Kisi kisi UAS Farmakologi Kategori Obat Pada Ibu Hamil Berdasarkan Australian Drugs Evaluation Committee (ADEC)

Kategori A Definisi Obat-obatan yg diberikan kepada ibu hamil Trimester I (penelitian terkontrol ) tdk menimbulkan efek buruk atau kemungkinan efek buruk terjadap fetus sangat jarang. Tidak ada penelitian pd ibu hamil trimester II dan III Penelitian terkontrol pada ibu hamil tidak menunjukkan peningkatan resiko kelainan janin, walaupun dijumpai kelainan pada hewan atau jika penbelitian pada manusia tidak mencukupi, penelitian pada hewan tidak menunjukkan resiko pada janin. Walaupun demikian tetap ada kemungkinan Penelitian terkonmtrol pada bumil tdk mencukupi utk menunjukkan efek yg merugikan pada janin, sedangkan penelitian pada hewan menunjukkan resiko pada janin atau kurangnya penelitian pada hewan terhadap obat tersebut. Obat kategori C dapat dibenarkan pemakaiannya pada kelompok bumil, jika keuntungan pemakaian obat tersebut > daripada efek buruk thd fetus. Obat-obat yg diberikan pd bumil ( trimester 1,2 dan 3) pasti menimbulkan efek buruk thd fetus. Obat kategori ini terpaksa diberi pd bumil utk menyelamatkan jiwa bumil karena tidak ada obat lain yg efektif sbg obat pengganti.

Obat2 yg diberikan pd kelompok hewan hamil dan bumil (trimester 1,2,3) yg pasti menimbulkan efek buruk thd janin. Kerugian dr pemakaian obat ini jauh lbh besar drpd manfaatnya. Pemakaian obat kategori X tdk dibenarkan pd bumil. Kategori obat menurut FDA

Kategori Obat menurut ADEC Kategori A C B1 Definisi Obat yg telah byk digunakan oleh bumil maupun wanita usia produktif tanpa disertai bukti peningkatanfrekuensi terjadinya malformasi ataupun efek lain yg membahayakan janin yg diteliti baik scr lgs maupun tdk lgs Obat yg bdasarkan efek farmakologinya tlh atau diduga dapat menyebabkan efek yg membahayakan pada janin manusia atau neonatus tanpa disertai malformasi. Efek tsb bisa jd reversibel. Obat yg digunakan hanya sejumlah kecul bumil maupun wanita usia reproduktif tanpa disertai bukti peningkatan kejadian malformasi atau efek lain yg membahayakan janin baik scr langsung maupun tidak langsung. Penelitian pd hewan tidak menunjukkan bukti peningkatan kejadian kerusakan pd janin Obat yg digunakan oleh sejumlah kecil bumil atau wanita usia reproduktif tanpa disertai bukti peningkatan frekuensi kejadian malformasi atau efek lain yg membahayakan janin manusia yg diteliti,baik lgs maupun tdk lgs. Data penelitian pd hewan tdk mencukupi atau tdk ada, tetapi data yg tersedia tdk menunjukkan peningkatan kejadian kerusakan pd janin. Obat yg digunakan hanya sejumlah kecil bumil tanpa disertai bukti peningkatan frek kejadian malformasi atau efek lain yg membahayakan janin manusia yg diteliti baik secara lgs/tdk lgs. Penelitian pd hewan menunjukkan bukti peningkatan kejadian kerusakan pd janin dgn kemaknaan efek tsb pd manusia blm jelas. Obat yg telah dicurigai atau diramalkan menyebabkan peningkatan kejadian malformasi janin manusia atau kerusakan yg bersifat menetap (irreversible). Obat yg mempunyai resiko tinggi utk menyebabkan kerusakan yg bersifat menetap terhadap janin shg tdk boleh digunakan pd masa kehamilan atau jika ada kemungkinan tjd kehamilan

