DAFTAR OBAT AMAN DAN BERBAHAYA UNTUK IBU HAMIL DAN MENYUSUI Disusun kembali oleh dr.Abu Hana 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
Obat untuk Penghilang Rasa Sakit (Pain Killer) AAP Kategori Risiko Nama Obat approved?* Kehamilan** Acetaminophen (Tylenol) Approved B C (1st, 2nd trim.) Aspirin Caution D (3rd trim.) Approved Azapropazone (Rheumox) -
Risiko Notes Menyusui** L1 L3
1
L2
Butalbital (Fioricet, Fiorinal, Bancap, Twodyne)
NR
D
L3
Butorphanol (Stadol)
Approved
B (1st, 2nd trim.) D (3rd trim.)
L3
2
Celecoxib (Celebrex)) Codeine (in Tylenol #3, #4) Colchicine Diclofenac (Cataflam, Voltaren) Fentanyl (Sublimaze) Flurbiprofen (Ansaid, Froben, Ocufen) Hydrocodone (Lortab, Vicodin) Hydromorphone (Dilaudid) Ibuprofen (Advil, Nuprin, Motrin, Pediaprofen)
NR Approved Approved
C C D
L2 L3 L4
NR
B
L2
Approved
B B (1st, 2nd trim.) C (3rd trim.)
L2
NR
B
L3
4
NR
C
L3
5
Indomethacin (Indocin)
Approved
Ketorolac (Toradol, Acular)
Approved
Meperidine (Demerol)
Approved
B
Methadone (Dolophine) Morphine (Duramorph, Infumorph, Epimorph, MS Contin) Nalbuphine (Nubain) Naproxen (Anaprox, Naprosyn, Naproxen, Aleve) Nefopam (Acupan) Oxycodone (Tylox, Percodan,Oxycontin, Roxicet, Endocet, Roxiprin, Percocet) Pentosan polysulfate (Elmiron) Piroxicam (Feldene) Propoxyphene (Darvocet N, Propacet, Darvon) Rofecoxib (Vioxx) Secobarbital (Seconal) Tolmetin (Tolectin) Tramadol HCL (Ultram, Ultracet)
Approved
B
L2; L3 early postpartum L3
Approved
B
L3
8
NR
B
Approved
B
9
Approved
-
L2 L3; L4 for chronic use NR
NR
B
L3
10
NR
B
L2
Approved
B
L2
Approved
C
L2
NR
Approved
L2
B (1st, 2nd trim.) D (3rd trim.) B (1st, 2nd trim.) D (3rd trim.) B (1st, 2nd trim.) D (3rd trim.)
L1 L3 L2
Withdrawn from the market Approved D Approved C NR
C
3
L3 L3 L3
6 7
11 12 13 14
Valdecoxib (Bextra) Withdrawn from the market more * Per the AAP Policy Statement The Transfer of Drugs and Other Chemicals Into Human Milk, revised September 2001.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). Lactation Risk Categories L1 (safest) L2 (safer) L3 (moderately safe) L4 (possibly hazardous) L5 (contraindicated)
Pregnancy Risk Categories 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] AAP Kategori Nama Generik Nama Dagang approved?* Risiko
Risiko Menyusui**
Azapropazone (apazone) Rheumox Dipyrone (banned in the US & UK)
Approved
Kehamilan** -
L2
Approved
-
NR
Flufenamic acid
-
Approved
NR
Ibuprofen
Advil, Nuprin, Motrin, Approved Pediaprofin
Indomethacin
Indocin
Approved
Ketorolac
Toradol, Acular
Approved
Mefenamic acid
Ponstan, Ponstel
Approved
B (1st, 2nd trim.) D (3rd trim.) B (1st, 2nd trim.) D (3rd trim.) B (1st, 2nd trim.) D (3rd trim.) -
Naproxen
Anaprox, Naprosyn, Naproxen, Aleve
Approved
B
Butazolidine Feldene Profenal Tolectin
Approved Approved Approved Approved
B C
Solu-Medrol, DepoMedrol, Medrol
Approved
C
L2
Approved Deltasone, Meticorten, Approved Orasone
C
L2
C
L2
Phenylbutazone Piroxicam Suprofen Tolmetin Steroid Methylprednisolone [ high dosage methylprednisolone] Prednisolone Prednisone
Terbutaline Theophylline
L3
