DAFTAR OBAT AMAN DAN BERBAHAYA

UNTUK IBU HAMIL DAN MENYUSUI

Di Edit Ulang oleh dr.Firda Lestari

dari sumber URL : http://www.kellymom.com/health/meds/aap-approved-meds.html

KELOMPOK ANALGETIK,  NSAIDS,  OBAT BATUK DAN PILEK, ANTI

ALERGI DAN ASMA, ANESTESI

1
Obat untuk Penghilang Rasa Sakit (Pain Killer)
AAP Kategori Risiko Risiko Note
Nama Obat
approved?* Kehamilan** Menyusui** s
Acetaminophen  (Tylenol) Approved B L1  
C (1st, 2nd trim.)
Aspirin Caution L3 1
D (3rd trim.)
Approved
Azapropazone
- L2  
(Rheumox)
 
Butalbital (Fioricet,
Fiorinal, Bancap, Two- NR D L3 2
dyne)
B (1st, 2nd trim.)
Butorphanol  (Stadol) Approved L3  
D (3rd trim.)
Celecoxib (Celebrex)) NR C L2  
Codeine (in Tylenol #3,
Approved C L3 3
#4)
Colchicine Approved D L4  
Diclofenac (Cataflam,
NR B L2  
Voltaren)
Fentanyl  (Sublimaze) Approved B L2  
Flurbiprofen (Ansaid, B (1st, 2nd trim.)
NR L2  
Froben, Ocufen) C (3rd trim.)
Hydrocodone (Lortab,
NR B L3 4
Vicodin)
Hydromorphone
NR C L3 5
(Dilaudid)
Ibuprofen (Advil, Nuprin, B (1st, 2nd trim.)
Approved L1  
Motrin, Pediaprofen) D (3rd trim.)
B (1st, 2nd trim.)
Indomethacin (Indocin) Approved L3  
D (3rd trim.)
Ketorolac (Toradol, B (1st, 2nd trim.)
Approved L2  
Acular) D (3rd trim.)
L2;
Meperidine (Demerol) Approved B L3 early 6
postpartum
Methadone (Dolophine) Approved B L3 7
Morphine (Duramorph,
Infumorph, Epimorph, MS Approved B L3 8
Contin)
Nalbuphine (Nubain) NR B L2  
Naproxen (Anaprox, L3;
Naprosyn, Naproxen, Approved B L4 for chronic 9
Aleve) use
Nefopam (Acupan) Approved - NR  
Oxycodone (Tylox,
Percodan,Oxycontin,
NR B L3 10
Roxicet, Endocet,
Roxiprin, Percocet)
Pentosan polysulfate
NR B L2  
(Elmiron)
Piroxicam (Feldene) Approved B L2  
Propoxyphene (Darvocet
Approved C L2 11
N, Propacet, Darvon)
Rofecoxib (Vioxx) Withdrawn from the market 12
Secobarbital (Seconal) Approved D L3 13
Tolmetin (Tolectin) Approved C L3  

2
Tramadol HCL (Ultram,
NR C L3 14
Ultracet)
Valdecoxib  (Bextra) Withdrawn from the market more
*  Per the AAP Policy Statement The Transfer of Drugs and Other Chemicals Into
Human Milk, revised September 2001.

 Approved: (Table 6) Maternal Medication Usually Compatible With

Breastfeeding
 Caution: (Table 5) Drugs That Have Been Associated With Significant Effects
on Some Nursing Infants and Should Be Given to Nursing Mothers With
Caution
 NR: Not Reviewed. This drug has not yet been reviewed by the AAP.

** Per Medications’ and Mothers’ Milk by Thomas Hale, PhD (2004 edition).

 Pregnancy Risk Categories 

 Lactation Risk Categories 
 L1 (safest)
 L2 (safer)
 L3 (moderately safe)
 L4 (possibly hazardous)
 L5 (contraindicated)
 A (controlled studies show no risk)
 B (no evidence of risk in humans)
 C (risk cannot be ruled out)
 D (positive evidence of risk)
 X (contraindicated in pregnancy)

NR: Not Reviewed. This drug has not yet been reviewed by Hale.

