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OBAT-OBAT

TERATOGENIK

PENDAHULUAN
Pemberian obat-obatan kepada ibu
hamil perubahan-perubahan
fisiologik N pe volume
plasma, perubahan motilitas
gastrointestinal dan perubahanperubahan dlm komponen plasma,
fungsi ginjal

Prinsip R/ obat selama kehamilan :


Hindari pemberian obat pada
trimester I kehamilan.
Mempertimbangkan
kermungkinan terjadi kehamilan.
R/ jangka panjang konseling.
R/ penting / dibutuhkan tdk
dihentikan.

Efek obat mengalami perubahan


selama kehamilan.
R/ tunggal & jangka pendek
daripada R/ jangka panjang /
kombinasi.
Gunakan dosis efektif terendah
jika tersedia.

Gunakan obat hanya jika


manfaat lebih besar daripada
risikonya.
Gunakan cara pemberian
alternatif.
Pilih obat tanpa ES.
Gunakan dosis lebih rendah

TERATOGENESIS
Defek fetus, malformasi,
deformasi, disrupsi.
Malformasi perubahan
embrionik dlm morfognesis
disebabkan proses
perkembangan intrinsik abN.

Defek deformasi bentuk,


kondisi atau posisi dari bagian
tubuh abN kekuatan mekanik
ekstrinsik.

Disrupsi kekuatan ekternal yg


merubah jar. sebelumnya N.

Teratogen bahan, organisme,


bahan fisik / keadaan defisiensi
menginduksi fungsi / struktur abN
postnatal.
Bahan teratogen infeksi, radiasi,
pestisida, metal, bahan organik,
peny. kronik dari ibu & obatobatan.

Tabel 1. FDA pregnancy drug risk categories


DRUG RISK
CATEGORIY

DEFINITION

Contraindicated in pregnancy
There is no reason to risk use of the drug in pregnancy

Positive evidence for risk to human fetus


However, benefits may outweigh risk of the drug

Risk cannot be ruled out-human studies are lacking


Animal studies may or may, not show risk
Potentials benefits may justify potential risk

No risk to human fetus despite posible animal risk


Or, no risk in animal studies and human studies have not
been does

Controlled studies show no fetal risk

Unrated

No pregnancy category has been assigned

Tabel 2. Drug with minimal risk to mother and


fetus during pregnancy contd
ANTIVIRAL AGENTS
(restrict use to
treatment of severe
herpesvirus infections)

Ayclovir
Famcyclovir
Vala\cyclovir

CORTICOSTEROISD

Oral : avoid high doses first


trimester
Topical : avoid high doses long term

MISCELLANEOUSOTHER DRUGS

Benzoyl peroxide
Tretinoin (except first trimester)

MISCELLANEOUSTOPICAL ANTIACNE
PRODUCTS

Calcipotriene topical (low doses)


Dapsone (except close to term)
Hydroquinone topical
Methoxsalen topical

Tabel 3. Drug with minimal risk to mother and


fetus during Lactation

ANALGESICS

ANESTHETICS

Acetaminophen
Codeine (low dose)
Meperidine (low dose)
Morphine (low dose)
Oxycodone (low dose)
Pentazocine (low dose)
Propoxyphene (low dose)
Bupivacaine (low strength)
Lidocaine
Lidocaine with epinephrine
Lidocaine-prilocaine
Mepivacaine

ANTIBACTERIAL AGENTS

ANTIFUNGAL AGENTS

ANTIFUNGAL AGENTS
contd

Bacitracin-topical
Cephalosporins
Erythromycins
Erythromycin-topical
Penicillins
Sulfur-topical
Sulfur with resorcinol-topical
Tetracycline-topical

Butoconazole-topical
Ciclopirox-topical
Clotrimazole-topical
Econazole-topical
Miconazole-topical
Naftifine-topical
Nystatin-oral and topical

Oxiconazole-topical
Sulconazole-topical
Terbinafine-topical

ANTIHISTAMINES

Concern for all antihistamines regarding


inhibition of milk production and
infantile irritability

ANTIVIRAL AGENTS

Acyclovir
Valacyclovir

ANTISCABETIC
AGENTS

Crotamiton-topical

CORTICOSTEROIDS
MISCELLNEOUSTOPICAL ANTIACNE

MISCELLANEOUSOTHER DRUGS

Oral : use prednisolone, avoid nursing


for 4 hours after use
Topical : aoid use of nipple or areola
Azelaic acid
Benzoyl peroxide
Tretinoid

Allopurinol
Calcipotriene-topical
Hydroquinone-topical
Masoprocol-topical
Methoxsalen-topical

Tabel 4. Pregnancy category X-avoid in


pregnancy and lactation
Acitretin

Flutamide

Estrogens

Isotretinoin

Etretinate

Methotrexate (both males and females


should avoid of pregnancy is
anticipoated)

Finasteride

Stanozolol

Fluorouracil

Thalidomide (both males and females


should avoid of pregnancy is
anticipoated)

