving multiple transdermal system applications andor ingestionmay be managed by initially ensuring the patient has an adequate airway and supportingrespiration and circulation This should be rapidly followed by removal of all transdermalsystems from the skin and the mouth If there is evidence of transdermal systemingestion endoscopic removal of swallowed transdermal systems or administration ofactivated charcoal should be considered as indicated by the clinical situation In anycase where there is serious overdosage or signs of evolving acute toxicity continuousmonitoring of vital signs and ECG establishment of intravenous access andadministration of oxygen are all recommendedThe signs and symptoms of overdosetoxicity due to scopolamine should be carefullydistinguished from the occasionally observed syndrome of withdrawal [see Warningsand Precautions (55)] Although mental confusion and dizziness may be observed withboth acute toxicity and withdrawal other characteristic findings differtachyarrhythmias dry skin and decreased bowel sounds suggest anticholinergictoxicity while bradycardia headache nausea and abdominal cramps and sweatingsuggest post-removal withdrawalIf over-exposure occurs call your Poison Control Center at 1-800-222-1222 for currentinformation on the management of poisoning or overdosage
11 DESCRIPTIONScopolamine transdermal system is designed for continuous release of scopolaminefollowing application to an area of intact skin on the head behind the ear Each systemcontains 13 mg of scopolamine base Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3310 ]nonan-7-yl) 3-hydroxy-2-phenylpropanoate The empirical formulais C H NO and its structural formula is
24
17 21 4
Scopolamine has a molecular weight of 30335 and a pKa of 755-781 The scopolaminetransdermal system is a circular 02 mm thick 25 cm film with four layers Proceedingfrom the visible surface towards the surface attached to the skin these layers are (1) abacking membrane of tan-colored aluminized polyester film (2) a drug layer ofscopolamine crospovidone isopropyl palmitate light mineral oil and polyisobutylene (3)an ethylene vinyl acetate copolymer membrane that controls the rate of delivery ofscopolamine from the system to the skin surface and (4) an contact layer formulationof crospovidone isopropyl palmitate light mineral oil polyisobutylene and scopolamineA release liner of siliconized polyester which covers the adhesive layer is removedbefore the system is usedCross section of the system
12 CLINICAL PHARMACOLOGY
121 Mechanism of ActionScopolamine a belladonna alkaloid is an anticholinergic Scopolamine acts i) as acompetitive inhibitor at postganglionic muscarinic receptor sites of the parasympatheticnervous system and ii) on smooth muscles that respond to acetylcholine but lackcholinergic innervation It has been suggested that scopolamine acts in the centralnervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei tohigher centers in the CNS and from the reticular formation to the vomiting centerScopolamine can inhibit the secretion of saliva and sweat decrease gastrointestinalsecretions and motility cause drowsiness dilate the pupils increase heart rate anddepress motor function
123 PharmacokineticsThe system is formulated to deliver approximately 1 mg of scopolamine to the systemiccirculation over 3 daysAbsorption
2
Following application to the skin behind the ear circulating plasma concentrations aredetected within 4 hours with peak concentrations being obtained on average within 24hours The average plasma concentration produced is 87 pgmL (028 nM) for freescopolamine and 354 pgmL for total scopolamine (free + conjugates) Followingremoval of the used transdermal system there is some degree of continued systemicabsorption of scopolamine bound in the skin layersDistribution The distribution of scopolamine is not well characterized It crosses the placenta and theblood brain barrier and may be reversibly bound to plasma proteinsEliminationMetabolism and Excretion Scopolamine is metabolized and conjugated with less than 5 of the total doseappearing unchanged in the urine The enzymes responsible for metabolizingscopolamine are unknown The exact elimination pattern of scopolamine has not beendetermined Following transdermal system removal plasma concentrations ofscopolamine decline in a log linear fashion with an observed half-life of 95 hours Lessthan 10 of the total dose is excreted in the urine as the parent drug and metabolitesover 108 hoursDrug Interaction StudiesAn in vitro study using human hepatocytes examined the induction of CYP1A2 andCYP3A4 by scopolamine Scopolamine did not induce CYP1A2 and CYP3A4 isoenzymesat the concentrations up to 10 nM In an in vitro study using human liver microsomeswhich evaluated the inhibition of CYP1A2 2C8 2C9 2C19 2D6 and 3A4 scopolaminedid not inhibit these cytochrome P450 isoenzymes at the concentrations up to 1micromolar No in vivo drug-drug interaction studies have been conducted
13 NONCLINICAL TOXICOLOGY
131 Carcinogenesis Mutagenesis Impairment of FertilityNo long-term studies in animals have been conducted to evaluate the carcinogenicpotential of scopolamine The mutagenic potential of scopolamine has not beenevaluatedFertility studies were performed in female rats and revealed no evidence of impairedfertility or harm to the fetus due to scopolamine hydrobromide administered by dailysubcutaneous injection Maternal body weights were reduced in the highest-dose group(plasma level approximately 500 times the level achieved in humans using a transdermalsystem) However fertility studies in male animals were not performed
14 CLINICAL STUDIES
141 Prevention of Motion SicknessIn 195 adult subjects of different racial origins who participated in clinical efficacy studiesat sea or in a controlled motion environment there was a 75 reduction in the incidenceof motion-induced nausea and vomiting Scopolamine transdermal system was applied
from 4 to 16 hours prior to the onset of motion in these studies
142 Prevention of Post-Operative Nausea and VomitingA clinical efficacy study evaluated 168 adult female patients undergoing gynecologicalsurgery with anesthesia and opiate analgesia Patients received scopolamine transdermalsystem or placebo applied approximately 11 hours before anesthesiaopiate analgesiaNo retchingvomiting during the 24-hour post-operative period was reported in 79 ofthose treated with scopolamine transdermal system compared to 72 of thosereceiving placebo When the need for additional antiemetic medication was assessedduring the same period there was no need for medication in 89 of patients treatedwith scopolamine transdermal system as compared to 72 of placebo-treated patients
16 HOW SUPPLIEDSTORAGE AND HANDLINGScopolamine Transdermal System 1 mg3 days is available as the following
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Store at 20degC to 25degC (68degF to 77degF) [see USP Controlled Room Temperature]Store pouch(es) in an upright positionDo not bend or roll pouch(es)Wash hands thoroughly with soap and water immediately after handling the transdermalsystem Upon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidental contactor ingestion by children pets or others [see Dosage and Administration (21) Warningsand Precautions (56)]
17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information andInstructions for Use)Administration InstructionsCounsel patients on how to apply and remove the transdermal system [see Dosage andAdministration (21)]
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Carton of 4 transdermal systems packaged into individual foil pouches NDC45802-580-84Carton of 10 transdermal systems packaged into individual foil pouches NDC45802-580-46Carton of 24 transdermal systems packaged into individual foil pouches NDC45802-580-62
Only wear one transdermal system at any timeDo not cut the transdermal systemApply the transdermal system to the skin in the postauricular (hairless area behindone ear) areaAfter the transdermal system is applied on the dry skin behind the ear wash handsthoroughly with soap and water and dry handsIf the transdermal system becomes displaced discard the transdermal system and
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Patients with Open-Angle GlaucomaAdvise patients with open-angle glaucoma to remove the scopolamine transdermalsystem immediately and contact their healthcare provider if they experience symptomsof acute angle closure glaucoma including pain and reddening of the eyes accompaniedby dilated pupils blurred vision andor seeing halos around lights [see Warnings andPrecautions (51)]Neuropsychiatric Adverse Reactions
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Decreased Gastrointestinal Motility and Urinary RetentionInstruct patients to remove the transdermal system if they develop symptoms ofintestinal obstruction (abdominal pain nausea or vomiting) or any difficulties in urinating[see Warnings and Precautions (54)]Drug WithdrawalPost-Removal SymptomsInform patients that if they remove the scopolamine transdermal system beforetreatment is complete withdrawal symptoms may occur and to seek immediate medicalcare if they develop severe symptoms after removing scopolamine transdermal system[see Warnings and Precautions (55)]Blurred VisionInform patients that temporary dilation of the pupils and blurred vision may occur ifscopolamine transdermal system comes in contact with the eyes Instruct patients towash their hands thoroughly with soap and water immediately after handling thetransdermal system [see Dosage and Administration (21) Warnings and Precautions(56)]MRI Skin BurnsInstruct patients to remove the scopolamine transdermal system before undergoing an
If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
Advise patients that psychiatric adverse reactions may occur especially in patientswith a past psychiatric history or in those receiving other drugs also associatedwith psychiatric effects and to report to their healthcare provider any new orworsening psychiatric symptomsAdvise patients to discontinue scopolamine transdermal system and contact ahealthcare provider immediately if they experience a seizureAdvise patients especially elderly patients that cognitive impairment may occurduring treatment with scopolamine transdermal system especially in thosereceiving other drugs also associated with CNS effects and to report to theirhealthcare provider if they develop signs or symptoms of cognitive impairmentsuch as hallucinations confusion or dizzinessInform patients not to operate motor vehicles or other dangerous machinery orparticipate in underwater sports until they are reasonably certain that scopolaminetransdermal system does not affect them adversely [see Warnings and Precautions(52)]
MRI [see Warnings and Precautions (57)]
Manufactured byAVEVA DRUG DELIVERY SYSTEMSAn APOTEX CompanyMiramar FL 33025Distributed ByPerrigoregAllegan MI 49010 wwwperrigocom5A800 RC BR7
Medication Guide
MEDICATION GUIDEScopolamine (skoe polrsquo a meen) Transdermal System
Read this Patient Information before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentWhat is scopolamine transdermal systemScopolamine transdermal system is a prescription medicine used for adults to helpprevent
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It is not known if scopolamine transdermal system is safe or effective in childrenWho should not use scopolamine transdermal systemDo not use Transderm Scōp if you
bullbull
What should I tell my doctor before using scopolamine transdermal systemBefore you use scopolamine transdermal system tell your doctor about all of yourmedical conditions including if you
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nausea and vomiting from motion sicknessnausea and vomiting from anesthesia or taking opioid pain medicines after surgery
have an eye problem called angle closure glaucomaare allergic to scopolamine belladonna alkaloids or any of the ingredients inscopolamine transdermal system See the end of this leaflet for a list of theingredients in scopolamine transdermal system Ask your doctor if you are notsure
have glaucoma (increased pressure in the eye)have a history of seizures or psychosishave problems with your stomach or intestineshave trouble urinatingare scheduled to have a gastric secretion testhave liver or kidney problemsare pregnant or plan to become pregnant It is not known if scopolamine
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Tell your doctor about all the medicines you take including prescription andover-the-counter medicines vitamins and herbal supplements Scopolamine transdermalsystem may affect the way other medicines work and other medicines may affect howscopolamine transdermal system works Medicines that you take by mouth may not beabsorbed well while you use scopolamine transdermal systemEspecially tell your doctor if you take
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Ask your doctor if you are not sure if your medicine is one that is listed aboveKnow the medicines you take Keep a list of them and show it to your doctor orpharmacist when you get a new medicineHow should I use scopolamine transdermal system
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What should I avoid while using scopolamine transdermal system
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What are the possible side effects of scopolamine transdermal systemScopolamine transdermal system may cause serious side effects including
transdermal system can harm your unborn babyare breastfeeding or plan to breastfeed Scopolamine can pass into your breastmilk and may harm your baby Talk to your doctor about the best way to feed yourbaby if you use scopolamine transdermal system
a sedative hypnotic opioid or anxiolytic (medicines that make you sleepy)an antidepressant medicinean anticholinergic medicine such as an allergy or cold medicine a medicine to treatbladder or bowel spasms certain asthma medicines or other medicines for motionsickness
See the detailed Instructions for Use for information about how to usescopolamine transdermal system at the end of this Patient Information leafletIt is important that you apply scopolamine transdermal system exactly as yourdoctor tells you toYour doctor may change your scopolamine transdermal system dose Do notchange your scopolamine transdermal system dose without talking to your doctorWear only one scopolamine transdermal system at any timeIf you use too much scopolamine transdermal system call your doctor or PoisonControl Center at 1-800-222-1222 or go to the nearest hospital emergency roomright away