1. Aspirin use is discouraged in children and nursing mothers due to the risk of Reye’s
syndrome and internal bleeding.
2. Fioricet (Fiorinal, Bancap, Two-dyne) contains acetaminaphen or asprin, caffeine,
and butalbital. Per Hale, baby should be observed for sedation.
3. Hale suggests weakened or premature infants be observed for sedation and apnea.
4. Hale suggests newborns be observed for sedation, apnea, constipation.
5. Per Hale, use of frequent, higher dose may result in infant sedation.
6. Per Hale, Meperidine use during labor or early postpartum has been associated with
sedation, poor sucking reflex, and neurobehavioral delay in infants.
7. Per Hale, observe infant for sedation, respiratory depression, addiction, withdrawal
syndrome.
8. Per Hale, higher doses may result in infant sedation.
9. Per Hale, should be used with caution due to its long half-life and its effect on
baby’s cardiovascular system, kidneys and GI tract; short-term, infrequent or
occasional use is not necessarily incompatible with breastfeeding.
10. Roxicet, Endocet, Roxiprin, Percocet also contain acetaminophen. Per Hale, observe
infant for sedation.
11. Per Hale, observe infant for sedation.
12. Per Hale, observe infant for GI cramping, distress, diarrhea.
13. Per Hale, observe infant for sedation.
14. Per Hale, observe infant for sedation.

     Non-steroidal anti-inflammatory analgesics (NSAIDs) [more]

Kategori
AAP Risiko
Nama Generik Nama Dagang
approved? Kehamilan* Risiko
* * Menyusui**
Azapropazone
Rheumox Approved - L2
(apazone)
Dipyrone (banned in
- Approved - NR
the US & UK)
         
Flufenamic acid - Approved - NR

3
 B (1st, 2nd
Advil, Nuprin,
Ibuprofen Approved trim.) L1
Motrin, Pediaprofin
D (3rd trim.)
B (1st, 2nd
Indomethacin Indocin Approved trim.) L3
D (3rd trim.)
B (1st, 2nd
Ketorolac Toradol, Acular Approved trim.) L2
D (3rd trim.)
Mefenamic acid Ponstan, Ponstel Approved - NR
L3
Anaprox, Naprosyn,
Naproxen Approved B L4 (for chronic
Naproxen, Aleve
use)
Phenylbutazone Butazolidine Approved - NR
Piroxicam Feldene Approved B L2
Suprofen Profenal Approved - NR
Tolmetin Tolectin Approved C L3
    Steroid [contents]
Methylprednisolone
Solu-Medrol, Depo-
[ high dosage Approved C L2
Medrol, Medrol
methylprednisolone]
Prednisolone - Approved C L2
Deltasone,
Prednisone Approved C L2
Meticorten, Orasone
         
Obat Asma [contents]
Dilor, Lufyllin,
Dyphylline Approved C L3
Dyphylline
Terbutaline Bricanyl, Brethine Approved B L2
Aminophylline,
Theophylline Approved C L3
Quibron, Theo-Dur
         
     Analgetik Narkotik  [more]
B (1st, 2nd
Butorphanol Stadol Approved trim.) L3
D (3rd trim.)
Codeine Tylenol #3, #4 Approved C L3
Fentanyl Sublimaze Approved B L2
L2
L3 (if used
Meperidine Demerol Approved B
early
postpartum)
Methadone Dolophine Approved B L3
Morphine Morphine Approved B L3
Darvocet N,
Propoxyphene Approved C L2
Propacet, Darvon

Obat Batuk
AAP
Nama Obat approved? Risiko Menyusui**
*
Codeine yes L3 (moderately safe)
not
Dextromethorphan L1 (safest)
reviewed

4
 not
Guaifenesin L2 (safer)
reviewed
Dekongestan (Obat Pilek)
AAP
Nama Obat approved? Risiko Menyusui**
*
not
Phenylephrine L3 (moderately safe)
reviewed
L3 (moderately safe) for acute use
Pseudoephedrine
yes L4 (possibly hazardous) for chronic use due to
(Sudafed, Actifed)
potential for decreasing milk supply
*  Per the AAP Policy Statement The Transfer of Drugs and Other Chemicals Into
Human Milk, revised September 2001.
** Per Medications’ and Mothers’ Milk by Thomas Hale, PhD (2006 edition)
Nasal Sprays (Spray Hidung)
AAP
Nama Obat approved? Risiko Menyusui**
*
Beclomethasone
not
(Vanceril, Beclovent, L2 (safer)
reviewed
Beconase, Vancenase)
Cromlyn sodium not
L1 (safest)
(Nasalcrom) reviewed
not
Fluticasone (Flonase) L3 (moderately safe)
reviewed
Mometasone not
L3 (moderately safe)
(Nasonex) reviewed
Phenylephrine (in
not
some forms of Sinex L3 (moderately safe)
reviewed
and Neo-Synephrine)
Triamcinolone not
L3 (moderately safe)
Acetonide (Nasacort) reviewed
Antihistamin (Anti Alergi)
AAP
  Nama Obat approved? Risiko Menyusui**
*
not
  Brompheniramine L3 (moderately safe)
reviewed
Chlorpheniramine
not
  (Chlor-Trimeton) L3 (moderately safe)
reviewed
CTM
not
  Cetirizine (Zyrtec) L2 (safer)
reviewed
Dexbrompheniramin
  e maleate yes not reviewed
with d-isoephedrine
Diphenhydramine not
  L2 (safer)
(Benadryl) reviewed
not
  Doxylamine L4 (possibly hazardous)
reviewed
Fexofenadine
  yes L3 (moderately safe)
(Allegra)
  Loratadine (Claritin) yes L2 (safer)
Terfenadine
  yes not reviewed
(Seldane)
Triprolidine (Actidil,
  yes L1 (safest)
Actifed)