B2

B3

D X

No 1 2 3 4

Nama Obat Acyclovir Amitriptilin Ba Contras Captopril

Kategori ADEC B3 C Not Classified/? D

Carbamazepine

Keterangan Not known be harmful, limited absorption from topical preparation Withdrawal symptoms in newborn infants have been reported with prolonged maternal use of this class of drugs Tidak direkomendasikan selama kehamilan When taken during the second and third trimesters, ACE inhibitors cause a range of abnormalities including renal dysfunction and oligohydramnios. These can be associatedwith fetal death in utero. Although no adverse fetal effects have been linked to first trimester drug use of ACE inhibitors, the number of exposures reported is too small to determine conclusively that ACE inhibitors are safe in the first trimester. Pregnant women who are taking ACE inhibitors should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ACE inhibitors for the management of hypertension in women who are likely to become pregnant. Spina bifida occurs in about one percent of pregnancies in which carbamazepine is used as monotherapy. Carbamazepine taken during pregnancy also has been associated with minor craniofacial defects, fingernail hypoplasia and developmental disability. Carbamazepine also can cause coagulation defects with consequent risk of haemorrhage in the fetus and the newborn infant which may be preventable by the prophylactic administration of vitamin K to the mother prior to delivery.

6 7 8 9

Cefazolin Ceftriaxone chloramphenicol chlorpromazine

B1 B1 A C

When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the newborn infant. Benzodiazepines may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs This drug taken during pregnancy has been associated with craniofacial defects, fingernail hypoplasia, developmental disability, growth retardation and less frequently, oral clefts cardiac anomalies. This clinical pattern is sometimes called fetal hydantoin syndrome. Phenytoin also can cause coagu defects with consequent risk of haemorrhage in the fetus an newborn infant which may be preventable by the prophylac administration of vitamin K to the mother prior to delivery There is evidence of selective uptake of aminoglycosides by the fetal kidney resulting in damage (probably reversible) to immature nephrons. Eighth cranial nerve damage has also been reported following in utero exposure to some of the aminoglycosides. Because of their chemical similarity, all aminoglycosides must be considered potentially nephrotoxic and ototoxic to the fetus. It should also be noted that therapeutic blood concentrations in the mother do not equate with safety for the fetus. It is important to achieve strict normoglycaemia during pregnancy. This may best be achieved by conversion to insulin therapy All of these agents can produce placental haemorrhage and subsequent prematurity and fetal loss. These agents inhibit prostaglandin synthesis and, when given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs These drugs carry the potential to produce fetal hypoxia associated with maternal hypotension. Pada hewan percobaan muda mengakibatkan artropati , pada bumil dan anak yang belum baligh tidak diindikasikan, karena ditakutkan terjadinya artropati pada janin dan anak-anak Should be avoided, Melewati sawar uri, yang bisa mengakibatkan kelainan kongenital Menyebabkan takhikardi pada janin yang bisa menebabnkan gawat janin These agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant.

10

Diazepam

11

Dilantin = phenitoin

12

Gentamicin

13 14 15 16

Glibenclamid Griseofulvin Heparin Ibuprofen

C B3 C C

17

Morpin

18 19

Nifedipin Ofloxacin

C B3

20 21 22

Piracetam Polidocanol Propanolol

? ? C

23 24 25

Questran (cholestiramin) Quinolon Reserpin

B2 B3 FDA kategori C

26

Rifampisin

Studies on animals show adverse effect and toxicity on fetus. No adequate and well controlled studies done on pregnant women. Drugs should be given only if the potential benefit outweighs the potential risk to the fetus. Bleeding attributable to hypoprothrombinaemia has been reported in newborn infants and in mothers after the use of rifampicin during late pregnancy. If rifampicin is used during the last few weeks of pregnancy, vitamin K should be given to the mother and the newborn infant. Cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, these drugs may cause fetal harm when administered to a pregnant woman. Sulfonamides may cause jaundice and haemolytic anaemia in the Newborn Idem Idem

27 28

Sildenafil (Viagra) Simvastatin

B1 C

29 30 31 32

Sulfadiazine sulfametoxazole Sulfonamide Terazosin

C C C B2