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Drugs In Pregnancy. Dr P K SHAH Professor and Unit incharge, Seth G.S. Medical college and KEM hospital, Parel, Mumbai. Secretary General, FOGSI.

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Presentation on theme: "Drugs In Pregnancy. Dr P K SHAH Professor and Unit incharge, Seth G.S. Medical college and KEM hospital, Parel, Mumbai. Secretary General, FOGSI."— Presentation transcript:

1 Drugs In Pregnancy

2 Dr P K SHAH Professor and Unit incharge, Seth G.S. Medical college and KEM hospital, Parel, Mumbai. Secretary General, FOGSI

3 INTRODUCTION The safety of approximately 50 % of medications for the mother and fetus remains unknown The safety of approximately 50 % of medications for the mother and fetus remains unknown Pharmacokinetics are profoundly affected by pregnancy associated physiologic changes and dose adjustments are sometimes necessary for optimal clinical outcome Pharmacokinetics are profoundly affected by pregnancy associated physiologic changes and dose adjustments are sometimes necessary for optimal clinical outcome

4 Current Categories for Drug Use in Pregnancy Category A : Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities. Category A : Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities. Examples: Magnesium sulphate Examples: Magnesium sulphate

5 Current Categories for Drug Use in Pregnancy Category B : Category B : Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well- controlled studies in pregnant women. or Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well- controlled studies in pregnant women. or Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus

6 Examples: Amoxiciliin Amoxiciliin Amoxicillin + Clavulanic acid Amoxicillin + Clavulanic acid Cefotaxime Cefotaxime Methyl dopa Methyl dopa Metronidazole Metronidazole Erythromycin Erythromycin

7 Current Categories for Drug Use in Pregnancy Category C: Category C: Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. or Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. or No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women

8 Examples: Diclofenac Diclofenac Rifampicin Rifampicin Fluoroquinolones Fluoroquinolones Aminoglycosides Aminoglycosides Glyburide Glyburide

9 Current Categories for Drug Use in Pregnancy Category D: Category D: Studies, adequate well-controlled or observational, in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential harm Studies, adequate well-controlled or observational, in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential harm

10 Examples: Tetracyclines Tetracyclines Phenytoin Phenytoin Valproic acid Valproic acid Carbamazepine Carbamazepine ACE inhibitors ACE inhibitors

11 Current Categories for Drug Use in Pregnancy Category X: Category X: Studies, adequate well-controlled or observational, in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. The use of the product is contraindicated in women who are or may become pregnant. Studies, adequate well-controlled or observational, in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. The use of the product is contraindicated in women who are or may become pregnant.

12 Examples: Examples: Thalidomide Thalidomide Oral contraceptive pills Oral contraceptive pills Misoprostol Misoprostol

13 DRUGS USED COMMONLY IN PREGNANCY ANTIBIOTICS: ANTIBIOTICS: Cephalosporins Cephalosporins Fluoroquinolones Fluoroquinolones Macrolides Macrolides Aminoglycosides Aminoglycosides Miscellaneous Miscellaneous

14 CEPHALOSPORINS (Eg: Ceftriaxone, Cefixime, Cefotaxime) Category B in pregnancy Category B in pregnancy Cross the placenta during pregnancy Cross the placenta during pregnancy Some reports of increased anomalies with specific cephalosporins (cefaclor, cephalexin, cephradrine) Some reports of increased anomalies with specific cephalosporins (cefaclor, cephalexin, cephradrine) Primarily cardiac and oral cleft defects Primarily cardiac and oral cleft defects Lactation Lactation Excreted into breastmilk in low concentrations Excreted into breastmilk in low concentrations Considered compatible with breastfeeding Considered compatible with breastfeeding

15 FLUOROQUINOLONES (Eg: Ciprofloxacin, Norfloxacin) Pregnancy Category C Pregnancy Category C Not recommended in pregnancy Not recommended in pregnancy Cartilage damage in animals Cartilage damage in animals Safer alternatives usually exist Safer alternatives usually exist Lactation Lactation Excreted into breastmilk Excreted into breastmilk Limited human data Limited human data AAP says compatible with breastfeeding AAP says compatible with breastfeeding

16 MACROLIDES (Eg: Azithromycin, Clarithromycin, Erythromycin) Pregnancy Categories B/C/B Pregnancy Categories B/C/B Cross the placenta in low amounts Cross the placenta in low amounts Limited data with azithromycin and clarithromycin Limited data with azithromycin and clarithromycin Lactation Lactation Erythromycin compatible Erythromycin compatible Others probably compatible Others probably compatible

