Celemin Nephro® - Concise Prescribing Information

Indications Parenteral nutrition supplement in conditions eg acute & chronic renal insufficiency, hemofiltration, peritoneal & hemodialysis.Click to view Celemin Nephro detailed prescribing infomation

Dosage Acute & chronic renal insufficiency Recommended daily dose: 0.5 g/kg body wt/day. Patients treated by hemodialysis, hemofiltration & peritoneal dialysis Max: 1 g/kg body wt/day.Click to view Celemin Nephro detailed prescribing infomation

Contraindications Disturbances of the amino acid metabolism. Hepatic coma, serious renal disturbances, hypernatremia, hyperkalemia, CHF, hyperhydration, metabolic acidosis. Long-term parenteral use.Click to view Celemin Nephro detailed prescribing infomation

Special Precautions

Monitor fluid, serum electrolytes, blood sugar levels & acid base balance. Fat should be included in the dietary regimen to avoid essential fatty acid deficiency.Click to view Celemin Nephro detailed prescribing infomation

Adverse Drug Reactions

Chest discomfort & palpitation. Nausea, vomiting, chills & fever.View ADR Monitoring Website

Storage View Celemin Nephro storage conditions for details to ensure optimal shelf-life.

Description View Celemin Nephro description for details of the chemical structure and excipients (inactive components).

MIMS Class Parenteral Nutritional Products

ATC Classification

A16AA - Amino acids and derivatives ; Used in treatment of alimentary tract and metabolism problems.

Nsg. Responsibilities

Lab tests: Perform C&S and renal function prior to first dose and periodically during therapy; therapy may begin pending test results. Determine creatinine clearance and serum drug concentrations at frequent intervals, particularly for patients with impaired renal function, infants (renal immaturity), older adults, patients receiving high doses or therapy beyond 10 d, patients with fever or extensive burns, edema, obesity.

Repeat C&S if improvement does not occur in 3–5 d; reevaluate therapy. Note: Dosages are generally adjusted to maintain peak serum gentamicin

concentrations of 4– 10 g/mL, and trough concentrations of 1–2 g/mL. Peak concentrations above 12 g/mL and trough concentrations above 2 g/mL are associated with toxicity.

Draw blood specimens for peak serum gentamicin concentration 30 min–1h after IM administration, and 30 min after completion of a 30–60 min IV infusion. Draw blood

specimens for trough levels just before the next IM or IV dose. Use nonheparinized tubes to collect blood.

SULPERAZONE 

   

Generic : Cefoperazone, Sulbactam

PPD Drug Class: Anti-infectives/ Antibiotics/ Cephalosporins/ Cephalosporins, 3rd Generation, Anti-infectives/ Antibiotics/ Antibiotics, Other

Needs a Prescription: Yes (please see your doctor for proper supervision)

Indications: Respiratory infection, urinary tract infection, peritonitis, cholecystitis, cholangitis & other intraabdominal infections. Septicemia, meningitis, skin & soft tissue infections, bone & joint infections. Pelvic inflammation disease, endometriosis, gonorrhea & other genital tract infections.

Recommended Dosage: For dosage information of prescription medicine, please consult with your doctor.

Contraindication: Allergy to penicillins, sulbactam or cephalosporins.

Precaution: Hypersensitivity. Hepatic dysfunction & renal impairment. Patients w/ poor diet, malabsorption states (e.g., cystic fibrosis) & patients on prolonged IV alimentation regimens. Prothrombin time should be monitored in patients receiving anticoagulant therapy, & exogenous vitamin K administered as indicated. Premature infants & neonates. Pregnancy & lactation.

Drug Interaction: Alcohol. False-positive reaction w/ Benedict's or Fehling's solution.

Side Effect: Anaphylactoid reactions (including shock), diarrhea, nausea & vomiting, pseudomembranous colitis. Maculopapular rash, urticaria, pruritus, Stevens Johnson syndrome. Headache, hypotension, leucopenia, hematuria & vasculitis.

Available Forms: Vial 1.5 g .

Harnal OCAS® - Detailed Prescribing Information

Manufacturer GlaxoSmithKline

Distributor Zuellig

Contents Tamsulosin HCl

Indications For the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

Dosage 1 tablet daily.

The tablet must be swallowed whole and not be broken, crunched or chewed, as this compromises the prolonged release properties of the tablet for the active ingredient.

Harnal OCAS can be taken on an empty stomach, or before, with or after food.

Overdosage Acute overdose with tamsulosin HCl 5 mg has been reported. Acute hypotension (systolic blood pressure 70 mm Hg), vomiting and diarrhoea were observed, which were treated with fluid replacement and the patient could be discharged the same day.

If acute hypotension occurs after overdosage, cardiovascular support should be given and maintained. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this is insufficient then volume expanders and when necessary, vasopressors could be administered. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as

tamsulosin is very highly bound to plasma proteins.

