Isotretinoin (Oral)

Generic Name

Isotretinoin-oral

Other Names

• Accutane
• Amnesteem
• Claravis
• Sotret

Drug Class

• Retinoid

Chemical Formula

C20H28O2

Molecular Weight

300.44 g/mol

Mechanism of Action

• Isotretinoin reduces sebum production and keratinization in the sebaceous glands.

Indications

• Severe nodular acne
• Acne unresponsive to conventional therapy

Common Dosage Forms

• Capsules

Typical Dosage

• 0.5-1 mg/kg/day in two divided doses with food

Pediatric Dosage

• Safety and efficacy not established in pediatric patients

Geriatric Dosage

• Adjust dosage based on renal function

Side Effects

• Dry skin
• Chapped lips
• Dry eyes
• Nosebleeds
• Joint pain
• Temporary hair thinning

Contraindications

• Pregnancy
• Breastfeeding
• Liver disease
• Hypervitaminosis A

Pregnancy Category

• Category X

Lactation Safety

• Not recommended. It is excreted in breast milk.

Drug Interactions

• Tetracyclines
• Vitamin A supplements
• Corticosteroids

Overdose Symptoms

• Headache
• Dizziness
• Vomiting
• Stomach pain

Antidote for Overdose

• There is no specific antidote. Supportive care is advised.

Storage Conditions

• Store at controlled room temperature (20-25°C)

Pharmacokinetics

• Absorption: Well absorbed after oral administration
• Distribution: Highly bound to plasma proteins
• Metabolism: Extensively metabolized by the liver
• Excretion: Primarily excreted in the feces

Precautions

• Monitor liver function tests
• Use effective contraception during treatment and for at least 1 month after stopping therapy

Warnings

• Teratogenicity - must not be used during pregnancy