prescribing medicine in pregnancy, by australian drug evaluation committee

Prescribingmedicines

inpregnancy

An Australiancategorisation of

risk of drug use inpregnancy

Australian Drug Evaluation Committee

The Australian categorisation consists of the following categories:

Category ADrugs which have been taken by a large number of pregnant women and women ofchildbearing age without any proven increase in the frequency of malformations or otherdirect or indirect harmful effects on the fetus having been observed.

Category CDrugs which, owing to their pharmacological effects, have caused or may be suspectedof causing, harmful effects on the human fetus or neonate without causing malformations.These effects may be reversible. Accompanying texts should be consulted for furtherdetails.

Category B1Drugs which have been taken by only a limited number of pregnant women and womenof childbearing age, without an increase in the frequency of malformation or other director indirect harmful effects on the human fetus having been observed.

Studies in animals have not shown evidence of an increased occurrence of fetal damage.


Studies in animals are inadequate or may be lacking, but available data show no evidenceof an increased occurrence of fetal damage.


Studies in animals have shown evidence of an increased occurrence of fetal damage,the significance of which is considered uncertain in humans.

Category DDrugs which have caused, are suspected to have caused or may be expected to cause,an increased incidence of human fetal malformations or irreversible damage. Thesedrugs may also have adverse pharmacological effects. Accompanying texts should beconsulted for further details.

Category XDrugs which have such a high risk of causing permanent damage to the fetus that theyshould not be used in pregnancy or when there is a possibility of pregnancy.

Prescribing medicines

in pregnancy

An Australian categorisation of riskof drug use in pregnancy

© Commonwealth of Australia 1999

ISBN 0 642 41553 6

This work is copyright. Apart from any use as permitted under theCopyright Act 1968, no part may be reproduced by any process withoutprior written permission from the Commonwealth available fromAusInfo. Requests and inquiries concerning reproduction and rightsshould be addressed to the Manager, Legislative Services, AusInfo, GPOBox 1920, Canberra ACT 2601.

First published 1989Second edition 1992Reprinted 1994Third edition 1996Fourth edition 1999

Prepared by the Medicines in Pregnancy Working Party of the Australian DrugEvaluation Committee (printing partially funded by the Pharmaceutical EducationProgram).

Enquiries should be directed to

Publications UnitTGAPO Box 100Woden ACT 2606

Publications approval number 2637

From the Chairman

It is now ten years and four editions since Medicines in Pregnancy wasfirst produced by the Australian Drug Evaluation Committee to assisthealth professionals in the appropriate prescription of drugs in pregnancy.Over one hundred new medicines have been evaluated and approved forregistration in Australia since the publication of the last edition in 1996and have been added to the current booklet. In addition, the introductionof colour printing has allowed a revision of the layout of the text toimprove the clarity of information provided.

This edition has been retitled Prescribing Medicines in Pregnancy, toemphasise the purpose of the booklet — guiding the prescriber in thecorrect choice of medication when drug therapy is required in pregnancy.This booklet is not intended for use in the more complex situation ofinadvertent drug exposure in early pregnancy, and for this circumstance,the reader is referred to the Obstetric Drug Information Services listedin Appendix B.

The Australian Drug Evaluation Committee is keen to ensure thatappropriate therapeutic options are available to all women needingmedical treatment or preventative therapy during pregnancy, withminimisation of any associated risk to the fetus. An essential prerequisite,and the aim of this booklet, is the provision of accurate, conciseinformation as a basis for informed consent and rational decision making.As always, the Committee welcomes feedback and is most grateful tothose who have offered constructive suggestions about past editions.

Dr Rosemary AytonChairmanMedicines in Pregnancy Working Party

v

CONTENTS

INTRODUCTION x

AUSTRALIAN CATEGORISATION OF DRUGS

ALIMENTARY SYSTEMHyperacidity, reflux, ulcers 2Antispasmodics 2Laxatives 2Antidiarrhoeals 2Cholelitholytics 3

CARDIOVASCULAR SYSTEMAntihypertensives 4Angiotensin converting enzyme (ACE) inhibitors 4Angiotensin II receptor antagonists (ARAs) 5Calcium channel blockers 5Beta-adrenergic blocking agents 6Diuretics 6Antiarrhythmics 7Antiangina agents 7Hypolipidaemic agents 8Cardiac inotropic agents 8Adrenergic stimulants 8Vasodilators 9Antimigraine preparations 9Anticoagulants and thrombolytic agents 9Haemostatic agents 10Fibrinolytic agents 10Other cardiovascular agents 11

CONTENTS

vi

BLOOD AND HAEMOPOIETIC TISSUESIron and haemopoietic agents 12

CENTRAL NERVOUS SYSTEMAnalgesics, antipyretics 13Opioid analgesics 13Hypnotics and sedatives 13Other hypnotics and sedatives 14Antianxiety agents 14Benzodiazepines 14Antipsychotic agents 14Other antipsychotic drugs 15Antidepressants 16Other antidepressants 16CNS stimulants 16Antiparkinson agents 17Anticonvulsants / Antiepileptics 17Other anticonvulsants / antiepileptics 19Antiemetics, antinauseants 20Others 20Other agents acting on the CNS 20

MUSCULOSKELETAL SYSTEMNon-steroidal anti-inflammatory drugs (NSAIDs) 21Antirheumatoid agents 21Muscle relaxants 21Agents used in gout and hyperuricaemia 22

ENDOCRINE SYSTEMOestrogens 23Progestogens 23Antiandrogens 23

vii

CONTENTS

Androgens and anabolic steroids 23Corticosteroids 24Pituitary hormones 24Antidiuretics 24Hypoglycaemic agents (oral) 25Thyroid hormones 25Antithyroid agents 25Agents affecting calcium and bone metabolism 25Other hormonal agents 25Pituitary inhibitors 26Ovulation inducers 26

GENITOURINARY SYSTEMUrinary antiseptics 27Bladder function disorders 27Agents acting on the uterus 27Topical vaginal medication 28

ANTIMICROBIALSCephalosporins 29Penicillins 29Tetracyclines 29Aminoglycosides 29Antifungal agents 30Quinolones 30Macrolide antibiotics 30Miscellaneous antibiotics 30Sulfonamides 31Antituberculotics and antileprotics 31Antimalarials 32Antiviral agents 33Anthelmintics 34

CONTENTS

viii

ANTINEOPLASTIC AGENTSAlkylating agents 35Antimetabolites 35Vinca alkaloids 35Antibiotic cytotoxic agents 35Hormonal antineoplastic agents 35Other Antineoplastic agents 36Non-cytotoxic supportive therapy 36

METABOLISMAnorectic and weight reducing agents 37Other drugs used for the treatment of metabolic disorders 37

RESPIRATORY SYSTEMAntitussives 38Expectorants and mucolytics 38Decongestants 38Bronchospasm relaxants 38Preventive aerosols and inhalations 38Other respiratory agents 38Propellant agents 39

ALLERGY AND IMMUNE SYSTEMAntihistamines 40Vaccines 40Killed vaccines 41Immunomodifiers 41

MOUTH PREPARATIONS 43

OPHTHALMIC DRUGS 44

ix

CONTENTS

DRUGS USED IN DERMATOLOGYSystemic 45Topical 45Topical antifungals, antiseptics 46Topical antiparasitics 46Topical antiviral 47

DRUGS USED IN ANAESTHESIAGeneral anaesthetics 48Local anaesthetics 48Neuromuscular blocking agents 48

CONTRACEPTIVE AGENTSOral contraceptives 49Vaginal spermicides 49

DIAGNOSTIC AGENTSRadiographic Agents 50Pituitary-adrenal response test 50

MISCELLANEOUSDetoxifying agents, antidotes 51Cholinergic and anticholinergic agents 51Drugs used in myasthenia gravis 51Agents used in dependency states 51Vitamins 52

INDEX 53

APPENDIXESA: Therapeutic goods exempted from pregnancy classification 71B: Obstetric Drug Information Services 73

INTRODUCTION

x

One in twenty five (1:25) babies born in this country has a birth defect.A small proportion of these birth defects are caused by medications takenby the mother during pregnancy.

This categorisation is intended to provide information which can be usedby health professionals as the basis for rational decision making whenplanning the medical management of pregnant patients or those intendingto become pregnant. Therefore, in many cases, this categorisation willnot be appropriate as the sole basis of decision making afterinadvertent or accidental drug exposure has occurred duringpregnancy. In this context, there can be no substitute for expertinformation based on a rigorous appraisal of all the specific circumstancesin each case. Appendix B should be used to ensure that appropriate adviceis obtained in such situations. This categorisation applies only torecommended therapeutic doses in women in the reproductive agegroup. In situations such as overdose, occupational exposure andothers when the recommended therapeutic dose is exceeded, it cannotbe assumed that the classifications assigned to individual medicinesare valid.

Most medicines cross the placenta. This categorisation has taken intoaccount the known harmful effects of medicines on the developing baby,including the potential to cause birth defects, the potential to causeunwanted pharmacological effects around the time of birth (effects whichmay or may not be reversible), and the potential to cause problems suchas cancer in later life. However, it does not take into account the rarecircumstance of an idiosyncratic reaction in the neonate to a medicinewhich crosses the placenta.

All gestational ages referred to in this booklet are based on the time ofconception. A medicine may have more than one harmful effect on the

xi

INTRODUCTION

developing baby depending on the timing of exposure. During the firsttwo weeks of development, from conception to the first missed period,the embryo is thought to be resistant to any teratogenic effects ofmedicines. The critical period of embryonic development, when the organsystems develop, starts at about 17 days post-conception and is completeby 60-70 days. Exposure to certain medicines during this period (17-70days) can cause major birth defects. In general, exposure to medicinesbeyond 70 days post-conception is not associated with the induction ofmajor birth defects.

However, some medicines can interfere with functional development oforgan systems in the second and third trimesters and produce seriousconsequences. An important example is renal dysfunction in the fetuscaused by ACE inhibitors taken during the second and third trimesters.

Also, the developing central nervous system, because of its prolongedperiod of histogenesis and functional maturation, can be damaged byexposure to certain medicines in the second and third trimesters, resultingin problems such as mental retardation, cerebral palsy or deafness.

In addition to gestational timing, the actual dose being given, comparedto a known harmful dose, needs to be considered in assessing whetherthere are likely to be any adverse effects.

The list of categorised medicines includes most of those used commonlyin Australia. The categorisation is based on currently available evidenceand changes may be necessary from year to year as new evidence ispresented and analysed. The class statements in italicised blue font shouldbe considered integral information about all of the drugs covered in thatclass.

