Generics: Azelaic acid
Dosage Form: Cream.
Azelaic Acid cream is indicated for the topical treatment of mild to moderate inflammatory acne vulgaris.
Azelaic acid has been shown to possess antimicrobial activity against Propionibacterium acnes and Staphylococcus epidennidis. The antimicrobial action may be attributable to the inhibition of microbial cellular protein synthesis. A normalization of keratinization leading to an anticomedonal effect of Azelaic acid may also contribute to its clinical activity.
Three times in daily.
After the skin is thoroughly washed and patted dry, a thin film of Azelaic Acid should be gently but thoroughly massaged into the affected areas twice daily, in the morning and evening. The hands should be washed following application. Safety and effectiveness in pediatric patients under 12 years of age have not been established. Or as directed by the physician.
Route of administration: Topically.
Azelaic acid is contraindicated in individuals who have shown hypersensitivity to any of its components.
Local skin irritation (e.g. erythema, scaling, itching or burning) occurs in occasional cases, usually at the start of treatment. However, in the majority of cases the irritation is mild and regresses as treatment continues.
Pregnancy & Lactation:
FDA Pregnancy Category B. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Azelaic acid is administered to a nursing mother.
Precautions & Warnings:
For external use only. If Azelaic acid comes into contact with the eyes they should immediately be thoroughly rinsed with copious amounts of water. The patients should consult a physician if eye irritation persists.
Acne treatment preparations.
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Manufactured by: Acme Laboratories Ltd.