L2 NR L3 L4 (for chronic use) NR L2 NR L3 [contents]
[contents]
Obat Asma Dyphylline
L1
Dilor, Lufyllin, Dyphylline Bricanyl, Brethine Aminophylline, Quibron, Theo-Dur
Approved
C
L3
Approved
B
L2
Approved
C
L3
Analgetik Narkotik [more] Butorphanol
Stadol
Codeine
Tylenol #3, #4
B (1st, 2nd trim.) D (3rd trim.) Approved C Approved
L3 L3
Fentanyl
Sublimaze
Approved
B
Meperidine
Demerol
Approved
B
Methadone Morphine
Dolophine Approved Morphine Approved Darvocet N, Propacet, Approved Darvon
B B
L2 L2 L3 (if used early postpartum) L3 L3
C
L2
Propoxyphene
Obat Batuk AAP approved?* Codeine yes Dextromethorphan not reviewed Guaifenesin not reviewed Dekongestan (Obat Pilek) AAP Nama Obat approved?* Phenylephrine not reviewed Nama Obat
Risiko Menyusui** L3 (moderately safe) L1 (safest) L2 (safer) Risiko Menyusui**
L3 (moderately safe) 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 Risiko Menyusui** approved?* Beclomethasone (Vanceril, Beclovent, not reviewed L2 (safer) Beconase, Vancenase) Cromlyn sodium not reviewed L1 (safest) (Nasalcrom) Fluticasone (Flonase) not reviewed L3 (moderately safe) Mometasone not reviewed L3 (moderately safe) (Nasonex) Phenylephrine (in some forms of Sinex not reviewed L3 (moderately safe) and Neo-Synephrine) Triamcinolone not reviewed L3 (moderately safe) Acetonide (Nasacort) Antihistamin (Anti Alergi)
Nama Obat
AAP approved?* not reviewed
Risiko Menyusui**
Brompheniramine L3 (moderately safe) Chlorpheniramine (Chlor-Trimeton) not reviewed L3 (moderately safe) CTM Cetirizine (Zyrtec) not reviewed L2 (safer) Dexbrompheniramine maleate yes not reviewed with d-isoephedrine Diphenhydramine not reviewed L2 (safer) (Benadryl) Doxylamine not reviewed L4 (possibly hazardous) Fexofenadine yes L3 (moderately safe) (Allegra) Loratadine (Claritin) yes L2 (safer) Terfenadine yes not reviewed (Seldane) Triprolidine (Actidil, yes L1 (safest) Actifed) * 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 Nama Obat Local anesthetics Articaine (Septocaine) Bupivacaine (Marcaine) Lidocaine (Xylocaine) Mepivacaine (Carbocaine, Polocaine) Procaine HCL (Novocaine) General anesthetics Halothane (Fluothane) Isoflurane (Forane) Ketamine Methohexital (Brevital) Nitrous oxide
AAP approved?*
Kategori Risiko Kehamilan**
Risiko Notes Menyusui**
NR NR Approved
C C
NR L2 L2
more
NR
C
L3
more
NR
C
L3
Approved NR NR Approved NR
C B -
L2 NR NR L3 L3
more 1 more
Sevoflurane (Ultane) NR Thiopental (Pentothal) Approved Other medications often used during anesthesia Sedatives Diazepam (Valium) Concern
B C
D
L3 L3
L3; L4 for chronic use L3 more L2 L3
Midazolam (Versed) Concern D Propofol (Diprivan) NR B Triazolam (Halcion) NR X 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 NR 2 C Naloxone (Narcan) NR NR 3 C Steroids Decadron (Dexamethasone) NR NR more C 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 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). Lactation Risk Categories L1 (safest) L2 (safer) L3 (moderately safe) L4 (possibly hazardous) L5 (contraindicated)
Pregnancy Risk Categories 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.