INTRODUCTION

xii

For pharmaceutical products containing two or more active medicines,the categorisation of the combination is based on the component forwhich the categorisation is most restrictive. When a medicine is only tobe used in men, it will not be found in the booklet although it will havea pregnancy category in the Product Information.

The Australian categorisation consists of the following categories:

Category ADrugs which have been taken by a large number of pregnant women andwomen of childbearing age without any proven increase in the frequencyof malformations or other direct or indirect harmful effects on the fetushaving been observed.

Category CDrugs which, owing to their pharmacological effects, have caused ormay be suspected of causing, harmful effects on the human fetus orneonate without causing malformations. These effects may be reversible.Accompanying texts should be consulted for further details.

Category B1Drugs which have been taken by only a limited number of pregnantwomen and women of childbearing age, without an increase in thefrequency of malformation or other direct or indirect harmful effects onthe human fetus having been observed.

Studies in animals have not shown evidence of an increased occurrenceof fetal damage.

xiii

INTRODUCTION


Studies in animals are inadequate or may be lacking, but available datashow no evidence of an increased occurrence of fetal damage.


Studies in animals have shown evidence of an increased occurrence offetal damage, the significance of which is considered uncertain in humans.

Category DDrugs which have caused, are suspected to have caused or may beexpected to cause, an increased incidence of human fetal malformationsor irreversible damage. These drugs may also have adversepharmacological effects. Accompanying texts should be consulted forfurther details.

Category XDrugs which have such a high risk of causing permanent damage to thefetus that they should not be used in pregnancy or when there is apossibility of pregnancy.

INTRODUCTION

xiv

Note: For drugs in the B1, B2 and B3 categories, human data are lackingor inadequate and subcategorisation is therefore based on available animaldata. The allocation of a B category does NOT imply greater safetythan the C category. Drugs in category D are not absolutelycontraindicated in pregnancy (e.g. anticonvulsants). Moreover, in somecases the ‘D’ category has been assigned on the basis of ‘suspicion’.

Due to legal considerations in this country, sponsor companies have, insome cases, applied a more restrictive category than can be justified onthe basis of the available data.

In some cases there may be discrepancies between the published ProductInformation and the information in this booklet due to the process ofongoing document revision.

Australian

categorisation

of drugs

(grouped by therapeutic class)

2

ALIMENTARY SYSTEM

HYPERACIDITY, REFLUX, ULCERSAlginates/antacids A

Bismuth subcitrate B2

Cimetidine, cisapride, famotidine, ranitidine, sucralfate B1

Lansoprazole, nizatidine, omeprazole, pantoprazole B3

Misoprostol XThis drug can produce serious birth defects. It also can causemiscarriage that could lead to potentially dangerous bleeding.

ANTISPASMODICSAtropine A

Glycopyrrolate, hyoscine-N-butylbromide, mebeverine,propantheline B2

LAXATIVESBisacodyl, cascara, docusate sodium, senna A

Dicyclomine hydrochloride B1

Phenolphthalein B2

ANTIDIARRHOEALSDiphenoxylate C

This drug is chemically related to the narcotic analgesic pethidine.Narcotic analgesics may cause respiratory depression in thenewborn infant. This drug should not be given at or near term.

Hyoscyamine B2

Loperamide B3

3

ALIMENTARY SYSTEM

Mesalazine, olsalazine CNon-steroidal anti-inflammatory drugs inhibit prostaglandinsynthesis and, when given during the latter part of pregnancy, maycause closure of the fetal ductus arteriosus, fetal renal impairment,inhibition of platelet aggregation, and delay labour and birth.Continuous treatment with non-steroidal anti-inflammatory drugsduring the last trimester of pregnancy should only be given onsound indications. During the last few days before expected birth,agents with an inhibitory effect on prostaglandin synthesis shouldbe avoided.

Sulfasalazine A

Systemic budesonide B3

CHOLELITHOLYTICSChenodeoxycholic acid B3

4

CARDIOVASCULAR SYSTEM

ANTIHYPERTENSIVESClonidine, doxazosin B3

Diazoxide CThis drug may cause fetal bradycardia. Hyperglycaemia has beenobserved in the newborn. Diazoxide is a potent relaxant of uterinesmooth muscle and may inhibit uterine contraction if given duringlabour. Diazoxide should be used with extreme caution duringpregnancy.

Guanethidine, methyldopa A

Hydralazine CFollowing intravenous administration, hydralazine has beenassociated with fetal distress and fetal arrhythmia in the lasttrimester of pregnancy.

Minoxidil CThis drug has been associated with hypertrichosis in the newborninfant following exposure in utero.

Prazosin, terazosin B2

Sodium nitroprusside CShort term use for the control of hypertensive crises may be safeprovided that the pH and cyanide concentrations in maternal bloodare monitored.

ANGIOTENSIN CONVERTING ENZYME (ACE) INHIBITORSWhen taken during the second and third trimesters, ACEinhibitors cause a range of abnormalities including renaldysfunction and oligohydramnios. These can be associatedwith fetal death in utero.

Although no adverse fetal effects have been linked to firsttrimester drug use of ACE inhibitors, the number of exposures

5


reported is too small to determine conclusively that ACE inhibitorsare safe in the first trimester. Pregnant women who are taking ACEinhibitors should be changed as quickly as possible to otherantihypertensive medication to maintain normal blood pressure.It is generally advisable not to use ACE inhibitors for themanagement of hypertension in women who are likely to becomepregnant.

Captopril, cilazapril, enalapril, fosinopril, lisinopril, perindopril,quinapril, ramipril, trandolapril D

ANGIOTENSIN II RECEPTOR ANTAGONISTS (ARAS)When used in pregnancy during the second and third trimesters,drugs that act directly on the renin-angiotensin system can causeinjury and even death in the developing fetus.

Although no adverse fetal effects have been linked to firsttrimester drug use of ARAs, the number of exposures reported istoo small to determine conclusively that ARAs are safe in the firsttrimester. Pregnant women who are taking ARAs should bechanged as quickly as possible to other antihypertensivemedication to maintain normal blood pressure. It is generallyadvisable not to use ARAs for the management of hypertension inwomen who are likely to become pregnant.

Candesartan cilexetil, eprosartan, irbesartan, losartan, valsartan D

CALCIUM CHANNEL BLOCKERSThese drugs carry the potential to produce fetal hypoxiaassociated with maternal hypotension.

Amlodipine, diltiazem, felodipine, isradipine, nicardipine, nifedipine,nimodipine, nisoldipine, verapamil C

6


BETA-ADRENERGIC BLOCKING AGENTSThese agents may cause pharmacological effects such asbradycardia in the fetus and newborn infant.

Alprenolol, atenolol, betaxolol, bevantolol, carvedilol, esmolol,labetalol, levobunolol, metoprolol, oxprenolol, pindolol,propranolol, sotalol, timolol C

DIURETICS

Carbonic anhydrase inhibitor

Acetazolamide B3

Thiazides, related diuretics and loop diureticsThese drugs may cause electrolyte disturbances in the fetus.Neonatal thrombocytopenia has been reported with thiazides andrelated diuretics. Loop diuretics, like frusemide and bumetanide,are probably also associated with this risk. During the latter part ofpregnancy products of this type should only be given on soundindications, and then in the lowest effective dose.

Bendrofluazide, bumetanide, chlorothiazide, chlorthalidone,clopamide, cyclopenthiazide, ethacrynic acid, frusemide,hydrochlorothiazide, indapamide, mefruside, methychlothiazide,metolazone, quinethazone C

Potassium sparing diuretics

Amiloride, triamterene CThese drugs may result in electrolyte disturbances in the fetus.

Spironolactone B3This drug carries the potential to cause feminisation of the malefetus and should be avoided during pregnancy.

7


ANTIARRHYTHMICSAdenosine, disopyramide, procainamide B2

Amiodarone CBecause of the long half-life of amiodarone and its majormetabolite, and the potential to cause abnormal thyroid functionand bradycardia in the fetus, its use is probably best avoided inthe three months before and throughout the duration of pregnancy.When exposure of the fetus is unavoidable, thyroid function(including TSH) should be assessed promptly in the newborninfant.

Bretylium tosylate CThis drug carries the potential for fetal hypoxia associated withmaternal hypotension.

Flecainide B3

Lignocaine A

Mexiletine B1

Quinidine CThis drug is structurally similar to quinine, which in high doses,has been shown to cause fetal damage. It has been used to treatfetal cardiac arrhythmia

ANTIANGINA AGENTSGlyceryl trinitrate, isosorbide mononitrate, perhexilene B2

Isosorbide dinitrate, tirofiban hydrochloride B1

Nicorandil B3

8


HYPOLIPIDAEMIC AGENTSThe physiological hyperlipidaemia of pregnancy does not requiretreatment.

Atorvastatin, cerivastatin, fluvastatin, pravastatin, simvastatin CCholesterol and other products of the cholesterol biosynthesispathway are essential components for fetal development, includingsynthesis of steroids and cell membranes. Because of the ability ofinhibitors of HMG-CoA reductase to decrease the synthesis ofcholesterol and possibly other products of the cholesterolbiosynthesis pathway, these drugs may cause fetal harm whenadministered to a pregnant woman.

Cholestyramine, colestipol, nicotinic acid B2

Clofibrate, probucol B1

Gemfibrozil B3

CARDIAC INOTROPIC AGENTSDigoxin and other cardiac glycosides A

Milrinone B3

ADRENERGIC STIMULANTSAdrenaline, ephedrine, fenoterol, isoprenaline, orciprenaline,rimiterol, salbutamol, terbutaline A

Dobutamine, phenylephrine, phenylpropanolamine,pseudoephedrine B2

Dopamine B3

Metaraminol CThis drug may cause fetal hypoxia by constricting the uterinevessels thereby limiting placental perfusion.

9


VASODILATORSBetahistine, glyceryl trinitrate, nicotinic acid B2

Dipyridamole, isosorbide dinitrate, nicotinyl alcohol, oxpentifylline,

phentolamine, sildenafil citrate B1

Isoxsuprine CMaternal isoxsuprine administration for prevention of prematurelabour has been associated with tachycardia, hypoglycaemia,hypocalcaemia, ileus and hypotension in the neonate.

Papaverine A

Phenoxybenzamine B2This drug is known to be mutagenic and carcinogenic in rodents.

