isotretinoin: clinical use

Prescribing considerations

• Reserve for severe acne resistant to adequate standard therapy.
• Initiation and supervision require expertise in systemic retinoids and risk management.
• Use the current Acknowledgement of Risk process and counsel about teratogenic, psychiatric and sexual-function risks.
• Assess mental health and sexual function before prescribing and during follow-up.

Contraindications and cautions

• Pregnancy or breastfeeding
• Potential for pregnancy unless every applicable Pregnancy Prevention Programme condition is met
• Hepatic insufficiency
• Excessively elevated blood lipids
• Hypervitaminosis A
• Concurrent tetracycline treatment
• Hypersensitivity to isotretinoin or an excipient; the selected capsules are contraindicated with peanut or soya allergy

Monitoring

• Pregnancy risk, contraception and medically supervised pregnancy testing where applicable
• Mental health and sexual function before treatment and at follow-up
• Liver enzymes and fasting serum lipids, adjusted to clinical risk
• Consider blood glucose and more frequent lipid monitoring in higher-risk patients
• Promptly assess significant visual, gastrointestinal, musculoskeletal, skin or neurological symptoms

Clinical pharmacology

Isotretinoin suppresses sebaceous-gland activity and sebum production. Active metabolites, including 4-oxo-isotretinoin, contribute to its effects; food improves capsule absorption.

Formulation and product differences

• The selected product is a soft gelatin capsule containing refined and partly hydrogenated soya-bean oil and sorbitol.
• It is contraindicated with peanut or soya allergy and unsuitable for hereditary fructose intolerance.
• Store the selected product in its original packaging below 30°C.

Capsule

Route: Oral

Strengths: 5 mg, 10 mg, 20 mg