Azelaic Acid

What it is and how it works

Mechanism of Action The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown.

Indications

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, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea . Limitations of Use Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.

Dosage and administration (summary)

• 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.

Contraindications

None. None.

Warnings and precautions

• Hypersensitivity: Hypersensitivity reactions, including cases of angioedema, eye swelling, facial swelling, dyspnea, urticaria, and adverse skin reactions, have been reported. In case of known hypersensitivity to any component of the gel, avoid the use of azelaic acid gel. If hypersensitivity develops, discontinue treatment and institute appropriate therapy. • Skin Reactions: Skin irritation (i.e. pruritus, burning or stinging) may occur, usually during the first few weeks of treatment.

Pregnancy

Pregnancy Risk Summary Azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug .

Storage and supply

How Supplied Azelaic Acid Gel, 15%, a white to yellowish white opaque gel, is supplied in 50 g tubes (NDC 68462-626-52). Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .

Source: Azelaic Acid (Azelaic Acid) — US FDA prescribing information, 2021-12-23, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.