Azelaic Acid Gel

Dosage form: gel
Drug classes:Topical acne agents, Topical anti-rosacea agents

Medically reviewed by Drugs.com. Last updated on Jan 1, 2022.

Indications and Usage for Azelaic Acid Gel

Azelaic Acid Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.

Limitations of Use

Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.

Azelaic Acid Gel Dosage and Administration

• Cleanse affected area(s) using only very mild soaps or soapless cleansing lotion and pat dry with a soft towel before application of Azelaic Acid Gel.
• Apply and gently massage a thin layer of Azelaic Acid Gel into the affected areas on the face twice daily (morning and evening).
• Wash hands immediately following application of Azelaic Acid Gel.
• Cosmetics may be applied after the application of Azelaic Acid Gel has dried.
• Reassess the diagnosis if no improvement is observed upon completing 12 weeks of therapy.
• Avoid the use of occlusive dressings or wrappings.
• Instruct patients to avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents.
• For topical use.
• Not for oral, ophthalmic or intravaginal use.

Dosage Forms and Strengths

Azelaic Acid Gel, 15% is a white to yellowish white opaque gel. Each gram of Azelaic Acid Gel contains 0.15 gm of azelaic acid (15% w/w).

Contraindications

None.

Warnings and Precautions

Hypersensitivity

Hypersensitivity reactions, including cases of angioedema, eye swelling, facial swelling, dyspnea, urticaria, and adverse skin reactions, have been reported during post marketing surveillance.

Avoid the use of Azelaic Acid Gel in patients with known hypersensitivity to any component of the gel. If hypersensiti...