ANTIMIGRAINE PREPARATIONSDihydroergotamine, ergotamine, methysergide C

Standard oral dose regimens for migraine headaches in the firsthalf of pregnancy do not appear to pose hazards to the fetus.Ergotamine induces uterine contraction and may therefore causepremature parturition or hypertonic labour. Larger doses or morefrequent use may jeopardise the fetus because of the potential forimpeding fetal blood supply.

Naratriptan, sumatriptan, zolmitriptan B3

Pizotifen B1

ANTICOAGULANTS AND THROMBOLYTIC AGENTSAll of these agents can produce placental haemorrhage andsubsequent prematurity and fetal loss.

Abciximab C

Dalteparin, danaparoid, enoxaparin, nadroparin, C

10


Desirudin B3

Heparin C

Phenindione DThis drug can cause birth defects when used in the first trimesterof pregnancy.

Ticlopidine B1

Warfarin DWarfarin has been associated with the development of a specificembryopathy following exposure at 6 to 9 weeks post conception.Exposure following first trimester of pregnancy can cause fetalbleeding leading to CNS damage. There is also an increased risk ofspontaneous abortion and perinatal bleeding. It should not be usedin the last few weeks of pregnancy.

HAEMOSTATIC AGENTSAprotinin, eptacog alfa, tranexamic acid B1

Human coagulation factor IX CThe safe use of this drug during pregnancy has not beenestablished in controlled clinical trials.

Kogenate, protamine B2

Aminocaproic acid, o rnipressin B3

FIBRINOLYTIC AGENTSAlteplase, urokinase B1

Reteplase C

Streptokinase COnly minimal amounts of streptokinase cross the placenta.Streptokinase-specific antibodies are found in fetal blood.

11


OTHER CARDIOVASCULAR AGENTSOxpentifylline B1

Tirilazad B2

12

DRUGS AFFECTING BLOOD AND HAEMOPOIETIC TISSUES

IRON AND HAEMOPOIETIC AGENTSErythropoietin, filgrastim, lenograstim, molgramostim B3

Folic acid A

Folinic acid A

Oral iron preparations (with or without folic acid), parenteral ironpreparations A

13

CENTRAL NERVOUS SYSTEM

ANALGESICS, ANTIPYRETICS(See also non-ster oidal anti-inflammator y drugs page 21)

OPIOID ANALGESICSOpioid analgesics may cause respiratory depression in thenewborn infant. Withdrawal symptoms in newborn infants havebeen reported with prolonged use of this class of drugs.

Alfentanil, buprenorphine, dextromoramide, dextropropoxyphene, fentanyl,hydromorphone, methadone, morphine, oxycodone, papaveretum,pentazocine, pethidine, phenoperidine, remifentanil, tramadol C

Aspirin CAspirin inhibits prostaglandin synthesis. When given late inpregnancy, it may cause premature closure of the fetal ductusarteriosus, delay labour and birth. Aspirin increases the bleedingtime both in the newborn infant and in the mother because of itsantiplatelet effects. Products containing aspirin should be avoidedin the last trimester. Low-dose aspirin (100mg/day) does not affectbleeding time.

Codeine, dihydrocodeine AProlonged high-dose use of codeine prior to delivery may producecodeine withdrawal symptoms in the neonate.

Paracetamol A

HYPNOTICS AND SEDATIVES

BarbituratesThese drugs can give rise to hypotension, respiratory depressionand hypothermia in the newborn infant. Continuous treatmentduring pregnancy and administration during labour should beavoided.

Amylobarbitone, pentobarbitone C

14


OTHER HYPNOTICS AND SEDATIVESChloral hydrate, chlormethiazole A

Meprobamate CThis drug may cause hypotension, respiratory depression andhypothermia in the newborn infant.

Zolpidem tartrate B3

Zopiclone CThis drug is likely to produce CNS depression in newborn infantswhen given during labour.

ANTIANXIETY AGENTSBuspirone B1

BENZODIAZEPINESBenzodiazepines may cause hypotonia, respiratory depression andhypothermia in the newborn infant if used in high doses duringlabour. Withdrawal symptoms in newborn infants have beenreported with prolonged use of this class of drugs.

Alprazolam, bromazepam, chlordiazepoxide, clobazam, clonazepam,clorazepate, diazepam, flunitrazepam, flurazepam, lorazepam,midazolam, nitrazepam, oxazepam, temazepam, triazolam C

ANTIPSYCHOTIC AGENTS

PhenothiazinesWhen given in high doses during late pregnancy, phenothiazineshave caused prolonged neurological disturbances in the newborninfant.

Chlorpromazine, fluphenazine, pericyazine, perphenazine,promazine, thiopropazate, thioridazine, trifluoperazine C

15


ButyrophenonesWhen given in high doses during late pregnancy, butyrophenonesmay cause prolonged neurological disturbances in the newborninfant.

Droperidol, haloperidol C

OTHER ANTIPSYCHOTIC DRUGSClozapine C

The adverse pharmacological and toxicological effects of clozapinein adults may also occur in the fetus.

Flupenthixol CWhen given in high doses during late pregnancy, relatedcompounds have caused prolonged neurological disturbances inthe newborn infant.

Lithium salts DThe risk of birth defects may be increased when lithium is usedduring the first trimester. Second trimester detailed ultrasoundexamination and fetal echocardiography should be considered forwomen who have been treated with lithium during the firsttrimester of pregnancy. The newborn may show signs of lithiumtoxicity.

Olanzapine, risperidone B3

Pimozide, thiothixene B1

Zuclopenthixol CWhen given in high doses during late pregnancy, relatedcompounds have caused prolonged neurological disturbances inthe newborn infant.

16


ANTIDEPRESSANTS

Selective serotonin reuptake inhibitors (SSRIs)SSRIs have had limited use in pregnancy without a reportedincrease in birth defects. The use of SSRIs in the third trimestermay result in a withdrawal state in the newborn infant.

Citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline C

Tricyclic antidepressantsWithdrawal symptoms in newborn infants have been reported withprolonged maternal use of this class of drugs.

Amitriptyline, clomipramine, desipramine, dothiepin, doxepin,imipramine, nortriptyline, protriptyline, trimipramine C

Tetracyclic antidepressants

Mianserin B2

Monoamine oxidase inhibitors

Phenelzine B3

Tranylcypromine B2

OTHER ANTIDEPRESSANTSMirtazapine, moclobemide, nefazodone B3

Venlafaxine B2

CNS STIMULANTSCaffeine A

Dextroamphetamine B3

Methylphenidate B2

17


ANTIPARKINSON AGENTSAmantadine, apomorphine, benserazide, carbidopa, entacapone,levodopa, ropinirole, B3

Benztropine, biperiden, selegiline B2

Benzhexol B1

Pergolide CStudies in rodents have shown no evidence of harm to the fetus.There are no adequate and well-controlled studies in pregnantwomen. This drug should be used during pregnancy only if clearlyneeded.

Procyclidine A

ANTICONVULSANTS / ANTIEPILEPTICSThe risk of having an abnormal child as a result of antiepilepticmedication is far outweighed by the dangers to the mother andfetus of uncontrolled epilepsy.

It is recommended that:

• women on antiepileptic drugs (AEDs) receive prepregnancycounselling with regard to the risk of fetal abnormalities;

• AEDs should be continued during pregnancy and monotherapyshould be used if possible at the lowest effective dose as riskof abnormality is greater in women taking combinedmedication;

• folic acid supplementation (5mg) should be commenced fourweeks prior to and continue for twelve weeks after conception;

• Specialist prenatal diagnosis including detailed mid-trimesterultrasound should be offered.

18


Commonly Prescribed Anticonvulsants/Antiepileptics

Carbamazepine DSpina bifida occurs in about one percent of pregnancies in whichcarbamazepine is used as monotherapy. Carbamazepine takenduring pregnancy also has been associated with minor craniofacialdefects, fingernail hypoplasia and developmental disability.Carbamazepine also can cause coagulation defects withconsequent risk of haemorrhage in the fetus and the newborninfant which may be preventable by the prophylacticadministration of vitamin K to the mother prior to delivery.

Phenytoin sodium DThis drug taken during pregnancy has been associated withcraniofacial defects, fingernail hypoplasia, developmentaldisability, growth retardation and less frequently, oral clefts andcardiac anomalies. This clinical pattern is sometimes called the‘fetal hydantoin syndrome’. Phenytoin also can cause coagulationdefects with consequent risk of haemorrhage in the fetus and thenewborn infant which may be preventable by the prophylacticadministration of vitamin K to the mother prior to delivery.

Methylphenobarbitone, phenobarbitone, primidone DThe use in pregnancy of primidone, phenobarbitone ormethylphenobarbitone has been associated with minorcraniofacial defects, fingernail hypoplasia and developmentaldisability. Their use in pregnancy alone, or in combination withother anticonvulsants, can cause coagulation defects in thenewborn infant which may be preventable by the prophylacticadministration of vitamin K to the mother prior to delivery.

19


Sodium valproate (valproic acid) DIf taken in the first trimester of pregnancy, sodium valproate(valproic acid) is associated with a one to two percent risk ofneural tube defects (especially spina bifida) in the exposed fetus.Women taking sodium valproate (valproic acid) who becomepregnant should be encouraged to consider detailed mid-trimestermorphology ultrasound for prenatal diagnosis of suchabnormalities.

Other anticonvulsants / antiepilepticsCompared to conventional anticonvulsants, the extent of the risk ofthe following drugs is unknown.

Clonazepam CClonazepam is a benzodiazepine. These drugs may causehypotonia, respiratory depression and hypothermia in the newborninfant if used in high doses during labour. Withdrawal symptoms innewborn infants have been reported with this class of drugs.

Ethosuximide, methsuximide, phensuximide, sulthiame, vigabatrin D

Gabapentin B1

Lamotrigine, tiagabine, topiramate B3

20


ANTIEMETICS, ANTINAUSEANTS

PhenothiazinesWhen given in high doses during late pregnancy, phenothiazineshave caused prolonged neurological disturbances in the infant.

Prochlorperazine, promethazine, thiethylperazine C

OTHERSDimenhydrinate, diphenhydramine, metoclopramide A

Dolasetron, granisetron, ondansetron B1

Domperidone, hyoscine, hyoscine hydrobromide B2

Tropisetron B3

OTHER AGENTS ACTING ON THE CNSTetrabenazine B2

21

MUSCULOSKELETAL SYSTEM

NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS)(See also analgesics, antipyretics page 13)

These agents inhibit prostaglandin synthesis and, when givenduring the latter part of pregnancy, may cause closure of the fetalductus arteriosus, fetal renal impairment, inhibition of plateletaggregation, and delay labour and birth. Continuous treatmentwith NSAIDs during the last trimester of pregnancy should only begiven on sound indications. During the last few days beforeexpected birth, agents with an inhibitory effect on prostaglandinsynthesis should be avoided.

