API

Isotretinoin (20mg)

Drug classification

Retinoid; specifically, a first-generation oral retinoid (vitamin A derivative).

Dosage form

Film-coated oral tablet containing 20 mg isotretinoin.

API strength per dosage

Dose

Isotretinoin dosing is individualized, typically starting at 0.5 mg/kg/day in divided doses for adults and adolescents, adjusted up to 1 mg/kg/day as tolerated. Use in children under 12 is not established. Contraindicated in severe hepatic or renal impairment. Dose adjustments or discontinuation may be required for adverse effects. Always follow specialist supervision and product guidelines.

Mechanism of action

Isotretinoin, the active ingredient in Glotret 20 Tablet, is a retinoid that modulates gene expression by binding to retinoic acid receptors (RARs) and retinoid X receptors (RXRs). This reduces sebaceous gland size and sebum production, inhibits keratinization, and decreases Propionibacterium acnes colonization, leading to improvement in severe acne.

Indications

Treatment of Acne

Side effects

Dry skin Increased liver enzymes Rash

Pregnancy category

Isotretinoin is contraindicated in pregnancy due to a high risk of severe birth defects; effective contraception is essential during treatment and for a period after discontinuation.

Precautions

Teratogenicity—strict contraception required, baseline and periodic liver function tests, lipid profile monitoring, monitor for depression or mood changes, avoid vitamin A supplements, caution in diabetes, avoid blood donation during and after treatment, monitor for musculoskeletal symptoms, assess for pseudotumor cerebri, regular follow-up for adverse effects.

Contraindications

Pregnancy, breastfeeding, hypersensitivity to isotretinoin or excipients, hepatic insufficiency, severe hyperlipidemia, concomitant use of tetracyclines, pre-existing hypervitaminosis A.