INTRODUCTIONINTRODUCTION The safety of approximately 50 % of medications The safety of approximately 50 % of medications

for the mother and fetus remains unknownfor the mother and fetus remains unknown

Pharmacokinetics are profoundly affected by Pharmacokinetics are profoundly affected by pregnancy associated physiologic changes and pregnancy associated physiologic changes and dose adjustments are sometimes necessary for dose adjustments are sometimes necessary for optimal clinical outcomeoptimal clinical outcome

Current Categories for Current Categories for Drug Use in PregnancyDrug Use in Pregnancy

Category A :Category A :Adequate, well-controlled studies in pregnant Adequate, well-controlled studies in pregnant women have not shown an increased risk of women have not shown an increased risk of fetal abnormalities.fetal abnormalities.

Examples: Magnesium sulphate

Examples: Magnesium sulphate

Current Categories for Current Categories for Drug Use in PregnancyDrug Use in Pregnancy

Category B :Category B : Animal studies have revealed no evidence of harm to Animal studies have revealed no evidence of harm to

the fetus, however, there are no adequate and well-the fetus, however, there are no adequate and well-controlled studies in pregnant women.controlled studies in pregnant women.oror

Animal studies have shown an adverse effect, but Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetuswomen have failed to demonstrate a risk to the fetus

Examples:Examples: Amoxiciliin Amoxiciliin Amoxicillin + Clavulanic acidAmoxicillin + Clavulanic acid CefotaximeCefotaxime Methyl dopaMethyl dopa Metronidazole Metronidazole Erythromycin Erythromycin

Current Categories for Current Categories for Drug Use in PregnancyDrug Use in Pregnancy

Category C:Category C: Animal studies have shown an adverse effect and Animal studies have shown an adverse effect and

there are no adequate and well-controlled studies there are no adequate and well-controlled studies in pregnant women. in pregnant women. or or

No animal studies have been conducted and there No animal studies have been conducted and there are no adequate and well-controlled studies in are no adequate and well-controlled studies in pregnant womenpregnant women

Examples:Examples:

DiclofenacDiclofenac

RifampicinRifampicin

FluoroquinolonesFluoroquinolones

AminoglycosidesAminoglycosides

Glyburide Glyburide

Current Categories for Current Categories for Drug Use in PregnancyDrug Use in Pregnancy

Category D:Category D: Studies, adequate well-controlled or Studies, adequate well-controlled or

observational, in pregnant women have observational, in pregnant women have demonstrated a risk to the fetus. demonstrated a risk to the fetus. However, the benefits of therapy may However, the benefits of therapy may outweigh the potential harmoutweigh the potential harm

Examples:Examples:

TetracyclinesTetracyclines

PhenytoinPhenytoin

Valproic acidValproic acid

CarbamazepineCarbamazepine

ACE inhibitors ACE inhibitors

Current Categories for Current Categories for Drug Use in PregnancyDrug Use in Pregnancy

Category X:Category X: Studies, adequate well-controlled or Studies, adequate well-controlled or

observational, in animals or pregnant women observational, in animals or pregnant women have demonstrated positive evidence of fetal have demonstrated positive evidence of fetal abnormalities. The use of the product is abnormalities. The use of the product is contraindicated in women who are or may contraindicated in women who are or may become pregnant.become pregnant.

Examples:Examples: ThalidomideThalidomide Oral contraceptive pillsOral contraceptive pills Misoprostol Misoprostol

DRUGS USED COMMONLY IN PREGNANCYDRUGS USED COMMONLY IN PREGNANCY ANTIBIOTICS:ANTIBIOTICS:

CephalosporinsCephalosporins

Fluoroquinolones Fluoroquinolones

MacrolidesMacrolides

Aminoglycosides Aminoglycosides

MiscellaneousMiscellaneous

CEPHALOSPORINSCEPHALOSPORINS(Eg: Ceftriaxone, Cefixime, Cefotaxime)(Eg: Ceftriaxone, Cefixime, Cefotaxime)