Measures to impede absorption eg, emesis can be taken. When large quantities of tamsulosin are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative eg, sodium sulphate can be administered.

Harnal OCAS is a sustained-release formulation. The signs and symptoms of overdose may be delayed or prolonged from the time of ingestion.

Administration May be taken with or without food (Swallow whole, do not break/ chew/ crush.).

Contraindications Hypersensitivity to tamsulosin HCl or any other component of Harnal OCAS. History of orthostatic hypotension. Severe hepatic impairment (Child-Pugh scores >9). Severe renal impairment with creatinine clearance of <10 mL/min. Concurrent use of another α1-adrenoceptor inhibitor.

Special Precautions Syncope and Postural Hypotension: Patients beginning treatment with Harnal OCAS tablets should be cautioned to avoid situations where injury could result should syncope occur. Postural hypotension can occur during treatment with Harnal OCAS but rarely results in syncope. However, the patient should be warned of this possibility and advised to sit or lie down if symptoms of hypotension should occur.

Exclusion of Prostatic Carcinoma and Other Urological Conditions: Carcinoma of the prostate and other conditions which can cause the same symptoms as benign prostatic hyperplasia should be excluded before starting therapy with Harnal OCAS. Digital rectal examination and as considered appropriate, determination of prostate specific antigen should be performed before treatment and at regular intervals afterwards.

Myocardial Ischaemia: Patients with myocardial infarction or angina pectoris within the preceding 6 months were excluded from the phase III clinical studies. As a result, the safety of Harnal OCAS in these patients has not been formally assessed.

Intraoperative Floppy Iris Syndrome: Intraoperative floppy iris syndrome (IFIS) has been observed during cataract surgery in some patients taking or who have previously been treated with α1-adrenoceptor antagonists. This variant of small pupil syndrome is characterised by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs and potential prolapse of the iris toward the phaco-emulsification incisions. The patient's ophthalmologist should

be prepared for possible modifications to their surgical technique eg, the utilisation of iris hooks, iris dilator rings, or visco-elastic substances. There does not appear to be a benefit of stopping α1-adrenoceptor antagonist therapy prior to cataract surgery.

Hepatic Impairment: In a study of patients with moderate hepatic impairment, free tamsulosin levels remained unchanged after treatment with tamsulosin HCl 400 mcg in a modified release capsule formulation when compared to normal subjects. Since the type of formulation will not affect the disposition of tamsulosin, no dose adjustment for Harnal OCAS is expected in patients with mild to moderate hepatic impairment.

Effects on the Ability to Drive or Operate Machinery: As Harnal OCAS may cause dizziness, patients should be warned to take care whilst operating machinery or driving.

Carcinogenicity, Mutagenicity & Impairment of Fertility: Reproduction toxicity in rats, carcinogenicity in mice and rats and in vivo and in vitro genotoxicity have been conducted.

Oral (dietary) administration of tamsulosin for up to 2 years in rats and mice was associated with an increased incidence of pituitary adenoma, mammary gland hyperplasia, mammary gland fibroadenoma and (in mice only) mammary gland adenocarcinoma. These effects occurred at plasma tamsulosin concentrations (AUC) up to 10 times lower than those expected in men undergoing treatment with Harnal OCAS, but they were observed only in female animals and are probably due to the hyperprolactinaemic effect of tamsulosin. It is not known if Harnal OCAS elevates prolactin during prolonged administration in humans. The relevance for human risk of the findings of prolactin-mediated endocrine tumours in female rodents is unknown.

Tamsulosin HCI produced no evidence of genotoxic potential in assays for gene mutation (Ames reverse mutation test and mouse lymphoma thymidine kinase assay), chromosomal damage (Chinese hamster ovary cells and mouse micronucleus assay) and other genotoxic effects (unscheduled DNA repair synthesis and in vivo sister chromatid exchange).

Alpha-adrenoceptor antagonists are known to reduce male fertility by affecting penile erection, emission and/or ejaculation. In male rats, a severe reduction in male copulation rate and fertility was observed after a single dose or after repeated oral doses of tamsulosin. Spermatogenesis was not affected in the rat studies and the effect on fertility was reversible. The no effect dose on male rat fertility was associated with

plasma tamsulosin levels (AUC) at least 50% of those expected in human male treated with Harnal OCAS.

Treatment of female rats with tamsulosin caused disruption of the oestrus cycle and a severe reduction in fertility, due to interference of fertilisation with the ova. These effects were shown to be reversible.

Use in pregnancy: Category B2. Harnal OCAS is not indicated for use in women. It is intended for use only in males.

Tamsulosin, at oral doses causing maternal toxicity, was not embryotoxic or teratogenic when administered during gestation in rats (doses up to 300 mg/kg/day) or rabbits (doses up to 50 mg/kg/day). However, administration of tamsulosin during the peri/postnatal period was associated with a higher incidence of stillbirths and reduced pup weight gain after birth. No adverse effects on development or reproductive performance were observed on surviving pups, however, there is some evidence for impairment of offspring reproductive capacity when maternal treatment with tamsulosin is started before pregnancy.

