Azelec20%

Azelec 20% cream is indicated for the topical treatment of mild to moderate inflammatory acne vulgaris.

Acne treatment preparations

Azelaic acid is a naturally-occurring aliphatic dicarboxylic acid that inhibits the growth of Propionibacterium acnes and reduces keratinisation, thus restricts the development of comedones.

Acne vulgaris: Adult: As 20% cream or 15% gel: Apply thinly into the affected areas bid (morning and evening) after cleansing. Improvement may be detectable w/n 4 wk. Duration of treatment: Up to 6 mth. Child: ≥12 yr Same as adult dose. Rosacea: Adult: As 15% gel: Apply thinly into the affected areas bid (morning and evening). Improvement occurs in 4-8 wk. Child: ≥12 yr Same as adult dose.

After the skin is thoroughly washed and patted dry, a thin film of Azelec 20% 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.

Avoid spicy foods, alcoholic beverages and hot drinks that might provoke erythema, flushing and blushing during treatment of rosacea.

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 Category B. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

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.

Store in a cool & dry place protected from light. Keep ail medicines out of reach of children.

Acne treatment preparations

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.

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.