Category B in pregnancyCategory B in pregnancy Cross the placenta during pregnancyCross the placenta during pregnancy Some reports of increased anomalies with specific Some reports of increased anomalies with specific

cephalosporins (cefaclor, cephalexin, cephradrine)cephalosporins (cefaclor, cephalexin, cephradrine) Primarily cardiac and oral cleft defectsPrimarily cardiac and oral cleft defects

LactationLactation Excreted into breastmilk in low concentrationsExcreted into breastmilk in low concentrations Considered compatible with breastfeedingConsidered compatible with breastfeeding

FLUOROQUINOLONESFLUOROQUINOLONES(Eg: Ciprofloxacin, Norfloxacin)(Eg: Ciprofloxacin, Norfloxacin)

Pregnancy Category CPregnancy Category C Not recommended in pregnancyNot recommended in pregnancy Cartilage damage in animalsCartilage damage in animals Safer alternatives usually existSafer alternatives usually exist

LactationLactation Excreted into breastmilkExcreted into breastmilk Limited human dataLimited human data AAP says compatible with breastfeedingAAP says compatible with breastfeeding

MACROLIDESMACROLIDES(Eg: Azithromycin, Clarithromycin, Erythromycin)(Eg: Azithromycin, Clarithromycin, Erythromycin)

Pregnancy Categories B/C/BPregnancy Categories B/C/B Cross the placenta in low amountsCross the placenta in low amounts Limited data with azithromycin and clarithromycinLimited data with azithromycin and clarithromycin

LactationLactation Erythromycin compatibleErythromycin compatible Others probably compatibleOthers probably compatible

AMINOGLYCOSIDESAMINOGLYCOSIDES(Gentamicin, Amikacin)(Gentamicin, Amikacin)

Pregnancy Category CPregnancy Category C Rapidly cross placenta Rapidly cross placenta Enter amniotic fluid through fetal circulationEnter amniotic fluid through fetal circulation

LactationLactation Compatible with breastfeedingCompatible with breastfeeding Not absorbed through GI tractNot absorbed through GI tract

MISCELLANEOUS ANTIBIOTICSMISCELLANEOUS ANTIBIOTICS ClindamycinClindamycin

Pregnancy Category B,Pregnancy Category B, commonly usedcommonly used

Lactation – Compatible per AAPLactation – Compatible per AAP

MetronidazoleMetronidazole Pregnancy Category B, carcinogenic in animals, avoid Pregnancy Category B, carcinogenic in animals, avoid

in 1in 1stst trimester if possible trimester if possible Lactation – hold feeds for 12-24hrs afterwardLactation – hold feeds for 12-24hrs afterward

MISCELLANEOUS ANTIBIOTICSMISCELLANEOUS ANTIBIOTICS Vancomycin Vancomycin

Pregnancy Category B, compatiblePregnancy Category B, compatible Lactation – likely compatible, not absorbedLactation – likely compatible, not absorbed

NitrofurantoinNitrofurantoin Pregnancy Category B, possible hemolytic anemia Pregnancy Category B, possible hemolytic anemia

with use at termwith use at term Lactation – Compatible, avoid with G-6-PD deficiencyLactation – Compatible, avoid with G-6-PD deficiency

ANTICONVULSANTSANTICONVULSANTSHYDANTOIN AGENTSHYDANTOIN AGENTSCategory DCategory D Hydantoin agents (Phenytoin) are teratogens long Hydantoin agents (Phenytoin) are teratogens long

recognised for constellation of congenital recognised for constellation of congenital anomalies known as anomalies known as fetal hydantoin syndromefetal hydantoin syndrome

The syndrome consists of craniofacial abnormalities The syndrome consists of craniofacial abnormalities , mental deficiency , hypoplasia of phalanges , mental deficiency , hypoplasia of phalanges

ANTICONVULSANTSANTICONVULSANTS

CARBAMAZEPINE:CARBAMAZEPINE:Category DCategory D Was considered relatively safe for use during Was considered relatively safe for use during

pregnancy but recent FDA reports suggest pregnancy but recent FDA reports suggest increased risk of neural tube defects with increased risk of neural tube defects with carbamazepine too and a pattern of carbamazepine too and a pattern of malformations similar to phenytoin malformations similar to phenytoin