Use in lactation: Harnal OCAS is intended for use only in males.

In female rats, tamsulosin and/or its metabolites were shown to pass into milk after oral administration of the drug during lactation. The effect on the newborn is not known.

Use in children: Harnal OCAS is not indicated for use in children.

Adverse Drug Reactions

Priapism: Rarely, tamsulosin, like other α1-antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Patients should be informed that this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction.Abnormal Ejaculation: Patients should be advised on the potential for abnormal ejaculation to occur upon commencement of Harnal OCAS treatment. Retrograde ejaculation is the most commonly reported abnormal ejaculation event associated with the use of Harnal OCAS.Clinical Trials: Table 4 shows the incidence of undesirable effects following Harnal OCAS 400 mcg treatment. This data is based on a phase 3 clinical study in which there were no relevant differences between the treatment and placebo groups in the percentage of patients reporting at least 1 treatment emergent adverse event (TEAE). Most TEAEs were of mild or moderate intensity. The most frequent TEAEs were ejaculation disorders. These are TEAEs that are often associated with α1-AR antagonists (see Table 4).

Click on icon to see table/diagram

A patient may experience a TEAE more than once or may experience >1 TEAE within the same system organ class. Data from clinical trial study 617-CL-307.The following treatment-related adverse events were reported from clinical trials; where common is ≥1% and <10%; uncommon is ≥0.01% and <1%; rare is ≥0.01% and <0.1% and very rare is <0.01%.Cardiac Disorders: Uncommon: Palpitations.Gastrointestinal Disorders: Uncommon: Constipation, diarrhoea, nausea, vomiting.General Disorders: Uncommon: Asthenia.Nervous System Disorders: Common: Dizziness (1.3%): Uncommon: Headache. Rare: Syncope.Reproductive System Disorders: Uncommon: Abnormal ejaculation. Very Rare: Priapism.Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Rhinitis.Skin and Subcutaneous Tissue Disorders: Uncommon: Rash, pruritus, urticaria. Rare: Angioedema.Vascular Disorders: Uncommon: Postural hypotension.During cataract surgery, a variant of small pupil syndrome known as intraoperative floppy iris syndrome (IFIS) has been reported during post-marketing surveillance in association with α1-adrenoceptor antagonist therapy (see Precautions).Click to view ADR Monitoring Form

Drug Interactions Drugs Known to Interact with Tamsulosin: Concomitant cimetidine leads to a rise in plasma levels of tamsulosin, whilefurosemide leads to a fall (about 12% following a single 20-mg IV dose). However, as levels remain within the normal range, dosage need not be adjusted.

Concurrent Administration of Harnal OCAS with other α1-adrenoceptor antagonists is contraindicated because of the potential for hypotensive effects (see Contraindications).

Drugs which may Interact with Tamsulosin: Tamsulosin binds extensively to plasma proteins and may displace other protein-bound drugs. Clinical trial data are not available.

No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions (representative of the cytochrome P-450-linked drug metabolising enzyme system), involving amitriptyline, salbutamol, glibenclamide and finasteride. Diclofenac and warfarin, however, may increase the elimination rate of tamsulosin.

Drugs which do not Interact Significantly with Tamsulosin: Harnal OCAS did not affect the pharmacokinetics of a single IV dose of digoxin 0.5mg.

No interactions have been seen when tamsulosin HCl was given concomitantly with either atenolol, enalapril, nifedipine or theophylline.

General: Limited clinical data are available on interactions between tamsulosin and other drugs. Tamsulosin is metabolised in the liver and may be expected to interact with other hepatically metabolised drugs. However, the specific cytochrome P-450 isoenzymes responsible for tamsulosin metabolism have not been identified. Tamsulosin should therefore be used with caution in patients who are taking other drugs, particularly those which undergo hepatic metabolism.

Other In Vitro Findings: In vitro, neither diazepam nor propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin, change the free fraction of tamsulosin in human plasma. Neither does tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone.

An in vitro study using human liver microsomal fractions showed no effect of amitriptyline, salbutamol, glibenclamide and finasteride on the rate of disappearance of tamsulosin. The clinical relevance of these findings is uncertain.View more drug interactions with Harnal OCAS

Pregnancy Category (US FDA)

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Storage Store below 30°C.

Description Each tablet contains tamsulosin HCl 400 mcg equivalent to tamsulosin 367 mcg.

Tamsulosin HCl, an α1-adrenoceptor blocking agent, has a high affinity for the α1A-receptor subtype predominantly present in the human prostate.

Tamsulosin HCl is (R)-5-[2-[[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-

2-methoxybenzenesulfonamide, monohydrochloride. The molecular weight is 444.98.

Harnal OCAS also contains the following excipients: Macrogol 7,000,000 and 8000, magnesium stearate, butylated hydroxytoluene, anhydrous colloidal silica, hypromellose and yellow iron oxide. None of these is derived from animal sources.