Tabel 5. Pregnancy category D or unrated


drugs to avoid in pregnancy and lactation
DRUG

CATEGORY D

Aspirin (high-dose, extende-release


form should be avoided)

Azathioprine

Bleomycin

Colchicines

Cyclophosphamide

Griseofulvin
Hydroxyurea

Mechlorethamine

Penicillamine

Potassium iodide

Spironolactone
Tetracycline

UNRATED

Tabel 6. Examples of known human teratogens


TERATOGEN

ADVERSE EFFECTS

CRITICAL
PERIOD

Maternal Conditions

Diabetes

Holoprosencephaly, pore cysts,


cardiac defects, sacral agenesis,
First
caudal regression, laterally
trimester
defects, facial clefts, renal
defects

Hypothyroidism /
Hyperthyroidism

Mental retardation (MR),


growth restriction

Phenylketonuria (PKU)

MR, microcephaly, craniofacial


defects

Hyperthermia

Anencephaly / other neural


tube defects (NTDs)

Systemic lupus
erythematosus (SLE)

Transient neonatal SLE,


intrauterine growth restriction
(IUGR), prematurity,
congenital heart block

Entire
pregnancy

2-4 weeks

TERATOGEN

ADVERSE EFFECTS

CRITICAL
PERIOD

Nonprescription
Substance Use

Alcohol

Short palpebra fissures,


altered facies, prenatal and
postnatal growth deficiency,
mild to moderate MR,
microcephaly

Entire
pregnancy

Tobacco

Low birth weight (LBW),


miscarriage

Unknown

Toluene

CNS (developmental delay,


microcephaly, IUGR)

Unknown

TERATOGEN

ADVERSE EFFECTS

CRITICAL
PERIOD

Medications
Aminopterin /
methotrexate

CNS, limb and skeletal defects

14-69 days

Amiodarone

Neonatal thyroid dysfunction

Second-third
trimester

ACE inhibitors

Oligohydramnios, renal
dysplasia/failure, IUGR, joint
contractures, prenatal death

Second-third
trimester

Carbamazepine

Spina bifida, hypoplasia of the


phalanges, IUGR

14-60 days

TERATOGEN

Cyclophosphamide

ADVERSE EFFECTS
CNS defects, skeletal defects
(especially cranial and digits),
IUGR cleft palate, neonatal
death

CRITICAL
PERIOD

14-60 days

Brachycephaly, abnormal facies,


Fluconazole (risk
abnormal calvarial
First
thought to be only with
development, cleft palate,
trimester
high doses, especially
cardiac defects, skeletal defects
parenteral)
(thinning)

Indomethacin

Oligohydramnios, anuria,
necrotizing enterocolitis,
premature ductus arteriosus
closure

Second-third
trimester

TERATOGEN

ADVERSE EFFECTS

CRITICAL
PERIOD

Lithium

Cardiac defects (Ebstein


anomaly)

14-60 days

Methylene blue

Jejunal atresia

Second
trimester

Misoprostol

Mobius anomaly, terminal


transverse limb deficiency,
arthrogryposis multiplex
congenital, talipes equinovarus

Firstsecond
trimester

Penicillamine

Connective tissue abnormalities

14-60 days

ADVERSE EFFECTS

CRITICAL
PERIOD

Phenytoin

CNS (structural and


development delay), facial
clefting, midface
hypoplasia, cardiac
defects, digital nail
hypoplasia

14-60 days

Retinoids
(isotretinoin,
acitretin)

CNS, ocular, cardiac, great


vessel, and lib defects;
microtia, micrognathia,
cleft lip/palate, thymic
deficiency

Unknown

Selective serotonin
reuptake inhibitors
(SSRIs)

Prenatal complication,
increase in minor
anomalies

Third
trimester

TERATOGEN

TERATOGEN

ADVERSE EFFECTS

CRITICAL
PERIOD

Tetracycline

Staining of primary
dentition

Secondthird
trimester

Thalidomide

Cranial nerve abnormalities,


limb shortening defects
(phocomelia), ocular and
cardiac defects, oral/facial
anomalies, renal and
urogenital defects

27-40 days

Trimethoprim

NTDs, oral clefts,


hypospadias, cardiovascular
defects

First
trimester

TERATOGEN

ADVERSE EFFECTS

CRITICAL
PERIOD

Medications-contd

Trimethadione

CNS (development delay),


microcephaly, cleft lip/palate,
broad nasal brigde,
genitourinary and
gastrointestinal defects, cardiac
defects

14-60 days

Valproic acid

CNS defects (including


development delay),
brachycephaly, craniosynostosis,
microcephaly, ocular
hypertelorism, midface
hypoplasia, cleft lip/palate, limb
abnormalities, spina bifida

14-60 days

Warfarin

CNS and ocular defects, IUGR,


neonatal hemorrhage, nasal
hypoplasia, vertebral anomalies,
stippled epiphysis

6-9 weeks; after


9 weeks, CNS,
ocular and
disruptive
defects