Diclofenac, diflunisal, ibuprofen, indomethacin, ketoprofen,ketorolac, mefenamic acid, nabumetone, naproxen,phenylbutazone, piroxicam, sodium salicylate, sulindac,tenoxicam, tiaprofenic acid C

ANTIRHEUMATOID AGENTSAurothioglucose, sodium aurothiomalate, B2

Auranofin B3

Hydroxychloroquine DWhen used in high doses and for prolonged periods, chloroquineand related substances may cause neurological disturbances andinterference with hearing, balance and vision in the fetus.

Penicillamine DThis drug can cause cutis laxa in the human fetus.

MUSCLE RELAXANTSBaclofen, botulinum type A B3

Dantrolene, methocarbamol, orphenadrine, B2

Physostigime C

22

MUSCULOSKELETAL SYSTEM

Quinine DAt standard doses, quinine has not been associated with fetaldamage. In toxic doses, quinine causes fetal damage includingdeafness. Its ability to induce uterine contractions also constitutesa risk of abortion.

AGENTS USED IN GOUT AND HYPERURICAEMIAAllopurinol, colchicine, probenecid, sulfinpyrazone B2

23

ENDOCRINE SYSTEM

OESTROGENS (SEE ORAL CONTRACEPTIVES)Dienoestrol X

Ethinyloestradiol, mestranol B3

Oestradiol, oestriol, oestrone, piperazine oestrone sulfate B1

Oestrogens conjugated D

PROGESTOGENS (SEE ORAL CONTRACEPTIVES)If taken by the mother at or after 8 weeks post conception, thesedrugs can cause virilisation of the female fetus. This is a dose-dependent effect. Prior to 8 weeks post conception, they have novirilising effects.

Dydrogesterone, hydroxyprogesterone, megestrol, norethisterone D

Medroxyprogesterone (oral high dose, 30-50mg daily)(see also contraceptives and anti-neoplastic agents) D

ANTIANDROGENSAntiandrogens carry the potential for feminisation of the malefetus at or after 8 weeks post conception and should be avoidedduring pregnancy.

Cyproterone acetate, spironolactone B3

ANDROGENS AND ANABOLIC STEROIDSAnabolic steroids and other substances with androgenic effectsmay have a virilising effect on the female fetus and should beavoided during pregnancy.

Fluoxymesterone, methenolone, nandrolone, oxandrolone,oxymetholone, testosterone D

24

ENDOCRINE SYSTEM

CORTICOSTEROIDS

Systemic

Betamethasone, cortisone, dexamethasone, fludrocortisone,hydrocortisone, methylprednisolone, prednisolone, prednisone,triamcinolone A

Topical

Betamethasone, fludrocortisone, flumethasone, fluocinolone,fluocortolone, halcinonide, triamcinolone A

Methylprednisolone aceponate C

Mometasone B3

Inhalation/IntranasalThe benefits of asthma control outweigh any potential for anadverse pregnancy outcome.

Beclomethasone, flunisolide, fluticasone, triamcinolone B3

Budesonide A

PITUITARY HORMONESCorticotrophin A

Nafarelin, goserelin DThere is a theoretical risk of abortion or fetal abnormality if GnRHagonists are used during pregnancy.

Somatropin, thyrotrophin B2

ANTIDIURETICSDesmopressin, lypressin, vasopressin B2

25

ENDOCRINE SYSTEM

HYPOGLYCAEMIC AGENTS (ORAL)It is important to achieve strict normoglycaemia during pregnancy.This may best be achieved by conversion to insulin therapy.

Acarbose, miglitol B3

Chlorpropamide, glibenclamide, gliclazide, glimepiride, glipizide,metformin, tolazamide, tolbutamide C

The sulphonylureas may enter the fetal circulation and may causeneonatal hypoglycaemia.

THYROID HORMONESLiothyronine, thyroxine A

ANTITHYROID AGENTSThese agents may cause congenital goitre by inhibiting thyroxinesynthesis in the fetus.

Carbimazole, propylthiouracil C

AGENTS AFFECTING CALCIUM AND BONE METABOLISMAlendronate, clodronate, pamidronate B3

Calcitonin, salcatonin, tiludronate disodium B2

Calcitriol, dihydrotachysterol B3

Raloxifene XThis drug causes abnormalities of the developing reproductivesystem when administered to pregnant rabbits and may have asimilar effect in human pregnancy.

26

ENDOCRINE SYSTEM

OTHER HORMONAL AGENTSAminoglutethimide D

There have been reports of pseudohermaphrodism with use of thisdrug in pregnancy.

Octreotide CThis drug may produce fetal growth retardation, probably due tosuppression of growth hormone.

PITUITARY INHIBITORSBromocriptine (oral) A

Bromocriptine (injection) B2

Cabergoline B1

Danazol DIf taken by the mother at or after 8 weeks post conception,danazol may cause virilisation of the female fetus. Prior to 8 weekspost conception it has no virilising effects. Danazol may not inhibitovulation in all women.

Gestrinone DThis drug may interfere with pregnancy and in animal tests causedmasculinisation of female fetuses. Gestrinone may not inhibitovulation in all women.

Quinagolide B3

OVULATION INDUCERS

Gonadotrophins

Human chorionic gonadotrophin A

Human menopausal gonadotrophin, urofollitrophin B2

27

GENITOURINARY SYSTEM

Recombinant follicle stimulating hormone (FSH) B3

Clomiphene B3

URINARY ANTISEPTICSHexamine A

BLADDER FUNCTION DISORDERSBethanechol B2

Bethanechol has a potent excitatory effect on smooth muscle andshould be avoided during pregnancy.

Finasteride XFinasteride may cause abnormalities of the external genitalia of amale fetus.

Oxybutynin, pentosan polysulfate sodium B1

Terazosin B2

AGENTS ACTING ON THE UTERUSErgometrine C

This drug induces uterine contraction and may cause premature orhypertonic labour. Products containing ergometrine should beavoided during pregnancy.

Gemeprost B3

Oxytocin AThere have been instances of idiosyncratic sensitivity of the uterusresulting in fetal anoxia.

Prostaglandin E2/Dinoprostone CThere have been instances of idiosyncratic sensitivity of the uterusresulting in fetal anoxia.

Salbutamol A

28

GENITOURINARY SYSTEM

TOPICAL VAGINAL MEDICATIONClindamycin, clotrimazole, econazole, miconazole, nystatin A

Dienosliterol B1

Isoconazole B2

29

ANTIMICROBIALS

CEPHALOSPORINSCefaclor , cefotaxime, cefotetan, cefoxitin, cefpodoxime, ceftazidime,

ceftriaxone, cephamandole, cephazolin B1

Cefodizime, cefpirome B2

Cephalexin, cephalothin A

PENICILLINSAmoxycillin, ampicillin, benzathine penicillin, benzylpenicillin,phenoxymethylpenicillin, procaine penicillin A

Amoxycillin with clavulanic acid, flucloxacillin, mezlocillin,piperacillin, piperacillin with tazobactam B1

Azlocillin B3

Dicloxacillin, ticarcillin sodium with potassium clavulanate B2

TETRACYCLINESTetracyclines are safe for use during the first 18 weeks ofpregnancy (16 weeks post conception) after which they causediscolouration of the baby’s teeth.

Demeclocycline, doxycycline, minocycline, tetracycline D

AMINOGLYCOSIDESThere is evidence of selective uptake of aminoglycosides by thefetal kidney resulting in damage (probably reversible) to immaturenephrons. Eighth cranial nerve damage has also been reportedfollowing in utero exposure to some of the aminoglycosides.Because of their chemical similarity, all aminoglycosides must beconsidered potentially nephrotoxic and ototoxic to the fetus. Itshould also be noted that therapeutic blood concentrations in themother do not equate with safety for the fetus.

Amikacin, gentamicin, kanamycin, neomycin, netilmicin, tobramycin D

30

ANTIMICROBIALS

ANTIFUNGAL AGENTS (See also topical antifungals page 46)

Amphotericin B3

Fluconazole DSingle dose therapy (150mg) does not appear to cause adversepregnancy effects. Repeated doses of fluconazole (400-800mgdaily) have been associated with a consistent pattern of birthdefects similar to those seen in animal studies.

Flucytosine, griseofulvin, itraconazole, ketoconazole B3

Terbinafine B1

Nystatin A

QUINOLONESAlatrofloxacin, ciprofloxacin, enoxacin, fleroxacin, norfloxacin,ofloxacin B3

MACROLIDE ANTIBIOTICSAzithromycin, roxithromycin B1

Clarithromycin B3

Erythromycin A

MISCELLANEOUS ANTIBIOTICSAtovaquone, colistin IV , meropenem, metronidazole, vancomycin B2

Aztreonam, mupirocin, spectinomycin B1

Chloramphenicol, clindamycin, lincomycin, nalidixic acid A

Clavulanic acid B1

Fusidic acid CThis drug may cause kernicterus in babies during the first monthof life by displacing bilirubin from plasma albumin. Fusidic acidshould be avoided if possible during the last month of pregnancy.

31

ANTIMICROBIALS

Imipenem-cilastatin combination, teicoplanin, tinidazole B3

Nitrofurantoin (short term therapy) ACaution should be exercised when administering nitrofurantoin atterm because of the possibility of producing haemolytic anaemiain patients with glucose-6-phosphate dehydrogenase (G6PD)deficiency and due to immature enzyme systems in the earlyneonatal period.

Pentamidine B3

Trimethoprim B3

SULFONAMIDESSulfonamides may cause jaundice and haemolytic anaemia in thenewborn.

Sulfadoxine, sulfadiazine, sulfamethizole, sulfamethoxazole CTrimethoprim-sulfonamide combinations C

ANTITUBERCULOTICS AND ANTILEPROTICSEthambutol, isoniazid A

Clofazimine CClofazimine may cause discolouration of the skin of the baby. Thisis reversible but recovery may be delayed because clofazimine hasan average serum half life of 70 days.

