API

Azelaic Acid (20% w/w)

Drug classification

Aziderm 20% Gel is a topical dermatological agent; specific subclass: dicarboxylic acid.

Dosage form

Topical gel containing 20% w/w azelaic acid.

API strength per dosage

Dose

Apply a thin layer of Aziderm 20% Gel to affected skin areas twice daily, morning and evening, after cleansing. Gently rub in. For sensitive skin, start with once daily. Safety and efficacy in children under 12 years are not established. No specific dose adjustments for renal or hepatic impairment are provided in product information.

Mechanism of action

Azelaic acid inhibits mitochondrial oxidoreductases and 5-α-reductase, reducing reactive oxygen species and sebum production. It also inhibits keratinocyte proliferation and modulates epidermal differentiation. Additionally, it has antimicrobial effects against Cutibacterium acnes and Staphylococcus epidermidis, reducing inflammation and comedone formation in acne and rosacea.

Indications

Treatment of Acne

Side effects

Application site reactions burning irritation itching and redness

Pregnancy category

Azelaic acid topical use in pregnancy appears low risk; limited human data show no increased fetal harm. Use if clearly needed and as directed.

Precautions

Avoid contact with eyes, mouth, and mucous membranes, monitor for skin irritation or hypersensitivity, use caution in patients with asthma, apply only to affected areas, discontinue if severe irritation occurs, use sunscreen to prevent photosensitivity, assess for improvement after several weeks, not for use on broken or sunburned skin.

Contraindications

Hypersensitivity to azelaic acid or any component of the formulation, history of severe allergic reactions to topical medications, avoid application to broken, sunburned, or eczematous skin.