You should not drink alcohol while using scopolamine transdermal system It canincrease your chances of having serious side effectsYou should not drive operate heavy machinery or do other dangerous activitiesuntil you know how scopolamine transdermal system affects youYou should not use scopolamine transdermal system during a Magnetic ResonanceImaging scan (MRI) Remove scopolamine transdermal system before undergoingan MRI It can cause your skin to burnYou should be careful if you use scopolamine transdermal system while youparticipate in watersports because you may feel lost or confused (disoriented)Limit contact with water while swimming and bathing because scopolaminetransdermal system may fall off If scopolamine transdermal system falls off throwit away and apply a new one on the hairless area behind your other ear
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The most common side effects of using scopolamine transdermal systeminclude
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Tell your doctor if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of scopolamine transdermal systemCall your doctor for medical advice about side effects You may report side effects toFDA at 1-800-FDA-1088General information about the safe and effective use of scopolaminetransdermal system
angle closure glaucoma If you have open angle glaucoma and use scopolaminetransdermal system remove scopolamine transdermal system and call a doctorright away if you feel pain or discomfort have blurred vision or see halos orcolored images around lights and reddening of your eyesworsening of seizures Tell your doctor about any worsening of seizures whileusing scopolamine transdermal systeman unusual reaction called acute psychosis Tell your doctor if you have anyof these symptoms
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confusionagitationrambling speechhallucinations (seeing or hearing things that are not there)paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy Some pregnant womenwith severe preeclampsia have had seizures after getting scopolamine by injectionin the muscle (intramuscular) or injection in the vein (intravenous)difficulty urinatingdifficulties in food passing from the stomach to the small intestineswhich may cause abdominal pain nausea or vomitingwithdrawal symptoms after removing scopolamine transdermal systemafter using it for several days Some people may have certain symptoms suchas difficulty with balance dizziness nausea vomiting stomach cramps sweatingconfusion muscle weakness low heart rate or low blood pressure that could start24 hours or more after removing scopolamine transdermal system Call yourdoctor right away if your symptoms become severetemporary increase in the size of your pupil and blurry vision especially ifscopolamine transdermal system comes in contact with your eyesskin burns at the site of scopolamine transdermal system This canhappen during a medical test called a Magnetic Resonance Imaging scan (MRI)Scopolamine transdermal system contains aluminum and should be removed fromyour skin before you have an MRI
dry mouth blurred vision oreye problems
feeling sleepy ordrowsy
disorientation(confusion)
dizziness feeling agitatedor irritable
pharyngitis(sore throat)
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
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To help prevent nausea and vomiting from motion sickness
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To help prevent nausea and vomiting after surgery
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How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
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Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
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How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
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Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
substance
93 DependenceTermination of scopolamine transdermal system usually after several days of use mayresult in withdrawal symptoms such as disturbances of equilibrium dizziness nauseavomiting abdominal cramps sweating headache mental confusion muscle weaknessbradycardia and hypotension These withdrawal symptoms indicate that scopolaminelike other anticholinergic drugs may produce physical dependence The onset of thesesymptoms generally 24 hours or more after the transdermal system has beenremoved can be severe and may require medical intervention [see Warnings andPrecautions (55)]
10 OVERDOSAGEThe signs and symptoms of anticholinergic toxicity include lethargy somnolence comaconfusion agitation hallucinations convulsion visual disturbance dry flushed skin drymouth decreased bowel sounds urinary retention tachycardia hypertension andsupraventricular arrhythmias These symptoms can be severe and may require medicalinterventionIn cases of toxicity remove the scopolamine transdermal system Serious symptomaticcases of overdosage involving multiple transdermal system applications andor ingestionmay be managed by initially ensuring the patient has an adequate airway and supportingrespiration and circulation This should be rapidly followed by removal of all transdermalsystems from the skin and the mouth If there is evidence of transdermal systemingestion endoscopic removal of swallowed transdermal systems or administration ofactivated charcoal should be considered as indicated by the clinical situation In anycase where there is serious overdosage or signs of evolving acute toxicity continuousmonitoring of vital signs and ECG establishment of intravenous access andadministration of oxygen are all recommendedThe signs and symptoms of overdosetoxicity due to scopolamine should be carefullydistinguished from the occasionally observed syndrome of withdrawal [see Warningsand Precautions (55)] Although mental confusion and dizziness may be observed withboth acute toxicity and withdrawal other characteristic findings differtachyarrhythmias dry skin and decreased bowel sounds suggest anticholinergictoxicity while bradycardia headache nausea and abdominal cramps and sweatingsuggest post-removal withdrawalIf over-exposure occurs call your Poison Control Center at 1-800-222-1222 for currentinformation on the management of poisoning or overdosage
11 DESCRIPTIONScopolamine transdermal system is designed for continuous release of scopolaminefollowing application to an area of intact skin on the head behind the ear Each systemcontains 13 mg of scopolamine base Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3310 ]nonan-7-yl) 3-hydroxy-2-phenylpropanoate The empirical formulais C H NO and its structural formula is
24
17 21 4
Scopolamine has a molecular weight of 30335 and a pKa of 755-781 The scopolaminetransdermal system is a circular 02 mm thick 25 cm film with four layers Proceedingfrom the visible surface towards the surface attached to the skin these layers are (1) abacking membrane of tan-colored aluminized polyester film (2) a drug layer ofscopolamine crospovidone isopropyl palmitate light mineral oil and polyisobutylene (3)an ethylene vinyl acetate copolymer membrane that controls the rate of delivery ofscopolamine from the system to the skin surface and (4) an contact layer formulationof crospovidone isopropyl palmitate light mineral oil polyisobutylene and scopolamineA release liner of siliconized polyester which covers the adhesive layer is removedbefore the system is usedCross section of the system
12 CLINICAL PHARMACOLOGY
121 Mechanism of ActionScopolamine a belladonna alkaloid is an anticholinergic Scopolamine acts i) as acompetitive inhibitor at postganglionic muscarinic receptor sites of the parasympatheticnervous system and ii) on smooth muscles that respond to acetylcholine but lackcholinergic innervation It has been suggested that scopolamine acts in the centralnervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei tohigher centers in the CNS and from the reticular formation to the vomiting centerScopolamine can inhibit the secretion of saliva and sweat decrease gastrointestinalsecretions and motility cause drowsiness dilate the pupils increase heart rate anddepress motor function
123 PharmacokineticsThe system is formulated to deliver approximately 1 mg of scopolamine to the systemiccirculation over 3 daysAbsorption
2
Following application to the skin behind the ear circulating plasma concentrations aredetected within 4 hours with peak concentrations being obtained on average within 24hours The average plasma concentration produced is 87 pgmL (028 nM) for freescopolamine and 354 pgmL for total scopolamine (free + conjugates) Followingremoval of the used transdermal system there is some degree of continued systemicabsorption of scopolamine bound in the skin layersDistribution The distribution of scopolamine is not well characterized It crosses the placenta and theblood brain barrier and may be reversibly bound to plasma proteinsEliminationMetabolism and Excretion Scopolamine is metabolized and conjugated with less than 5 of the total doseappearing unchanged in the urine The enzymes responsible for metabolizingscopolamine are unknown The exact elimination pattern of scopolamine has not beendetermined Following transdermal system removal plasma concentrations ofscopolamine decline in a log linear fashion with an observed half-life of 95 hours Lessthan 10 of the total dose is excreted in the urine as the parent drug and metabolitesover 108 hoursDrug Interaction StudiesAn in vitro study using human hepatocytes examined the induction of CYP1A2 andCYP3A4 by scopolamine Scopolamine did not induce CYP1A2 and CYP3A4 isoenzymesat the concentrations up to 10 nM In an in vitro study using human liver microsomeswhich evaluated the inhibition of CYP1A2 2C8 2C9 2C19 2D6 and 3A4 scopolaminedid not inhibit these cytochrome P450 isoenzymes at the concentrations up to 1micromolar No in vivo drug-drug interaction studies have been conducted
13 NONCLINICAL TOXICOLOGY
131 Carcinogenesis Mutagenesis Impairment of FertilityNo long-term studies in animals have been conducted to evaluate the carcinogenicpotential of scopolamine The mutagenic potential of scopolamine has not beenevaluatedFertility studies were performed in female rats and revealed no evidence of impairedfertility or harm to the fetus due to scopolamine hydrobromide administered by dailysubcutaneous injection Maternal body weights were reduced in the highest-dose group(plasma level approximately 500 times the level achieved in humans using a transdermalsystem) However fertility studies in male animals were not performed
14 CLINICAL STUDIES
141 Prevention of Motion SicknessIn 195 adult subjects of different racial origins who participated in clinical efficacy studiesat sea or in a controlled motion environment there was a 75 reduction in the incidenceof motion-induced nausea and vomiting Scopolamine transdermal system was applied
from 4 to 16 hours prior to the onset of motion in these studies
142 Prevention of Post-Operative Nausea and VomitingA clinical efficacy study evaluated 168 adult female patients undergoing gynecologicalsurgery with anesthesia and opiate analgesia Patients received scopolamine transdermalsystem or placebo applied approximately 11 hours before anesthesiaopiate analgesiaNo retchingvomiting during the 24-hour post-operative period was reported in 79 ofthose treated with scopolamine transdermal system compared to 72 of thosereceiving placebo When the need for additional antiemetic medication was assessedduring the same period there was no need for medication in 89 of patients treatedwith scopolamine transdermal system as compared to 72 of placebo-treated patients
16 HOW SUPPLIEDSTORAGE AND HANDLINGScopolamine Transdermal System 1 mg3 days is available as the following
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Store at 20degC to 25degC (68degF to 77degF) [see USP Controlled Room Temperature]Store pouch(es) in an upright positionDo not bend or roll pouch(es)Wash hands thoroughly with soap and water immediately after handling the transdermalsystem Upon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidental contactor ingestion by children pets or others [see Dosage and Administration (21) Warningsand Precautions (56)]
17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information andInstructions for Use)Administration InstructionsCounsel patients on how to apply and remove the transdermal system [see Dosage andAdministration (21)]
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Carton of 4 transdermal systems packaged into individual foil pouches NDC45802-580-84Carton of 10 transdermal systems packaged into individual foil pouches NDC45802-580-46Carton of 24 transdermal systems packaged into individual foil pouches NDC45802-580-62
Only wear one transdermal system at any timeDo not cut the transdermal systemApply the transdermal system to the skin in the postauricular (hairless area behindone ear) areaAfter the transdermal system is applied on the dry skin behind the ear wash handsthoroughly with soap and water and dry handsIf the transdermal system becomes displaced discard the transdermal system and
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Patients with Open-Angle GlaucomaAdvise patients with open-angle glaucoma to remove the scopolamine transdermalsystem immediately and contact their healthcare provider if they experience symptomsof acute angle closure glaucoma including pain and reddening of the eyes accompaniedby dilated pupils blurred vision andor seeing halos around lights [see Warnings andPrecautions (51)]Neuropsychiatric Adverse Reactions
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Decreased Gastrointestinal Motility and Urinary RetentionInstruct patients to remove the transdermal system if they develop symptoms ofintestinal obstruction (abdominal pain nausea or vomiting) or any difficulties in urinating[see Warnings and Precautions (54)]Drug WithdrawalPost-Removal SymptomsInform patients that if they remove the scopolamine transdermal system beforetreatment is complete withdrawal symptoms may occur and to seek immediate medicalcare if they develop severe symptoms after removing scopolamine transdermal system[see Warnings and Precautions (55)]Blurred VisionInform patients that temporary dilation of the pupils and blurred vision may occur ifscopolamine transdermal system comes in contact with the eyes Instruct patients towash their hands thoroughly with soap and water immediately after handling thetransdermal system [see Dosage and Administration (21) Warnings and Precautions(56)]MRI Skin BurnsInstruct patients to remove the scopolamine transdermal system before undergoing an