5
 *  Per the AAP Policy Statement The Transfer of Drugs and Other Chemicals Into
  Human Milk, revised September 2001.
** Per Medications’ and Mothers’ Milk by Thomas Hale, PhD (2002 edition)
      

Obat Anestesi
AAP Risiko
Kategori Risiko Note
Nama Obat approved? Menyusui*
Kehamilan** s
* *
       Local anesthetics
Articaine (Septocaine) NR - NR more
Bupivacaine (Marcaine) NR C L2  
Lidocaine (Xylocaine) Approved C L2  
Mepivacaine (Carbocaine,
NR C L3 more
Polocaine)
Procaine HCL (Novocaine) NR C L3  
       General anesthetics
Halothane (Fluothane) Approved C L2 more
Isoflurane (Forane) NR - NR 1
Ketamine NR - NR more
Methohexital (Brevital) Approved B L3  
Nitrous oxide NR - L3  
Sevoflurane (Ultane) NR B L3  
Thiopental (Pentothal) Approved C L3  
       Other medications often used during anesthesia
Sedatives
Diazepam (Valium) Concern D L3; L4 for  
chronic use
Midazolam (Versed) Concern D L3  
Propofol (Diprivan) NR B L2 more
Triazolam (Halcion) NR X L3  
Narcotic Analgesics
Alfentanil (Alfenta) NR C L2  
Fentanyl (Sublimaze) Approved B L2  
Hydromorphone (Dilaudid) NR C L3  
Morphine Approved B L3  
Reversal Medication
Flumazenil (Romazicon) NR C NR 2
Naloxone (Narcan) NR C NR 3
Steroids
Decadron (Dexamethasone) NR C NR more
Stimulants
Epinephrine (Adrenaline) NR C L1  
Anti-nausea
Promethazine (Phenergan) NR C L2  
*  Per the AAP Policy Statement The Transfer of Drugs and Other Chemicals Into
Human Milk, revised September 2001.

 Approved: (Table 6) Maternal Medication Usually Compatible With

Breastfeeding
 Concern: (Table 4) Drugs for Which the Effect on Nursing Infants Is
Unknown but May Be of Concern
 Caution: (Table 5) Drugs That Have Been Associated With Significant Effects

6
 on Some Nursing Infants and Should Be Given to Nursing Mothers With
Caution
 NR: Not Reviewed. This drug has not yet been reviewed by the AAP.

** Per Medications’ and Mothers’ Milk by Thomas Hale, PhD (2004 edition).

 Pregnancy Risk Categories 

 Lactation Risk Categories 
 L1 (safest)
 L2 (safer)
 L3 (moderately safe)
 L4 (possibly hazardous)
 L5 (contraindicated)
 A (controlled studies show no risk)
 B (no evidence of risk in humans)
 C (risk cannot be ruled out)
 D (positive evidence of risk)
 X (contraindicated in pregnancy)

NR: Not Reviewed. This drug has not yet been reviewed by Hale.

1. Isoflurane (Forane) is used for c-sections and directly in newborns. Induction of and
recovery from isoflurane anesthesia are rapid, so the majority of the medication is
out of the body (and milk) very quickly. More here.
2. Flumazenil (Romazicon) is used directly in children aged 12 months and up.
3. Naloxone (Narcan) is used directly in newborns and children.
4. Many forms of Robitussin, Delsym and Benylin are considered compatible with
breastfeeding. Always check the active ingredients, as there are many versions.

