daftar obat aman dan berbahaya untuk ibu hamil dan menyusui
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obatTRANSCRIPT
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)
Nama ObatAAP
approved?*Kategori Risiko
Kehamilan**Risiko
Menyusui**Note
sAcetaminophen (Tylenol) Approved B L1
Aspirin CautionC (1st, 2nd trim.)
D (3rd trim.)L3 1
Azapropazone (Rheumox)Approved
- L2
Butalbital (Fioricet, Fiorinal, Bancap, Two-dyne)
NR D L3 2
Butorphanol (Stadol) ApprovedB (1st, 2nd trim.)
D (3rd trim.)L3
Celecoxib (Celebrex)) NR C L2 Codeine (in Tylenol #3, #4) Approved C L3 3Colchicine Approved D L4 Diclofenac (Cataflam, Voltaren)
NR B L2
Fentanyl (Sublimaze) Approved B L2 Flurbiprofen (Ansaid, Froben, Ocufen)
NRB (1st, 2nd trim.)
C (3rd trim.)L2
Hydrocodone (Lortab, Vicodin)
NR B L3 4
Hydromorphone (Dilaudid)
NR C L3 5
Ibuprofen (Advil, Nuprin, Motrin, Pediaprofen)
ApprovedB (1st, 2nd trim.)
D (3rd trim.)L1
Indomethacin (Indocin) ApprovedB (1st, 2nd trim.)
D (3rd trim.)L3
Ketorolac (Toradol, Acular)
ApprovedB (1st, 2nd trim.)
D (3rd trim.)L2
Meperidine (Demerol) Approved BL2;
L3 early postpartum
6
Methadone (Dolophine) Approved B L3 7Morphine (Duramorph, Infumorph, Epimorph, MS Contin)
Approved B L3 8
Nalbuphine (Nubain) NR B L2 Naproxen (Anaprox, Naprosyn, Naproxen, Aleve)
Approved BL3;
L4 for chronic use
9
Nefopam (Acupan) Approved - NR Oxycodone (Tylox, Percodan,Oxycontin, Roxicet, Endocet, Roxiprin, Percocet)
NR B L3 10
Pentosan polysulfate (Elmiron)
NR B L2
Piroxicam (Feldene) Approved B L2 Propoxyphene (Darvocet N, Propacet, Darvon)
Approved C L2 11
Rofecoxib (Vioxx) Withdrawn from the market 12Secobarbital (Seconal) Approved D L3 13Tolmetin (Tolectin) Approved C L3 Tramadol HCL (Ultram, Ultracet)
NR C L3 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Valdecoxib (Bextra) Withdrawn from the market more* Per the AAP Policy Statement The Transfer of Drugs and Other Chemicals Into Human Milk, revised September 2001.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 Pregnancy 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]Nama Generik Nama Dagang AAP Kategori Risiko
approved?*
Risiko Kehamilan** Menyusui**
Azapropazone (apazone) Rheumox Approved - L2Dipyrone (banned in the US & UK)
- Approved - NR
Flufenamic acid - Approved - NR
IbuprofenAdvil, Nuprin, Motrin, Pediaprofin
ApprovedB (1st, 2nd
trim.)D (3rd trim.)
L1
Indomethacin Indocin ApprovedB (1st, 2nd
trim.)D (3rd trim.)
L3
Ketorolac Toradol, Acular ApprovedB (1st, 2nd
trim.)D (3rd trim.)
L2
Mefenamic acid Ponstan, Ponstel Approved - NR
NaproxenAnaprox, Naprosyn, Naproxen, Aleve
Approved BL3
L4 (for chronic use)
Phenylbutazone Butazolidine Approved - NRPiroxicam Feldene Approved B L2Suprofen Profenal Approved - NRTolmetin Tolectin Approved C L3 Steroid [contents]Methylprednisolone[ high dosage methylprednisolone]
Solu-Medrol, Depo-Medrol, Medrol
Approved C L2
Prednisolone - Approved C L2
PrednisoneDeltasone, Meticorten, Orasone
Approved C L2
Obat Asma [contents]
DyphyllineDilor, Lufyllin, Dyphylline
Approved C L3
Terbutaline Bricanyl, Brethine Approved B L2
TheophyllineAminophylline, Quibron, Theo-Dur
Approved C L3
Analgetik Narkotik [more]
Butorphanol Stadol ApprovedB (1st, 2nd
trim.)D (3rd trim.)