Dapsone, pyrazinamide B2

Rifabutin CBleeding attributable to hypoprothrombinaemia has been reportedin newborn infants and in mothers after the use of rifampicinduring late pregnancy. If rifabutin is used during the last fewweeks of pregnancy, vitamin K should be given to the mother andthe newborn infant.

32

ANTIMICROBIALS

Rifampicin CBleeding attributable to hypoprothrombinaemia has been reportedin newborn infants and in mothers after the use of rifampicinduring late pregnancy. If rifampicin is used during the last fewweeks of pregnancy, vitamin K should be given to the mother andthe newborn infant.

ANTIMALARIALSThe use of these drugs in the treatment of malaria is acceptedbecause the small risk to the fetus is outweighed by the benefitsto the mother and fetus. Prophylaxis in high risk situations is alsojustified.

Chloroquine (prophylaxis) A

Chloroquine (treatment), hydroxychloroquine DWhen used in high doses and for prolonged periods, chloroquineand related substances may cause neurological disturbances andinterference with hearing, balance and vision in the fetus.

Doxycycline DTetracyclines are safe for use during the first 18 weeks ofpregnancy (16 weeks post conception) after which they causediscolouration of the baby’s teeth.

Mefloquine, pyrimethamine-dapsone combination B3

Primaquine phosphate DAvoid use in third trimester as primaquine may cause neonatalhaemolysis and methaemoglobinaemia.

Proguanil B2If given during pregnancy, folic acid supplementation should begiven. Proguanil has been used extensively with no adversepregnancy outcome.

33

ANTIMICROBIALS

Pyrimethamine B3This drug may interfere with folic acid metabolism and animalexperiments have shown that administration of very high doses ofpyrimethamine during organ development may give rise to birthdefects typical of folic acid antagonism. If pyrimethamine is givenduring pregnancy, folic acid supplementation should be given.

Pyrimethamine-sulfadoxine combination CPyrimethamine may interfere with folic acid metabolism and if it isgiven during pregnancy folic acid supplementation should begiven. Sulfonamides may cause jaundice and haemolytic anaemiain the newborn.

Quinine (treatment) DIn toxic doses, quinine causes fetal damage including deafness. Itsability to induce uterine contractions also constitutes a risk ofabortion.

ANTIVIRAL AGENTSAciclovir , indinavir, ritonavir, valaciclovir B3

Cidofovir DThis drug could be expected to cause fetal loss and birth defects.

Delavirdine, foscarnet, lamivudine, nevirapine, stavudine,zidovudine B3

Didanosine B2

Famciclovir , saquinavir B1

Ganciclovir DThis drug has been shown to be teratogenic and embryotoxic inanimals.

Nelfinavir B2

34

ANTIMICROBIALS

Ribavirin XAlthough there are no pertinent human data, ribavirin has beenfound to be teratogenic and/or embryolethal in nearly all species inwhich it has been tested. Malformations of skull, palate, eye, jaw,skeleton and gastrointestinal tract were noted in animal studies.Survival of fetuses and offspring was reduced.

Zalcitabine DThis drug is teratogenic in two animal species.

ANTHELMINTICSAlbendazole D

In animal studies albendazole is teratogenic in several species.Until human data are available, it must be suspected of beingteratogenic.

Ivermectin, mebendazole, thiabendazole B3

Praziquantel B1

Pyrantel embonate, diethylcarbamazine B2

35

ANTINEOPLASTIC AGENTS

Cytotoxic agents can pr oduce spontaneous abor tion, fetal loss andbirth defects.

ALKYLATING AGENTSBusulfan, carmustine, chlorambucil, cyclophosphamide,estramustine, fotemustine, ifosfamide, lomustine, melphalan,mustine, thiotepa D

ANTIMETABOLITESCladribine, colaspase, cytarabine, docetaxel, fluorouracil,gemcitabine, hydroxyurea, methotrexate, mercaptopurine,paclitaxel, raltitrexed, thioguanine, topotecan D

VINCA ALKALOIDSV inblastine, vincristine, vindesine, vinorelbine tartrate D

ANTIBIOTIC CYTOTOXIC AGENTSBleomycin, dactinomycin, daunorubicin, doxorubicin, epirubicin,fludarabine, idarubicin, mitomycin, mitozantrone D

HORMONAL ANTINEOPLASTIC AGENTSAminoglutethimide D

There have been reports of pseudohermaphrodism with use of thisdrug in pregnancy.

Anastrozole CThis drug disrupts oestrogen dependent metabolism and mayresult in abortion.

Goserelin, letrozole, leuprorelin DThere is a theoretical risk of abortion or fetal abnormality if GnRHagonists are used during pregnancy.

36

ANTINEOPLASTIC AGENTS

Medroxyprogesterone (oral and IM high dose) DMay cause virilisation of fetus if taken 8 weeks after conception.

Tamoxifen, toremifene B3

OTHER ANTINEOPLASTIC AGENTSAltretamine, amsacrine, carboplatin, cisplatin, dacarbazine,etoposide, irinotecan, procarbazine, samarium[153 Sm], teniposide D

Tretinoin (Oral) XThis is a potent teratogen when taken systemically during earlypreganancy, producing a pattern of birth defects termed retinoicacid embryopathy. The teratogenic effect is dose-dependent.

NON-CYTOTOXIC SUPPORTIVE THERAPYAmifostine B3

Mesna B1

37

METABOLISM

ANORECTIC AND WEIGHT REDUCING AGENTSWeight reduction using appetite suppressant drugs is notrecommended in pregnancy.

Dexfenfluramine, mazindol, phentermine B3

Diethylpropion, fenfluramine B2

OTHER DRUGS USED FOR THE TREATMENT OF METABOLICDISORDERSAlglucerase, cysteamine bitartrate B3

38

RESPIRATORY SYSTEM

ANTITUSSIVESOpium alkaloids and derivatives: codeine, dextromethorphan,dihydrocodeine, pholcodine A

EXPECTORANTS AND MUCOLYTICSAcetylcysteine (inhaled) B2

Ammonium chloride, bromhexine, emetine, guaiphenesin,ipecacuanha, saponins A

DECONGESTANTSPhenylephrine, phenylpropanolamine, pseudoephedrine B2

INHALATIONAL AGENTSThe agents that contain norflurane as the propellant have hadlimited human exposure. Norflurane has been shown to be safe inanimals. The prescriber should consult the full pi for moreinformation.

Bronchospasm relaxants

Eformoterol, salmeterol B3

Ephedrine, fenoterol, isoprenaline, orciprenaline, rimiterol,salbutamol, terbutaline, theophylline derivatives A

Ipratropium bromide B1

Preventive aerosols and inhalations

Beclomethasone, budesonide, fluticasone, salmeterol B3The benefits of asthma control outweigh any potential for anadverse pregnancy outcome.

Nedocromil B1

Sodium cromoglycate A

39

RESPIRATORY SYSTEM

OTHER RESPIRATORY AGENTSAcetylcysteine B2

Dornase alfa, montelukast, zafirlukast B1

40

ALLERGY AND IMMUNE SYSTEM

ANTIHISTAMINESAzatadine, cetirizine, diphenylpyraline, fexofenadine,methdilazine, terfenadine B2

Brompheniramine, chlorpheniramine, clemastine,cyproheptadine,dexchlorpheniramine, diphenhydramine, diphenylamine,doxylamine, pheniramine, triprolidine A

Chlorcyclizine, cyclizine, hydroxyzine A

Levocabastine B3Inadvertent short term exposure during the first trimester isunlikely to cause a hazard to the fetus but it has been shown to beteratogenic in two species of animals and until human data areavailable, it should be suspected of being teratogenic.

Loratadine B1

Trimeprazine, promethazine CWhen given in high doses during late pregnancy, phenothiazineshave caused prolonged neurological disturbances in the infant.

VACCINES

LIVE ATTENUATED VIRUS VACCINESCurrently available live virus vaccines have not caused teratogeniceffects in humans. The NHMRC publication, The AustralianImmunisation Procedures Handbook, should be consulted for morecomprehensive information.

B.C.G., measles, measles-mumps, measles-mumps-rubella,mumps, typhoid (oral), yellow fever B2

Poliomyelitis (oral), typhoid (injection) A

41


Rubella B2Women of child bearing age should be tested for rubella antibodiesprior to pregnancy. All seronegative women, provided they are notpregnant, should be offered rubella vaccine. Those administeringthe vaccine should be careful to instruct women to whom it isgiven that they should not become pregnant for at least two fullmenstrual cycles because rubella vaccine can cause fetalinfection. However, to date, there have not been any rubella-likebirth defects in the live born infants (about 400) of seronegativemothers vaccinated during or just before pregnancy. Based on thisexperience, rubella vaccination during pregnancy need not be thereason to recommend interruption of pregnancy.

KILLED VACCINESCholera, haemophilus influenzae type B, hepatitis A, hepatitis B,influenza, meningococcal, pneumococcal,poliomyelitis (injection) B2

Diphtheria, tetanus A

Rabies vaccine B2The benefit clearly outweighs the risk for post exposure situations.

IMMUNOMODIFIERSAzathioprine D

This drug has been associated with a slightly increased risk offetal malformations, neonatal immunosuppression and bonemarrow suppression in the infant.

Cyclosporin C This drug may cause immunosuppression in the infant.

Interferon alpha-2a, interferon alpha-2b, interferon gamma-1b B3

42


Interferon beta-1a DInterferon beta-1a has abortifacient activity in monkeys.

Interferon beta-1b DThis drug has abortifacient activity in monkeys. Spontaneousabortions have been reported in subjects with multiple sclerosis incontrolled clinical trials.

Levamisole B3

Mycophenolate mofetil DMycophenolate has been shown to be teratogenic in two speciesof animals. It inhibits nucleic acid synthesis and may cause fetalmalformations/death.

Rituximab CAntibodies of this class are known to cross the fetoplacentalbarrier and may cause B cell depletion and/or other unknowneffects.

Tacrolimus CThis drug may cause immunosuppression in the infant. Use oftacrolimus during pregnancy has been associated with neonatalhyperkalaemia and renal dysfunction.

43

MOUTH PREPARATIONS

Benzydamine (topical oropharyngeal) B2

44

OPHTHALMIC DRUGS

Acetazolamide, apraclonidine, dorzolamide, latanoprost,levocabastine B3

Betaxolol, levobunolol, timolol CBeta-adrenergic blocking agents may cause pharmacologicaleffects such as bradycardia in the fetus and newborn infant.