7
Kelompok Antasida, Antibiotik, Antivirus, Antijamur, Kontrasepsi, Obat jantung &
Hipertensi, Vitamin, dll

Kategori
Nama Risiko Risiko
Nama Generik
Dagang AAP Kehamilan* Menyusui*
approved?* * *
Antasida [contents]
Cimetidine (Antacid) Tagamet Approved B L2
Cisapride (GI tract stimulant) Propulsid Approved C L2
Domperidone (used for nausea
& vomiting, stimulates Motilum Approved - L1
lactation) [more]
Antibiotika [contents]
Larotid,
Amoxicillin Approved B L1
Amoxil
Aztreonam Azactam Approved B L2
Ultracef,
Cefadroxil Approved B L1
Duricef
Cefazolin Ancef, Kefzol Approved B L1
Cefotaxime Claforan Approved B L2
Cefoxitin Mefoxin Approved B L1
Cefprozil Cefzil Approved C L1
Ceftazidime,
Ceftazidime Fortaz, Approved B L1
Taxidime
Ceftriaxone Rocephin Approved B L2
Ciprofloxacin [more] Cipro Approved C L3
Clindamycin Cleocin Approved B L3
E-Mycin,
L1
Ery-tab,
Erythromycin Approved B L3 early
ERYC,
postnatal
Ilosone
Fleroxacin - Approved - NR
Gentamicin Garamycin Approved C L2
Kebecil,
Kanamycin Approved D L2
Kantrex
Moxalactam Moxam Approved - NR
Nitrofurantoin Macrobid Approved B L2
Ofloxacin Floxin Approved C L2
Penicillin - Approved B L1
Streptomycin Streptomycin Approved D L3
Sulbactam - Approved - NR
Gantrisin,
Sulfisoxazole Approved C L2
Azo-Gantrisin
Achromycin,
Tetracycline Sumycin, Approved D L2
Terramycin
Ticarcillin Ticarcillin, Approved B L1

8
 Ticar,
Timentin
Trimethoprim/sulfamethoxazol Proloprim,
Approved C L3
e Trimpex
Antikoagulan [contents]
Bishydroxycoumarin
- Approved - NR
(dicumarol)
Coumadin,
Warfarin Approved D L2
Panwarfin
Antikonvulsan (Anti kejang) [contents]
Tegretol,
Carbamazepine Approved C L2
Epitol
Ethosuximide Zarontin Approved C L4
Magnesium sulfate Epsom salt Approved B L1
Phenytoin Dilantin Approved D L2
Depakene,
Valproic acid Approved D L2
Depakote
Anti Jamur [contents]
Fluconazole [more] Diflucan Approved C L2
Nizoral
Ketoconazole Shampoo, Approved C L2
Nizoral
Antivirus [contents]
Acyclovir [more] Zovirax Approved C L2
Alferon N,
Interferon-alpha [more] Interferon Approved C L2
Alpha
Arthritis meds (see also: pain meds) [contents]
Ridaura,
Gold salts Myochrysine, Approved C L5
Solganal
Kontrasepsi, Hormon [contents]
L3 (may
Estratab,
interfere
Estradiol Permarin, Approved X
with milk
Menest
production)
Clogestone - Approved - NR
Contraceptive pill with Preven, Approved X L3 (may
estrogen/progesterone Seasonale, interfere
Norinyl, with milk
Norlestin, production)
Ortho-
Novum,
Ovral,
Lunelle
injection,
Ortho-Evra
patch, etc.
Norplant,
Levonorgestrel Mirena, Plan Approved X L2
B
Provera, L1
Depo- L4 (if used
Medroxyprogesterone Approved D
Provera, first 3 days
Cycrin postpartum)
Norethynodrel Enovid Approved X L2
Progesterone Crinone, Approved - L3

9
 Prometrium
Obat Diabetes [contents]
Note: Insulin has not been reviewed by the AAP. Pregnancy risk category = B; Lactation
risk category = L1.
Oramide,
Tolbutamide Approved D L3
Orinase
Obat Diare [contents]
Imodium,
Pepto
Diarrhea
Control,
Maalox
Loperamide Antidiarrheal Approved B L2
Caplets,
Kaopectate II
Caplets,
Immodium
Advanced
** Note: Pepto-Bismol & Kaopectate (bismuth subsalicylate is the active ingredient in
both) are not recommended for routine use by nursing moms, due to the association of
salicylates with Reyes syndrome in children. [more]
Diuretik (Peluruh Kencing) [contents]
Dazamide,
Acetazolamide Approved C L2
Diamox
L4 (may
Bendroflumethiazide Naturetin Approved D inhibit
lactation)
Chlorothiazide Hydrodiuril Approved D L3
Chlorthalidone Hygroton Approved D L3
Hydrodiuril,
Hydrochlorothiazide (HCT) Esidrix, Approved D L2
Oretic
Spironolactone Aldactone Approved D L2
Anti Muntah  [more] [contents]
Domperidone Motilum Approved - L1
Anti Hipertensi, Obat Jantung [contents]
       Anti aritmia
Norpace,
Disopyramide Approved C L2
Napamide
Flecainide Tambocor Approved C L3
Mexiletine Mexitil Approved B L2
Pronestyl,
Procainamide Approved C L3
Procan
Quinaglute,
Quinidine Approved C L2
Quinidex
   Anti Hipertensi
L3 (if used
Captopril Capoten Approved D after 30
days)
Cardizem Sr,
Dilacor-XR,
Diltiazem/Diltiazem HCL Approved C L3
Diltiazem,
Cardizem CD
C (1st trim.)
Enalapril/Enalapril Maleate Vasotec Approved D (2nd, 3rd L2
trim.)
Hydralazine Apresoline Approved C L2

