Azelaic Acid
Class: Skin and Mucous Membrane Agents, Miscellaneous
ATC Class: D10AX03
VA Class: DE752
Chemical Name: Nonanedioic acid
Molecular Formula: C9H16O4
CAS Number: 123-99-9
Brands: Azelex, Finacea
Introduction
Antibacterial and antiproliferative agent; naturally occurring aliphatic dicarboxylic acid.
Uses for Azelaic Acid
Acne
Treatment of mild to moderate inflammatory acne vulgaris.
Not for the treatment of noninflammatory acne vulgaris.
Rosacea
Treatment of inflammatory lesions (papules and pustules) associated with mild to moderate rosacea.
Treatment of erythema in rosacea without papules and pustules has not been evaluated.
Azelaic Acid Dosage and Administration
Administration
Topical Administration
Apply topically to the skin as a 20% cream or 15% gel.
For dermatologic use only; avoid contact with eyes, mouth, or other mucous membranes. If contact with the eye(s) occurs, wash with large amounts of water; consult clinician if ocular irritation persists.
Wash skin and pat dry before applying cream or gel to affected areas. Use only very mild soaps or soapless cleansing lotions before applying gel for treatment of rosacea.
Apply in a thin layer of cream or gel and rub gently into affected areas. Wash hands after application.
If irritation is excessive or persists in patients with acne, decrease frequency of application to once daily or discontinue until manifestations subside.
If irritation is excessive or persists in patients with rosacea, discontinue therapy.
Do not use occlusive dressings or wrappings.
Allow gel to dry before applying cosmetics to skin.
Dosage
Pediatric Patients
Acne
Topical
Adolescents ≥12 years of age: Apply 20% cream in a thin film to affected areas twice daily (morning and evening).
Improvement usually is detectable within 1–2 months of initiating therapy; however, maximum benefit generally requires more prolonged treatment.
Usual duration of therapy is ≤6 months; however, therapy for ≥1 year has been required for control of individual lesions and repeat courses have been used for recurrences.
Adults
Acne
Topical
Apply 20% cream in a thin film to affected areas twice daily (morning and evening).
Improvement usually is detectable within 1–2 months of initiating therapy; however, maximum benefit generally requires more prolonged treatment.
Usual duration of therapy is ≤6 months; however, therapy for ≥1 year has been required for control of individual lesions and repeat courses have been used for recurrences.
Rosacea
Topical
Apply 15% gel in a thin film to affected area twice daily (morning and evening).
Safety and efficacy of therapy with gel for >12 weeks not established.