If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
Advise patients that psychiatric adverse reactions may occur especially in patientswith a past psychiatric history or in those receiving other drugs also associatedwith psychiatric effects and to report to their healthcare provider any new orworsening psychiatric symptomsAdvise patients to discontinue scopolamine transdermal system and contact ahealthcare provider immediately if they experience a seizureAdvise patients especially elderly patients that cognitive impairment may occurduring treatment with scopolamine transdermal system especially in thosereceiving other drugs also associated with CNS effects and to report to theirhealthcare provider if they develop signs or symptoms of cognitive impairmentsuch as hallucinations confusion or dizzinessInform patients not to operate motor vehicles or other dangerous machinery orparticipate in underwater sports until they are reasonably certain that scopolaminetransdermal system does not affect them adversely [see Warnings and Precautions(52)]
MRI [see Warnings and Precautions (57)]
Manufactured byAVEVA DRUG DELIVERY SYSTEMSAn APOTEX CompanyMiramar FL 33025Distributed ByPerrigoregAllegan MI 49010 wwwperrigocom5A800 RC BR7
Medication Guide
MEDICATION GUIDEScopolamine (skoe polrsquo a meen) Transdermal System
Read this Patient Information before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentWhat is scopolamine transdermal systemScopolamine transdermal system is a prescription medicine used for adults to helpprevent
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It is not known if scopolamine transdermal system is safe or effective in childrenWho should not use scopolamine transdermal systemDo not use Transderm Scōp if you
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What should I tell my doctor before using scopolamine transdermal systemBefore you use scopolamine transdermal system tell your doctor about all of yourmedical conditions including if you
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nausea and vomiting from motion sicknessnausea and vomiting from anesthesia or taking opioid pain medicines after surgery
have an eye problem called angle closure glaucomaare allergic to scopolamine belladonna alkaloids or any of the ingredients inscopolamine transdermal system See the end of this leaflet for a list of theingredients in scopolamine transdermal system Ask your doctor if you are notsure
have glaucoma (increased pressure in the eye)have a history of seizures or psychosishave problems with your stomach or intestineshave trouble urinatingare scheduled to have a gastric secretion testhave liver or kidney problemsare pregnant or plan to become pregnant It is not known if scopolamine
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Tell your doctor about all the medicines you take including prescription andover-the-counter medicines vitamins and herbal supplements Scopolamine transdermalsystem may affect the way other medicines work and other medicines may affect howscopolamine transdermal system works Medicines that you take by mouth may not beabsorbed well while you use scopolamine transdermal systemEspecially tell your doctor if you take
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Ask your doctor if you are not sure if your medicine is one that is listed aboveKnow the medicines you take Keep a list of them and show it to your doctor orpharmacist when you get a new medicineHow should I use scopolamine transdermal system
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What should I avoid while using scopolamine transdermal system
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What are the possible side effects of scopolamine transdermal systemScopolamine transdermal system may cause serious side effects including
transdermal system can harm your unborn babyare breastfeeding or plan to breastfeed Scopolamine can pass into your breastmilk and may harm your baby Talk to your doctor about the best way to feed yourbaby if you use scopolamine transdermal system
a sedative hypnotic opioid or anxiolytic (medicines that make you sleepy)an antidepressant medicinean anticholinergic medicine such as an allergy or cold medicine a medicine to treatbladder or bowel spasms certain asthma medicines or other medicines for motionsickness
See the detailed Instructions for Use for information about how to usescopolamine transdermal system at the end of this Patient Information leafletIt is important that you apply scopolamine transdermal system exactly as yourdoctor tells you toYour doctor may change your scopolamine transdermal system dose Do notchange your scopolamine transdermal system dose without talking to your doctorWear only one scopolamine transdermal system at any timeIf you use too much scopolamine transdermal system call your doctor or PoisonControl Center at 1-800-222-1222 or go to the nearest hospital emergency roomright away
You should not drink alcohol while using scopolamine transdermal system It canincrease your chances of having serious side effectsYou should not drive operate heavy machinery or do other dangerous activitiesuntil you know how scopolamine transdermal system affects youYou should not use scopolamine transdermal system during a Magnetic ResonanceImaging scan (MRI) Remove scopolamine transdermal system before undergoingan MRI It can cause your skin to burnYou should be careful if you use scopolamine transdermal system while youparticipate in watersports because you may feel lost or confused (disoriented)Limit contact with water while swimming and bathing because scopolaminetransdermal system may fall off If scopolamine transdermal system falls off throwit away and apply a new one on the hairless area behind your other ear
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The most common side effects of using scopolamine transdermal systeminclude
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Tell your doctor if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of scopolamine transdermal systemCall your doctor for medical advice about side effects You may report side effects toFDA at 1-800-FDA-1088General information about the safe and effective use of scopolaminetransdermal system
angle closure glaucoma If you have open angle glaucoma and use scopolaminetransdermal system remove scopolamine transdermal system and call a doctorright away if you feel pain or discomfort have blurred vision or see halos orcolored images around lights and reddening of your eyesworsening of seizures Tell your doctor about any worsening of seizures whileusing scopolamine transdermal systeman unusual reaction called acute psychosis Tell your doctor if you have anyof these symptoms
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confusionagitationrambling speechhallucinations (seeing or hearing things that are not there)paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy Some pregnant womenwith severe preeclampsia have had seizures after getting scopolamine by injectionin the muscle (intramuscular) or injection in the vein (intravenous)difficulty urinatingdifficulties in food passing from the stomach to the small intestineswhich may cause abdominal pain nausea or vomitingwithdrawal symptoms after removing scopolamine transdermal systemafter using it for several days Some people may have certain symptoms suchas difficulty with balance dizziness nausea vomiting stomach cramps sweatingconfusion muscle weakness low heart rate or low blood pressure that could start24 hours or more after removing scopolamine transdermal system Call yourdoctor right away if your symptoms become severetemporary increase in the size of your pupil and blurry vision especially ifscopolamine transdermal system comes in contact with your eyesskin burns at the site of scopolamine transdermal system This canhappen during a medical test called a Magnetic Resonance Imaging scan (MRI)Scopolamine transdermal system contains aluminum and should be removed fromyour skin before you have an MRI
dry mouth blurred vision oreye problems
feeling sleepy ordrowsy
disorientation(confusion)
dizziness feeling agitatedor irritable
pharyngitis(sore throat)
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
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To help prevent nausea and vomiting from motion sickness
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To help prevent nausea and vomiting after surgery
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How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
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Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
Scopolamine has a molecular weight of 30335 and a pKa of 755-781 The scopolaminetransdermal system is a circular 02 mm thick 25 cm film with four layers Proceedingfrom the visible surface towards the surface attached to the skin these layers are (1) abacking membrane of tan-colored aluminized polyester film (2) a drug layer ofscopolamine crospovidone isopropyl palmitate light mineral oil and polyisobutylene (3)an ethylene vinyl acetate copolymer membrane that controls the rate of delivery ofscopolamine from the system to the skin surface and (4) an contact layer formulationof crospovidone isopropyl palmitate light mineral oil polyisobutylene and scopolamineA release liner of siliconized polyester which covers the adhesive layer is removedbefore the system is usedCross section of the system
12 CLINICAL PHARMACOLOGY
121 Mechanism of ActionScopolamine a belladonna alkaloid is an anticholinergic Scopolamine acts i) as acompetitive inhibitor at postganglionic muscarinic receptor sites of the parasympatheticnervous system and ii) on smooth muscles that respond to acetylcholine but lackcholinergic innervation It has been suggested that scopolamine acts in the centralnervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei tohigher centers in the CNS and from the reticular formation to the vomiting centerScopolamine can inhibit the secretion of saliva and sweat decrease gastrointestinalsecretions and motility cause drowsiness dilate the pupils increase heart rate anddepress motor function
123 PharmacokineticsThe system is formulated to deliver approximately 1 mg of scopolamine to the systemiccirculation over 3 daysAbsorption
2
Following application to the skin behind the ear circulating plasma concentrations aredetected within 4 hours with peak concentrations being obtained on average within 24hours The average plasma concentration produced is 87 pgmL (028 nM) for freescopolamine and 354 pgmL for total scopolamine (free + conjugates) Followingremoval of the used transdermal system there is some degree of continued systemicabsorption of scopolamine bound in the skin layersDistribution The distribution of scopolamine is not well characterized It crosses the placenta and theblood brain barrier and may be reversibly bound to plasma proteinsEliminationMetabolism and Excretion Scopolamine is metabolized and conjugated with less than 5 of the total doseappearing unchanged in the urine The enzymes responsible for metabolizingscopolamine are unknown The exact elimination pattern of scopolamine has not beendetermined Following transdermal system removal plasma concentrations ofscopolamine decline in a log linear fashion with an observed half-life of 95 hours Lessthan 10 of the total dose is excreted in the urine as the parent drug and metabolitesover 108 hoursDrug Interaction StudiesAn in vitro study using human hepatocytes examined the induction of CYP1A2 andCYP3A4 by scopolamine Scopolamine did not induce CYP1A2 and CYP3A4 isoenzymesat the concentrations up to 10 nM In an in vitro study using human liver microsomeswhich evaluated the inhibition of CYP1A2 2C8 2C9 2C19 2D6 and 3A4 scopolaminedid not inhibit these cytochrome P450 isoenzymes at the concentrations up to 1micromolar No in vivo drug-drug interaction studies have been conducted
13 NONCLINICAL TOXICOLOGY
131 Carcinogenesis Mutagenesis Impairment of FertilityNo long-term studies in animals have been conducted to evaluate the carcinogenicpotential of scopolamine The mutagenic potential of scopolamine has not beenevaluatedFertility studies were performed in female rats and revealed no evidence of impairedfertility or harm to the fetus due to scopolamine hydrobromide administered by dailysubcutaneous injection Maternal body weights were reduced in the highest-dose group(plasma level approximately 500 times the level achieved in humans using a transdermalsystem) However fertility studies in male animals were not performed
14 CLINICAL STUDIES
141 Prevention of Motion SicknessIn 195 adult subjects of different racial origins who participated in clinical efficacy studiesat sea or in a controlled motion environment there was a 75 reduction in the incidenceof motion-induced nausea and vomiting Scopolamine transdermal system was applied
from 4 to 16 hours prior to the onset of motion in these studies
142 Prevention of Post-Operative Nausea and VomitingA clinical efficacy study evaluated 168 adult female patients undergoing gynecologicalsurgery with anesthesia and opiate analgesia Patients received scopolamine transdermalsystem or placebo applied approximately 11 hours before anesthesiaopiate analgesiaNo retchingvomiting during the 24-hour post-operative period was reported in 79 ofthose treated with scopolamine transdermal system compared to 72 of thosereceiving placebo When the need for additional antiemetic medication was assessedduring the same period there was no need for medication in 89 of patients treatedwith scopolamine transdermal system as compared to 72 of placebo-treated patients
16 HOW SUPPLIEDSTORAGE AND HANDLINGScopolamine Transdermal System 1 mg3 days is available as the following
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Store at 20degC to 25degC (68degF to 77degF) [see USP Controlled Room Temperature]Store pouch(es) in an upright positionDo not bend or roll pouch(es)Wash hands thoroughly with soap and water immediately after handling the transdermalsystem Upon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidental contactor ingestion by children pets or others [see Dosage and Administration (21) Warningsand Precautions (56)]
17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information andInstructions for Use)Administration InstructionsCounsel patients on how to apply and remove the transdermal system [see Dosage andAdministration (21)]
