Composition
Cap/Tab 2.5 mg/5 mg/10 mg/20 mg/40 mg: Isotretinoin 2.5 mg/5 mg/10 mg/20 mg/40 mg.
Indications & Dosage
Acne vulgaris, Cysticand conglobate acne, severe acne unre-sponsive to antibiotic therapy: Adults: Initially 0.5 mg/kg body wt. daily as a single dose or in two divided doses with food for 4 weeks. Adjust according to response in range 0.1-1 mg/kg body Wt. daily for a further 8-12 wk. Discontinue if no response within first 4 weeks Children: Not recommended.
Contraindications
Renal or hepatic impairment, Hyperlipidaemia, pregnancy (effective contraceptive measures must be taken 1 month before, during and 1 month after therapy) lactation
Precautions
Monitor liver function before and during treatment; reduce dose or discontinue if transaminase levels exceed normal. Monitor fasting serum lipids before and during treatment; discontinue if hyper-triglyceridaemia is uncontrolled or symptoms of pancreatitis occur. History of depression; monitor all patients for signs of depression and suicidal ideation. Avoid dermabrasion for 5-6 months, or wax epilation for minimum 6 months, after treatment. History of intestinal disorders: discontinue if severe diarrhoea. Monitor for keratitis with dry eye.
Interactions
High dose vitamin A, tetracyclines.
Side Effects
Local irritation, dryness, erosion of mucosa, alopecia, rise in liver enzymes and serum triglycerides (risk of fatal pancreatitis), nausea, headache, drowsiness, sweating, mood changes, neurological disorders, psychiatric reactions, seizures, menstrual irregularities, myalgia, arthralgia, reversible haematuria and proteinuria, allergic vasculitis, thrombocytopenia, visual disturbances (consider withdrawal). Rarely: facial hyperpigmentation, hirsutism, acne fulminans, lymphadenopathy.