Brimonidine tartrate, lodoxamide trometamol B1

Chloramphenicol A

Ecothiopate B2

Flurbiprofen B2

Idoxuridine B3

45

DRUGS USED IN DERMATOLOGY

SYSTEMICAcitretin, etretinate X

These drugs are teratogenic at doses within the therapeutic range.They are stored in the body for several months after cessation.Because of the long half-life of these drugs and storage in fat,patients are advised not to conceive until two years after cessationof treatment because of risk of birth defects. Should pregnancyoccur during treatment with these drugs, there is a high risk ofbirth defects.

Isotretinoin XIsotretinoin is teratogenic and must not be used by females whoare pregnant or who may possibly become pregnant whileundergoing treatment and for one month after isotretinoin hasstopped. Should pregnancy occur during treatment with this drug,there is a high risk of birth defects (refer to current ProductInformation).

TOPICALAdapalene D

There have been isolated reports of birth defects in babies born towomen using this drug. Because of the potential risk of adverseeffects on fetal development, adapalene should not be used bywomen who are pregnant or who plan to become pregnant duringtreatment.

Azelaic acid, calcipotriol B1

Desonide B3

Finasteride XFinasteride may cause abnormalities of the external genitalia of amale fetus.

46


Isotretinoin DIsotretinoin is known to be teratogenic when administered orally inhuman beings. It is associated with major birth defects and with asmall risk of spontaneous abortion.

Methoxsalen B2

Tretinoin DUse of tretinoin cream formulation during the first trimester doesnot appear to cause birth defects. Other formulations should notbe used during pregnancy. There have been isolated reports ofbirth defects in babies born to women using topical tretinoin inpregnancy, some similar to those reported with oral retinoids.While a retrospective cohort study on women exposed to tretinoinin the first trimester did not reveal an association with thistreatment, the numbers in this study are too small to establish thesafety of use in pregnancy.

TOPICAL ANTIFUNGALS, ANTISEPTICSAmorolfine, bifonazole, B3

Cetylpyridinium, chlorhexidine, chlorquinaldol, clotrimazole,econazole, hydroxyquinoline, miconazole A

TOPICAL ANTIPARASITICSBenzyl benzoate, bioallethrin, crotamiton, maldison (malathion),permethrin, pyrethrins B2

Lindane B3Lindane penetrates human skin and has been reported to causesigns of CNS irritation. Because of this toxic potential it ispreferable, whenever possible, to use other medications duringpregnancy.

Piperonyl butoxide B3

47


TOPICAL ANTIVIRALAciclovir B3

Idoxuridine, imiquimod, penciclovir B1

48

DRUGS USED IN ANAESTHESIA

GENERAL ANAESTHETICSAll general anaesthetics carry the potential to produce centralnervous system and respiratory depression in the newborn infant.In routine practice this does not appear to be a problem. However,in the compromised fetus, careful consideration should be given tothis potential depression and to the selection of particularanaesthetic drugs, doses and techniques.

Enflurane, halothane, ketamine, thiopentone A

Desflurane, isoflurane B3

Methohexitone, sevoflurane B2

Methoxyflurane C

Nitrous oxide A

Propofol C

LOCAL ANAESTHETICSBupivacaine, cinchocaine, lignocaine, mepivacaine, prilocaine A

Etidocaine, ropivacaine B1

Procaine hydrochloride B2

NEUROMUSCULAR BLOCKING AGENTSAlcuronium, mivacurium, pancuronium, rocuronium B2

Atracurium, gallamine, pipecuronium, tubocurarine, vecuronium CThere have been no demonstrated adverse effects in the fetus orthe newborn infant.

Suxamethonium A

49

CONTRACEPTIVE AGENTS

Medroxyprogesterone (IM contraceptive dose) A

ORAL CONTRACEPTIVESCombined, progestogen only B3

Accumulated evidence reports that inadvertent exposure to theseagents in early pregnancy has not been associated with anincreased risk of birth defects.

VAGINAL SPERMICIDESNonoxynol 9, octoxinol A

50

DIAGNOSTIC AGENTS

If a radiological contrast or other diagnostic agent is not in thisbooklet refer to the product information or contact an obstetricdrug information service (see Appendix B).

RADIOGRAPHIC AGENTSIoversol B1

Gadodiamide, iomeprol B3

Galactose and palmitic acid B2

PITUITARY-ADRENAL RESPONSE TESTMetyrapone B2

Tetracosactrin DThere have been some reports of miscarriage or fetalmalformation occurring in pregnant women treated withtetracosactrin.

51

MISCELLANEOUS

DETOXIFYING AGENTS, ANTIDOTESAcetylcysteine (intravenous), digoxin immune fab B2

Desferrioxamine, flumazenil B3

Naloxone B1

Penicillamine DPenicillamine can cause cutis laxa in the human fetus.

CHOLINERGIC AND ANTICHOLINERGIC AGENTSAtropine, hyoscine methobromide, papaverine A

Atropine methonitrate, belladonna, glycopyrrolate, hyoscine,

hyoscine-N-butylbromide, hyoscyamine, propantheline B2

Bethanechol B2This drug has a potent excitatory effect on smooth muscle andshould be avoided during pregnancy.

Donepezil B3

Tacrine CThis drug may produce cholinergic effects in the fetus.

DRUGS USED IN MYASTHENIA GRAVISAmbenonium chloride, neostigmine B2

Pyridostigmine CThe maternal requirement for this drug in the context ofmyasthenia gravis may be absolute. Cholinergic effects in theneonate are rare.

AGENTS USED IN DEPENDENCY STATESCalcium carbimide A

Disulfiram B2

52

MISCELLANEOUS

Methadone CNarcotic analgesics may cause respiratory depression in thenewborn infant. Withdrawal symptoms in newborn infants havebeen reported with prolonged use of this drug.

Naltrexone B3

Nicotine — transdermal D— in chewing gum D

The harmful effects of cigarette smoking on maternal and fetalhealth are clearly established. The specific effects of nicotinetherapy on fetal development are unknown. Short-term exposureduring the first trimester is unlikely to cause a hazard to the fetus.

VITAMINSNicotinic acid B2

Vitamin A DExcess vitamin A may cause birth defects. Women should considertheir dietary intake of vitamin A before taking supplements. TheAustralian diet usually contains the recommended daily allowanceof 2500 IU.

53

INDEX

abciximab 9acarbose 25acetazolamide 6, 44acetylcysteine (injection) 51acetylcysteine (inhaled) 38acitretin 45aciclovir 33, 47adapalene 45adenosine 7adrenaline 8adrenergic stimulants 8alatrofloxacin 30albendazole 34alcuronium 48alendronate 25alfentanil 13alginates 2alglucerase 37alkylating agents 35allopurinol 22alprazolam 14alprenolol 6alteplase 10altretamine 36amantadine 17ambenonium chloride 51amifostine 36amikacin 29amiloride 6

aminocaproic acid 10aminoglutethimide 26, 35aminoglycosides 29amiodarone 7amitriptyline 16amlodipine 5ammonium chloride 38amorolfine 46amoxycillin 29amoxycillin with clavulanic acid 29amphotericin 30ampicillin 29amsacrine 36amylobarbitone 13anabolic steroids 23anaesthetics general 48anaesthetics local 48analgesics 13analgesics, opioid 13anastrozole 35androgens 23angiotensin coverting enzyme

(ACE) inhibitors 4angiotensin II receptor antagonists

(ARAS) 5anorectic agents 37antacids 2anthelmintics 34antiandrogens 23

54

INDEX

antiangina agents 7antianxiety agents 14antiarrhythmic drugs 7antibiotic cytotoxic agents 35antibiotics 30, 35anti-cancer agents 35anticholinergic agents 51anticoagulants 9anticonvulsants 17, 18antidepressants, tetracyclic 16antidepressants, tricyclic 16antidiarrhoeals 2antidiuretics 24antidotes 51antiemetics (see also

phenothiazines) 20antiepileptics 17, 18antifungal agents 30antifungals, topical 46antihistamines 40antihypertensives 4anti-inflammatories,

non-steroidal 21antileprotics 31antimalarials 32antimetabolites 35antimicrobials 30antimigraine preparations 9antimycotics (see antifungals) 30

antinauseants 20antineoplastic agents, hormonal 35antineoplastic agents,

non-cytotoxic 36antineoplastic agents, other 36antiparasitics, topical 46antiparkinson agents 17antipsychotic agents 14antipyretics 13antirheumatoid drugs (see also

NSAIDs) 21antiseptics, topical 46antiseptics, urinary 27antispasmodics 2antithyroid agents 25antituberculotics 31antitussives 38antiulcerants 2antiviral agents 33antiviral agents, topical 47apomorphine 17appetite suppressants 37apraclonidine 44aprotinin 10aspirin 13asthma, drugs used in

treatment of 38atenolol 6atorvastatin 8

55

INDEX

atovaquone 30atracurium besylate 48atropine 2, 51atropine methonitrate 51auranofin 21aurothioglucose 21aurothiomalate sodium 21azatadine 40azathioprine 41azelaic acid 45azithromycin 30azlocillin 29aztreonam 30

B.C.G. vaccine 40baclofen 21barbiturates (see also

phenobarbitone) 13beclomethasone 24, 38belladonna 51bendrofluazide 6benserazide 17benzathine penicillin 29benzhexol 17benzodiazepines 14benztropine 17benzydamine (topical

oropharyngeal) 43benzyl benzoate 46

benzylpenicillin 29beta-adrenergic blocking agents 6betahistine 9betamethasone (systemic) 24betamethasone (topical) 24betaxolol 6, 44bethanechol 27, 51bevantolol 6bifonazole 46bioallethrin 46biperiden 17bisacodyl 2bismuth subcitrate 2bladder function disorders 27bleomycin 35botulinum type A 21bretylium tosylate 7brimonidine tartrate 44bromazepam 14bromhexine 38bromocriptine (oral and injection) 26brompheniramine 40bronchospasm relaxants 38budesonide 3, 24, 38bumetanide 6bupivacaine 48buprenorphine 13buspirone 14

