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FARMAKOTERAPI
PADA KEHAMILANDAN LAKTASI
Welly Ratwita, dr., MKes.
Lab Farmakologi FK Unjani
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TeratologiMempelajari malformasi kongenital yang dapat
diamati saat kelahiran dan diinduksi oleh agen
eksogen selama periode organogenesis
Dismorfisme
Abnormalitas fungsional dan struktural padafetus
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Thalidomide Tragedy
Akhir 1950-Awal 1960 thalidomide dianggap
aman pada kehamilan
Penelitian pada hewan belum sempurna
Amelia, phocomelia, abnormalitas jantung,
defek pada mata
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Mekanisme Dismorfogenitas1. Efek Langsung Obat pada Fetus
Dipengaruhi oleh:
Distribusi obat ke plasenta
aliran darah maternal & uterus
Struktur & biokimia plasenta
Komponen obat (BM
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2. Efek Obat pada Fungsi Plasenta
Biotransformasi obat pada plasenta dapatmempengaruhi fungsi plasenta melalui
kompetisi enzimatik, produksi hormon &
inhibisi transpor energi
Rokok: Mengganggu nutrisi dan oksigenasi
fetal, resistensi vaskular,
benzopiren hidroksilase plasenta
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3. Efek Obat terhadap Metabolisme Maternal
Misal: Efek hipotensi yang diinduksi anestesispinal
4. Tahapan Perkembangan Fetus All or none pada awal kehamilan
Diferensiasi & Organosintesis
Hambatan pertumbuhan, gangguan fungsi, padaperiode fetogenik
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5. Genetik
6. Metabolisme Obat
Cyt P450 mempengaruhi metabolisme
obat, keseimbangan hormonal yangdapat mempengaruhi viabilitas fetus
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Guidelines for Prescribing1. Penggunaan obat esensial yang memiliki
efek dismorfogenik harus dibatasi pada
WUS, atau berikan dengan disertaikontrasepsi adekuat & tes kehamilan
secara teratur
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2. Penggunaan obat esensial dengan
komplikasi (-) pada fetus diberikandengan dosis rendah dan waktu singkat
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3. Jika memungkinkan ganti dengan obat
lain. Misal: OHO Insulin
4. Apabila tidak ada obat pengganti,
pertimbangkan risiko & keuntungan.
Biarkan pasien mengambil keputusan.
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Klasifikasi keamanan Obat padaKehamilan (FDA): Category A:
Controlled studies in women fail to
demonstrate a risk to the fetus in the firsttrimester (and there is no evidence of a
risk in later trimesters), and the possibility
of fetal harm appears remote.
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Category B:
Eitheranimal-reproduction studies havenot demonstrated a fetal risk but there are
no controlled studies in pregnant women or
animal-reproduction studies have shownan adverse effect (other than a decrease in
fertility) that was not confirmed in
controlled studies in women in the first
trimester (and there is no evidence of a risk
in later trimesters.)
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Category C:
Eitherstudies in animals have revealed
adverse effects on the fetus (teratogenic
or embryocidal, or other) and there are no
controlled studies in women or studies in
women and animals are not available.
Drugsshould be given only if the potential
benefit justifies the potential risk to thefetus.
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Category D:There is positive evidence of human fetal
risk, but the benefits from use in pregnant
women may be acceptable despite the risk( e.g., if the drug is needed in a life-
threatening situation or for a serious
disease for which safer drugs cannot beused or are ineffective).
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Category X:Studies in animals or human beings have
demonstrated fetal abnormalities, or there
is evidence of fetal risk based on humanexperience, or both, and the risk ofthe
use of the drug in pregnant women clearly
outweighs any possible benefit. The drugis contraindicated in women who are or
may become pregnant.
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Key:
++++ : Contraindicated
+++ : Avoid in preference for safer
categories
++ : Use cautiously, weighing risk and
benefits
+ : Seems safe but information limited - : Proven safe in pregnancy
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Antiulcer DrugsWeek 0 12 24
termAntasid ++ 1 st suggest malform
Mg++ ++ ++ ++ Large, frequent dose:
neuromusc, CVS, renal
damageBicarbonat ++ ++ ++ Large dose: metabolic
acidosisSimetidin ++ ++ ++ 1 case report: no ADR
17-24w
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Analgetik
Week 0 12 24 term
Codein ++ Withdrawal effects
Aspirin ++ ++ ++++ 3rd: impaired plateletfunc, haemorrhage,
kernicterus
NSAIDs + ++ ++++ No evidence effecton organogenesis.
Premature closure of
ductus arteriosus,pulmonary HT
PCT + + +
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Anti TBC
Week 0 12 24 term
Rifampicin +++ +++ +++ Neonatal bleeding,suggested embryotoxicity,IUFD, malformation
Ethambuthol ++ ++ ++ Theoretical malformation, noevidence of damage
Isoniazid ++ ++ ++ Pyridoxine 10 mg shouldaccompany each Isoniazid
dose to prevent fetal neural
damage
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Anti-InfectivesWeek 0 12 24
termAminoglikosid ++++ ++++ ++++ Ototoxicity, renal
damage
Sulfonamid ++ ++ +++ Haemolysis in G6PDdef., kernicterus
Penisilin No reported fetal rx
Cefalosporin No reported fetal rx
Kloramfenikol ++++ Grey syndrome, CVS
collaps, +Tetrasiklin ++++ ++++ ++++ Dental discolourisation,
bone growth disturb.
Cotrimoksazol ++ ++ +++ Risk of kernicterus
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DRUGS IN LACTATION Endocrine SystemContraindicated Caution May be
pescribedComments
Corticosteroid
Betamethasone
Prednisone
Prednisolon
Insignificant amounts in milk
CS inhalated, low
dose
Cortisone
Dexa
Hydrocortison
(systemic)
Methylprednisolon
Triamcinolone
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Hypoglycaemic agentsContraindicated Caution May be precribed Comments
OHO-theoritical
risk of infanthypoglicaemia.
Monitor
Chlorpropramide Exreted in milk.
Effects on infant
unknown
Glibenclamide
Metformin
Tolazamide
Tobutamide Infant dose 18 %
maternal dose.
Avoid in
neonatal period
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GITContraindicated Caution May be prescribed Comments
Antacids
Al+3, Mg +2 Not absorbed
Cimetidine Infant dose 5 % maternaldose. Avoid in prematurity
Nizatidine Secreted & cocentrated in
milk (rats)
Ranitidine Exreted in milk. ADRR (-)
but long term effect?
Sucralfat
Bisacodyl
Loperamide
Infection
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InfectionContraindicated Caution May be
prescribed
Comments
Amoxycillin Insignificant amount in milk.
Cephalosporin Insignificant amount in milk. No ADRR
Chloramphenicol Gray syndrome. Theoritical risk of blood
dyscrasia
Cotrimoxazole Minimal risk from sulpha component.
No ADRR
Sulphonamide May cause diarrhoea, rash, kernicterus
Tetracycline Probable negligible abs. in infant due to
chelation w/ Ca in mik. Remote
possibility of toth staining/bone growth
abn.
Ethambuthol
Isoniazid Infant dose 50 % maternal. Theoritical
risk of convulsion and neuopathy. Avoid
in newborn
Pennicillin No ADRR, possibility of
hypersensitivity in infant
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