API

Adapalene (0.1% w/w)

Drug classification

Topical retinoid; naphthoic acid derivative.

Dosage form

Topical gel containing adapalene 0.1% w/w.

API strength per dosage

Dose

Adiff Gel (adapalene 0.1%) is typically applied once daily in a thin layer to affected skin areas after cleansing. Safety and efficacy are established in patients 12 years and older. Use in severe renal or hepatic impairment has not been specifically studied; caution is advised. Avoid application to damaged or eczematous skin.

Mechanism of action

Adapalene is a synthetic retinoid that selectively binds to retinoic acid receptors (RAR-β and RAR-γ) in the skin, modulating gene expression. This normalizes keratinocyte differentiation, decreases microcomedone formation, and reduces inflammation, resulting in improved acne lesion clearance.

Indications

Acne

Side effects

Erythema skin redness Dry skin Skin peeling Skin burn Itching

Pregnancy category

Adapalene topical use in pregnancy should be avoided unless clearly needed; limited human data, animal studies show potential fetal risk with systemic exposure.

Precautions

Avoid contact with eyes, lips, mucous membranes, broken skin; use sunscreen, minimize sun exposure; may cause local irritation, dryness, erythema; discontinue if severe irritation or allergic reaction occurs; not for use in pregnancy; monitor for worsening acne or dermatitis; avoid concurrent use of other irritant topical products.

Contraindications

Hypersensitivity to adapalene or any component of the formulation, eczema, sunburn, pregnancy, history of photosensitivity, use on damaged or broken skin.