56

INDEX

busulfan 35butyrophenones 15

cabergoline 26caffeine 16calcipotriol 45calcitonin 25calcitriol 25calcium and bone metabolism,

agents 25calcium carbimide 51calcium channel blockers 5candesartan cilexetil 5captopril 5carbamazepine 18carbidopa 17carbimazole 25carbonic anhydrase inhibitor 6carboplatin 36cardiac glycosides 8cardiac inotropic agents 8carmustine 35carvedilol 6cascara 2cefaclor 29cefodizime 29cefotaxime 29cefotetan 29cefoxitin 29

cefpirome 29cefpodoxime 29ceftazidime 29ceftriaxone 29cephalexin 29cephalosporins 29cephalothin 29cephamandole 29cephazolin 29cerivastatin 8cetirizine 40cetylpyridinium 46chenodeoxycholic acid 3chloral hydrate 14chlorambucil 35chloramphenicol 30, 44chlorcyclizine 40chlordiazepoxide 14chlorhexidine 46chlormethiazole 14chloroquine (prophylaxis,

treatment) 32chlorothiazide 6chlorpheniramine 40chlorpromazine 14chlorpropamide 25chlorquinaldol 46chlorthalidone 6cholelitholytics 3

57

INDEX

cholera vaccine 41cholestyramine 8cholinergic agents 51chorionic gonadotrophin 26cidofovir 33cilazapril 5cimetidine 2cinchocaine 48ciprofloxacin 30cisapride 2cisplatin 36citalopram 16cladribine 35clarithromycin 30clavulanic acid 30clemastine 40clindamycin 28, 30clobazam 14clodronate 25clofazimine 31clofibrate 8clomiphene 27clomipramine 16clonazepam 14, 19clonidine 4clopamide 6clorazepate 14clotrimazole 28, 46clozapine 15

CNS stimulants 16codeine 13, 38colaspase 35colchicine 22colestipol 8colistin injection 30contraceptives agents 49contraceptives, oral 23corticosteroids 24corticotrophin 24cortisone 24cromoglycate sodium 38crotamiton 46cyclizine 40cyclopenthiazide 6cyclophosphamide 35cyclosporin 41cyproheptadine 40cyproterone acetate 23cysteamine bitartrate 37cytarabine 35cytotoxic agents 35

dacarbazine 36dactinomycin 35dalteparin 9danaparoid 9danazol 26dantrolene 21

58

INDEX

dapsone 31daunorubicin 35decongestants 38delavirdine 33demeclocycline 29dependancy states, drugs used in51dermatology, drugs used in,

systemic 45dermatology, drugs used in,

topical 45desferrioxamine 51desflurane 48desipramine 16desirudin 10desmopressin 24desonide 45detoxifying agents 51dexamethasone 24dexchlorpheniramine 40dexfenfluramine 37dextroamphetamine 16dextromethorphan 38dextromoramide 13dextropropoxyphene 13diagnostic agents 50diazepam 14diazoxide 4diclofenac 21dicyclomine hydrochloride 2

dicloxacillin 29didanosine 33dienoestrol 23dienoslilerol 28diethylcarbamazine 34diethylpropion 37diflunisal 21digoxin 8digoxin immune fab 51dihydrocodeine 13, 38dihydroergotamine 9dihydrotachysterol 25diltiazem 5dimenhydrinate 20dinoprostone 27diphenhydramine 20, 40diphenoxylate 2diphenylamine 40diphenylpyraline 40diphtheria vaccine 41dipyridamole 9disodium pamidronate 25disopyramide 7disulfiram 51diuretics, carbonic anhydrase

inhibitor 6diuretics, loop 6diuretics, potassium sparing 6diuretics, thiazide 6

59

INDEX

dobutamine 8docetaxel 35docusate sodium 2dolasetron 20domperidone 20donepezil 51dopamine 8dornase alfa 39dorzolamide 44dothiepin 16doxazosin 4doxepin 16doxorubicin 35doxycycline 29, 32doxylamine 40droperidol 15dydrogesterone 23

econazole 28, 46ecothiopate 44eformoterol 38emetine 38enalapril 5endocrine system 24enflurane 48enoxacin 30enoxaparin 9entacapone 17ephedrine 8, 38

epirubicin 35eptacog alfa 10eprosartan 5ergometrine 27ergotamine 9erythromycin 30erythropoietin 12esmolol 6estramustine 35ethacrynic acid 6ethambutol 31ethinyloestradiol 23ethosuximide 19etidocaine 48etoposide 36etretinate 45expectorants 38

famciclovir 33famotidine 2felodipine 5fenfluramine 37fenoterol 8. 38fentanyl 13fexofenadine 40fibrinolytic agents 10filgrastim 12finasteride 12, 45flecainide 7

60

INDEX

fleroxacin 30flucloxacillin 29fluconazole 30flucytosine 30fludarabine 35fludrocortisone (systemic) 24fludrocortisone (topical) 24flumazenil 51flumethasone 24flunisolide 24flunitrazepam 14fluocinolone 24fluocortolone (topical) 24fluorouracil 35fluvoxamine 16fluoxetine 16fluoxymesterone 23flupenthixol 15fluphenazine 14flurazepam 14flurbiprofen 44fluticasone 24, 38fluvastatin 8folic acid 12folinic acid 12foscarnet 33fosinopril 5fotemustine 35

frusemide 6fusidic acid 30

gabapentin 19gadodiamide 50galactose and palmitic acid 50gallamine 48ganciclovir 33gemcitabine 35gemeprost 27gemfibrozil 8general anaesthetics 48gentamicin 29gestrinone 26glibenclamide 25gliclazide 25glimepiride 25glipizide 25glyceryl trinitrate 7, 9glycopyrrolate 2, 51glycosides, cardiotonic 8gonadotrophins 26goserelin 24, 35gout, agents used in 22granisetron 20griseofulvin 30guaiphenesin 38guanethidine 4

61

INDEX

haemophilus influenzae type Bvaccine 41

haemopoietic agents 12haemostatic agents 10halcinonide 24haloperidol 15halothane 48heparin 10hepatitis A vaccine 41hepatitis B vaccine 41hexamine 27hormonal antineoplastic agents 35hormones, pituitary 26hormones, thyroid 25human coagulation factor IX 10human chorionic gonadotrophin 26human menopausal

gonadotrophin 26hydralazine 4hydrochlorothiazide 6hydrocortisone (systemic and

topical) 24hydromorphone 13hydroxychloroquine 21, 32hydroxyprogesterone 23hydroxyquinoline 46hydroxyurea 35hydroxyzine 40hyoscine 20, 51

hyoscine hydrobromide 20hyoscine methobromide 51hyoscine-N-butylbromide 2, 51hyoscyamine 2, 51hyperlipidaemia, agents used in 8hyperuricaemia, agents used in 22hypnotics 13, 14hypocalcaemia, agents used in 25hypoglycaemic agents 25hypolipidaemic agents 8

ibuprofen 21idarubicin 35idoxuridine 44, 47ifosfamide 35imipenem-cilastatin combination 31imipramine 16imiquimod 47immunomodifiers 41indapamide 6indinavir 33indomethacin 21influenza vaccine 41inhalation agents 38inhalational agents, bronchospasm

relaxants 39inhalational agents, preventative

aerosols and inhalations 39interferon alpha-2a 41

62

INDEX

interferon alpha-2b 41interferon beta-1a 42interferon beta-1b 42interferon gamma-1b 41iomeprol 50ioversol 50ipecacuanha 38ipratropium bromide 38irbesartan 5irinotecan 36iron and haemopoietic agents 12iron preparations (oral and

parenteral) 12isoconazole 28isoflurane 48isoniazid 31isoprenaline 8, 38isosorbide dinitrate 7, 9isosorbide mononitrate 7isotretinoin 45isotretinoin (topical) 46isoxsuprine 9isradipine 5itraconazole 30ivermectin 34

kanamycin 29ketamine 48ketoconazole 30

ketoprofen 21ketorolac 21kogenate 10

labetalol 6lamivudine 33lamotrigine 19lansoprazole 2lataneprost 44laxatives 2lenograstim 12letrozole 35leuprorelin 35levamisole 42levobunolol 6, 44levocabastine 40, 44levodopa 17lignocaine 7, 48lincomycin 30lindane 46liothyronine 25lisinopril 5lithium salts 15local anaesthetics 48lodoxamide trometamol 44lomustine 35loop diuretics 6loperamide 2loratadine 40

63

INDEX

lorazepam 14losartan 5lypressin 24

macrolide antibiotics 30malathion (see maldison) 46maldison (malathion) 46mazindol 37measles-mumps-rubella vaccine 40measles-mumps vaccine 40measles vaccine 40mebendazole 34mebeverine 2medroxyprogesterone (injection) 49medroxyprogesterone (oral) 23, 36mefenamic acid 21mefloquine 32mefruside 6megestrol 23melphalan 35meningococcal vaccine 41mepivacaine 48meprobamate 14mercaptopurine 35meropenem 30mesalazine 3mesna 36mestranol 23metabolic disorders, drugs

used in 37

metaraminol 8metformin 25methadone 13, 52methdilazine 40methenolone 23methocarbamol 21methohexitone 48methotrexate 35methoxsalen 46methoxyflurane 48methsuximide 19methychlothiazide 6methyldopa 4methylphenidate 16methylphenobarbitone 18methylprednisolone 24methylprednisolone aceponate 24methysergide 9metoclopramide 20metolazone 6metoprolol 6metronidazole 30metyrapone 50mexiletine 7mezlocillin 29mianserin 16miconazole (topical) 28, 46midazolam 14miglitol 25

64

INDEX

migraine drugs 9milrinone 8minocycline 29minoxidil 4mirtazapine 16misoprostol 2mitomycin 35mitozantrone 35mivacurium 48moclobemide 16molgramostim 12mometasone 24monoamine oxidase inhibitors 16montelukast 39morphine 13mouth preparations 43mucolytic agents 38mumps vaccine 40mupirocin 30muscle relaxants 21mustine 35myasthenia gravis, drugs used in 51mycophenolate mofetil 42

nabumetone 21nadroparin 9nafarelin 24nalidixic acid 30naloxone 51

naltrexone 52nandrolone 23naproxen 21naratriptan 9nedocromil 38nefazodone 16nelfinavir 33neomycin 29neostigmine 51netilmicin 29neuromuscular blocking agents 48nevirapine 33nicardipine 5nicorandil 7nicotine (transdermal) 52nicotine (in chewing gum) 52nicotinic acid 8, 9, 52nicotinyl alcohol 9nifedipine 5nimodipine 5nisoldipine 5nitrazepam 14nitrofurantoin 31nitroprusside 4nitrous oxide 48nizatidine 2nonoxynol 9 49non-cytotoxic supportive therapy 36