ANTICONVULSANTSANTICONVULSANTS

VALPROIC ACID:VALPROIC ACID:

Category DCategory D It is commonly used for petit mal seizuresIt is commonly used for petit mal seizures 1 to 2 % risk of neural tube defects with use in 1 to 2 % risk of neural tube defects with use in

pregnancy pregnancy

PROSTAGLANDINSPROSTAGLANDINS They are synthesised from essential fatty acidsThey are synthesised from essential fatty acids PGF2a promotes myometrial contractility , is PGF2a promotes myometrial contractility , is

produced mainly from deciduaproduced mainly from decidua PGE2 helps cervical maturation / ripening , is PGE2 helps cervical maturation / ripening , is

mainly produced from amnion mainly produced from amnion They also sensitise myometrium to oxytocinThey also sensitise myometrium to oxytocin Commonly used for induction of labourCommonly used for induction of labour

PROSTAGLANDINSPROSTAGLANDINSPGE1 – MisoprostolPGE1 – Misoprostol: (Category X): (Category X) PGE1 promotes cervical ripening and myometrial PGE1 promotes cervical ripening and myometrial

contractility is increasedcontractility is increased Transvaginally used for induction of labourTransvaginally used for induction of labour Failure of induction is less Failure of induction is less Can be used per rectally /orally alsoCan be used per rectally /orally also Incidence of tachysystole is high and thus should not Incidence of tachysystole is high and thus should not

be used in cases with previous ceasarean birthbe used in cases with previous ceasarean birth

ANTIHYPERTENSIVESANTIHYPERTENSIVESMETHYL DOPA:METHYL DOPA:Category BCategory B It is the drug of first choice in pregnancyIt is the drug of first choice in pregnancy Has central and peripheral anti adrenergic actionHas central and peripheral anti adrenergic action Safe for both mother and fetusSafe for both mother and fetus Postural hypotension is a common side effectPostural hypotension is a common side effect May be given orally or i.v May be given orally or i.v Doses start from 25o mg bd to 500 mg four times a dayDoses start from 25o mg bd to 500 mg four times a day

ANTIHYPERTENSIVESANTIHYPERTENSIVES

NIFEDIPINE:NIFEDIPINE: Cause direct arteriolar vasodilatation by Cause direct arteriolar vasodilatation by

inhibition of slow calcium channelsinhibition of slow calcium channels Flushing , hypotension , headache , tachycardia Flushing , hypotension , headache , tachycardia

are side effects notedare side effects noted

ANTIHYPERTENSIVESANTIHYPERTENSIVESLABETALOL:LABETALOL: Has combined alpha and beta adrenergic Has combined alpha and beta adrenergic

blocking actionsblocking actions Can be used orally and as iv infusionCan be used orally and as iv infusion Efficacy and safety appears to be equal to Efficacy and safety appears to be equal to

methyl dopamethyl dopa Dose is 100 mg twice a dayDose is 100 mg twice a day

ANTIHYPERTENSIVESANTIHYPERTENSIVESACE INHIBITORS:ACE INHIBITORS:

Category C or DCategory C or D Not used in pregnancy as studies show increased Not used in pregnancy as studies show increased

risk of oligohydramnios , neonatal anuria , renal risk of oligohydramnios , neonatal anuria , renal anomalies and nephrotoxicity when used in 2 nd anomalies and nephrotoxicity when used in 2 nd and 3 rd trimestersand 3 rd trimesters

Thus considered human teratogensThus considered human teratogens

ANTIHYPERTENSIVESANTIHYPERTENSIVESSODIUM NITROPRUSSIDE:SODIUM NITROPRUSSIDE: It is used to treat serious , life threatening It is used to treat serious , life threatening

hypertensionhypertension Animal studies have shown fetal cyanide toxicity but Animal studies have shown fetal cyanide toxicity but

human studies have not proved the samehuman studies have not proved the same Nonetheless , it is avoided in preganancy and is only Nonetheless , it is avoided in preganancy and is only

used as last resortused as last resort

ANTIHYPERTENSIVESANTIHYPERTENSIVES

MAGNESIUM SULPHATE:MAGNESIUM SULPHATE: Category ACategory A Mechanism of action :Mechanism of action : It decreases acetycholine release from nerve It decreases acetycholine release from nerve

endings and reduces motor end plate sensitivity to endings and reduces motor end plate sensitivity to acetylcholineacetylcholine

