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isotretinoin

D10AD04

Forms & Strengths

Oral capsules: 10 mg, 20 mg, 30 mg, 40 mg

Adult Dosing

Severe recalcitrant nodular acne: 0.5 to 2 mg/kg/day given in two divided doses for 15 to 20 weeks
Initial dose typically 0.5 to 1 mg/kg/day adjusted based on clinical response and tolerability
Cumulative target dose: 120 to 150 mg/kg per course

Pediatric Dosing

Children >= 12 years (puberty reached): Same as adult dosing for severe recalcitrant nodular acne
Safety and efficacy in patients < 12 years have not been established

Indications

Severe recalcitrant nodular acne unresponsive to conventional therapy, including systemic antibiotics

Mechanism of Action

Retinoid that binds to nuclear retinoic acid receptors, modulating gene transcription
Reduces sebaceous gland size and inhibits sebum production
Inhibits comedogenesis and decreases Cutibacterium acnes colonization
Exerts anti-inflammatory effects on skin lesions

Contraindications

Pregnancy (Category X; highly teratogenic, causes severe birth defects)
Hypersensitivity to isotretinoin, parabens, or other components of the formulation
Hepatic impairment
Hypervitaminosis A
Concomitant tetracycline therapy due to risk of pseudotumor cerebri

Adverse Reactions

Cheilitis, dry skin, pruritus, epistaxis, dry eyes, rash
Elevated liver enzymes (ALT, AST), hypertriglyceridemia, hypercholesterolemia
Arthralgia, myalgia, back pain
Depression, anxiety, mood changes, psychosis, suicidal ideation
Benign intracranial hypertension (pseudotumor cerebri)
Corneal opacities, decreased night vision

Drug Interactions

Tetracyclines: Increased risk of pseudotumor cerebri (contraindicated)
Vitamin A supplements: Increased risk of additive toxicities resembling hypervitaminosis A
Micro-dosed progestin-only contraceptives ('minipills'): May be inadequate for pregnancy prevention during therapy
Phenytoin: Risk of osteomalacia
Systemic corticosteroids: Increased risk of osteoporosis

Curated Content: Needs Vetting Before Put to Clinical Use