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Carton of 4 transdermal systems packaged into individual foil pouches NDC45802-580-84Carton of 10 transdermal systems packaged into individual foil pouches NDC45802-580-46Carton of 24 transdermal systems packaged into individual foil pouches NDC45802-580-62
Only wear one transdermal system at any timeDo not cut the transdermal systemApply the transdermal system to the skin in the postauricular (hairless area behindone ear) areaAfter the transdermal system is applied on the dry skin behind the ear wash handsthoroughly with soap and water and dry handsIf the transdermal system becomes displaced discard the transdermal system and
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Patients with Open-Angle GlaucomaAdvise patients with open-angle glaucoma to remove the scopolamine transdermalsystem immediately and contact their healthcare provider if they experience symptomsof acute angle closure glaucoma including pain and reddening of the eyes accompaniedby dilated pupils blurred vision andor seeing halos around lights [see Warnings andPrecautions (51)]Neuropsychiatric Adverse Reactions
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Decreased Gastrointestinal Motility and Urinary RetentionInstruct patients to remove the transdermal system if they develop symptoms ofintestinal obstruction (abdominal pain nausea or vomiting) or any difficulties in urinating[see Warnings and Precautions (54)]Drug WithdrawalPost-Removal SymptomsInform patients that if they remove the scopolamine transdermal system beforetreatment is complete withdrawal symptoms may occur and to seek immediate medicalcare if they develop severe symptoms after removing scopolamine transdermal system[see Warnings and Precautions (55)]Blurred VisionInform patients that temporary dilation of the pupils and blurred vision may occur ifscopolamine transdermal system comes in contact with the eyes Instruct patients towash their hands thoroughly with soap and water immediately after handling thetransdermal system [see Dosage and Administration (21) Warnings and Precautions(56)]MRI Skin BurnsInstruct patients to remove the scopolamine transdermal system before undergoing an
If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
Advise patients that psychiatric adverse reactions may occur especially in patientswith a past psychiatric history or in those receiving other drugs also associatedwith psychiatric effects and to report to their healthcare provider any new orworsening psychiatric symptomsAdvise patients to discontinue scopolamine transdermal system and contact ahealthcare provider immediately if they experience a seizureAdvise patients especially elderly patients that cognitive impairment may occurduring treatment with scopolamine transdermal system especially in thosereceiving other drugs also associated with CNS effects and to report to theirhealthcare provider if they develop signs or symptoms of cognitive impairmentsuch as hallucinations confusion or dizzinessInform patients not to operate motor vehicles or other dangerous machinery orparticipate in underwater sports until they are reasonably certain that scopolaminetransdermal system does not affect them adversely [see Warnings and Precautions(52)]
MRI [see Warnings and Precautions (57)]
Manufactured byAVEVA DRUG DELIVERY SYSTEMSAn APOTEX CompanyMiramar FL 33025Distributed ByPerrigoregAllegan MI 49010 wwwperrigocom5A800 RC BR7
Medication Guide
MEDICATION GUIDEScopolamine (skoe polrsquo a meen) Transdermal System
Read this Patient Information before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentWhat is scopolamine transdermal systemScopolamine transdermal system is a prescription medicine used for adults to helpprevent
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It is not known if scopolamine transdermal system is safe or effective in childrenWho should not use scopolamine transdermal systemDo not use Transderm Scōp if you
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What should I tell my doctor before using scopolamine transdermal systemBefore you use scopolamine transdermal system tell your doctor about all of yourmedical conditions including if you
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nausea and vomiting from motion sicknessnausea and vomiting from anesthesia or taking opioid pain medicines after surgery
have an eye problem called angle closure glaucomaare allergic to scopolamine belladonna alkaloids or any of the ingredients inscopolamine transdermal system See the end of this leaflet for a list of theingredients in scopolamine transdermal system Ask your doctor if you are notsure
have glaucoma (increased pressure in the eye)have a history of seizures or psychosishave problems with your stomach or intestineshave trouble urinatingare scheduled to have a gastric secretion testhave liver or kidney problemsare pregnant or plan to become pregnant It is not known if scopolamine
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Tell your doctor about all the medicines you take including prescription andover-the-counter medicines vitamins and herbal supplements Scopolamine transdermalsystem may affect the way other medicines work and other medicines may affect howscopolamine transdermal system works Medicines that you take by mouth may not beabsorbed well while you use scopolamine transdermal systemEspecially tell your doctor if you take
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Ask your doctor if you are not sure if your medicine is one that is listed aboveKnow the medicines you take Keep a list of them and show it to your doctor orpharmacist when you get a new medicineHow should I use scopolamine transdermal system
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What should I avoid while using scopolamine transdermal system
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What are the possible side effects of scopolamine transdermal systemScopolamine transdermal system may cause serious side effects including
transdermal system can harm your unborn babyare breastfeeding or plan to breastfeed Scopolamine can pass into your breastmilk and may harm your baby Talk to your doctor about the best way to feed yourbaby if you use scopolamine transdermal system
a sedative hypnotic opioid or anxiolytic (medicines that make you sleepy)an antidepressant medicinean anticholinergic medicine such as an allergy or cold medicine a medicine to treatbladder or bowel spasms certain asthma medicines or other medicines for motionsickness
See the detailed Instructions for Use for information about how to usescopolamine transdermal system at the end of this Patient Information leafletIt is important that you apply scopolamine transdermal system exactly as yourdoctor tells you toYour doctor may change your scopolamine transdermal system dose Do notchange your scopolamine transdermal system dose without talking to your doctorWear only one scopolamine transdermal system at any timeIf you use too much scopolamine transdermal system call your doctor or PoisonControl Center at 1-800-222-1222 or go to the nearest hospital emergency roomright away
You should not drink alcohol while using scopolamine transdermal system It canincrease your chances of having serious side effectsYou should not drive operate heavy machinery or do other dangerous activitiesuntil you know how scopolamine transdermal system affects youYou should not use scopolamine transdermal system during a Magnetic ResonanceImaging scan (MRI) Remove scopolamine transdermal system before undergoingan MRI It can cause your skin to burnYou should be careful if you use scopolamine transdermal system while youparticipate in watersports because you may feel lost or confused (disoriented)Limit contact with water while swimming and bathing because scopolaminetransdermal system may fall off If scopolamine transdermal system falls off throwit away and apply a new one on the hairless area behind your other ear
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The most common side effects of using scopolamine transdermal systeminclude
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Tell your doctor if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of scopolamine transdermal systemCall your doctor for medical advice about side effects You may report side effects toFDA at 1-800-FDA-1088General information about the safe and effective use of scopolaminetransdermal system
angle closure glaucoma If you have open angle glaucoma and use scopolaminetransdermal system remove scopolamine transdermal system and call a doctorright away if you feel pain or discomfort have blurred vision or see halos orcolored images around lights and reddening of your eyesworsening of seizures Tell your doctor about any worsening of seizures whileusing scopolamine transdermal systeman unusual reaction called acute psychosis Tell your doctor if you have anyof these symptoms
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confusionagitationrambling speechhallucinations (seeing or hearing things that are not there)paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy Some pregnant womenwith severe preeclampsia have had seizures after getting scopolamine by injectionin the muscle (intramuscular) or injection in the vein (intravenous)difficulty urinatingdifficulties in food passing from the stomach to the small intestineswhich may cause abdominal pain nausea or vomitingwithdrawal symptoms after removing scopolamine transdermal systemafter using it for several days Some people may have certain symptoms suchas difficulty with balance dizziness nausea vomiting stomach cramps sweatingconfusion muscle weakness low heart rate or low blood pressure that could start24 hours or more after removing scopolamine transdermal system Call yourdoctor right away if your symptoms become severetemporary increase in the size of your pupil and blurry vision especially ifscopolamine transdermal system comes in contact with your eyesskin burns at the site of scopolamine transdermal system This canhappen during a medical test called a Magnetic Resonance Imaging scan (MRI)Scopolamine transdermal system contains aluminum and should be removed fromyour skin before you have an MRI
dry mouth blurred vision oreye problems
feeling sleepy ordrowsy
disorientation(confusion)
dizziness feeling agitatedor irritable
pharyngitis(sore throat)
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
bull
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To help prevent nausea and vomiting from motion sickness
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To help prevent nausea and vomiting after surgery
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How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
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Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
Following application to the skin behind the ear circulating plasma concentrations aredetected within 4 hours with peak concentrations being obtained on average within 24hours The average plasma concentration produced is 87 pgmL (028 nM) for freescopolamine and 354 pgmL for total scopolamine (free + conjugates) Followingremoval of the used transdermal system there is some degree of continued systemicabsorption of scopolamine bound in the skin layersDistribution The distribution of scopolamine is not well characterized It crosses the placenta and theblood brain barrier and may be reversibly bound to plasma proteinsEliminationMetabolism and Excretion Scopolamine is metabolized and conjugated with less than 5 of the total doseappearing unchanged in the urine The enzymes responsible for metabolizingscopolamine are unknown The exact elimination pattern of scopolamine has not beendetermined Following transdermal system removal plasma concentrations ofscopolamine decline in a log linear fashion with an observed half-life of 95 hours Lessthan 10 of the total dose is excreted in the urine as the parent drug and metabolitesover 108 hoursDrug Interaction StudiesAn in vitro study using human hepatocytes examined the induction of CYP1A2 andCYP3A4 by scopolamine Scopolamine did not induce CYP1A2 and CYP3A4 isoenzymesat the concentrations up to 10 nM In an in vitro study using human liver microsomeswhich evaluated the inhibition of CYP1A2 2C8 2C9 2C19 2D6 and 3A4 scopolaminedid not inhibit these cytochrome P450 isoenzymes at the concentrations up to 1micromolar No in vivo drug-drug interaction studies have been conducted
13 NONCLINICAL TOXICOLOGY
131 Carcinogenesis Mutagenesis Impairment of FertilityNo long-term studies in animals have been conducted to evaluate the carcinogenicpotential of scopolamine The mutagenic potential of scopolamine has not beenevaluatedFertility studies were performed in female rats and revealed no evidence of impairedfertility or harm to the fetus due to scopolamine hydrobromide administered by dailysubcutaneous injection Maternal body weights were reduced in the highest-dose group(plasma level approximately 500 times the level achieved in humans using a transdermalsystem) However fertility studies in male animals were not performed
14 CLINICAL STUDIES
141 Prevention of Motion SicknessIn 195 adult subjects of different racial origins who participated in clinical efficacy studiesat sea or in a controlled motion environment there was a 75 reduction in the incidenceof motion-induced nausea and vomiting Scopolamine transdermal system was applied
from 4 to 16 hours prior to the onset of motion in these studies
142 Prevention of Post-Operative Nausea and VomitingA clinical efficacy study evaluated 168 adult female patients undergoing gynecologicalsurgery with anesthesia and opiate analgesia Patients received scopolamine transdermalsystem or placebo applied approximately 11 hours before anesthesiaopiate analgesiaNo retchingvomiting during the 24-hour post-operative period was reported in 79 ofthose treated with scopolamine transdermal system compared to 72 of thosereceiving placebo When the need for additional antiemetic medication was assessedduring the same period there was no need for medication in 89 of patients treatedwith scopolamine transdermal system as compared to 72 of placebo-treated patients
16 HOW SUPPLIEDSTORAGE AND HANDLINGScopolamine Transdermal System 1 mg3 days is available as the following
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Store at 20degC to 25degC (68degF to 77degF) [see USP Controlled Room Temperature]Store pouch(es) in an upright positionDo not bend or roll pouch(es)Wash hands thoroughly with soap and water immediately after handling the transdermalsystem Upon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidental contactor ingestion by children pets or others [see Dosage and Administration (21) Warningsand Precautions (56)]