10
 Trandate,
Labetalol Approved C L2
Normodyne
Methyldopa Aldomet Approved C L2
Toprol XL,
Metoprolol Approved B L3
Lopressor
Loniten, L2
Minoxidil Minodyl, Approved C (topically)
Rogaine L3 (orally)
Corgard,
Nadolol Approved C L4
Nadolol
Adalat,
Nifedipine Approved C L2
Procardia
Apsolox,
Slow-
Oxprenolol Approved - NR
Trasicor,
Trasicor
Propranolol Inderol Approved C L2
Sotalol Betapace Approved B L3
Timolol Blocadren Approved C L2
Calan,
Verapamil Isoptin, Approved C L2
Covera-HS
       Cardiac stimulants
Lanoxin,
Digoxin Approved C L2
Lanoxicaps
Laksan (Pelancar BAB) [more] [contents]
Cascara/Cascara Sagrada - Approved C L3
Danthron - Approved - NR
Magnesium sulfate Epsom salt Approved B L1
Senna - Approved - L3
Obat malaria [contents]
Aralen,
Chloroquine Novo- Approved C L3
chloroquine
Hydroxychloroquine Plaquenil Approved C L2
Pyrimethamine Daraprim Approved C L4
Quinine Quinamm Approved D L2
Medical Testing [more] [contents]
Diatrizoate - Approved - NR
Fluorescein - Approved C L3
Gadopentetic (Gadolinium) - Approved C L2
Iohexol Omnipaque Approved B L2
Iopanoic acid Telepaque Approved D L2
Metrizamide Amipaque Approved B L2
Metrizoate Isopaque Approved B L2
Obat Migren [more] [contents]
Sumatriptan Imitrex Approved C L3
Obat Sedativ [more] [contents]
Aquachloral,
Chloral hydrate Approved C L3
Noctec
Methyprylon (withdrawn from
- Approved - NR
use in US & Canada)
Bromide - Approved D L5
Secobarbital Seconal Approved D L3
Obat Tidur [contents]
Zolpidem/Zolpidem Tartrate Ambien Approved B L3

11
Obat Anti Tiroid  [more] [contents]
Carbimazole - Approved D L3
Methimazole (active metabolite
Tapazole Approved D L3
of carbimazole)
Propylthiouracil PTU Approved D L2
Thiouracil - Approved - NR
Synthroid,
Levothroid,
Levothyroxine Thyroid, Approved A L1
Levo-T,
Levoxyl
Obat TBC [contents]
Cycloserine Seromycin Approved C L3
Ethambutol,
Ethambutol Approved B L2
Myambutol
INH,
Isoniazid Approved C L3
Laniazid
Rifadin,
Rifampin Approved C L2
Rimactane
VITAMIN [more] [contents]
B-1 (thiamin) - Approved - NR
B-12 (Cyanocobalamin) - Approved A L1
L2; L4 in
high doses
B-6 (pyridoxine) - Approved A
(may inhibit
lactation)
Calciferol, L3 (do not
D, vitamin Approved A
Delta-d overdose)
A (1st, 2nd
Folic acid - Approved trim.) L1
C (3rd trim.)
K-1, vitamin (Phytonadione) - Approved C L1
Riboflavin/B2  - Approved A L1
Lain-lain [contents]
Acitretin (Anti-psoriasis) Soriatane Approved - NR
Alcohol/Ethanol [more] - Approved D L3
Zyloprim,
Allopurinol Approved C L2
Lopurin
Antimony - Approved - NR
Atropine (Anticholinergic, Belladonna,
Approved C L3
drying agent) Atropine
Azapropazone/apazone
Rheumox Approved - L2
(Antirheumatic)
Lioresal,
Baclofen (muscle relaxant) Approved C L2
Atrofen
Barbiturate - Approved - NR
Vivarin,
Caffeine [more] NoDoz, Approved B L2
Coffee
Carbetocin (Antihemorrhagic) Duratocin Approved - NR
Chloroform - Approved - NR
Cisplatin (Anti-cancer) Platinol Approved D L4
Avlosulfon,
Dapsone (Antileprosy) Approved C L4
DDS
Hydroxychloroquine
Plaquenil Approved C L2
(Antirheumatic, lupus)

