The composition is indicated for the topical treatment of mild to moderate inflammatory acne vulgaris.
Azelaic acid possess antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis. The antimicrobial action is attributable to inhibition of microbial cellular protein synthesis. A normalization of keratinization leading to an anticomedonal effect of azelaic acid also contributes to its action.
Thoroughly wash and pat dry the skin, a thin film of Azelaic acid cream should be gently but thoroughly massaged into the affected areas twice daily, in the morning and evening.
Hypersensitivity to any of its components or any other excipients of the formulation.
Known hypersensitivity, Skin irritation may occur, monitor the patients for early signs of hypopigmentation in patients with dark complexion, Avoid contact with the eyes and mucous membranes.
Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women, caution should be exercised when administered to a nursing mother, Safety and effectiveness in pediatric patients have not been established.
There have been no formal studies of the interaction of Azelaic acid cream with other drugs.
The most common adverse reactions are pruritus, burning, stinging and tingling.