17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information andInstructions for Use)Administration InstructionsCounsel patients on how to apply and remove the transdermal system [see Dosage andAdministration (21)]
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Carton of 4 transdermal systems packaged into individual foil pouches NDC45802-580-84Carton of 10 transdermal systems packaged into individual foil pouches NDC45802-580-46Carton of 24 transdermal systems packaged into individual foil pouches NDC45802-580-62
Only wear one transdermal system at any timeDo not cut the transdermal systemApply the transdermal system to the skin in the postauricular (hairless area behindone ear) areaAfter the transdermal system is applied on the dry skin behind the ear wash handsthoroughly with soap and water and dry handsIf the transdermal system becomes displaced discard the transdermal system and
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Patients with Open-Angle GlaucomaAdvise patients with open-angle glaucoma to remove the scopolamine transdermalsystem immediately and contact their healthcare provider if they experience symptomsof acute angle closure glaucoma including pain and reddening of the eyes accompaniedby dilated pupils blurred vision andor seeing halos around lights [see Warnings andPrecautions (51)]Neuropsychiatric Adverse Reactions
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Decreased Gastrointestinal Motility and Urinary RetentionInstruct patients to remove the transdermal system if they develop symptoms ofintestinal obstruction (abdominal pain nausea or vomiting) or any difficulties in urinating[see Warnings and Precautions (54)]Drug WithdrawalPost-Removal SymptomsInform patients that if they remove the scopolamine transdermal system beforetreatment is complete withdrawal symptoms may occur and to seek immediate medicalcare if they develop severe symptoms after removing scopolamine transdermal system[see Warnings and Precautions (55)]Blurred VisionInform patients that temporary dilation of the pupils and blurred vision may occur ifscopolamine transdermal system comes in contact with the eyes Instruct patients towash their hands thoroughly with soap and water immediately after handling thetransdermal system [see Dosage and Administration (21) Warnings and Precautions(56)]MRI Skin BurnsInstruct patients to remove the scopolamine transdermal system before undergoing an
If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
Advise patients that psychiatric adverse reactions may occur especially in patientswith a past psychiatric history or in those receiving other drugs also associatedwith psychiatric effects and to report to their healthcare provider any new orworsening psychiatric symptomsAdvise patients to discontinue scopolamine transdermal system and contact ahealthcare provider immediately if they experience a seizureAdvise patients especially elderly patients that cognitive impairment may occurduring treatment with scopolamine transdermal system especially in thosereceiving other drugs also associated with CNS effects and to report to theirhealthcare provider if they develop signs or symptoms of cognitive impairmentsuch as hallucinations confusion or dizzinessInform patients not to operate motor vehicles or other dangerous machinery orparticipate in underwater sports until they are reasonably certain that scopolaminetransdermal system does not affect them adversely [see Warnings and Precautions(52)]
MRI [see Warnings and Precautions (57)]
Manufactured byAVEVA DRUG DELIVERY SYSTEMSAn APOTEX CompanyMiramar FL 33025Distributed ByPerrigoregAllegan MI 49010 wwwperrigocom5A800 RC BR7
Medication Guide
MEDICATION GUIDEScopolamine (skoe polrsquo a meen) Transdermal System
Read this Patient Information before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentWhat is scopolamine transdermal systemScopolamine transdermal system is a prescription medicine used for adults to helpprevent
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It is not known if scopolamine transdermal system is safe or effective in childrenWho should not use scopolamine transdermal systemDo not use Transderm Scōp if you
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What should I tell my doctor before using scopolamine transdermal systemBefore you use scopolamine transdermal system tell your doctor about all of yourmedical conditions including if you
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nausea and vomiting from motion sicknessnausea and vomiting from anesthesia or taking opioid pain medicines after surgery
have an eye problem called angle closure glaucomaare allergic to scopolamine belladonna alkaloids or any of the ingredients inscopolamine transdermal system See the end of this leaflet for a list of theingredients in scopolamine transdermal system Ask your doctor if you are notsure
have glaucoma (increased pressure in the eye)have a history of seizures or psychosishave problems with your stomach or intestineshave trouble urinatingare scheduled to have a gastric secretion testhave liver or kidney problemsare pregnant or plan to become pregnant It is not known if scopolamine
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Tell your doctor about all the medicines you take including prescription andover-the-counter medicines vitamins and herbal supplements Scopolamine transdermalsystem may affect the way other medicines work and other medicines may affect howscopolamine transdermal system works Medicines that you take by mouth may not beabsorbed well while you use scopolamine transdermal systemEspecially tell your doctor if you take
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Ask your doctor if you are not sure if your medicine is one that is listed aboveKnow the medicines you take Keep a list of them and show it to your doctor orpharmacist when you get a new medicineHow should I use scopolamine transdermal system
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What should I avoid while using scopolamine transdermal system
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What are the possible side effects of scopolamine transdermal systemScopolamine transdermal system may cause serious side effects including
transdermal system can harm your unborn babyare breastfeeding or plan to breastfeed Scopolamine can pass into your breastmilk and may harm your baby Talk to your doctor about the best way to feed yourbaby if you use scopolamine transdermal system
a sedative hypnotic opioid or anxiolytic (medicines that make you sleepy)an antidepressant medicinean anticholinergic medicine such as an allergy or cold medicine a medicine to treatbladder or bowel spasms certain asthma medicines or other medicines for motionsickness
See the detailed Instructions for Use for information about how to usescopolamine transdermal system at the end of this Patient Information leafletIt is important that you apply scopolamine transdermal system exactly as yourdoctor tells you toYour doctor may change your scopolamine transdermal system dose Do notchange your scopolamine transdermal system dose without talking to your doctorWear only one scopolamine transdermal system at any timeIf you use too much scopolamine transdermal system call your doctor or PoisonControl Center at 1-800-222-1222 or go to the nearest hospital emergency roomright away
You should not drink alcohol while using scopolamine transdermal system It canincrease your chances of having serious side effectsYou should not drive operate heavy machinery or do other dangerous activitiesuntil you know how scopolamine transdermal system affects youYou should not use scopolamine transdermal system during a Magnetic ResonanceImaging scan (MRI) Remove scopolamine transdermal system before undergoingan MRI It can cause your skin to burnYou should be careful if you use scopolamine transdermal system while youparticipate in watersports because you may feel lost or confused (disoriented)Limit contact with water while swimming and bathing because scopolaminetransdermal system may fall off If scopolamine transdermal system falls off throwit away and apply a new one on the hairless area behind your other ear
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The most common side effects of using scopolamine transdermal systeminclude
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Tell your doctor if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of scopolamine transdermal systemCall your doctor for medical advice about side effects You may report side effects toFDA at 1-800-FDA-1088General information about the safe and effective use of scopolaminetransdermal system
angle closure glaucoma If you have open angle glaucoma and use scopolaminetransdermal system remove scopolamine transdermal system and call a doctorright away if you feel pain or discomfort have blurred vision or see halos orcolored images around lights and reddening of your eyesworsening of seizures Tell your doctor about any worsening of seizures whileusing scopolamine transdermal systeman unusual reaction called acute psychosis Tell your doctor if you have anyof these symptoms
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confusionagitationrambling speechhallucinations (seeing or hearing things that are not there)paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy Some pregnant womenwith severe preeclampsia have had seizures after getting scopolamine by injectionin the muscle (intramuscular) or injection in the vein (intravenous)difficulty urinatingdifficulties in food passing from the stomach to the small intestineswhich may cause abdominal pain nausea or vomitingwithdrawal symptoms after removing scopolamine transdermal systemafter using it for several days Some people may have certain symptoms suchas difficulty with balance dizziness nausea vomiting stomach cramps sweatingconfusion muscle weakness low heart rate or low blood pressure that could start24 hours or more after removing scopolamine transdermal system Call yourdoctor right away if your symptoms become severetemporary increase in the size of your pupil and blurry vision especially ifscopolamine transdermal system comes in contact with your eyesskin burns at the site of scopolamine transdermal system This canhappen during a medical test called a Magnetic Resonance Imaging scan (MRI)Scopolamine transdermal system contains aluminum and should be removed fromyour skin before you have an MRI
dry mouth blurred vision oreye problems
feeling sleepy ordrowsy
disorientation(confusion)
dizziness feeling agitatedor irritable
pharyngitis(sore throat)
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
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To help prevent nausea and vomiting from motion sickness
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To help prevent nausea and vomiting after surgery
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How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
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Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
from 4 to 16 hours prior to the onset of motion in these studies
142 Prevention of Post-Operative Nausea and VomitingA clinical efficacy study evaluated 168 adult female patients undergoing gynecologicalsurgery with anesthesia and opiate analgesia Patients received scopolamine transdermalsystem or placebo applied approximately 11 hours before anesthesiaopiate analgesiaNo retchingvomiting during the 24-hour post-operative period was reported in 79 ofthose treated with scopolamine transdermal system compared to 72 of thosereceiving placebo When the need for additional antiemetic medication was assessedduring the same period there was no need for medication in 89 of patients treatedwith scopolamine transdermal system as compared to 72 of placebo-treated patients
16 HOW SUPPLIEDSTORAGE AND HANDLINGScopolamine Transdermal System 1 mg3 days is available as the following
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Store at 20degC to 25degC (68degF to 77degF) [see USP Controlled Room Temperature]Store pouch(es) in an upright positionDo not bend or roll pouch(es)Wash hands thoroughly with soap and water immediately after handling the transdermalsystem Upon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidental contactor ingestion by children pets or others [see Dosage and Administration (21) Warningsand Precautions (56)]
17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information andInstructions for Use)Administration InstructionsCounsel patients on how to apply and remove the transdermal system [see Dosage andAdministration (21)]
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Carton of 4 transdermal systems packaged into individual foil pouches NDC45802-580-84Carton of 10 transdermal systems packaged into individual foil pouches NDC45802-580-46Carton of 24 transdermal systems packaged into individual foil pouches NDC45802-580-62
Only wear one transdermal system at any timeDo not cut the transdermal systemApply the transdermal system to the skin in the postauricular (hairless area behindone ear) areaAfter the transdermal system is applied on the dry skin behind the ear wash handsthoroughly with soap and water and dry handsIf the transdermal system becomes displaced discard the transdermal system and
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Patients with Open-Angle GlaucomaAdvise patients with open-angle glaucoma to remove the scopolamine transdermalsystem immediately and contact their healthcare provider if they experience symptomsof acute angle closure glaucoma including pain and reddening of the eyes accompaniedby dilated pupils blurred vision andor seeing halos around lights [see Warnings andPrecautions (51)]Neuropsychiatric Adverse Reactions
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bull
Decreased Gastrointestinal Motility and Urinary RetentionInstruct patients to remove the transdermal system if they develop symptoms ofintestinal obstruction (abdominal pain nausea or vomiting) or any difficulties in urinating[see Warnings and Precautions (54)]Drug WithdrawalPost-Removal SymptomsInform patients that if they remove the scopolamine transdermal system beforetreatment is complete withdrawal symptoms may occur and to seek immediate medicalcare if they develop severe symptoms after removing scopolamine transdermal system[see Warnings and Precautions (55)]Blurred VisionInform patients that temporary dilation of the pupils and blurred vision may occur ifscopolamine transdermal system comes in contact with the eyes Instruct patients towash their hands thoroughly with soap and water immediately after handling thetransdermal system [see Dosage and Administration (21) Warnings and Precautions(56)]MRI Skin BurnsInstruct patients to remove the scopolamine transdermal system before undergoing an
