Overview
11 DESCRIPTION Azelaic Acid Gel, 15%, is a white to yellowish white opaque gel which contains azelaic acid, a naturally-occurring saturated dicarboxylic acid. It is for topical use. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The molecular formula for azelaic acid is C 9 H 16 O 4 . It has the following structure: Azelaic acid has a molecular weight of 188.22 g/mol.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown. 12.2 Pharmacodynamics The pharmacodynamics of azelaic acid in association with the treatment of rosacea are unknown. 12.3 Pharmacokinetics The percutaneous absorption of azelaic acid after topical application of azelaic acid gel could not be reliably determined. Mean plasma azelaic acid concentrations in rosacea subjects treated with azelaic acid gel twice daily for at least 8 weeks are in the range of 42 to 63.1 ng/mL. These values are within the maximum concentration range of 24 to 90.5 ng/mL observed in rosacea subjects treated with vehicle only.
Indications
- 1 INDICATIONS AND USAGE 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 ( 1 ).
Common Doses
- Refer to label
Dosage
2 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.
Contraindications
- 4 CONTRAINDICATIONS None. None. ( 4 )
Side Effects
- 6 ADVERSE REACTIONS The most common adverse reactions are burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates...
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.