Azelaic acid

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. 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.

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

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. Apply a thin layer twice daily to affected area(s).

None. None.

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. If sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy. Hypopigmentation: Isolated cases of hypopigmentation occurred after azelaic acid use. Monitor patients with dark complexion for early signs of hypopigmentation. Eye and Mucous Membrane Irritation: azelaic acid gel has been reported to cause irritation of the eyes.

The most common adverse reactions are burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%).

Store at 25°C (77°F), excursions permitted between 15-30°C (59-86°F).