17 AMINOGLYCOSIDES (Gentamicin, Amikacin) Pregnancy Category C Pregnancy Category C Rapidly cross placenta Rapidly cross placenta Enter amniotic fluid through fetal circulation Enter amniotic fluid through fetal circulation Lactation Lactation Compatible with breastfeeding Compatible with breastfeeding Not absorbed through GI tract Not absorbed through GI tract

18 MISCELLANEOUS ANTIBIOTICS Clindamycin Clindamycin Pregnancy Category B, commonly used Pregnancy Category B, commonly used Lactation – Compatible per AAP Lactation – Compatible per AAP Metronidazole Metronidazole Pregnancy Category B, carcinogenic in animals, avoid in 1 st trimester if possible Pregnancy Category B, carcinogenic in animals, avoid in 1 st trimester if possible Lactation – hold feeds for 12-24hrs afterward Lactation – hold feeds for 12-24hrs afterward

19 MISCELLANEOUS ANTIBIOTICS Vancomycin Vancomycin Pregnancy Category B, compatible Pregnancy Category B, compatible Lactation – likely compatible, not absorbed Lactation – likely compatible, not absorbed Nitrofurantoin Nitrofurantoin Pregnancy Category B, possible hemolytic anemia with use at term Pregnancy Category B, possible hemolytic anemia with use at term Lactation – Compatible, avoid with G-6-PD deficiency Lactation – Compatible, avoid with G-6-PD deficiency

20 ANTICONVULSANTS HYDANTOIN AGENTS Category D Hydantoin agents (Phenytoin) are teratogens long recognised for constellation of congenital anomalies known as fetal hydantoin syndrome Hydantoin agents (Phenytoin) are teratogens long recognised for constellation of congenital anomalies known as fetal hydantoin syndrome The syndrome consists of craniofacial abnormalities, mental deficiency, hypoplasia of phalanges The syndrome consists of craniofacial abnormalities, mental deficiency, hypoplasia of phalanges

21 ANTICONVULSANTS CARBAMAZEPINE: Category D Was considered relatively safe for use during pregnancy but recent FDA reports suggest increased risk of neural tube defects with carbamazepine too and a pattern of malformations similar to phenytoin Was considered relatively safe for use during pregnancy but recent FDA reports suggest increased risk of neural tube defects with carbamazepine too and a pattern of malformations similar to phenytoin

22 ANTICONVULSANTS VALPROIC ACID: Category D It is commonly used for petit mal seizures It is commonly used for petit mal seizures 1 to 2 % risk of neural tube defects with use in pregnancy 1 to 2 % risk of neural tube defects with use in pregnancy

23 PROSTAGLANDINS They are synthesised from essential fatty acids They are synthesised from essential fatty acids PGF2a promotes myometrial contractility, is produced mainly from decidua PGF2a promotes myometrial contractility, is produced mainly from decidua PGE2 helps cervical maturation / ripening, is mainly produced from amnion PGE2 helps cervical maturation / ripening, is mainly produced from amnion They also sensitise myometrium to oxytocin They also sensitise myometrium to oxytocin Commonly used for induction of labour Commonly used for induction of labour

24 PROSTAGLANDINS PGE1 – Misoprostol: (Category X) PGE1 promotes cervical ripening and myometrial contractility is increased PGE1 promotes cervical ripening and myometrial contractility is increased Transvaginally used for induction of labour Transvaginally used for induction of labour Failure of induction is less Failure of induction is less Can be used per rectally /orally also Can be used per rectally /orally also Incidence of tachysystole is high and thus should not be used in cases with previous ceasarean birth Incidence of tachysystole is high and thus should not be used in cases with previous ceasarean birth

25 ANTIHYPERTENSIVES METHYL DOPA: Category B It is the drug of first choice in pregnancy It is the drug of first choice in pregnancy Has central and peripheral anti adrenergic action Has central and peripheral anti adrenergic action Safe for both mother and fetus Safe for both mother and fetus Postural hypotension is a common side effect Postural 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 day Doses start from 25o mg bd to 500 mg four times a day

26 ANTIHYPERTENSIVES NIFEDIPINE: NIFEDIPINE: Cause direct arteriolar vasodilatation by inhibition of slow calcium channels Cause direct arteriolar vasodilatation by inhibition of slow calcium channels Flushing, hypotension, headache, tachycardia are side effects noted Flushing, hypotension, headache, tachycardia are side effects noted