L3
Codeine Tylenol #3, #4 Approved C L3Fentanyl Sublimaze Approved B L2
Meperidine Demerol Approved BL2
L3 (if used early postpartum)
Methadone Dolophine Approved B L3Morphine Morphine Approved B L3
PropoxypheneDarvocet N, Propacet, Darvon
Approved C L2
Obat Batuk
Nama ObatAAP
approved?*Risiko Menyusui**
Codeine yes L3 (moderately safe)Dextromethorphan not reviewed L1 (safest)Guaifenesin not reviewed L2 (safer)Dekongestan (Obat Pilek)
Nama ObatAAP
approved?*Risiko Menyusui**
Phenylephrine not reviewed L3 (moderately safe)
Pseudoephedrine (Sudafed, Actifed)
yesL3 (moderately safe) for acute use
L4 (possibly hazardous) for chronic use due to 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)
Nama ObatAAP
approved?*Risiko Menyusui**
Beclomethasone (Vanceril, Beclovent, Beconase, Vancenase)
not reviewed L2 (safer)
Cromlyn sodium (Nasalcrom)
not reviewed L1 (safest)
Fluticasone (Flonase) not reviewed L3 (moderately safe)Mometasone (Nasonex)
not reviewed L3 (moderately safe)
Phenylephrine (in some forms of Sinex and Neo-Synephrine)
not reviewed L3 (moderately safe)
Triamcinolone Acetonide (Nasacort)
not reviewed L3 (moderately safe)
Antihistamin (Anti Alergi)
Nama ObatAAP
approved?*Risiko Menyusui**
Brompheniramine not reviewed L3 (moderately safe)
Chlorpheniramine (Chlor-Trimeton) CTM
not reviewed L3 (moderately safe)
Cetirizine (Zyrtec) not reviewed L2 (safer)
Dexbrompheniramine maleatewith d-isoephedrine
yes not reviewed
Diphenhydramine (Benadryl)
not reviewed L2 (safer)
Doxylamine not reviewed L4 (possibly hazardous)
Fexofenadine (Allegra)
yes L3 (moderately safe)
Loratadine (Claritin) yes L2 (safer)
Terfenadine (Seldane)
yes not reviewed
Triprolidine (Actidil, Actifed)
yes L1 (safest)
* 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 ObatAAP
approved?*
Kategori Risiko Kehamilan**
Risiko Menyusui*
*
Notes
Local anesthetics Articaine (Septocaine) NR - NR moreBupivacaine (Marcaine) NR C L2 Lidocaine (Xylocaine) Approved C L2 Mepivacaine (Carbocaine, Polocaine)
NR C L3 more
Procaine HCL (Novocaine) NR C L3 General anestheticsHalothane (Fluothane) Approved C L2 moreIsoflurane (Forane) NR - NR 1Ketamine 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 anesthesiaSedativesDiazepam (Valium) Concern D L3; L4 for
chronic use
Midazolam (Versed) Concern D L3 Propofol (Diprivan) NR B L2 moreTriazolam (Halcion) NR X L3 Narcotic AnalgesicsAlfentanil (Alfenta) NR C L2 Fentanyl (Sublimaze) Approved B L2 Hydromorphone (Dilaudid) NR C L3 Morphine Approved B L3 Reversal MedicationFlumazenil (Romazicon) NR C NR 2Naloxone (Narcan) NR C NR 3SteroidsDecadron (Dexamethasone) NR C NR moreStimulantsEpinephrine (Adrenaline) NR C L1 Anti-nauseaPromethazine (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 Pregnancy Risk Categories
L1 (safest) L2 (safer) L3 (moderately safe) L4 (possibly hazardous)
A (controlled studies show no risk) B (no evidence of risk in humans) C (risk cannot be ruled out) D (positive evidence of risk)
L5 (contraindicated) 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 Nama DagangAAP
approved?*
Kategori Risiko
Kehamilan**
Risiko Menyusui*
*Antasida [contents]Cimetidine (Antacid) Tagamet Approved B L2Cisapride (GI tract stimulant) Propulsid Approved C L2Domperidone (used for nausea & vomiting, stimulates lactation) [more]
Motilum Approved - L1
Antibiotika [contents]Amoxicillin Larotid, Amoxil Approved B L1Aztreonam Azactam Approved B L2
CefadroxilUltracef, Duricef
Approved B L1