12
Iodides - Approved - NR
Iodine - Approved - NR
Iodine (povidone-iodine, eg, in
- Approved - NR
a vaginal douche)
Ivermectin (Antiparasitic) Mectizan Approved C L3
Nalidixic acid (Urinary Anti-
NegGram Approved B L4
infective)
Norsteroids - Approved - NR
Pyridostigmine (Muscle Mestinon,
Approved C L2
stimulant) Regonol
Transderm
Scopolamine (Motion sickness) Approved C L3
Scope
Sulfapyridine Dagenan Approved - NR
Timolol (glaucoma med) Blocadren Approved D L3
*  Per the AAP Policy Statement The Transfer of Drugs and Other Chemicals Into
Human Milk, revised September 2001.

 Approved: (Table 6) Maternal Medication Usually Compatible With

Breastfeeding
 Caution: (Table 5) Drugs That Have Been Associated With Significant Effects
on Some Nursing Infants and Should Be Given to Nursing Mothers With Caution
 NR: Not Reviewed. This drug has not yet been reviewed by the AAP.

** Per Medications’ and Mothers’ Milk by Thomas Hale, PhD (2004 edition).

 Pregnancy Risk Categories 

 Lactation Risk Categories 
 L1 (safest)
 L2 (safer)
 L3 (moderately safe)
 L4 (possibly hazardous)
 L5 (contraindicated)
 A (controlled studies show no risk)
 B (no evidence of risk in humans)
 C (risk cannot be ruled out)
 D (positive evidence of risk)
 X (contraindicated in pregnancy)

NR: Not Reviewed. This drug has not yet been reviewed by Hale

Keamanan obat pada kehamilan

Pada umumnya para ibu hamil akan memberitahu dokter saat berobat bahwa dirinya hamil sekian
bulan. Demikian pula jika berobat saat menyusui (ASI bayinya. Informasi tersebut diberikan si ibu
dengan harapan dokter akan memberikan obat yang aman bagi janin yang dikandungnya. Itupun tak
jarang si ibu masih mananyakan kepada dokter apakah obat yang dgunakan benar-benar aman. Hal
ini sangat wajar dan kita patut menghargainya.

Di sisi lain, ketika seorang ibu hamil sakit adakalanya enggan ke dokter lantaran takut menggunakan
obat. Alhasil keluhannya makin bertambah dan akhirnya datang juga ke dokter untuk berobat.

Seorang dokter tentu sangat paham bahwa saat memberikan(meresepkan) obat  bagi wanita hamil
akan dipilihkan obat yang aman, baik dalam hal jenis obat (berdasarkan indeks keamanan obat),
dosis maupun lamanya penggunaan. Selain itu akan dipertimbangkan pula aspek-aspek lain
berdasarkan penyakitnya, misalnya: resiko penularan kepada anggota keluarga lain, dan
pertimbangan lain terkait kondisi janin maupun si ibu sendiri.

Pun manakala seorang dokter dihadapkan pada 2 pilihan sulit yang menyangkut life saving, aspek
manfaat akan dikedepankan dibanding resiko yang bakal dihadapi baik bagi janin maupun ibunya.

Sebagai contoh, seorang ibu hamil yang kebetulan menderita asma, justru seyogyanya segera
berobat agar tidak mengalami sesak berkepanjangan yang justru tidak baik bagi janin karena

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beresiko terjadinya hipoksia (kekurangan oksigen) yang akan mempengaruhi pasokan oksigen bagi
janin.

INDEKS KEAMANAN OBAT PADA KEHAMILAN

Hingga kini kita di Indonesia masih menggunakan kriteria keamanan obat bagi ibu hamil yang dilansir
oleh FDA (Food and Drug Administration) sebagai pedoman dalam memberikan obat pada ibu hamil.

Pada posting ini penulis hanya menampilkan garis-garis besar batasan keamanan obat bagi ibu
hamil yang tersusun dalam 5 kategori (kategori A, B, C, D dan X) beserta contoh-contohnya agar
diketahui khalayak dengan harapan dapat memberikan informasi yang bermanfaat.

Kategori-kategori tersebut dibuat berdasarkan ada tidaknya (besar kecilnya) resiko terhadap sistem
reproduksi, efek samping dan manfaat yag diharapkan.

Obat Kategori A: adalah golongan obat yang pada studi (terkontrol) pada kehamilan tidak
menunjukkan resiko bagi janin pada trimester 1 dan trimester berikutnya. Obat dalam kategori ini
amat kecil kemungkinannya bagi keselamatan janin.