27 ANTIHYPERTENSIVES LABETALOL: Has combined alpha and beta adrenergic blocking actions Has combined alpha and beta adrenergic blocking actions Can be used orally and as iv infusion Can be used orally and as iv infusion Efficacy and safety appears to be equal to methyl dopa Efficacy and safety appears to be equal to methyl dopa Dose is 100 mg twice a day Dose is 100 mg twice a day

28 ANTIHYPERTENSIVES ACE INHIBITORS: Category C or D Not used in pregnancy as studies show increased risk of oligohydramnios, neonatal anuria, renal anomalies and nephrotoxicity when used in 2 nd and 3 rd trimesters Not used in pregnancy as studies show increased risk of oligohydramnios, neonatal anuria, renal anomalies and nephrotoxicity when used in 2 nd and 3 rd trimesters Thus considered human teratogens Thus considered human teratogens

29 ANTIHYPERTENSIVES SODIUM NITROPRUSSIDE: It is used to treat serious, life threatening hypertension It is used to treat serious, life threatening hypertension Animal studies have shown fetal cyanide toxicity but human studies have not proved the same Animal studies have shown fetal cyanide toxicity but human studies have not proved the same Nonetheless, it is avoided in preganancy and is only used as last resort Nonetheless, it is avoided in preganancy and is only used as last resort

30 ANTIHYPERTENSIVES MAGNESIUM SULPHATE: MAGNESIUM SULPHATE: Category A Category A Mechanism of action : Mechanism of action : It decreases acetycholine release from nerve endings and reduces motor end plate sensitivity to acetylcholine It decreases acetycholine release from nerve endings and reduces motor end plate sensitivity to acetylcholine It blocks calcium channels and causes vasodilation It blocks calcium channels and causes vasodilation

31 Can be given by Pritchard regime or Zuspan regime Can be given by Pritchard regime or Zuspan regime Pritchard Regime: Pritchard Regime: 4 gm iv slowly followed by 5 gm in each buttock deep im -- loading dose 4 gm iv slowly followed by 5 gm in each buttock deep im -- loading dose 5 gm deep im 4 hourly in alternate buttock 5 gm deep im 4 hourly in alternate buttock

32 Indications: Indications: In eclampsia, as an anticonvulsant In eclampsia, as an anticonvulsant As a tocolytic As a tocolytic Contraindications Contraindications In patients with renal impairment In patients with renal impairment Dosage: Dosage: For I.V infusion, 50% solution must be diluted to 20 % before administration For I.V infusion, 50% solution must be diluted to 20 % before administration 50% solution (undiluted) is given for intramuscular injections 50% solution (undiluted) is given for intramuscular injections

33 It is relatively safe. Muscular paresis, respiratory failure and renal effects on mother are known side effects It is relatively safe. Muscular paresis, respiratory failure and renal effects on mother are known side effects Thus deep tendon reflexes, respiratory rate and urine output monitoring is essential in a patient receiving Magnesium Sulpahate Thus deep tendon reflexes, respiratory rate and urine output monitoring is essential in a patient receiving Magnesium Sulpahate Has no harmful effects on fetus though neonatal respiratory depression may be seen Has no harmful effects on fetus though neonatal respiratory depression may be seen

34 TOCOLYTICS BETAMIMETICS:( Terbutaline, Isoxsuprine ) Category C Category C Mechanism of action: Mechanism of action: They activate intracellular enzymes and reduce intracellular free calcium which leads to reduced interaction of actin and myosin They activate intracellular enzymes and reduce intracellular free calcium which leads to reduced interaction of actin and myosin

35 Dosage: Terbutaline can be subcutaneously 0.25 mg 6 hourly or orally 0.5 mg 6 hourly Terbutaline can be subcutaneously 0.25 mg 6 hourly or orally 0.5 mg 6 hourly Isoxsuprine is given either as intravenous infusion drip or intramuscularly(10mg 6 hourly) or orally (10 mg 6/8 hourly) Isoxsuprine is given either as intravenous infusion drip or intramuscularly(10mg 6 hourly) or orally (10 mg 6/8 hourly)

36 Contraindications : Contraindications : Cardiac arrhythmias Cardiac arrhythmias Poorly controlled diabetes mellitus Poorly controlled diabetes mellitus Poorly controlled thyroid disorders Poorly controlled thyroid disorders

37 Maternal side effects are headache, palpitations, pulmonary edema, hyperglycemia and hypotension Maternal side effects are headache, palpitations, pulmonary edema, hyperglycemia and hypotension Fetal tachycardia, heart failure may be seen Fetal tachycardia, heart failure may be seen