Cefazolin Ancef, Kefzol Approved B L1Cefotaxime Claforan Approved B L2Cefoxitin Mefoxin Approved B L1Cefprozil Cefzil Approved C L1
CeftazidimeCeftazidime, Fortaz, Taxidime
Approved B L1
Ceftriaxone Rocephin Approved B L2Ciprofloxacin [more] Cipro Approved C L3Clindamycin Cleocin Approved B L3
ErythromycinE-Mycin, Ery-tab, ERYC, Ilosone
Approved BL1
L3 early postnatal
Fleroxacin - Approved - NRGentamicin Garamycin Approved C L2
KanamycinKebecil, Kantrex
Approved D L2
Moxalactam Moxam Approved - NRNitrofurantoin Macrobid Approved B L2Ofloxacin Floxin Approved C L2Penicillin - Approved B L1Streptomycin Streptomycin Approved D L3Sulbactam - Approved - NR
SulfisoxazoleGantrisin, Azo-Gantrisin
Approved C L2
TetracyclineAchromycin, Sumycin, Terramycin
Approved D L2
TicarcillinTicarcillin, Ticar, Timentin
Approved B L1
Trimethoprim/sulfamethoxazole
Proloprim, Trimpex
Approved C L3
Antikoagulan [contents]Bishydroxycoumarin (dicumarol)
- Approved - NR
WarfarinCoumadin, Panwarfin
Approved D L2
Antikonvulsan (Anti kejang) [contents]Carbamazepine Tegretol, Epitol Approved C L2Ethosuximide Zarontin Approved C L4Magnesium sulfate Epsom salt Approved B L1Phenytoin Dilantin Approved D L2
Valproic acidDepakene, Depakote
Approved D L2
Anti Jamur [contents]Fluconazole [more] Diflucan Approved C L2
KetoconazoleNizoral Shampoo, Nizoral
Approved C L2
Antivirus [contents]Acyclovir [more] Zovirax Approved C L2
Interferon-alpha [more]Alferon N, Interferon Alpha
Approved C L2
Arthritis meds (see also: pain meds) [contents]
Gold saltsRidaura, Myochrysine, Solganal
Approved C L5
Kontrasepsi, Hormon [contents]
EstradiolEstratab, Permarin, Menest
Approved X
L3 (may interfere with milk
production)Clogestone - Approved - NR
Contraceptive pill with estrogen/progesterone
Preven, Seasonale, Norinyl, Norlestin, Ortho-Novum, Ovral, Lunelle injection, Ortho-Evra patch, etc.
Approved X
L3 (may interfere with milk
production)
LevonorgestrelNorplant, Mirena, Plan B
Approved X L2
MedroxyprogesteroneProvera, Depo-Provera, Cycrin
Approved D
L1L4 (if used first 3 days postpartum)
Norethynodrel Enovid Approved X L2
ProgesteroneCrinone, Prometrium
Approved - L3
Obat Diabetes [contents]Note: Insulin has not been reviewed by the AAP. Pregnancy risk category = B; Lactation risk category = L1.
TolbutamideOramide, Orinase
Approved D L3
Obat Diare [contents]
Loperamide
Imodium, Pepto Diarrhea Control, Maalox Antidiarrheal Caplets, Kaopectate II Caplets, Immodium Advanced
Approved B L2
** 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]
AcetazolamideDazamide, Diamox
Approved C L2
Bendroflumethiazide Naturetin Approved DL4 (may inhibit
lactation)Chlorothiazide Hydrodiuril Approved D L3Chlorthalidone Hygroton Approved D L3
Hydrochlorothiazide (HCT)Hydrodiuril, Esidrix, Oretic
Approved D L2
Spironolactone Aldactone Approved D L2Anti Muntah [more] [contents]Domperidone Motilum Approved - L1Anti Hipertensi, Obat Jantung [contents] Anti aritmia
DisopyramideNorpace, Napamide
Approved C L2
Flecainide Tambocor Approved C L3Mexiletine Mexitil Approved B L2
ProcainamidePronestyl, Procan
Approved C L3
QuinidineQuinaglute, Quinidex
Approved C L2
Anti Hipertensi
Captopril Capoten Approved DL3 (if used
after 30 days)
Diltiazem/Diltiazem HCL
Cardizem Sr, Dilacor-XR, Diltiazem, Cardizem CD
Approved C L3
Enalapril/Enalapril Maleate Vasotec ApprovedC (1st trim.)D (2nd, 3rd
trim.)L2
Hydralazine Apresoline Approved C L2
LabetalolTrandate, Normodyne
Approved C L2
Methyldopa Aldomet Approved C L2
