Kategori Obat Pada Ibu Hamil Berdasarkan Australian Drugs Evaluation Committee (ADEC)
Kategori Definisi
A 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
B 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
C 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.
D 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.
X 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
10 Diazepam C 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
11 Dilantin = phenitoin D 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
12 Gentamicin D 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.
13 Glibenclamid C It is important to achieve strict normoglycaemia during pregnancy. This may best be
achieved by conversion to insulin therapy
14 Griseofulvin B3
15 Heparin C All of these agents can produce placental haemorrhage and subsequent prematurity
and fetal loss.
16 Ibuprofen C 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
17 Morpin C 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
18 Nifedipin C These drugs carry the potential to produce fetal hypoxia associated with maternal
hypotension.
19 Ofloxacin B3 Pada hewan percobaan muda mengakibatkan artropati , pada bumil dan anak yang
belum baligh tidak diindikasikan, karena ditakutkan terjadinya artropati pada janin dan
anak-anak
20 Piracetam ? Should be avoided, Melewati sawar uri, yang bisa mengakibatkan kelainan kongenital
21 Polidocanol ? Menyebabkan takhikardi pada janin yang bisa menebabnkan gawat janin
22 Propanolol C These agents may cause pharmacological effects such as
bradycardia in the fetus and newborn infant.
23 Questran B2
(cholestiramin)
24 Quinolon B3
25 Reserpin FDA kategori C 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.
26 Rifampisin C 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.
27 Sildenafil (Viagra) B1
28 Simvastatin C 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.
29 Sulfadiazine C Sulfonamides may cause jaundice and haemolytic anaemia in the
Newborn
30 sulfametoxazole C Idem
31 Sulfonamide C Idem
32 Terazosin B2
Soal Tambahan :
NY. Y keluham bengkak nyeri ibu jari kaki sinistra, sering kencing malam,lab As.urat 9, GDP 180 mg/dl. Obat yg diberikan dan alasan
farmakologinya.
Diagnosis : Hiperuricemia dan DM
Terapi :
- Anti hiperuricemia : Alopurinol 1-3 x 100 mg, allopurinol merupakan enzin inhibitor di liver meningkatkan resiko hipoglikemi, efek
alopurinol tidak dikurangi oleh salisilat jadi bisa digunakan dosis yg lebih rendah atau tidak perlu menggunakan dosis maksimal.
- Anti diabetik oral : glibenclamide dosis rendah (2,5 mg) pagi hari setengah jam sebelum makan karena diberikan bersama allopurinol
dan aspirin yg bisa meningkatkan resiko hipoglikemia.
- Antiinflamasi : Aspirin 3 x 250 mg sesudah makan, dipilih obat ini karena dikombinasi dengan allopurinol sehingga dosis diturunkan.
Hati-hati penggunaan NSAID oleh karena bisa menggeser ikatan OAD dengan protein sehingga OAD bebas meningkat dan bisa
menimbulkan hipoglikemia. Aspirin punya efek anti gout + analgesik + antiinflamasi. Efek anti gout didapatkan jika aspirin diberikan
pd dosis besar dimana aspirin dapat menghambat reabsorbsi asam urat sehingga terjadi peningkatan ekskresi asam urat. Pd dosis kecil
aspirin justru menghambat ekskresi asam urat.
Tambahan dr SRI :
Faktor yg mempengaruhi terapi pd lansia :
1. Adanya degenerasi
2. Penyakit2 yg diderita
3. Nafsu makan turun / kurang nutrisi
4. Kekurangan cairan
5. Immobilisasi
6. Pelupa
7. Tidak sanggup merawat diri sendiri