If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
Advise patients that psychiatric adverse reactions may occur especially in patientswith a past psychiatric history or in those receiving other drugs also associatedwith psychiatric effects and to report to their healthcare provider any new orworsening psychiatric symptomsAdvise patients to discontinue scopolamine transdermal system and contact ahealthcare provider immediately if they experience a seizureAdvise patients especially elderly patients that cognitive impairment may occurduring treatment with scopolamine transdermal system especially in thosereceiving other drugs also associated with CNS effects and to report to theirhealthcare provider if they develop signs or symptoms of cognitive impairmentsuch as hallucinations confusion or dizzinessInform patients not to operate motor vehicles or other dangerous machinery orparticipate in underwater sports until they are reasonably certain that scopolaminetransdermal system does not affect them adversely [see Warnings and Precautions(52)]
MRI [see Warnings and Precautions (57)]
Manufactured byAVEVA DRUG DELIVERY SYSTEMSAn APOTEX CompanyMiramar FL 33025Distributed ByPerrigoregAllegan MI 49010 wwwperrigocom5A800 RC BR7
Medication Guide
MEDICATION GUIDEScopolamine (skoe polrsquo a meen) Transdermal System
Read this Patient Information before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentWhat is scopolamine transdermal systemScopolamine transdermal system is a prescription medicine used for adults to helpprevent
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It is not known if scopolamine transdermal system is safe or effective in childrenWho should not use scopolamine transdermal systemDo not use Transderm Scōp if you
bullbull
What should I tell my doctor before using scopolamine transdermal systemBefore you use scopolamine transdermal system tell your doctor about all of yourmedical conditions including if you
bullbullbullbullbullbullbull
nausea and vomiting from motion sicknessnausea and vomiting from anesthesia or taking opioid pain medicines after surgery
have an eye problem called angle closure glaucomaare allergic to scopolamine belladonna alkaloids or any of the ingredients inscopolamine transdermal system See the end of this leaflet for a list of theingredients in scopolamine transdermal system Ask your doctor if you are notsure
have glaucoma (increased pressure in the eye)have a history of seizures or psychosishave problems with your stomach or intestineshave trouble urinatingare scheduled to have a gastric secretion testhave liver or kidney problemsare pregnant or plan to become pregnant It is not known if scopolamine
bull
Tell your doctor about all the medicines you take including prescription andover-the-counter medicines vitamins and herbal supplements Scopolamine transdermalsystem may affect the way other medicines work and other medicines may affect howscopolamine transdermal system works Medicines that you take by mouth may not beabsorbed well while you use scopolamine transdermal systemEspecially tell your doctor if you take
bullbullbull
Ask your doctor if you are not sure if your medicine is one that is listed aboveKnow the medicines you take Keep a list of them and show it to your doctor orpharmacist when you get a new medicineHow should I use scopolamine transdermal system
bull
bull
bull
bullbull
What should I avoid while using scopolamine transdermal system
bull
bull
bull
bull
bull
What are the possible side effects of scopolamine transdermal systemScopolamine transdermal system may cause serious side effects including
transdermal system can harm your unborn babyare breastfeeding or plan to breastfeed Scopolamine can pass into your breastmilk and may harm your baby Talk to your doctor about the best way to feed yourbaby if you use scopolamine transdermal system
a sedative hypnotic opioid or anxiolytic (medicines that make you sleepy)an antidepressant medicinean anticholinergic medicine such as an allergy or cold medicine a medicine to treatbladder or bowel spasms certain asthma medicines or other medicines for motionsickness
See the detailed Instructions for Use for information about how to usescopolamine transdermal system at the end of this Patient Information leafletIt is important that you apply scopolamine transdermal system exactly as yourdoctor tells you toYour doctor may change your scopolamine transdermal system dose Do notchange your scopolamine transdermal system dose without talking to your doctorWear only one scopolamine transdermal system at any timeIf you use too much scopolamine transdermal system call your doctor or PoisonControl Center at 1-800-222-1222 or go to the nearest hospital emergency roomright away
You should not drink alcohol while using scopolamine transdermal system It canincrease your chances of having serious side effectsYou should not drive operate heavy machinery or do other dangerous activitiesuntil you know how scopolamine transdermal system affects youYou should not use scopolamine transdermal system during a Magnetic ResonanceImaging scan (MRI) Remove scopolamine transdermal system before undergoingan MRI It can cause your skin to burnYou should be careful if you use scopolamine transdermal system while youparticipate in watersports because you may feel lost or confused (disoriented)Limit contact with water while swimming and bathing because scopolaminetransdermal system may fall off If scopolamine transdermal system falls off throwit away and apply a new one on the hairless area behind your other ear
bull
bull
bull
bull
bullbull
bull
bull
bull
The most common side effects of using scopolamine transdermal systeminclude
bull bull bull bull
bull bull bull
Tell your doctor if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of scopolamine transdermal systemCall your doctor for medical advice about side effects You may report side effects toFDA at 1-800-FDA-1088General information about the safe and effective use of scopolaminetransdermal system
angle closure glaucoma If you have open angle glaucoma and use scopolaminetransdermal system remove scopolamine transdermal system and call a doctorright away if you feel pain or discomfort have blurred vision or see halos orcolored images around lights and reddening of your eyesworsening of seizures Tell your doctor about any worsening of seizures whileusing scopolamine transdermal systeman unusual reaction called acute psychosis Tell your doctor if you have anyof these symptoms
bullbullbullbullbull
confusionagitationrambling speechhallucinations (seeing or hearing things that are not there)paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy Some pregnant womenwith severe preeclampsia have had seizures after getting scopolamine by injectionin the muscle (intramuscular) or injection in the vein (intravenous)difficulty urinatingdifficulties in food passing from the stomach to the small intestineswhich may cause abdominal pain nausea or vomitingwithdrawal symptoms after removing scopolamine transdermal systemafter using it for several days Some people may have certain symptoms suchas difficulty with balance dizziness nausea vomiting stomach cramps sweatingconfusion muscle weakness low heart rate or low blood pressure that could start24 hours or more after removing scopolamine transdermal system Call yourdoctor right away if your symptoms become severetemporary increase in the size of your pupil and blurry vision especially ifscopolamine transdermal system comes in contact with your eyesskin burns at the site of scopolamine transdermal system This canhappen during a medical test called a Magnetic Resonance Imaging scan (MRI)Scopolamine transdermal system contains aluminum and should be removed fromyour skin before you have an MRI
dry mouth blurred vision oreye problems
feeling sleepy ordrowsy
disorientation(confusion)
dizziness feeling agitatedor irritable
pharyngitis(sore throat)
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
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To help prevent nausea and vomiting from motion sickness
bull
bull
To help prevent nausea and vomiting after surgery
bull
bull
How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
bull
bullbull
Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
bull
bull
Patients with Open-Angle GlaucomaAdvise patients with open-angle glaucoma to remove the scopolamine transdermalsystem immediately and contact their healthcare provider if they experience symptomsof acute angle closure glaucoma including pain and reddening of the eyes accompaniedby dilated pupils blurred vision andor seeing halos around lights [see Warnings andPrecautions (51)]Neuropsychiatric Adverse Reactions
bull
bull
bull
bull
Decreased Gastrointestinal Motility and Urinary RetentionInstruct patients to remove the transdermal system if they develop symptoms ofintestinal obstruction (abdominal pain nausea or vomiting) or any difficulties in urinating[see Warnings and Precautions (54)]Drug WithdrawalPost-Removal SymptomsInform patients that if they remove the scopolamine transdermal system beforetreatment is complete withdrawal symptoms may occur and to seek immediate medicalcare if they develop severe symptoms after removing scopolamine transdermal system[see Warnings and Precautions (55)]Blurred VisionInform patients that temporary dilation of the pupils and blurred vision may occur ifscopolamine transdermal system comes in contact with the eyes Instruct patients towash their hands thoroughly with soap and water immediately after handling thetransdermal system [see Dosage and Administration (21) Warnings and Precautions(56)]MRI Skin BurnsInstruct patients to remove the scopolamine transdermal system before undergoing an
If the transdermal system becomes displaced discard the transdermal system andapply a new transdermal system on the hairless area behind the other earUpon removal fold the used transdermal system in half with the sticky sidetogether and discard in household trash in a manner that prevents accidentalcontact or ingestion by children pets or others
Advise patients that psychiatric adverse reactions may occur especially in patientswith a past psychiatric history or in those receiving other drugs also associatedwith psychiatric effects and to report to their healthcare provider any new orworsening psychiatric symptomsAdvise patients to discontinue scopolamine transdermal system and contact ahealthcare provider immediately if they experience a seizureAdvise patients especially elderly patients that cognitive impairment may occurduring treatment with scopolamine transdermal system especially in thosereceiving other drugs also associated with CNS effects and to report to theirhealthcare provider if they develop signs or symptoms of cognitive impairmentsuch as hallucinations confusion or dizzinessInform patients not to operate motor vehicles or other dangerous machinery orparticipate in underwater sports until they are reasonably certain that scopolaminetransdermal system does not affect them adversely [see Warnings and Precautions(52)]
MRI [see Warnings and Precautions (57)]
Manufactured byAVEVA DRUG DELIVERY SYSTEMSAn APOTEX CompanyMiramar FL 33025Distributed ByPerrigoregAllegan MI 49010 wwwperrigocom5A800 RC BR7
Medication Guide
MEDICATION GUIDEScopolamine (skoe polrsquo a meen) Transdermal System
Read this Patient Information before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentWhat is scopolamine transdermal systemScopolamine transdermal system is a prescription medicine used for adults to helpprevent
bullbull
It is not known if scopolamine transdermal system is safe or effective in childrenWho should not use scopolamine transdermal systemDo not use Transderm Scōp if you
bullbull
What should I tell my doctor before using scopolamine transdermal systemBefore you use scopolamine transdermal system tell your doctor about all of yourmedical conditions including if you
bullbullbullbullbullbullbull
nausea and vomiting from motion sicknessnausea and vomiting from anesthesia or taking opioid pain medicines after surgery
have an eye problem called angle closure glaucomaare allergic to scopolamine belladonna alkaloids or any of the ingredients inscopolamine transdermal system See the end of this leaflet for a list of theingredients in scopolamine transdermal system Ask your doctor if you are notsure
have glaucoma (increased pressure in the eye)have a history of seizures or psychosishave problems with your stomach or intestineshave trouble urinatingare scheduled to have a gastric secretion testhave liver or kidney problemsare pregnant or plan to become pregnant It is not known if scopolamine
bull
Tell your doctor about all the medicines you take including prescription andover-the-counter medicines vitamins and herbal supplements Scopolamine transdermalsystem may affect the way other medicines work and other medicines may affect howscopolamine transdermal system works Medicines that you take by mouth may not beabsorbed well while you use scopolamine transdermal systemEspecially tell your doctor if you take
bullbullbull
Ask your doctor if you are not sure if your medicine is one that is listed aboveKnow the medicines you take Keep a list of them and show it to your doctor orpharmacist when you get a new medicineHow should I use scopolamine transdermal system
bull
bull
bull
bullbull
What should I avoid while using scopolamine transdermal system
bull
bull
bull
bull
bull
What are the possible side effects of scopolamine transdermal systemScopolamine transdermal system may cause serious side effects including
transdermal system can harm your unborn babyare breastfeeding or plan to breastfeed Scopolamine can pass into your breastmilk and may harm your baby Talk to your doctor about the best way to feed yourbaby if you use scopolamine transdermal system
a sedative hypnotic opioid or anxiolytic (medicines that make you sleepy)an antidepressant medicinean anticholinergic medicine such as an allergy or cold medicine a medicine to treatbladder or bowel spasms certain asthma medicines or other medicines for motionsickness