Obat Kategori B: adalah golongan obat yang pada studi terhadap sistem reproduksi binatang
percobaan tidak menunjukkan resiko bagi janin. Belum ada studi terkontrol pada wanita hamil yang
menunjukkan adanya efek samping, kecuali adanya penurunan fertilitas pada kehamilan trimester
pertama, sedangkan pada trimester berikutnya tidak didapatkan bukti adanya resiko.

Obat Kategori C: adalah golongan obat yang pada studi terhadap sistem reproduksi binatang
percobaan menunjukkan adanya efek samping bagi janin. Sedangkan pada wanita hamil belum ada
study terkontrol. Obat golongan ini hanya dapat dipergunakan jika manfaatnya lebih besar ketimbang
resiko yang mungkin terjadi pada janin.

Obat Kategoti D: adalah golongan obat yang menunjukkan adanya resiko bagi janin. Pada keadaan
khusus obat ini digunakan jika manfaatnya kemungkinan lebih besar dibanding resikonya.
Penggunaan obat golongan ini terutama untuk mengatasi keadaan yang mengancam jiwa atau jika
tidak ada obat lain yang lebih aman.

Obat Kategori X: adalah golongan obat yang pada studi terhadap binatang percobaan maupun pada
manusia menunjukkan bukti adanya resiko bagi janin. Obat golongan ini tidak boleh dipergunakan
(kontra indikasi) untuk wanita hamil, atau kemungkinan dalam keadaan hamil.

CONTOH OBAT KATEGORI A (nama generik): Ascorbic acid (vitamin C) *masuk kategori C jika
dosisnya melebihi US RDA*, Doxylamine, Ergocalciferol *masuk kategori D jika dosisnya melebihi
US RDA*, Folic acid *masuk kategori C jika dosisnya melebihi 0,8 mg per hari*, Hydroxocobalamine
*masuk kategori C jika dosisnya melebihi US RDA*, Liothyronine, Nystatin vaginal sup *masuk
kategori C jika digunakan per oral dan topikal*, Pantothenic acid *masuk kategori C jika dosisnya
melebihi US RDA*, Potassium chloride, Potassium citrate, Potassium gluconate, Pyridoxine (vitamin
B6), Riboflavin *masuk kategori C jika dosisnya melebihi US RDA*, Thiamine (vitamin B1) *masuk
kategori C jika dosisnya melebihi US RDA*, Thyroglobulin, Thyroid hormones, Vitamin D *masuk
kategori D jika dosisnya melebihi US RDA*, Vitamin E *masuk kategori C jika dosisnya melebihi US
RDA*.

CONTOH OBAT KATEGORI B (nama generik): Acetylcysteine, Acyclovir, Amiloride *masuk kategori
D jika digunakan untuk hipertensi yang diinduksi oleh kehamilan*, Ammonium chloride, Ammonium
lactate *topical*, Amoxicillin, Amphotericin B, Ampicillin, Atazanavir, Azatadine, Azelaic acid,
Benzylpenicillin, Bisacodyl, Budesonide *inhalasi, nasal*, Buspiron, Caffeine, Carbenicillin, Camitine,
Cefaclor, Cefadroxil, Cefalexin, Cefalotin, Cefamandole, Cefapirin, Cefatrizine, Cefazolin, Cefdinir,
Cefditoren, Cefepime, Cefixime, Cefmetazole, Cefonicid, Cefoperazone, Ceforanide, Cefotaxime,
Cefotetan disodium, Cefoxitin, Cefpodoxime, Cefprozil, Cefradine, Ceftazidime, Ceftibuten,
Ceftizoxime, Ceftriaxone, Cefuroxime, Cetirizine, Chlorhexidine *mulut dan tenggorokan*,
Chlorpenamine, Chlortalidone *masuk kategori D jika digunakan untuk hipertensi yang diinduksi oleh
kehamilan*, Ciclacillin, Ciclipirox, Cimetidine, Clemastine, Clindamycin, Clotrimazole, Cloxacillin,
Clozapine, Colestyramine, …. dll ….. dll buanyak

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CONTOH OBAT KATEGORI C (nama generik): Acetazolamide, Acetylcholine chloride, Adenosine,

Albendazole, Albumin, Alclometasone, Allopurinol, Aluminium hydrochloride, Aminophylline,

Amitriptyline, Amlodipine, Antazoline, Astemizole, Atropin, Bacitracin, Beclometasone, Belladonna,