38 INDOMETHACIN AND CALCIUM CHANNEL BLOCKERS : INDOMETHACIN AND CALCIUM CHANNEL BLOCKERS : They are also used commonly for tocolysis They are also used commonly for tocolysis Indomethacin may cause gastric disturbances in mother Indomethacin may cause gastric disturbances in mother Calcium channel blockers may cause headache, flushing Calcium channel blockers may cause headache, flushing Both cause no known fetal harm Both cause no known fetal harm

39 OXYTOCIN Mechanism of action: Mechanism of action: It acts through calcium channels to initiate myometrial contractions It acts through calcium channels to initiate myometrial contractions Also stimulate amniotic and decidual prostaglandin production Also stimulate amniotic and decidual prostaglandin production

40 OXYTOCIN Routes of administration: Routes of administration: Can be given intramuscularly or by controlled intravenous infusion Can be given intramuscularly or by controlled intravenous infusion It is also available as nasal solution, buccal tablets It is also available as nasal solution, buccal tablets

41 OXYTOCIN Indications: Indications: Induction of labour Induction of labour Augmentation of labour Augmentation of labour In active management of third stage, as an alternative to methergin In active management of third stage, as an alternative to methergin To control postpartum hemorrhage To control postpartum hemorrhage

42 OXYTOCIN Contraindications: Contraindications: Obstructed labour Obstructed labour Malpresentations Malpresentations Contracted pelvis Contracted pelvis History of previous Caesarean section/hysterotomy (relative contraindication) History of previous Caesarean section/hysterotomy (relative contraindication)

43 OXYTOCIN Maternal side effects: Maternal side effects: Uterine hyperstimulation (sometimes rupture) Uterine hyperstimulation (sometimes rupture) Water intoxication due to its antidiuretic effect Water intoxication due to its antidiuretic effect Hypotension Hypotension

44 OXYTOCIN Fetal side effects: Fetal side effects: Fetal distress, fetal hypoxia or even fetal death may occur due to hyperstimulation Fetal distress, fetal hypoxia or even fetal death may occur due to hyperstimulation

45 ERGOT DERIVATIVES METHERGIN: (Category X) Mechanism of action: Acts directly on myometrium and cause tetanic uterine contractions Acts directly on myometrium and cause tetanic uterine contractions Route of administration: Parenterally – 0.2 mg ampoules available Parenterally – 0.2 mg ampoules available Orally – 0.5 or 1 mg tablets available Orally – 0.5 or 1 mg tablets available

46 ERGOT DERIVATIVES Indications: Therapeutic: Therapeutic: To stop atonic uterine bleeding following delivery or abortion To stop atonic uterine bleeding following delivery or abortion Prophylactic : Prophylactic : Should be only used in second stage of labour after delivery of anterior shoulder or following delivery of baby Should be only used in second stage of labour after delivery of anterior shoulder or following delivery of baby

47 ERGOT DERIVATIVES Contraindications: In cardiac diseases In cardiac diseases Rh negative pregnancies Rh negative pregnancies Severe pre-eclampsia/eclampsia Severe pre-eclampsia/eclampsia

48 IRON DEXTRAN It is intramuscularly used iron preparation for treatment of iron deficiency anemia It is intramuscularly used iron preparation for treatment of iron deficiency anemia 1 ml of iron dextran contains 50 mg elemental iron 1 ml of iron dextran contains 50 mg elemental iron Oral iron to be stopped 24 hour before therapy to avoid reactions Oral iron to be stopped 24 hour before therapy to avoid reactions

49 IRON DEXTRAN Mode of administration: Mode of administration: Dose to be given is initially calculated Dose to be given is initially calculated Initial test dose is given Initial test dose is given This is followed by daily or alternate day injections given deep im by Z technique This is followed by daily or alternate day injections given deep im by Z technique

50 IRON DEXTRAN Drawbacks: Drawbacks: Injections are painful Injections are painful May cause staining of skin May cause staining of skin Allergic reactions, though rare, may occur Allergic reactions, though rare, may occur Abscess formation over injection site may occur Abscess formation over injection site may occur

51 IRON DEXTRAN Indications: Iron deficiency anemia, when oral iron therapy is unsatisfactory or not tolerated Iron deficiency anemia, when oral iron therapy is unsatisfactory or not toleratedContraindications: Anemia other than iron deficiency Anemia other than iron deficiency Hypersensitivity to the product Hypersensitivity to the product

52 THANK YOU


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