See the detailed Instructions for Use for information about how to usescopolamine transdermal system at the end of this Patient Information leafletIt is important that you apply scopolamine transdermal system exactly as yourdoctor tells you toYour doctor may change your scopolamine transdermal system dose Do notchange your scopolamine transdermal system dose without talking to your doctorWear only one scopolamine transdermal system at any timeIf you use too much scopolamine transdermal system call your doctor or PoisonControl Center at 1-800-222-1222 or go to the nearest hospital emergency roomright away
You should not drink alcohol while using scopolamine transdermal system It canincrease your chances of having serious side effectsYou should not drive operate heavy machinery or do other dangerous activitiesuntil you know how scopolamine transdermal system affects youYou should not use scopolamine transdermal system during a Magnetic ResonanceImaging scan (MRI) Remove scopolamine transdermal system before undergoingan MRI It can cause your skin to burnYou should be careful if you use scopolamine transdermal system while youparticipate in watersports because you may feel lost or confused (disoriented)Limit contact with water while swimming and bathing because scopolaminetransdermal system may fall off If scopolamine transdermal system falls off throwit away and apply a new one on the hairless area behind your other ear
bull
bull
bull
bull
bullbull
bull
bull
bull
The most common side effects of using scopolamine transdermal systeminclude
bull bull bull bull
bull bull bull
Tell your doctor if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of scopolamine transdermal systemCall your doctor for medical advice about side effects You may report side effects toFDA at 1-800-FDA-1088General information about the safe and effective use of scopolaminetransdermal system
angle closure glaucoma If you have open angle glaucoma and use scopolaminetransdermal system remove scopolamine transdermal system and call a doctorright away if you feel pain or discomfort have blurred vision or see halos orcolored images around lights and reddening of your eyesworsening of seizures Tell your doctor about any worsening of seizures whileusing scopolamine transdermal systeman unusual reaction called acute psychosis Tell your doctor if you have anyof these symptoms
bullbullbullbullbull
confusionagitationrambling speechhallucinations (seeing or hearing things that are not there)paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy Some pregnant womenwith severe preeclampsia have had seizures after getting scopolamine by injectionin the muscle (intramuscular) or injection in the vein (intravenous)difficulty urinatingdifficulties in food passing from the stomach to the small intestineswhich may cause abdominal pain nausea or vomitingwithdrawal symptoms after removing scopolamine transdermal systemafter using it for several days Some people may have certain symptoms suchas difficulty with balance dizziness nausea vomiting stomach cramps sweatingconfusion muscle weakness low heart rate or low blood pressure that could start24 hours or more after removing scopolamine transdermal system Call yourdoctor right away if your symptoms become severetemporary increase in the size of your pupil and blurry vision especially ifscopolamine transdermal system comes in contact with your eyesskin burns at the site of scopolamine transdermal system This canhappen during a medical test called a Magnetic Resonance Imaging scan (MRI)Scopolamine transdermal system contains aluminum and should be removed fromyour skin before you have an MRI
dry mouth blurred vision oreye problems
feeling sleepy ordrowsy
disorientation(confusion)
dizziness feeling agitatedor irritable
pharyngitis(sore throat)
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
bull
bullbull
To help prevent nausea and vomiting from motion sickness
bull
bull
To help prevent nausea and vomiting after surgery
bull
bull
How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
bull
bullbull
Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
MRI [see Warnings and Precautions (57)]
Manufactured byAVEVA DRUG DELIVERY SYSTEMSAn APOTEX CompanyMiramar FL 33025Distributed ByPerrigoregAllegan MI 49010 wwwperrigocom5A800 RC BR7
Medication Guide
MEDICATION GUIDEScopolamine (skoe polrsquo a meen) Transdermal System
Read this Patient Information before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentWhat is scopolamine transdermal systemScopolamine transdermal system is a prescription medicine used for adults to helpprevent
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It is not known if scopolamine transdermal system is safe or effective in childrenWho should not use scopolamine transdermal systemDo not use Transderm Scōp if you
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What should I tell my doctor before using scopolamine transdermal systemBefore you use scopolamine transdermal system tell your doctor about all of yourmedical conditions including if you
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nausea and vomiting from motion sicknessnausea and vomiting from anesthesia or taking opioid pain medicines after surgery
have an eye problem called angle closure glaucomaare allergic to scopolamine belladonna alkaloids or any of the ingredients inscopolamine transdermal system See the end of this leaflet for a list of theingredients in scopolamine transdermal system Ask your doctor if you are notsure
have glaucoma (increased pressure in the eye)have a history of seizures or psychosishave problems with your stomach or intestineshave trouble urinatingare scheduled to have a gastric secretion testhave liver or kidney problemsare pregnant or plan to become pregnant It is not known if scopolamine
bull
Tell your doctor about all the medicines you take including prescription andover-the-counter medicines vitamins and herbal supplements Scopolamine transdermalsystem may affect the way other medicines work and other medicines may affect howscopolamine transdermal system works Medicines that you take by mouth may not beabsorbed well while you use scopolamine transdermal systemEspecially tell your doctor if you take
bullbullbull
Ask your doctor if you are not sure if your medicine is one that is listed aboveKnow the medicines you take Keep a list of them and show it to your doctor orpharmacist when you get a new medicineHow should I use scopolamine transdermal system
bull
bull
bull
bullbull
What should I avoid while using scopolamine transdermal system
bull
bull
bull
bull
bull
What are the possible side effects of scopolamine transdermal systemScopolamine transdermal system may cause serious side effects including
transdermal system can harm your unborn babyare breastfeeding or plan to breastfeed Scopolamine can pass into your breastmilk and may harm your baby Talk to your doctor about the best way to feed yourbaby if you use scopolamine transdermal system
a sedative hypnotic opioid or anxiolytic (medicines that make you sleepy)an antidepressant medicinean anticholinergic medicine such as an allergy or cold medicine a medicine to treatbladder or bowel spasms certain asthma medicines or other medicines for motionsickness
See the detailed Instructions for Use for information about how to usescopolamine transdermal system at the end of this Patient Information leafletIt is important that you apply scopolamine transdermal system exactly as yourdoctor tells you toYour doctor may change your scopolamine transdermal system dose Do notchange your scopolamine transdermal system dose without talking to your doctorWear only one scopolamine transdermal system at any timeIf you use too much scopolamine transdermal system call your doctor or PoisonControl Center at 1-800-222-1222 or go to the nearest hospital emergency roomright away
You should not drink alcohol while using scopolamine transdermal system It canincrease your chances of having serious side effectsYou should not drive operate heavy machinery or do other dangerous activitiesuntil you know how scopolamine transdermal system affects youYou should not use scopolamine transdermal system during a Magnetic ResonanceImaging scan (MRI) Remove scopolamine transdermal system before undergoingan MRI It can cause your skin to burnYou should be careful if you use scopolamine transdermal system while youparticipate in watersports because you may feel lost or confused (disoriented)Limit contact with water while swimming and bathing because scopolaminetransdermal system may fall off If scopolamine transdermal system falls off throwit away and apply a new one on the hairless area behind your other ear
bull
bull
bull
bull
bullbull
bull
bull
bull
The most common side effects of using scopolamine transdermal systeminclude
bull bull bull bull
bull bull bull
Tell your doctor if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of scopolamine transdermal systemCall your doctor for medical advice about side effects You may report side effects toFDA at 1-800-FDA-1088General information about the safe and effective use of scopolaminetransdermal system
angle closure glaucoma If you have open angle glaucoma and use scopolaminetransdermal system remove scopolamine transdermal system and call a doctorright away if you feel pain or discomfort have blurred vision or see halos orcolored images around lights and reddening of your eyesworsening of seizures Tell your doctor about any worsening of seizures whileusing scopolamine transdermal systeman unusual reaction called acute psychosis Tell your doctor if you have anyof these symptoms
bullbullbullbullbull
confusionagitationrambling speechhallucinations (seeing or hearing things that are not there)paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy Some pregnant womenwith severe preeclampsia have had seizures after getting scopolamine by injectionin the muscle (intramuscular) or injection in the vein (intravenous)difficulty urinatingdifficulties in food passing from the stomach to the small intestineswhich may cause abdominal pain nausea or vomitingwithdrawal symptoms after removing scopolamine transdermal systemafter using it for several days Some people may have certain symptoms suchas difficulty with balance dizziness nausea vomiting stomach cramps sweatingconfusion muscle weakness low heart rate or low blood pressure that could start24 hours or more after removing scopolamine transdermal system Call yourdoctor right away if your symptoms become severetemporary increase in the size of your pupil and blurry vision especially ifscopolamine transdermal system comes in contact with your eyesskin burns at the site of scopolamine transdermal system This canhappen during a medical test called a Magnetic Resonance Imaging scan (MRI)Scopolamine transdermal system contains aluminum and should be removed fromyour skin before you have an MRI
dry mouth blurred vision oreye problems
feeling sleepy ordrowsy
disorientation(confusion)
dizziness feeling agitatedor irritable
pharyngitis(sore throat)
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
bull
bullbull
To help prevent nausea and vomiting from motion sickness
bull
bull
To help prevent nausea and vomiting after surgery
bull
bull
How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
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Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
bull
Tell your doctor about all the medicines you take including prescription andover-the-counter medicines vitamins and herbal supplements Scopolamine transdermalsystem may affect the way other medicines work and other medicines may affect howscopolamine transdermal system works Medicines that you take by mouth may not beabsorbed well while you use scopolamine transdermal systemEspecially tell your doctor if you take
bullbullbull
Ask your doctor if you are not sure if your medicine is one that is listed aboveKnow the medicines you take Keep a list of them and show it to your doctor orpharmacist when you get a new medicineHow should I use scopolamine transdermal system
bull
bull
bull
bullbull
What should I avoid while using scopolamine transdermal system
bull
bull
bull
bull
bull
What are the possible side effects of scopolamine transdermal systemScopolamine transdermal system may cause serious side effects including
transdermal system can harm your unborn babyare breastfeeding or plan to breastfeed Scopolamine can pass into your breastmilk and may harm your baby Talk to your doctor about the best way to feed yourbaby if you use scopolamine transdermal system
a sedative hypnotic opioid or anxiolytic (medicines that make you sleepy)an antidepressant medicinean anticholinergic medicine such as an allergy or cold medicine a medicine to treatbladder or bowel spasms certain asthma medicines or other medicines for motionsickness
See the detailed Instructions for Use for information about how to usescopolamine transdermal system at the end of this Patient Information leafletIt is important that you apply scopolamine transdermal system exactly as yourdoctor tells you toYour doctor may change your scopolamine transdermal system dose Do notchange your scopolamine transdermal system dose without talking to your doctorWear only one scopolamine transdermal system at any timeIf you use too much scopolamine transdermal system call your doctor or PoisonControl Center at 1-800-222-1222 or go to the nearest hospital emergency roomright away
You should not drink alcohol while using scopolamine transdermal system It canincrease your chances of having serious side effectsYou should not drive operate heavy machinery or do other dangerous activitiesuntil you know how scopolamine transdermal system affects youYou should not use scopolamine transdermal system during a Magnetic ResonanceImaging scan (MRI) Remove scopolamine transdermal system before undergoingan MRI It can cause your skin to burnYou should be careful if you use scopolamine transdermal system while youparticipate in watersports because you may feel lost or confused (disoriented)Limit contact with water while swimming and bathing because scopolaminetransdermal system may fall off If scopolamine transdermal system falls off throwit away and apply a new one on the hairless area behind your other ear
bull
bull
bull
bull
bullbull
bull
bull
bull
The most common side effects of using scopolamine transdermal systeminclude
bull bull bull bull
bull bull bull
Tell your doctor if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of scopolamine transdermal systemCall your doctor for medical advice about side effects You may report side effects toFDA at 1-800-FDA-1088General information about the safe and effective use of scopolaminetransdermal system