Tamsulosin HCl is sparingly soluble in water (1:85) and slightly soluble in alcohol. It is stable in an acid environment.

Mechanism of Action

Pharmacology: The tone of the human prostate smooth muscle is maintained primarily by noradrenaline released from adrenergic nerves and stimulating post-junctional α1-adrenoceptors. This provides the rationale for the use of α1-adrenoceptor antagonists for lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).Pharmacodynamics: Pharmacological studies have established that tamsulosin is a selective, potent and competitive α1-adrenoceptor antagonist and that it has a greater affinity for the α1A-receptor subtype, predominantly present in the human prostate.Alpha1-adrenoceptor antagonists generally can reduce blood pressure by lowering peripheral resistance. However, no reduction in blood pressure of any clinical significance was observed during studies with Harnal OCAS.The binding of tamsulosin to α1-adrenoceptors in the prostate results in relaxation of prostate smooth muscle followed by improvements in urodynamics. Thus, Harnal OCAS increases maximum urinary flow rate by reducing smooth muscle tension in the prostate and urethra and thereby relieving obstruction. It also improves the symptoms related to bladder instability and tension of the smooth muscle of the lower urinary tract.These effects on urinary storage and voiding symptoms are maintained during long-term therapy. The need for surgery or catheterisation is significantly delayed.Pharmacokinetics: Absorption and Distribution: Harnal OCAS is a prolonged-release tablet of the non-ionic gel matrix type. Its formulation provides consistent slow release of tamsulosin, which is maintained over the whole pH range encountered in the GIT, resulting in an adequate exposure, with little fluctuation, over 24 hrs.Tamsulosin administered as Harnal OCAS is absorbed from the intestine. Of the administered dose, approximately 55-59% is estimated to be absorbed. The rate and extent of absorption of tamsulosin HCl administered as Harnal OCAS tablets are only slightly affected by food, but this is unlikely to be clinically significant.Tamsulosin HCl administered as Harnal OCAS tablets exhibits near linear pharmacokinetics (plasma concentrations Cmaxand AUC versus

dose) over the dosage range 0.4 mg through 0.8-1.2 mg once daily. Steady state is reached by day 4 of multiple dosing. The pharmacokinetics of tamsulosin HCl, as Harnal OCAS, 400-mcg tablets once daily as a single dose under fasted conditions, and steady state under fed and fasted conditions are shown in Table 1.

Click on icon to see table/diagram

As a result of the prolonged release characteristic of Harnal OCAS, the trough concentrations at steady state of tamsulosin HCl in plasma, amount to approximately 40% of the peak plasma concentrations under fasted and fed conditions.There is a considerable inter-patient variation in the plasma concentrations of tamsulosin HCl, after both single and multiple dosing.In man, tamsulosin is about 99% bound to plasma proteins. The volume of distribution is small (about 0.2 L/kg).Metabolism and Excretion: Harnal OCAS 400 mcg contains tamsulosin as the R(-) isomer. In humans, there is no in vivoconversion to the less active S(+) isomer. Tamsulosin has a low first-pass effect, being metabolised slowly. Most tamsulosin is present in plasma in the form of unchanged drug. Tamsulosin is metabolised in the liver, but the specific cytochrome P-450 isoenzymes responsible for this metabolism have not been identified. In rats, tamsulosin was seen to cause minimal induction of microsomal liver enzymes. No dose adjustment is warranted in hepatic insufficiency (see Contraindications).None of the metabolites is more active than the original precursor compound.Tamsulosin and its metabolites are mainly excreted in the urine. The amount excreted as unchanged drug is estimated to be about 4-6% of the dose administered as Harnal OCAS.No dose adjustment is warranted in renal impairment (see Contraindications).Clinical Trials: The efficacy of Harnal OCAS has been evaluated in 2 randomised, placebo-controlled studies: The phase 2 dose-response study 617-CL-303 and the phase 3 study 617-CL-307. A total of 2962 patients were studied, of which 560 were treated with Harnal OCAS 0.4 mg and 564 were treated with placebo. The remaining subjects were treated with 0.4 mg (capsules), 0.8 mg and 1.2 mg (tablets) doses of tamsulosin HCl.Inclusion Criteria: In both studies the inclusion criteria were male patients ≥45 years, diagnosed as having lower urinary tract symptoms (LUTS) suggestive of BPH, with voiding/obstructive symptoms (including incomplete emptying of the bladder, intermittency, poor stream or hesitancy), and/or storage/irritative/filling symptoms (including daytime frequency, urgency or nocturia).These patients had a total international prostate symptom score (I-PSS) of

≥13, both at enrollment (visit 1) and at baseline after the 2-week placebo run-in period (visit 2). At enrollment, they also had to have a maximum flow rate (Qmax) of ≥4 mL/sec and ≤12 mL/sec, with a voided volume ≥120 mL during free flow.Patients with cardiac ischaemia were excluded from participation in these trials. Safety in such patients has not been formally assessed.Study 617-CL-303: Study 617-CL-303 was a multicenter, double-blind, randomized placebo-controlled, parallel group, dose-response study. In this study, 211 patients received placebo and 203 patients received Harnal OCAS tablets 400 mcg once daily for 12 weeks of the double-blind randomized treatment. The results of study 617-CL-303 are summarised in Table 2.

