Azelaic Acid 20% topical

Indications

Azelaic Acid 20% topical is used for: Acne vulgaris, Rosacea, Rosacea melasma, Post inflammatory hyperpigmentation

Adult Dose

Topical Acne vulgaris Adult: As 20% cream: Apply into the affected areas bid (morning and evening). Improvement may be detectable w/n 4 wk. Duration of treatment: Up to 6 mth. Topical Rosacea Adult: Apply into the affected areas bid (morning and evening). Improvement occurs in 4-8 wk.

Child Dose

Topical Acne vulgaris, Rosacea Child: >12 yr Same as adult dose. <12 years: Safety and efficacy not established

Renal Dose

Administration

Cleanse affected area with mild soap or soapless cleansing lotion and pat dry before applying. Apply thinly into the affected areas bid (morning and evening) after cleansing.

Contra Indications

Hypersensitivity to any of the ingredients.

Precautions

Pregnancy, lactation. Avoid contact with eyes, mouth or other mucous membranes. Occlusive dressings or wrappings should not be used. Recommend patient to use only very mild soaps or soapless cleansing lotions for facial washing. Monitor for hypopigmentation in patients with dark complexion. Safety and efficacy not established in children <12 yr. Lactation: enters breast milk; use with caution

Pregnancy-Lactation

Pregnancy Category: B Lactation: enters breast milk; use with caution

Interactions

There have been no formal studies of the interaction of Azelaic Acid Gel with other drugs.

Adverse Effects

Side effects of Azelaic Acid 20% topical : >10% Burning/ stinging/ tingling (4-16%) 1-10% Pruritus (1-6%), Scaling/ dry skin/ xerosis (1-5%), Erythema/ irritation (1-2%) <1% Contact dermatitis, Edema, Acne

Mechanism of Action

Azelaic acid is a naturally-occurring aliphatic dicarboxylic acid. The exact mechanism of action in treatment of acne vulgaries has not been fully established. It is believed to inhibit the growth of susceptible organisms (mainly Propionibacteria Acnes) on the skin surface, and inhibits follicular keratinisation thus restricts the development of comedones. Mechanism of action in the treatment of rosacea is unknown.