65

INDEX

non-steroidal anti-inflammatorydrugs (NSAIDs) 21

norethisterone 23norfloxacin 30norflurane propellant 38nortriptyline 16nystatin 28, 30

octoxinol 49octreotide 26oestradiol 23oestriol 23oestrogens 23oestrogens conjugated 23oestrone 23ofloxacin 30olanzapine 15olsalazine 3omeprazole 2ondansetron 20ophthalmic drugs 44opioid analgesics 13opium alkaloids and derivatives 38oral contraceptives (see

contraceptives, oral) 23, 49orciprenaline 8, 38ornipressin 10orphenadrine 21ovulation inducers 26

oxandrolone 23oxazepam 14oxpentifylline 9, 11oxprenolol 6oxybutynin 27oxycodone 13oxymetholone 23oxytocin 27

paclitaxel 35pamidronate disodium 25pancuronium 48pantoprazole 2papaveretum 13papaverine 9, 51paracetamol 13paroxetine 16penciclovir 47penicillamine 21, 51penicillins 29pentamidine 31pentazocine 13pentobarbitone 13pentosan polysulfate sodium 27pergolide 17perhexilene 7pericyazine 14perindopril 5permethrin 46

66

INDEX

perphenazine 14pethidine 13phenelzine 16phenindione 10pheniramine 40phenobarbitone 18phenolphthalein 2phenoperidine 13phenothiazines 14, 20phenoxybenzamine 9phenoxymethylpenicillin 29phensuximide 19phentermine 37phentolamine 9phenylbutazone 21phenylephrine 8, 38phenylpropanolamine 8, 38phenytoin sodium 18pholcodine 38physostigime 21pimozide 15pindolol 6pipecuronium 48piperacillin 29piperacillin with tazobactam 29piperazine oestrone sulfate 23piperonyl butoxide 46piroxicam 21pituitary-adrenal response test 50

pituitary hormones 24pituitary inhibitors 26pizotifen 9pneumococcal vaccine 41poliomyelitis vaccine (injection) 41poliomyelitis vaccine (oral) 40pravastatin 8praziquantel 34prazosin 4prednisolone 24prednisone 24preventive aerosols and

inhalations 38prilocaine 48primaquine phosphate 32primidone 18probenecid 22probucol 8procainamide 7procaine penicillin 29procaine hydrochloride 48procarbazine 36prochlorperazine 20procyclidine 17progestogens 23, 49proguanil 32promazine 14promethazine 20, 40propantheline 2, 51

67

INDEX

propellant agents 38propofol 48propranolol 6propylthiouracil 25prostaglandin E2 27protamine 10protriptyline 16pseudoephedrine 8, 38pyrantel embonate 34pyrazinamide 31pyrethrins 46pyridostigmine 51pyrimethamine 33pyrimethamine-dapsone

combination 32pyrimethamine-sulfadoxine

combination 33

quinagolide 26quinapril 5quinethazone 6quinidine 7quinine 22, 33quinolones 30

rabies vaccine 41radiographic agents 50ramipril 5raloxifene 25raltitrexed 35

ranitidine 2recombinant follicle stimulating

hormone (FSH) 27remifentanil 13respiratory agents, other 39reteplase 10ribavirin 34rifabutin 31rifampicin 32rimiterol 8, 38risperidone 15ritonavir 33rituximab 42rocuronium 48ropinirole 17ropivacaine 48roxithromycin 30rubella vaccine 41

salbutamol 8, 27, 38salcatonin 25salicylate sodium 21salmeterol 38samarium [153 Sm] 36saponins 38saquinavir 33sedatives 13, 14selegiline 17senna 2

68

INDEX

sertraline 16sevoflurane 48sildenafil citrate 9simvastatin 8sodium aurothiomalate 21sodium cromoglycate 38sodium nitroprusside 4sodium salicylate 21sodium valproate 19somatropin 24sotalol 6spectinomycin 30spermicides, vaginal 49spironolactone 6, 23selective serotonin reuptake

inhibitors (SSRIs) 16stavudine 33steroids 23steroids, topical 24stimulants 16streptokinase 10sucralfate 2sulfadiazine 31sulfadoxine 31sulfamethizole 31sulfamethoxazole 31sulfasalazine 3sulfinpyrazone 22sulfonamides 31

sulindac 21sulphonylureas 25sulthiame 19sumatriptan 9suxamethonium 48

tacrine 51tacrolimus 42tamoxifen 36tazobactam 29teicoplanin 31temazepam 14teniposide 36tenoxicam 21terazosin 4, 27terbinafine 30terbutaline 8, 38terfenadine 40testosterone 23tetanus vaccine 41tetrabenazine 20tetracosactrin 50tetracyclic antidepressants 16tetracyclines 29theophylline derivatives 38thiabendazole 34thiazides 6thiethylperazine 20thioguanine 35

69

INDEX

thiopentone 48thiopropazate 14thioridazine 14thiotepa 35thiothixene 15thrombolytic agents 9thyroid hormones 25thyrotrophin 24thyroxine 25tiagabine 19tiaprofenic acid 21ticarcillin 29ticlopidine 10tiludronate disodium 25timolol 6, 44tinidazole 31tirilazad 11tirofiban hydrochloride 7tobramycin 29tolazamide 25tolbutamide 25topiramate 19topotecan 35toremifene 36tramadol 13trandolapril 5tranexamic acid 10tranylcypromine 16tretinoin 36, 46

triamcinolone (inhaled) 24triamcinolone (systemic) 24triamcinolone (topical) 24triamterene 6triazolam 14tricyclic antidepressants 16trifluoperazine 14trimeprazine 40trimethoprim 31trimethoprim-sulfonamide

combinations 31trimipramine 16triprolidine 40tropisetron 20tubocurarine 48typhoid vaccine (injection) 40typhoid vaccine (oral) 40

urinary antiseptics 27urofollitrophin 26urokinase 10uterus, agents acting on 27

vaccines 40, 41vaginal medication, topical 28valaciclovir 33valproate sodium (valproic acid) 19valsartan 5vancomycin 30

70

INDEX

vasodilators 9vasopressin 24vecuronium 48venlafaxine 16verapamil 5vigabatrin 19vinblastine 35vinca alkaloids 35vincristine 35vindesine 35vinorelbine tartrate 35vitamin A 52

warfarin 10weight reducing agents 37

yellow fever vaccine 40

zalcitabine 34zafirlukast 39zidovudine 33zolmitriptan 9zolpidem tartrate 14zopiclone 14zuclopenthixol 15

71

APPENDIX A

Therapeutic goods exempted frompregnancy classification

The following classes of therapeutic goods have not been generally includedin this categorisation. There are, however, some therapeutic goods withinthese classes which have been assigned a pregnancy classification atregistration and have been listed in the text.

• Antiflatulents (silicones)

• Antigen preparations for desensitisation

• Antihaemorrhagics: antifibrinolytics, fibrinogen, blood coagulation factors

• Certain anti-poisoning agents: potassium iodide

• Topical antirheumatics

• Antivenoms & antitoxins

• Charcoal preparations

• Contact lens preparations

• Diagnostic agents (urinalysis agents, ocular staining agents etc.)

• Digestives, including enzymes

• Ear preparations for topical use

• Enzymes (haematological), including fibrinolytics and hyaluronidase

• Topical preparations for haemorrhoids, except those containingcorticosteroids

• Herbal medicines

72

APPENDIX A

• Hormones that are indicated only for termination of pregnancy,postmenopausal substitution therapy, male hypogonadism,amenorrhoea, cystic glandular hyperplasia, or prostatic cancer

• Infant formulas

• Insulins and glucagon

• Keratolytics, cleansers, bath additives

• Certain laxatives: lactulose, bulk producers and enemas

• All medical devices (including prostheses, surgical implants, ostomy aids,surgical dressings, contraceptive devices, etc.)

• Mineral supplements

• Mouth preparations excluding those containing benzydamine

• Topical nasal decongestants, sympathomimetics and combinationsexcluding steroids

• Nutritional supplements

• Ocular irrigants

• Topical organoheparinoids

• Parenteral nutrition preparations

• Plasma substitutes and intravenous solutions, including solutions forintravenous feeding

• Scabicides, except when containing DDT, lindane or maldison (malathion)

• Sera and gammaglobulins

• Urinary sediment solvents

• Varicose vein therapies

• Vitamins (other than vitamin A and nicotinic acid)

• Zinc bandages

73

APPENDIX B

Obstetric Drug Information Services

The following services are available to health professionals.

AUSTRALIAN CAPITAL TERRITORYA.C.T. Drug Information ServiceWoden Valley HospitalGarran ACT 2605

Phone: (02) 6244 3333Fax: (02) 6244 3334

NEW SOUTH WALESPregnancy and Neonatal Drug Advisory ServicePoisons Information CentreThe New Children’s HospitalHawksbury RoadWestmead NSW 2148

Phone: (02) 9845 3111131126

Fax: (02) 9845 3597

VICTORIARoyal Women’s HospitalObstetric Drug Information Centre132 Grattan StreetCarlton VIC 3053

Phone: (03) 9344 2277Fax: (03) 9349 2756

74

APPENDIX B

Monash Medical CentreObstetric Drug Information246 Clayton RoadClayton VIC 3168

Phone: (03) 9594 2361Fax: (03) 9594 2595

SOUTH AUSTRALIADrugs in Pregnancy and Lactation Information ServiceWomen’s and Children’s Hospital72 King William RoadNorth Adelaide SA 5006

Phone: (08) 8204 7555Fax: (08) 8204 6049

WESTERN AUSTRALIAObstetric Drug Information ServiceKing Edward Memorial Hospital for Women374 Bagot RoadSubiaco WA 6008

Phone: (08) 9340 2723Fax: (08) 9340 2713

QUEENSLANDRoyal Women’s HospitalObstetric Drug Information ServiceBrisbane QLD

Phone: (07) 3253 7300Fax: (07) 3253 3544

75

APPENDIX B

Queensland Drug Information CentreRoyal Brisbane HospitalE Floor, Block 7Herston RoadHerston QLD 4029

Phone: (07) 3253 7098(07) 3253 7599

Fax: (07) 3253 1393

TASMANIADrug Information CentrePharmacy DepartmentRoyal Hobart HospitalGPO Box 1061LHobart TAS 7001

Phone: (03) 6238 8737Fax: (03) 6222 8029 or (03) 6231 2905

NORTHERN TERRITORYNorthern Territory Drug Information CentreRoyal Darwin HospitalPO Box 41 326Casuarina NT 0811

Phone: (08) 8922 8424Fax: (08) 8922 8499

prescribing medicine in pregnancy, by australian drug evaluation committee

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