Click on icon to see table/diagram

Study 617-CL-307: Study 617-CL-307 was a multicenter, double-blind, randomised, placebo and active-controlled, parallel group study. In this study, 353 patients received placebo and 357 patients received Harnal OCAS tablets 400 mcg once daily for 12 weeks of the double-blind randomised treatment. The results of study 617-CL-307 are summarised in Table 3.

Click on icon to see table/diagram

The primary efficacy parameter in both studies following Harnal OCAS 400-mcg treatment was the change from baseline to endpoint in total I-PSS scores. The secondary efficacy analyses contained the changes from baseline in voiding and storage I-PSS subscores and I-PSS quality of life scores.The I-PSS questionnaire was developed and validated by the American Urological Association (I-PSS previously called the AUA Symptom Index) and consisted of 7 questions evaluating the frequency of 7 urinary symptoms. These included 4 voiding symptoms (poor stream, hesitancy, intermittency and incomplete bladder emptying) and 3 storage symptoms (daytime frequency, nocturia and urgency). The patient rated each of the 7 symptoms on a scale of 0-5 of increasing symptom severity. The total score could therefore range from 0-35, the voiding subscore from 0-20 and the storage subscore from 0-15. The questionnaire was adopted by the World Health Organization, who added a further question assessing the impact of the urinary symptoms on the Quality of Life. The Quality of Life question asked how the patient would feel about his current level of symptoms for the rest of his life, ranging from 1 (delighted) to 6 (terrible).

MIMS Class Drugs for Bladder & Prostate Disorders

ATC Classification G04CA02 - Tamsulosin ; Belongs to the class of alpha-adrenoreceptor antagonists. Used in the treatment of benign prostatic hypertrophy.

Poison Schedule [?] POM

Presentation/Packing

Tab (yellow, round, biconvex, film-coated, prolonged release, debossed with the code '04' on one side) 400 mcg x 30's.

Calcium CarbonateCategory Drug Study »

Calcium carbonate is a chemical substance found usually in rocks in all parts of the world. It is commonly used as a supplement or antacid though excessive quantities are found to be hazardous. Common brand names are Apo-Cal, Calbone, Calcid, Calsan, Caltrate, Calvit, Contylan, Dicarbosil, Esvical, Exofat, Gaviscon, Megavit, Oscal, Osteofos, Titralac, Tums, and Ultima. Calcium carbonate is classified as Electrolyte replenisher, antacid, antihypocalcemic, antihyperkalemic, antihypermagnesemic, antihyperphosphatemic.

Indication for Calcium Carbonate

Calcium carbonate may be used for Acute hypocalcemia, electrolyte depletion, cardiac arrest, hyperkalemia, and hypermagnesemia.

It can also be used in Chronic hypocalcemia, calcium deficiency, and as an antacid. It is also used in the treatment of hyperphosphatemia.

Routes and Dosage of Calcium Carbonate

HypocalcemiaPO: ADULTS, ELDERLY: 1-2 g/day in 3-4 divided doses. CHILDREN: 45-65 mg/kg/day in 3-4 divided doses.

AntacidPO: ADULTS, ELDERLY: 1-2 tabs (5-10 ml) every 2 hours as needed.

OsteoporosisPO: ADULTS, ELDERLY: 1,200 mg/day.

Action of Calcium Carbonate

Calcium is essential for function, integrity of nervous, muscular, and skeletal systems. It plays an important role in normal cardiac and renal functions, respiration, blood coagulation, cell membrane, and capillary permeability. It assists in regulating the release and storage of neurotransmitters and hormones. Calcium neutralizes or reduces gastric acid production.

Side Effects and Adverse Reactions of Calcium Carbonate

Side Effects of Calcium Carbonateo Hypotension

o Flushing

o Warmth

o Nausea

o Vomiting

o Pain

o Rash

o Redness

o Burning at the injection site

o Sweating

o Decreased blood pressure

o Chalky taste

o Mild constipation

o Fecal impaction

o Swelling of the hands or feet

o Metabolic alkalosis

o Milk-alkali syndrome (headache, decreased appetite, nausea, vomiting, unusual tiredness)

o Difficult or painful urination

Adverse Reactions of Calcium Carbonateo Hypercalcemia (Early Signs: Constipation, headache, dry mouth, increased thirst,

irritability, decreased appetite, metallic taste, fatigue, weakness, depression.)

o Hypercalcemia (Late signs: Confusion, drowsiness, increased blood pressure, light sensitivity, urination, irregular heartbeat, nausea, vomiting)

Nursing Considerations for Clients Taking Calcium Carbonate

o Assess blood pressure, ECG readings, renal function, magnesium, phosphate, and potassium concentrations.

o Take tablets with full glass of water 30 minutes to 1 hour after meals.

o Give syrup diluted in juice or water.

o Chew chewable tablets well before swallowing.

o Monitor blood pressure, ECG, renal function, magnesium, phosphate, potassium, serum, and urine calcium concentrations.

o Monitor for signs of hypercalcemia.