angle closure glaucoma If you have open angle glaucoma and use scopolaminetransdermal system remove scopolamine transdermal system and call a doctorright away if you feel pain or discomfort have blurred vision or see halos orcolored images around lights and reddening of your eyesworsening of seizures Tell your doctor about any worsening of seizures whileusing scopolamine transdermal systeman unusual reaction called acute psychosis Tell your doctor if you have anyof these symptoms
bullbullbullbullbull
confusionagitationrambling speechhallucinations (seeing or hearing things that are not there)paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy Some pregnant womenwith severe preeclampsia have had seizures after getting scopolamine by injectionin the muscle (intramuscular) or injection in the vein (intravenous)difficulty urinatingdifficulties in food passing from the stomach to the small intestineswhich may cause abdominal pain nausea or vomitingwithdrawal symptoms after removing scopolamine transdermal systemafter using it for several days Some people may have certain symptoms suchas difficulty with balance dizziness nausea vomiting stomach cramps sweatingconfusion muscle weakness low heart rate or low blood pressure that could start24 hours or more after removing scopolamine transdermal system Call yourdoctor right away if your symptoms become severetemporary increase in the size of your pupil and blurry vision especially ifscopolamine transdermal system comes in contact with your eyesskin burns at the site of scopolamine transdermal system This canhappen during a medical test called a Magnetic Resonance Imaging scan (MRI)Scopolamine transdermal system contains aluminum and should be removed fromyour skin before you have an MRI
dry mouth blurred vision oreye problems
feeling sleepy ordrowsy
disorientation(confusion)
dizziness feeling agitatedor irritable
pharyngitis(sore throat)
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
bull
bullbull
To help prevent nausea and vomiting from motion sickness
bull
bull
To help prevent nausea and vomiting after surgery
bull
bull
How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
bull
bullbull
Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
bull
bull
bull
bull
bullbull
bull
bull
bull
The most common side effects of using scopolamine transdermal systeminclude
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Tell your doctor if you have any side effect that bothers you or that does not go awayThese are not all the possible side effects of scopolamine transdermal systemCall your doctor for medical advice about side effects You may report side effects toFDA at 1-800-FDA-1088General information about the safe and effective use of scopolaminetransdermal system
angle closure glaucoma If you have open angle glaucoma and use scopolaminetransdermal system remove scopolamine transdermal system and call a doctorright away if you feel pain or discomfort have blurred vision or see halos orcolored images around lights and reddening of your eyesworsening of seizures Tell your doctor about any worsening of seizures whileusing scopolamine transdermal systeman unusual reaction called acute psychosis Tell your doctor if you have anyof these symptoms
bullbullbullbullbull
confusionagitationrambling speechhallucinations (seeing or hearing things that are not there)paranoid behaviors and delusions (false belief in something)
worsening of your preeclampsia during pregnancy Some pregnant womenwith severe preeclampsia have had seizures after getting scopolamine by injectionin the muscle (intramuscular) or injection in the vein (intravenous)difficulty urinatingdifficulties in food passing from the stomach to the small intestineswhich may cause abdominal pain nausea or vomitingwithdrawal symptoms after removing scopolamine transdermal systemafter using it for several days Some people may have certain symptoms suchas difficulty with balance dizziness nausea vomiting stomach cramps sweatingconfusion muscle weakness low heart rate or low blood pressure that could start24 hours or more after removing scopolamine transdermal system Call yourdoctor right away if your symptoms become severetemporary increase in the size of your pupil and blurry vision especially ifscopolamine transdermal system comes in contact with your eyesskin burns at the site of scopolamine transdermal system This canhappen during a medical test called a Magnetic Resonance Imaging scan (MRI)Scopolamine transdermal system contains aluminum and should be removed fromyour skin before you have an MRI
dry mouth blurred vision oreye problems
feeling sleepy ordrowsy
disorientation(confusion)
dizziness feeling agitatedor irritable
pharyngitis(sore throat)
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
bull
bullbull
To help prevent nausea and vomiting from motion sickness
bull
bull
To help prevent nausea and vomiting after surgery
bull
bull
How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
bull
bullbull
Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
Medicines are sometimes prescribed for purposes other than those listed in a patientinformation leaflet Do not use scopolamine transdermal system for a condition forwhich it was not prescribed Do not give scopolamine transdermal system to otherpeople even if they have the same symptoms you have It may harm themYou can ask your pharmacist or doctor for information about scopolamine transdermalsystem that is written for health professionalsWhat are the ingredients in scopolamine transdermal systemActive ingredient scopolamineInactive ingredients crospovidone isopropyl palmitate light mineral oil polyisobutyleneethylene vinyl acetate copolymer and aluminized polyester filmManufactured by AVEVA DRUG DELIVERY SYSTEMS an APOTEX Company Miramar FL 33025Distributed by PerrigoAllegan MI 49010
For more information go to wwwperrigocom or call Perrigo at 1-866-634-9120
Instructions for UseINSTRUCTIONS FOR USEScopolamine (skoe polrsquo a meen) Transdermal SystemRead this Instructions for Use before you start using scopolamine transdermal systemand each time you get a refill There may be new information This information does nottake the place of talking to your doctor about your medical condition or your treatmentInformation about scopolamine transdermal system
bull
bullbull
To help prevent nausea and vomiting from motion sickness
bull
bull
To help prevent nausea and vomiting after surgery
bull
bull
How to use scopolamine transdermal system
Scopolamine transdermal system is a tan-colored circle shaped transdermalsystem (patch) with ldquoSCOP 1 mg3 daysrdquo printed on itWear only one scopolamine transdermal system at any timeDo not cut scopolamine transdermal system
Apply one scopolamine transdermal system to your skin on a hairless area behindone ear at least 4 hours before the activity to prevent nausea and vomitingIf the treatment is needed for longer than 3 days remove scopolamine transdermalsystem from the hairless area behind your ear Get a new scopolamine transdermalsystem and place it on the hairless area behind your other ear
Follow your doctorrsquos instructions about when to apply scopolamine transdermalsystem before your scheduled surgeryScopolamine transdermal system should be left in place for 24 hours after surgeryAfter 24 hours scopolamine transdermal system should be removed and thrownaway
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
bull
bullbull
Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
Inside the scopolamine transdermal system package you will find one scopolaminetransdermal system An imprinted tan backing membrane with a metallic (silver) stickysurface is adhered to a clear disposable release liner (See Figure 1)
1
2
3
Select a hairless area of skin behind one of your ears Avoid areas on your skin thatmay have cuts pain or tenderness Wipe the area of your skin with a clean drytissueCut along the dashed line on the scopolamine transdermal system package to open(See Figure 2)
Remove the clear plastic backing from the tan-colored round scopolaminetransdermal system (See Figure 3)
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
bull
bullbull
Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
4
5
How to remove scopolamine transdermal system
Do not touch the metallic adhesive (sticky) surface on scopolamine transdermalsystem with your hands (See Figure 4)
Apply the metallic adhesive surface of scopolamine transdermal system firmly tothe dry area of skin behind your ear The imprinted tan colored side of thetransdermal system should be facing up and showing (See Figure 5) Wash yourhands with soap and water right away after applying scopolamine transdermalsystem so that any medicine from scopolamine transdermal system that gets onyour hands will not get into your eyes
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
bull
bullbull
Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
After removing scopolamine transdermal system be sure to wash your hands and thearea behind your ear thoroughly with soap and water Please note that the usedscopolamine transdermal system will still contain some of the active ingredient after useTo avoid accidental contact or ingestion by children pets or others fold the usedscopolamine transdermal system in half with the sticky side together Throw away(dispose of) scopolamine transdermal system in the household trash out of the reach ofchildren pets or othersHow should I store scopolamine transdermal system
bull
bullbull
Keep scopolamine transdermal system and all medicines out of reach ofchildrenThe Medication Guide and Instructions for Use have been approved by the US Foodand Drug Administration Revised April 2019
PackageLabel Display PanelRx OnlyScopolamine Transdermal System1 mg3 daysFormulated delivery of approximately 1 mg over three daysMotion Sickness and Post-operative Nausea amp Vomiting Prevention TransdermalSystems24 Transdermal Systems
Store scopolamine transdermal system at room temperature between 68degF and77degF (20degC and 25degC) until you are ready to use itStore scopolamine transdermal system in an upright positionDo not bend or roll scopolamine transdermal system
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
The following image is a placeholder representing the product identifier that is eitheraffixed or imprinted on the drug package label during the packaging operation
SCOPOLAMINE TRANDERMAL SYSTEM scolopamine transdermal system patch extended release
Product InformationProduct Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC45802-580
Route of Administration TRANSDERMAL
Active IngredientActive Moiety
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
-
Padagis Israel Pharmaceuticals Ltd
Ingredient Name Basis of Strength StrengthSCOPOLAMINE (UNII DL48G20X8X) (SCOPOLAMINE - UNIIDL48G20X8X) SCOPOLAMINE 1 mg
Inactive IngredientsIngredient Name Strength
CROSPOVIDONE (15 MPAS AT 5) (UNII 68401960MK) ISOPROPYL PALMITATE (UNII 8CRQ2TH63M) LIGHT MINERAL OIL (UNII N6K5787QVP) POLYISOBUTYLENE (55000 MW) (UNII TQ77WR8A02) POLYISOBUTYLENE (1100000 MW) (UNII FLT10CH37X)
Product CharacteristicsColor WHITE (TO ALMOST WHITE) Score Shape SizeFlavor Imprint CodeContains
Packaging Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC45802-580-
84 4 in 1 CARTON 06132017
1 1 in 1 POUCH Type 0 Not a CombinationProduct
2 NDC45802-580-46 10 in 1 CARTON 06132017
2 1 in 1 POUCH Type 0 Not a CombinationProduct
3 NDC45802-580-62 24 in 1 CARTON 06132017
3 1 in 1 POUCH Type 0 Not a CombinationProduct
4 NDC45802-580-01
1 in 1 POUCH Type 0 Not a CombinationProduct 06132017
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
ANDA ANDA078830 06132017
Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
Revised 112021
- HIGHLIGHTS OF PRESCRIBING INFORMATION
- RECENT MAJOR CHANGES
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- DOSAGE FORMS AND STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- FULL PRESCRIBING INFORMATION CONTENTS
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
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- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
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- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
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- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
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- 7 DRUG INTERACTIONS
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- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
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- 8 USE IN SPECIFIC POPULATIONS
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- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
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- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
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- 121 Mechanism of Action
- 123 Pharmacokinetics
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- 13 NONCLINICAL TOXICOLOGY
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- 131 Carcinogenesis Mutagenesis Impairment of Fertility
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- 14 CLINICAL STUDIES
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- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- FULL PRESCRIBING INFORMATION
- 1 INDICATIONS AND USAGE
- 2 DOSAGE AND ADMINISTRATION
-
- 21 Important Application and Removal Instructions
- 22 Recommended Adult Dosage
-
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
-
- 51 Acute Angle Closure Glaucoma
- 52 Neuropsychiatric Adverse Reactions
- 53 Eclamptic Seizures in Pregnant Women
- 54 Gastrointestinal and Urinary Disorders
- 55 Drug WithdrawalPost-Removal Symptoms
- 56 Blurred Vision
- 57 Magnetic Resonance Imaging (MRI) Skin Burns
-
- 6 ADVERSE REACTIONS
-
- 61 Clinical Trials Experience
- 62 Postmarketing Experience
-
- 7 DRUG INTERACTIONS
-
- 71 Drugs Causing Central Nervous System (CNS) Adverse Reactions
- 72 Anticholinergic Drugs
- 73 Oral Drugs Absorbed in the Stomach
- 74 Interaction with Gastric Secretion Test
-
- 8 USE IN SPECIFIC POPULATIONS
-
- 81 Pregnancy
- 82 Lactation
- 84 Pediatric Use
- 85 Geriatric Use
- 86 Renal or Hepatic Impairment
-
- 9 DRUG ABUSE AND DEPENDENCE
-
- 91 Controlled Substance
- 93 Dependence
-
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
-
- 121 Mechanism of Action
- 123 Pharmacokinetics
-
- 13 NONCLINICAL TOXICOLOGY
-
- 131 Carcinogenesis Mutagenesis Impairment of Fertility
-
- 14 CLINICAL STUDIES
-
- 141 Prevention of Motion Sickness
- 142 Prevention of Post-Operative Nausea and Vomiting
-
- 16 HOW SUPPLIEDSTORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- Medication Guide
- Instructions for Use
- PackageLabel Display Panel
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