Kelompok Antasida, Antibiotik, Antivirus, Antijamur, Kontrasepsi, Obat jantung & Hipertensi, Vitamin, dll
Nama Generik Antasida Cimetidine (Antacid) Cisapride (GI tract stimulant) Domperidone (used for nausea & vomiting, stimulates lactation) [more] Antibiotika Amoxicillin Aztreonam Cefadroxil Cefazolin Cefotaxime Cefoxitin Cefprozil Ceftazidime Ceftriaxone Ciprofloxacin [more] Clindamycin Erythromycin Fleroxacin Gentamicin Kanamycin Moxalactam
Nama Dagang
AAP approved?*
Tagamet Propulsid
Approved Approved
Motilum
Approved
Larotid, Amoxil Azactam Ultracef, Duricef Ancef, Kefzol Claforan Mefoxin Cefzil Ceftazidime, Fortaz, Taxidime Rocephin Cipro Cleocin E-Mycin, Erytab, ERYC, Ilosone Garamycin Kebecil, Kantrex Moxam
Kategori Risiko Risiko Kehamilan** Menyusui** [contents] B L2 C L2 -
L1
Approved Approved Approved Approved Approved Approved Approved
B B B B B B C
[contents] L1 L2 L1 L1 L2 L1 L1
Approved
B
L1
Approved Approved Approved
B C B
Approved
B
Approved Approved Approved Approved
C D -
L2 L3 L3 L1 L3 early postnatal NR L2 L2 NR
Nitrofurantoin Ofloxacin Penicillin Streptomycin Sulbactam
Macrobid Floxin Streptomycin Gantrisin, AzoSulfisoxazole Gantrisin Achromycin, Tetracycline Sumycin, Terramycin Ticarcillin, Ticarcillin Ticar, Timentin Proloprim, Trimethoprim/sulfamethoxazole Trimpex Antikoagulan Bishydroxycoumarin (dicumarol) Coumadin, Warfarin Panwarfin Antikonvulsan (Anti kejang) Carbamazepine Tegretol, Epitol Ethosuximide Zarontin Magnesium sulfate Epsom salt Phenytoin Dilantin Depakene, Valproic acid Depakote Anti Jamur Fluconazole [more] Diflucan Nizoral Ketoconazole Shampoo, Nizoral Antivirus Acyclovir [more] Zovirax Alferon N, Interferon-alpha [more] Interferon Alpha Arthritis meds (see also: pain meds) Ridaura, Gold salts Myochrysine, Solganal Kontrasepsi, Hormon Estratab, Estradiol Permarin, Menest
Approved Approved Approved Approved Approved
B C B D -
L2 L2 L1 L3 NR
Approved
C
L2
Approved
D
L2
Approved
B
L1
Approved
C
L3 [contents]
Approved
-
NR
Approved
D
L2
Approved Approved Approved Approved
C C B D
[contents] L2 L4 L1 L2
Approved
D
L2
Approved
C
[contents] L2
Approved
C
L2
Approved
C
[contents] L2
Approved
C
L2 [contents]
Approved
Approved
C
X
L5 [contents] L3 (may interfere with milk
Clogestone
Contraceptive pill with estrogen/progesterone
Levonorgestrel
Medroxyprogesterone Norethynodrel Progesterone
Preven, Seasonale, Norinyl, Norlestin, OrthoNovum, Ovral, Lunelle injection, OrthoEvra patch, etc. Norplant, Mirena, Plan B Provera, DepoProvera, Cycrin Enovid Crinone, Prometrium
Approved
-
production) NR
Approved
X
L3 (may interfere with milk production)
Approved
X
L2
Approved
D
Approved
X
L1 L4 (if used first 3 days postpartum) L2
Approved
-
L3
[contents] Obat Diabetes Note: Insulin has not been reviewed by the AAP. Pregnancy risk category = B; Lactation risk category = L1. Oramide, Tolbutamide Approved D L3 Orinase [contents] Obat Diare Imodium, Pepto Diarrhea Control, Maalox Antidiarrheal Loperamide Caplets, Approved B L2 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] [contents] Diuretik (Peluruh Kencing) Dazamide, Acetazolamide Approved C L2 Diamox L4 (may Bendroflumethiazide Naturetin inhibit Approved D lactation) Chlorothiazide Hydrodiuril Approved D L3
Chlorthalidone Hydrochlorothiazide (HCT)
Hygroton Hydrodiuril, Esidrix, Oretic Aldactone
Spironolactone Anti Muntah [more] Domperidone Motilum Anti Hipertensi, Obat Jantung Anti aritmia Norpace, Disopyramide Napamide Flecainide Tambocor Mexiletine Mexitil Pronestyl, Procainamide Procan Quinaglute, Quinidine Quinidex Anti Hipertensi
Approved
D
L3
Approved
D
L2
Approved
D
Approved
-
L2 [contents] L1 [contents]
Approved
C
L2
Approved Approved
C B
L3 L2
Approved
C
L3
Approved
C
L2
Captopril
Capoten
Approved
D
L3 (if used after 30 days)
Diltiazem/Diltiazem HCL
Cardizem Sr, Dilacor-XR, Diltiazem, Cardizem CD
Approved
C
L3
Enalapril/Enalapril Maleate
Vasotec
Approved
Hydralazine
Apresoline Trandate, Normodyne Aldomet Toprol XL, Lopressor Loniten, Minodyl, Rogaine Corgard, Nadolol Adalat, Procardia Apsolox, SlowTrasicor, Trasicor Inderol
