Azedrem

“Cream”

 

 

Composition:

AZELAIC ACID 20 %.

 

Clinical pharmacology:

Azelaic acid demonstrated a reduction in the thickness of the stratum comeum, a reduction in number and size of keratohyaline granules.

 

Indications and usage:

Indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.

 

Contraindications:

Contraindicated in individuals who have shown hypersensitivity to any of its components.

 

Warnings:

-       Azederm is indicated for dermatological use only and not for ophthalmic use.

-       Use Azederm for the full-prescribed treatment period.

-       Avoid the use of occlusive dressings or wrappings.

-       Keep away from the mouth, eyes, and other mucous membranes. If Azederm comes into contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists.

-       This drug should be used during pregnancy only if clearly needed.

-       Caution should be exercised when it is administered to a nursing mother.

-       Safety and effectiveness in pediatric patients less than 12 years of age have not been established.

 

Side effects:

Pruritus, burning, stinging, tingling, and peeling were rarely reported.

 

Dosage and administration:

-       After the skin is thoroughly washed and patted dry, a thin film of Azederm should be gently but thoroughly massaged into the effected areas twice daily, in the morning and evening.

-       Hands should be washed following application.

-       The duration of use 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.

 

v  Protect from freezing.

v  Store between 15-30°C.

 

Presentation:

Aluminum tube containing 20 g of Azederm Cream.