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DERMATOLOGICALS › ANTI-ACNE PREPARATIONS › ANTI-ACNE PREPARATIONS FOR SYSTEMIC USE › Retinoids for treatment of acne
isotretinoin
D10BA01
Forms & Strengths
- Oral capsules: 10 mg
- Oral capsules: 20 mg
- Oral capsules: 30 mg
- Oral capsules: 40 mg
Adult Dosing
- Initial dose: 0.5 mg/kg/day to 1.0 mg/kg/day given in two divided doses with food for 15 to 20 weeks
- Maintenance/Adjustment: May adjust dose based on toxicity and clinical response up to 2.0 mg/kg/day
- Cumulative target dose: 120 mg/kg to 150 mg/kg per course to minimize relapse
Pediatric Dosing
- Children <12 years: Safety and efficacy not established
- Adolescents (12 years and older): Same as adult dosing based on weight (0.5 to 1.0 mg/kg/day)
Indications
- Severe recalcitrant nodular acne
- Acne unresponsive to conventional anti-acne therapies including systemic antibiotics
Mechanism of Action
- Retinoid that binds to nuclear retinoic acid receptors (RAR) and retinoid X receptors (RXR)
- Induces apoptosis in sebocytes, reducing sebaceous gland size and sebum production
- Inhibits comedogenesis and decreases Cutibacterium acnes colonization by altering follicular keratinization
Contraindications
- Pregnancy (Category X; highly teratogenic, causes severe birth defects)
- Hypersensitivity to isotretinoin, vitamin A, or other retinoids
- Significant hepatic impairment
- Hypervitaminosis A
- Concomitant tetracycline therapy (risk of pseudotumor cerebri)
Adverse Reactions
- Common: Cheilitis, dry skin, dry eyes, epistaxis, xerostomia, pruritus, myalgia, arthralgia
- Serious: Teratogenicity, depression, suicidal ideation, psychosis, pseudotumor cerebri, hepatotoxicity, pancreatitis
- Laboratory abnormalities: Elevated serum triglycerides, cholesterol, transaminases, and creatine kinase
Drug Interactions
- Tetracyclines: Increased risk of pseudotumor cerebri (benign intracranial hypertension); avoid concurrent use
- Vitamin A supplements: Additive toxic effects; avoid concurrent use
- Micro-dose progestin-only contraceptives ('minipills'): Reduced efficacy; barrier methods required
- Systemic corticosteroids: May increase risk of osteoporosis and myopathy
- Phenytoin: Increased risk of osteomalacia
Curated Content: Needs Vetting Before Put to Clinical Use