Patient Teachings for Clients Taking Calcium Carbonate

o Stress importance of diet.

o Take tablets with full glass of water, 30 minutes to 1 hour after meals.

o Give liquid before meals.

o Do not take within 1-2 hours of other oral medications, fiber-containing foods.

o Avoid excessive alcohol, tobacco, and caffeine.

NAMECLASSIFICATIONACTIONINDICATIONCONTRAINDICATIONADVERSEEFFECTNURSINGRESPONSIBILITIESRanitidineHydrochlorideBrandName:ZantacHistamine2antagonistsCompetitively inhibitsthe actionof histamineat the H2receptors of the parietalcells of thestomach,inhibitingbasalgastric acidsecretionand gastricacidsecretionthat isstimulatedby food,insulin,histamine,cholinergicagonists,gastrin andpentagastrin.• Short-termtreatment of activeduodenalulcer• Short-termtreatment of active,benigngastric ulcer•Maintenancetherapy forduodenalulcer atreduceddosage.• Short-termtreatmentfor GERD.• Pathologichypersecretoryconditions• Treatmentof erosiveesophagitis• Treatmentof heartburn,acidindigestion,Contraindicatedwith allergy toranitidine,lactation Usecautiously withimpaired renal orhepatic function,pregnancy• CNS:headache,malaise,dizziness,somnolence,insomnia,vertigo• CV:tachycardia,bradycardia• Dermatologic:rash, alopecia• GI:constipation,diarrhea,nausea andvomiting,abdominal pain,hepatitis• Hematologic:leucopenia,granulocytopenia,thrombocytopenia,pancytopenia• GU:assessment:1. History:allergy toranitidine,impaired renalor hepaticfunction,lactation,pregnancy.2. Physical: skinlesions,orientation,affect, liverevaluation,abdominalexamination,normal output,renal functiontests, CBC IInterventions:1. Administeroral drug withmeals and atbedtime.2. Decreasedoses in renaland liver failure.3. Provideconcurrentantacid therapyto relieve

 sourstomach(Zollinger-Ellisonsyndrome)impotence ordecreasedlibidopain.4. Administer IMdose undiluted,deep into largemuscle group.5. Arrange forregular follow-upincluding bloodtest, to evaluateeffects.

Ranitidine

Ranitidne reduces the amount of acid produced in the stomach. The most commonly experienced side-effects are diarrhoea, dizziness and tiredness. These effects

are usually mild and do not last long.

About ranitidine

Type of medicine H2-receptor antagonist

Used for Conditions caused by too much acid being produced in the stomach. To treat irritation and ulceration of the stomach caused by non-steroidal anti-inflammatory drugs

Also called Histac®; Ranitil®; Zantac®

Available as Tablets, effervescent tablets, oral liquid and injection

Ranitidine is used to treat certain conditions caused by too much acid being produced in the

stomach, such as stomach ulcers (gastric ulcers), ulcers of the upper part of the intestine

(duodenal ulcers), reflux oesophagitis (acid reflux or heartburn) and Zollinger-Ellison

disease.

Ranitidine can also be used to treat irritation and ulceration of the stomach caused by non-

steroidal anti-inflammatory drugs (NSAIDs).

Acid is produced naturally in the stomach to help digest food. Excessive amounts of acid can

irritate the stomach lining, causing inflammation, ulcers and other conditions.

Ranitidine works by reducing the amount of acid produced in the stomach, relieving pain

and helping to repair the damage.

Before taking ranitidine

Before taking ranitidine make sure your doctor or pharmacist knows:

If you are pregnant, trying for a baby or breast-feeding. If you suffer from kidney problems. If you suffer from porphyria (a blood disorder). If you are taking other medicines, including those available to buy without a prescription,

herbal or complementary medicines. If you have ever had an allergic reaction to this or any other medicine.

How to take ranitidine

Before beginning treatment, read the manufacturer's printed information leaflet.

Take your medication exactly as directed by your doctor. If you have been prescribed ranitidine effervescent tablets, dissolve them in water to take

them. Try not to miss any doses. If you forget to take a dose, take one as soon as you

remember unless it is nearly time for your next dose. Do not take two doses at the same time to make up.

Getting the most from your treatment

Do not smoke. Smoking increases the amount of acid produced by the stomach and will aggravate your condition.