Approved
C (1st trim.) D (2nd, 3rd trim.) C
Approved
C
L2
Approved
C
L2
Approved
B
L3
Approved
C
L2 (topically) L3 (orally)
Approved
C
L4
Approved
C
L2
Approved
-
NR
Approved
C
L2
Labetalol Methyldopa Metoprolol Minoxidil Nadolol Nifedipine Oxprenolol Propranolol
L2 L2
Sotalol Timolol Verapamil
Betapace Blocadren Calan, Isoptin, Covera-HS
Approved Approved
B C
L3 L2
Approved
C
L2
Approved
C
L2
Approved Approved Approved Approved
C B -
[contents] L3 NR L1 L3 [contents]
Approved
C
L3
Approved Approved Approved
C C D
Approved Approved Approved Approved Approved Approved Approved
C C B D B B
Approved
C
L2 L4 L2 [contents] NR L3 L2 L2 L2 L2 L2 [contents] L3 [contents]
Approved
C
L3
Approved
-
NR
Approved Approved
D D
Approved
B
Approved
D
L5 L3 [contents] L3 [contents] L3
Approved
D
L3
Approved
D
L2
Cardiac stimulants Lanoxin, Lanoxicaps Laksan (Pelancar BAB) [more] Cascara/Cascara Sagrada Danthron Magnesium sulfate Epsom salt Senna Obat malaria Aralen, NovoChloroquine chloroquine Hydroxychloroquine Plaquenil Pyrimethamine Daraprim Quinine Quinamm Medical Testing [more] Diatrizoate Fluorescein Gadopentetic (Gadolinium) Iohexol Omnipaque Iopanoic acid Telepaque Metrizamide Amipaque Metrizoate Isopaque Obat Migren [more] Sumatriptan Imitrex Obat Sedativ [more] Aquachloral, Chloral hydrate Noctec Methyprylon (withdrawn from use in US & Canada) Bromide Secobarbital Seconal Obat Tidur Zolpidem/Zolpidem Tartrate Ambien Obat Anti Tiroid [more] Carbimazole Methimazole (active metabolite Tapazole of carbimazole) Propylthiouracil PTU Digoxin
Thiouracil
Synthroid, Levothroid, Thyroid, LevoT, Levoxyl
Approved
-
NR
Approved
A
L1
Seromycin Ethambutol, Myambutol INH, Laniazid Rifadin, Rimactane
Approved
C
[contents] L3
Approved
B
L2
Approved
C
L3
Approved
C
L2
VITAMIN [more] B-1 (thiamin) B-12 (Cyanocobalamin)
-
Approved Approved
A
B-6 (pyridoxine)
-
Approved
A
D, vitamin
Calciferol, Delta-d
Approved
A
Folic acid
-
Approved
K-1, vitamin (Phytonadione) Riboflavin/B2 Lain-lain Acitretin (Anti-psoriasis) Alcohol/Ethanol [more]
-
Approved Approved
A (1st, 2nd trim.) C (3rd trim.) C A
Soriatane Zyloprim, Lopurin Belladonna, Atropine
Approved Approved
D
L1 L1 [contents] NR L3
Approved
C
L2
Approved
-
NR
Approved
C
L3
Rheumox
Approved
-
L2
Approved Approved
C -
L2 NR
Approved
B
L2
Approved Approved Approved
D
NR NR L4
Levothyroxine Obat TBC Cycloserine Ethambutol Isoniazid Rifampin
Allopurinol Antimony Atropine (Anticholinergic, drying agent) Azapropazone/apazone (Antirheumatic) Baclofen (muscle relaxant) Barbiturate
Lioresal, Atrofen Vivarin, NoDoz, Caffeine [more] Coffee Carbetocin (Antihemorrhagic) Duratocin Chloroform Cisplatin (Anti-cancer) Platinol
[contents] NR L1 L2; L4 in high doses (may inhibit lactation) L3 (do not overdose) L1
Dapsone (Antileprosy) Hydroxychloroquine (Antirheumatic, lupus) Iodides Iodine Iodine (povidone-iodine, eg, in a vaginal douche) Ivermectin (Antiparasitic) Nalidixic acid (Urinary Antiinfective) Norsteroids Pyridostigmine (Muscle stimulant)
Avlosulfon, DDS
Approved
C
L4
Plaquenil
Approved
C
L2
-
Approved Approved
-
NR NR
-
Approved
-
NR
Mectizan
Approved
C
L3
NegGram
Approved
B
L4
NR Approved Mestinon, Approved C L2 Regonol Transderm Scopolamine (Motion sickness) Approved C L3 Scope Sulfapyridine Dagenan NR Approved 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). Lactation Risk Categories L1 (safest) L2 (safer) L3 (moderately safe) L4 (possibly hazardous) L5 (contraindicated)
Pregnancy Risk Categories 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 Diterbitkan Juni 3, 2008 Artikel , Gaya Hidup , Health , Informasi , Kedokteran , Kesehatan , Reviews 42 Komentar Tag:Artikel, Gaya Hidup, Hamil, Health, Informasi, Kedokteran, Kesehatan, Obat, Reviews, Wanita
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 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 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, Methyl
prednisolone, …dll …dll … 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
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.
