Isotretinoin (13-Cis-Retinoic Acid, Vitamin A Metabolite)(eye so tret’ i noyn)
AmnesteemDNC, ClaravisDNC, SotretDNC
PREGNANCY CATEGORY X
Drug Classes
Acne product
Retinoid (first generation)
Vitamin metabolite
Therapeutic Actions
Decreases sebaceous gland size and inhibits sebaceous gland differentiation, resulting in a reduction in sebum secretion; inhibits follicular keratinization; exact mechanism of action is not known.
Indications
Treatment of severe recalcitrant nodular acne unresponsive to conventional treatments
Unlabeled uses: Treatment of cutaneous disorders of keratinization, cutaneous T-cell lymphoma and leukoplakia, psoriasis, rosacea, pityriasis rubra pilaris, keratoacanthomas
Contraindications and Cautions
Contraindicated with allergy to isotretinoin, parabens, or product component; pregnancy (has caused severe fetal malformations and spontaneous abortions); lactation.
Use cautiously with history of severe depression, suicidal ideation, diabetes mellitus, pediatric patients with genetic predisposition to age-related osteoporosis, a history of childhood osteoporosis, osteomalacia, other diseases of bone metabolism.
Available Forms
CapsulesDNC—10, 20, 30, 40 mg; soft gel capsulesDNC—10, 20, 30, 40 mg
Dosages
Adults and pediatric patients 12 yr and older
Individualize dosage based on side effects and disease response. Initial dose, 0.5–1 mg/kg/day PO; usual dosage range is 0.5–2 mg/kg/day PO divided into two doses for 15–20 wk. Maximum daily dose, 2 mg/kg. If a second course of therapy is needed, allow a rest period of at least 8 wk between courses. Must take with food or absorption of drug will decrease.
Pharmacokinetics
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Metabolism: Hepatic; T1/2: 10–20 hr
Distribution: Crosses placenta; may enter breast milk
Excretion: Urine