It blocks calcium channels and causes vasodilationIt blocks calcium channels and causes vasodilation

Can be given by Can be given by Pritchard regimePritchard regime or or Zuspan regimeZuspan regime

Pritchard Regime:Pritchard Regime: 4 gm iv slowly followed by 5 gm in each buttock 4 gm iv slowly followed by 5 gm in each buttock

deep im -- loading dosedeep im -- loading dose 5 gm deep im 4 hourly in alternate buttock 5 gm deep im 4 hourly in alternate buttock

Indications:Indications: In eclampsia , as an anticonvulsantIn eclampsia , as an anticonvulsant As a tocolytic As a tocolytic ContraindicationsContraindications In patients with renal impairmentIn patients with renal impairment Dosage:Dosage: For I.V infusion , 50% solution must be diluted to 20 % For I.V infusion , 50% solution must be diluted to 20 %

before administrationbefore administration 50% solution (undiluted) is given for intramuscular 50% solution (undiluted) is given for intramuscular

injectionsinjections

It is relatively safe . Muscular paresis , respiratory It is relatively safe . Muscular paresis , respiratory failure and renal effects on mother are known side failure and renal effects on mother are known side effectseffects

Thus deep tendon reflexes, respiratory rate and Thus deep tendon reflexes, respiratory rate and urine output monitoring is essential in a patient urine output monitoring is essential in a patient receiving Magnesium Sulpahatereceiving Magnesium Sulpahate

Has no harmful effects on fetus though neonatal Has no harmful effects on fetus though neonatal respiratory depression may be seenrespiratory depression may be seen

TOCOLYTICSTOCOLYTICS

BETAMIMETICS:( Terbutaline , IsoxsuprineBETAMIMETICS:( Terbutaline , Isoxsuprine)) Category CCategory C Mechanism of action:Mechanism of action: They activate intracellular enzymes and reduce They activate intracellular enzymes and reduce

intracellular free calcium which leads to reduced intracellular free calcium which leads to reduced interaction of actin and myosin interaction of actin and myosin

Dosage:Dosage: Terbutaline can be subcutaneously 0.25 mg 6 Terbutaline can be subcutaneously 0.25 mg 6

hourly or orally 0.5 mg 6 hourlyhourly or orally 0.5 mg 6 hourly Isoxsuprine is given either as intravenous Isoxsuprine is given either as intravenous

infusion drip or intramuscularly(10mg 6 hourly) infusion drip or intramuscularly(10mg 6 hourly) or orally (10 mg 6/8 hourly)or orally (10 mg 6/8 hourly)

Contraindications :Contraindications :

Cardiac arrhythmiasCardiac arrhythmias

Poorly controlled diabetes mellitusPoorly controlled diabetes mellitus

Poorly controlled thyroid disordersPoorly controlled thyroid disorders

Maternal side effects are headache , palpitations Maternal side effects are headache , palpitations , pulmonary edema , hyperglycemia and , pulmonary edema , hyperglycemia and hypotensionhypotension

Fetal tachycardia , heart failure may be seenFetal tachycardia , heart failure may be seen

INDOMETHACIN AND CALCIUM CHANNEL INDOMETHACIN AND CALCIUM CHANNEL BLOCKERS :BLOCKERS :

They are also used commonly for tocolysisThey are also used commonly for tocolysis Indomethacin may cause gastric disturbances in Indomethacin may cause gastric disturbances in

mothermother Calcium channel blockers may cause headache , Calcium channel blockers may cause headache ,

flushingflushing Both cause no known fetal harmBoth cause no known fetal harm

OXYTOCINOXYTOCIN Mechanism of action:Mechanism of action: It acts through calcium channels to initiate It acts through calcium channels to initiate

myometrial contractionsmyometrial contractions Also stimulate amniotic and decidual Also stimulate amniotic and decidual

prostaglandin productionprostaglandin production

OXYTOCINOXYTOCIN

Routes of administration:Routes of administration:

Can be given intramuscularly or by controlled Can be given intramuscularly or by controlled intravenous infusionintravenous infusion

It is also available as nasal solution , buccal It is also available as nasal solution , buccal tablets tablets

OXYTOCINOXYTOCIN

Indications:Indications: Induction of labourInduction of labour Augmentation of labourAugmentation of labour In active management of third stage, as an In active management of third stage, as an

alternative to metherginalternative to methergin To control postpartum hemorrhageTo control postpartum hemorrhage

OXYTOCINOXYTOCIN Contraindications:Contraindications: Obstructed labourObstructed labour MalpresentationsMalpresentations Contracted pelvisContracted pelvis History of previous Caesarean History of previous Caesarean

section/hysterotomy (relative contraindication)section/hysterotomy (relative contraindication)

OXYTOCINOXYTOCIN

Maternal side effects:Maternal side effects:

Uterine hyperstimulation (sometimes rupture)Uterine hyperstimulation (sometimes rupture)

Water intoxication due to its antidiuretic effectWater intoxication due to its antidiuretic effect

Hypotension Hypotension

OXYTOCINOXYTOCIN

Fetal side effects:Fetal side effects: Fetal distress , fetal hypoxia or even fetal death Fetal distress , fetal hypoxia or even fetal death

may occur due to hyperstimulationmay occur due to hyperstimulation

ERGOT DERIVATIVESERGOT DERIVATIVESMETHERGIN: (Category X)METHERGIN: (Category X)Mechanism of actionMechanism of action:: Acts directly on myometrium and cause tetanic Acts directly on myometrium and cause tetanic

uterine contractionsuterine contractionsRoute of administration:Route of administration: Parenterally – 0.2 mg ampoules availableParenterally – 0.2 mg ampoules available Orally – 0.5 or 1 mg tablets availableOrally – 0.5 or 1 mg tablets available

ERGOT DERIVATIVESERGOT DERIVATIVESIndications: Indications: Therapeutic:Therapeutic: To stop atonic uterine bleeding following delivery or To stop atonic uterine bleeding following delivery or

abortionabortion Prophylactic :Prophylactic : Should be only used in second stage of labour after Should be only used in second stage of labour after

delivery of anterior shoulder or following delivery of delivery of anterior shoulder or following delivery of babybaby

ERGOT DERIVATIVESERGOT DERIVATIVES

Contraindications:Contraindications:

In cardiac diseases In cardiac diseases

Rh negative pregnancies Rh negative pregnancies

Severe pre-eclampsia/eclampsiaSevere pre-eclampsia/eclampsia

IRON DEXTRANIRON DEXTRAN It is intramuscularly used iron It is intramuscularly used iron

preparation for treatment of preparation for treatment of iron deficiency anemiairon deficiency anemia

1 ml of iron dextran contains 1 ml of iron dextran contains 50 mg elemental iron50 mg elemental iron

Oral iron to be stopped 24 hour Oral iron to be stopped 24 hour before therapy to avoid reactionsbefore therapy to avoid reactions

IRON DEXTRANIRON DEXTRAN Mode of administrationMode of administration::

Dose to be given is initially calculatedDose to be given is initially calculated

Initial test dose is givenInitial test dose is given

This is followed by daily or alternate day This is followed by daily or alternate day injections given deep im by Z techniqueinjections given deep im by Z technique

IRON DEXTRANIRON DEXTRAN

Drawbacks:Drawbacks:

Injections are painfulInjections are painful

May cause staining of skinMay cause staining of skin

Allergic reactions , though rare , may occurAllergic reactions , though rare , may occur

Abscess formation over injection site may occurAbscess formation over injection site may occur

IRON DEXTRANIRON DEXTRANIndications:Indications:

Iron deficiency anemia , when oral iron therapy is Iron deficiency anemia , when oral iron therapy is unsatisfactory or not toleratedunsatisfactory or not tolerated

Contraindications:Contraindications:

Anemia other than iron deficiencyAnemia other than iron deficiency

Hypersensitivity to the productHypersensitivity to the product

THANK YOUTHANK YOU