MetoprololToprol XL, Lopressor
Approved B L3
MinoxidilLoniten, Minodyl, Rogaine
Approved CL2
(topically)L3 (orally)
NadololCorgard, Nadolol
Approved C L4
NifedipineAdalat, Procardia
Approved C L2
OxprenololApsolox, Slow-Trasicor, Trasicor
Approved - NR
Propranolol Inderol Approved C L2Sotalol Betapace Approved B L3Timolol Blocadren Approved C L2
VerapamilCalan, Isoptin, Covera-HS
Approved C L2
Cardiac stimulants
DigoxinLanoxin, Lanoxicaps
Approved C L2
Laksan (Pelancar BAB) [more] [contents]Cascara/Cascara Sagrada - Approved C L3Danthron - Approved - NRMagnesium sulfate Epsom salt Approved B L1Senna - Approved - L3Obat malaria [contents]
ChloroquineAralen, Novo-chloroquine
Approved C L3
Hydroxychloroquine Plaquenil Approved C L2Pyrimethamine Daraprim Approved C L4Quinine Quinamm Approved D L2Medical Testing [more] [contents]Diatrizoate - Approved - NRFluorescein - Approved C L3Gadopentetic (Gadolinium) - Approved C L2Iohexol Omnipaque Approved B L2Iopanoic acid Telepaque Approved D L2Metrizamide Amipaque Approved B L2Metrizoate Isopaque Approved B L2Obat Migren [more] [contents]Sumatriptan Imitrex Approved C L3Obat Sedativ [more] [contents]
Chloral hydrateAquachloral, Noctec
Approved C L3
Methyprylon (withdrawn from use in US & Canada)
- Approved - NR
Bromide - Approved D L5Secobarbital Seconal Approved D L3
Obat Tidur [contents]Zolpidem/Zolpidem Tartrate Ambien Approved B L3Obat Anti Tiroid [more] [contents]Carbimazole - Approved D L3Methimazole (active metabolite of carbimazole)
Tapazole Approved D L3
Propylthiouracil PTU Approved D L2Thiouracil - Approved - NR
Levothyroxine
Synthroid, Levothroid, Thyroid, Levo-T, Levoxyl
Approved A L1
Obat TBC [contents]Cycloserine Seromycin Approved C L3
EthambutolEthambutol, Myambutol
Approved B L2
Isoniazid INH, Laniazid Approved C L3
RifampinRifadin, Rimactane
Approved C L2
VITAMIN [more] [contents]B-1 (thiamin) - Approved - NRB-12 (Cyanocobalamin) - Approved A L1
B-6 (pyridoxine) - Approved A
L2; L4 in high doses
(may inhibit lactation)
D, vitaminCalciferol, Delta-d
Approved AL3 (do not overdose)
Folic acid - ApprovedA (1st, 2nd
trim.)C (3rd trim.)
L1
K-1, vitamin (Phytonadione) - Approved C L1Riboflavin/B2 - Approved A L1Lain-lain [contents]Acitretin (Anti-psoriasis) Soriatane Approved - NRAlcohol/Ethanol [more] - Approved D L3
AllopurinolZyloprim, Lopurin
Approved C L2
Antimony - Approved - NRAtropine (Anticholinergic, drying agent)
Belladonna, Atropine
Approved C L3
Azapropazone/apazone (Antirheumatic)
Rheumox Approved - L2
Baclofen (muscle relaxant)Lioresal, Atrofen
Approved C L2
Barbiturate - Approved - NR
Caffeine [more]Vivarin, NoDoz, Coffee
Approved B L2
Carbetocin (Antihemorrhagic) Duratocin Approved - NRChloroform - Approved - NRCisplatin (Anti-cancer) Platinol Approved D L4
Dapsone (Antileprosy)Avlosulfon, DDS
Approved C L4
Hydroxychloroquine (Antirheumatic, lupus)
Plaquenil Approved C L2
Iodides - Approved - NRIodine - Approved - NRIodine (povidone-iodine, eg, in a vaginal douche)
- Approved - NR
Ivermectin (Antiparasitic) Mectizan Approved C L3Nalidixic acid (Urinary Anti-infective)
NegGram Approved B L4
Norsteroids - Approved - NRPyridostigmine (Muscle stimulant)
Mestinon, Regonol
Approved C L2
Scopolamine (Motion sickness)Transderm Scope
Approved C L3
Sulfapyridine Dagenan Approved - NRTimolol (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 Pregnancy 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
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.