Product Description.:
AZELEX
(azelaic acid) Cream 20%
For Dermatologic Use Only
Not for Ophthalmic Use
DRUG DESCRIPTION
AZELEX (azelaic acid cream) 20% contains azelaic acid, a naturally occurring saturated dicarboxylic acid.
Structural Formula: HOOC-(CH2)7-COOH.
Chemical Name: 1,7-heptanedicarboxylic acid
Empirical Formula: C9H16O4
Molecular Weight: 188.22
Active Ingredient: Each gram of AZELEX contains azelaic acid..........0.2 gm (20% w/w).
Inactive Ingredients: cetearyl octanoate glycerin glyceryl stearate and cetearyl alcohol and cetyl palmitate and cocoglycerides PEG-5 glyceryl stearate propylene glycol and purified water. Benzoic acid is present as a preservative.
INDICATIONS
AZELEX Cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.
DOSAGE AND ADMINISTRATION
After the skin is thoroughly washed and patted dry, a thin film of AZELEX Cream should be gently but thoroughly massaged into the affected areas twice daily, in the morning and evening. The hands should be washed following application. The duration of use of AZELEX Cream can vary from person to person and depends on the severity of the acne. Improvement of the condition occurs in the majority of patients with inflammatory lesions within four weeks.
SIDE EFFECTS
During U.S. clinical trials with AZELEX Cream, adverse reactions were generally mild and transient in nature. The most common adverse reactions occurring in approximately 1-5% of patients were pruritus, burning, stinging and tingling. Other adverse reactions such as erythema, dryness, rash, peeling, irritation, dermatitis, and contact dermatitis were reported in less than 1% of subjects. There is the potential for experiencing allergic reactions with use of AZELEX Cream. In patients using azelaic acid formulations, the following additional adverse experiences have been reported rarely: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris), and exacerbation of recurrent herpes labialis.