Benzatropine mesilate, Benzocaine, Buclizine, Butoconazole, Calcitonin, Calcium acetate, Calcium

ascorbate, Calcium carbonate, Calcium chloride, Calcium citrate, Calcium folinate, Calcium

glucoheptonade, Calcium gluconate, Calcium lactate, Calcium phosphate, Calcium polystyrene

sulfonate, Capreomycin, Captopril, Carbachol, Carbidopa, Carbinoxamine, Chloral hydrate,

Chloramphenicol, Chloroquine, Chlorothiazide, Chlorpromazine, Choline theophyllinate, Cidofovir,

Cilastatin, Cinnarizine, Cyprofloxacin, Cisapride, Clarithromycin, Clinidium bromide, Clonidine, Co-

trimoxazole, Codeine, Cyanocobalamin, Deserpidine, Desonide, Desoximetasone, Dexamethasone,

Dextromethorphan, Digitoxin, Digoxin, Diltiazem, Dopamine, Ephedrine, Epinephrine, Fluconazole,

Fluocinolone, Fosinopril, Furosemide, Gemfibrozil, Gentamicin, Glibenclamide, Glimepiride, Glipizide,

Griseofulvin, Hydralazine, Hydrocortisone, Hyoscine, Hyoscyamine, Isoniazid, Isoprenaline, Isosorbid

dinitrate, Ketoconazole, Ketotifen fumarate, Magaldrate, Mefenamic acid, Methylprednisolone, …dll

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CONTOH OBAT KATEGORI D (nama generik): Amikacin, Amobarbital, Atenolol, Carbamazepine,

Carbimazole, Chlordizepoxide, Cilazapril, Clonazepam, Diazepam, Doxycycline, Imipramine,

Kanamycin, Lorazepam, Lynestrenol, Meprobamate, Methimazole, Minocycline, Oxazepam,

Oxytetracycline, Tamoxifen, Tetracycline, Uracil, Voriconazole… dll … dll.

CONTOH OBAT KATEGORI X (nama generik): Acitretin, Alprotadil *parenteral*, Atorvastatin,

Bicalutamide, Bosentan, Cerivastatin disodium, Cetrorelix, Chenodeoxycholic acid, Chlorotrianisene,

Chorionic gonadotrophin, Clomifen, Coumarin, Danazol, Desogestrel, Dienestrol, Diethylstilbestrol,

Dihydro ergotamin, Dutasteride, Ergometrin, Ergotamin, Estazolam, Etradiol, Estramustine, Estriol

succinate, Estrone, Estropipate, Ethinyl estradiol, Etretinate, Finasteride, Fluorescein *parenteral*,

Flurouracil, Fluoxymesterone, Flurazepam, Fluvastatin, Floritropin, Ganirelix, Gestodene, Goserelin,

Human menopausal gonadotrophin, Iodinated glycerol, Isotretinoin, Leflunomide, Leuprorelin,

Levonorgestrel, Lovastatin, Medrogestrone, Medroxyprogesterone, Menotrophin, Mestranol,

Methotrexate, Methyl testosterone, Mifeprestone, Miglustat, Misoprostol, Nafarelin, nandrolone,

Nicotine *po*, Norethisterone, Noretynodrel, Norgestrel, Oxandrolone,Oxymetholone,  Oxytocin,

Pravastatin, Quinine, Raloxifene, Ribavirin, Rosuvastatin, Simvastatin, Stanozolol, Tazarotene,

Temazepam, tetosterone, Thalidomide, Triazolam, Triproretin, Urofolitropin, Warfarin.

Ooopsss … banyak banget, mana namanya rumit pula. … hehehe, maaf

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Obat-obat kategori A (yang paling aman pada kehamilan) dan obat kategori X (kontra indikasi pada

kehamilan) sengaja ditulis lengkap agar dapat diketahui oleh khalayak. *padahal alasan sebenarnya

karena itemnya ga banyak* …sedangkan obat kategori B, C dan D hanya ditulis sebagian kecil saja

karena saking banyaknya item dan jenisnya.

PESAN-PESAN:

Bagi khalayak, penggunaan obat menyangkut jenis, dosis dan lamanya pemakaian seyogyanya atas

petunjuk dokter.

Tawaran obat (dengan jargon apapun) disertai klaim-klaim aduhai (seolah paling aman dan paling

ampuh) tanpa diketahui dengan jelas kandungan yang ada di dalamnya, patut diwaspadai, … apalagi

jika tidak mencantumkan efek samping, peringatan hati-hati pada kondisi tertentu dan kontra-indikasi.

Obat hanya akan bermanfaat jika digunakan dengan tepat sesuai indikasi, dosis dan lamanya

pengobatan berlandaskan pengetahuan yang dapat dipertanggung jawabkan.

Semoga bermanfaat.

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