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Drugs In Pregnancy.

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Presentation on theme: "Drugs In Pregnancy."— Presentation transcript:

1 Drugs In Pregnancy

2 Secretary General, FOGSI
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 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. Examples: Magnesium sulphate

5 Current Categories for Drug Use in Pregnancy
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 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 Amoxicillin + Clavulanic acid Cefotaxime Methyl dopa Metronidazole Erythromycin

7 Current Categories for Drug Use in Pregnancy
Category C: 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

8 Examples: Diclofenac Rifampicin Fluoroquinolones Aminoglycosides Glyburide

9 Current Categories for Drug Use in Pregnancy
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

10 Examples: Tetracyclines Phenytoin Valproic acid Carbamazepine ACE inhibitors

11 Current Categories for Drug Use in Pregnancy
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.

12 Examples: Thalidomide Oral contraceptive pills Misoprostol

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

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

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

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

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

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

19 MISCELLANEOUS ANTIBIOTICS
Vancomycin Pregnancy Category B, compatible Lactation – likely compatible, not absorbed Nitrofurantoin Pregnancy Category B, possible hemolytic anemia with use at term 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 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

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

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

24 PROSTAGLANDINS PGE1 – Misoprostol: (Category X)
PGE1 promotes cervical ripening and myometrial contractility is increased Transvaginally used for induction of labour Failure of induction is less Can be used per rectally /orally also 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 Has central and peripheral anti adrenergic action Safe for both mother and fetus Postural hypotension is a common side effect May be given orally or i.v Doses start from 25o mg bd to 500 mg four times a day

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

27 ANTIHYPERTENSIVES LABETALOL:
Has combined alpha and beta adrenergic blocking actions Can be used orally and as iv infusion Efficacy and safety appears to be equal to methyl dopa 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 Thus considered human teratogens

29 ANTIHYPERTENSIVES SODIUM NITROPRUSSIDE:
It is used to treat serious , life threatening hypertension 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

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

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

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

34 TOCOLYTICS BETAMIMETICS:( Terbutaline , Isoxsuprine) Category C
Mechanism of action: 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 Isoxsuprine is given either as intravenous infusion drip or intramuscularly(10mg 6 hourly) or orally (10 mg 6/8 hourly)

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

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

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

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

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

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

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

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

44 OXYTOCIN Fetal side effects:
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 Route of administration: Parenterally – 0.2 mg ampoules available Orally – 0.5 or 1 mg tablets available

46 ERGOT DERIVATIVES Indications: Therapeutic:
To stop atonic uterine bleeding following delivery or abortion Prophylactic : 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
Rh negative pregnancies Severe pre-eclampsia/eclampsia

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

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

50 IRON DEXTRAN Drawbacks: Injections are painful
May cause staining of skin Allergic reactions , though rare , 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 Contraindications: Anemia other than iron deficiency Hypersensitivity to the product

52 THANK YOU


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