Try to avoid foods that may upset your stomach such as, alcohol, citrus fruits and juices, drinks containing caffeine, tomatoes and spicy food.

Can ranitidine cause problems?

Along with their useful effects all medicines can cause unwanted side effects, which usually

improve as your body adjusts to the new medicine. Speak with your doctor or pharmacist if

any of the following side effects continue or become troublesome.

Common side-effects - these affect less than 1 in 10 people who take this medicine

What can I do if I experience this

Diarrhoea Drink plenty of water to replace any lost fluids

Headache Ask your pharmacist to recommend a suitable pain killer

Stomach upset, dizziness, skin rash, and tiredness Speak with your doctor if troublesome

Important: If you experience any unexplained fever, sore throat, bruising, or swelling of the face and mouth with difficulty breathing, speak with your doctor immediately or go to your local accident and emergency department without delay.

If you experience any other symptoms which you think may be due to this medicine, speak with your doctor or pharmacist.

How to store ranitidine

Keep all medicines out of the reach of children. Store in a cool, dry place, away from direct heat and light.

Important information about all medicines

If you buy any medicines, check with a pharmacist that they are safe to take with your other medicines.

If you are having any treatment like an operation or dental treatment, tell the person carrying out the treatment which medicines you are taking.

Never take more than the prescribed dose. If you suspect that you or someone else has taken an overdose of this medicine, go to the accident and emergency department of your local hospital at once. Take the container with you, even if it is empty.

This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

Never keep out of date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.

If you have any questions about this medicine ask your pharmacist.

OmeprazoleCategory Drug Study »

Omeprazole is used to treat conditions where there is an increase in the gastric acid of the stomach. Common brand

names are Acifre, Acipres, Famazol, Flazomel, Gastriloc, Hovizol, Lomezek, Lopep, Loprezol, Losec, Megapraz,

Mepracid, Mepraz, Nocid, Omelon, Omepron, Prexon, Prosec, Risek, Ulsek, and Zosec. Omeprazole is classified as

a Benzimidazole and a Gastric acid pump inhibitor.

Indications for Omeprazole

Shot-term treatment for erosive esophagitis and symptomatic gastroesophageal reflux disease (GERD) poorly

responsive to other treatment. Omeprazole is used for the long-term treatment of pathologic hypersecretory

conditions and active duodenal cancer. It is a maintenance healing of erosive esophagitis. Omeprazole can also be

used in the treatment of H. pylori associated with duodenal ulcer and active benign gastric ulcers. It is also used in

the prevention and treatment of NSAID-induced ulcers.

Routes and Dosage of Omeprazole

Erosive Esophagitis, Poorly Responsive GERD, Active Duodenal Ulcer, Prevention or Treatment of NSAID-

Induced Ulcers

PO: ADULTS, ELDERLY: 20 mg per day.

Maintenance Healing of Erosive Esophagitis

PO: ADULTS, ELDERLY: 20 mg per day.

Pathologic Hypersecretory Conditions

PO: ADULTS, ELDERLY: Initially, 60 mg per day up to 120 mg three time a day.

H. Pylori Duodenal Ulcer

PO: ADULTS, ELDERLY: 20 mg two times per day for 10 days.

Active Benign Gastric Ulcer

PO: ADULTS, ELDERLY: 40 mg per day for 4-8 weeks.

Usual Dosage for Children >2 years

PO: (GERD, erosive gastritis): <20 kg: 10 mg per day. >20 kg: 20 mg per day.

Action of Omeprazole

Omeprazole is converted to active metabolites that irreversibly bind and inhibit H+ -K+ -ATPase (an enzyme on the

surface of gastric parietal cells). It inhibits transport of hydrogen ions into the gastric lumen. Omeprazole increases

the gastric pH and reduces gastric acid formation.

Side Effects and Adverse Reactions of Omeprazole

Side Effects of Omeprazole

o Headache

o Diarrhea

o Abdominal pain

o Nausea

o Dizziness

o Asthenia (loss of strength)

o Vomiting

o Constipation

o Upper respiratory tract infection

o Back pain

o Rash

o Cough

Adverse Reactions of Omeprazole

None known.

Nursing Considerations for Clients Taking Omeprazole

o Give before meals

o Do not crush or chew tablets, swallow whole

o Evaluate for therapeutic response like relief of Gastrointestinal symptoms

o Question if Gastrointestinal discomfort, nausea, and diarrhea occurs.

Patient Teachings for Clients Taking Omeprazole

o Report headache

o Do not chew or crush tablets

o Take before eating

RanitidineCategory Drug Study »

Ranitidine inhibits gastric acid production and is used in the treatment of peptic ulcer disease (PUD) and

gastroesophageal reflux (GERD). Ranitidine can be used along side other antihistamines to treat skin conditions.

Common brand names are Aceptin, Aciloc, Aciran, Ameket, Contracid, Danitin, Entac, Loracid, Ranitab, Raxide,

Zantac, and Zidaxim. Ranitidine is classified as aHistamine H2 receptor antagonist and an Antiulcer.

Indication for Ranitidine

Ranitidine is used for short-term treatment of active duodenal ulcer. It is also used in the prevention of duodenal ulcer

recurrence. Ranitidine can be used for the treatment of active benign gastric ulcer, pathologic GI hypersecretory

conditions, acute gastroesophageal reflux disease (GERD), and erosive esophagitis.

Routes and Dosage of Ranitidine

Duodenal, Gastric Ulcers, GERD

PO: ADULTS, ELDERLY: 150 mg 2 times per day or 300 mg at bedtime. MAINTENANCE: 150 mg at bedtime.

CHILDREN: 2-4 mg/kg/day in divided doses 2 times per day. Maximum: 300 mg per day.

Erosive Esophagitis

PO: ADULTS, ELDERLY: 150 mg 4 times a day. MAINTENANCE: 150mg 2 times a day or 300 mg at bedtime.

CHILDREN: 4-10 mg/kg/day in 2 divided doses. Maximum: 600 mg per day.

Hypersecretory Conditions

PO: ADULTS, ELDERLY: 150 mg 2 times a day. May increase up to 6g per day.

Usual Parenteral Dosage

IV/IM: ADULTS, ELDERLY: 50mg per dose every 6-8 hours. Maximum: 400mg per day. CHILDREN: 2-4 mg/kg/day

in divided doses every 6-8 hours. Maximum: 200mg per day.

Usual Neonatal Dose

IV: Initially, 1.5 mg/kg/dose, then 1.5-2 mg/kg/day in divided doses every 12 hours.

PO: 2 mg/kg/day in divided doses every 12 hours.

Dosage in Renal Impairment

PO: 150 mg every 24 hours.

IM/IV: 50mg every 18-24 hours.

Action of Ranitidine

Ranitidine inhibits histamine action at the H2 receptors of gastric parietal cells. It inhibits gastric acid secretion and

reduces volume and hydrogen ion concentration of gastric juice.

Side Effects and Adverse Reactions of Ranitidine

Side Effects of Ranitidine

o Diarrhea

o Constipation

o Headache

Adverse Reactions of

o Reversible hepatitis

o Blood dyscrasias

Nursing Considerations for Clients Taking Ranitidine

o Obtain baseline hepatic and renal function tests.

o Monitor serum AST, ALT levels.

o Assess mental status in elderly.

o Antacids may decrease absorption.

o May decrease absorption of ketoconazole.

o Give without regards to meals, best given after meals or at bedtime.

o Do not administer within 1 hour of magnesium- or aluminum- containing antacids.

Patient Teachings for Clients Taking

o Smoking decreases effectiveness of medication.

o Do not take medicine within 1 hour of magnesium- or aluminum- containing antacids.

o Transient burning or itching may occur with IV administration.

o Report headache.

o Avoid alcohol and aspirin.

TamsulosinCategory Drug Study »

Tamsulosin or Tamsulosin Hydrochloride is used to treat benign prostatic hyperplasia. Common brand names of

Tamsulosin are Flomax, Flomaxtra, Harnal, Prozelax, and Urimax. Tamsulosin is classified as Alpha1-adrenergic

blocker and benign prostatic hyperplasia agent.

Indication for Tamsulosin

Tamsulosin is used in the treatment of symptoms of benign prostatic hyperplasia.

Routes and Dosage of Tamsulosin

Benign Prostatic Hypertrophy

PO: ADULTS: 0.4 mg once daily. approximately 30 minutes after same meal each day. May increase dosage if

inadequate response in 2-4 weeks.

Action of Tamsulosin

An alpha1 antagonist targets receptors around the bladder neck and prostate capsule. It results in the relaxation of

smooth muscle with improvement in urinary flow and relief from the symptoms of prostate hyperplasia.

Side Effects and Adverse Reactions of Tamsulosin

Side Effects of Tamsulosin

o Dizziness

o Drowsiness

o Headache

o Anxiety

o Insomnia

o Postural hypotension

o Nasal congestion

o Pharyngitis

o Rhinitis

o Nausea

o Vertigo

o Impotence

Adverse Reactions of Tamsulosin

o First dose syncope may occur 30-90 minutes after giving initial dose.

o May be preceeded by tachycardia.

Nursing Considerations for Clients Taking Tamsulosin

o Ask for history of sensitivity to tamsulosin, use of other alpha-adrenergic blocker, and warfarin.

o Give at same time each day, 30 minutes after the same meal.

o Do not crush or open capsules unless directed by physician.

o Assist with ambulation if dizziness occurs.

o Monitor renal function and blood pressure.

Patient Teachings for Clients Taking Tamsulosin

o Take at the same time each day, 30 minutes after the same meal.

o Use caution when getting up from sitting or lying position.

o Avoid tasks that require alertness, motor skills until response to drug is established.

o Do not chew, crush, or open capsule.