"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
AVITA® Gel is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of this product in the treatment of other disorders have not been established.
DOSAGE AND ADMINISTRATION
AVITA® Gel should be applied once a day, in the evening, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Application may cause a transient feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment. Alterations of dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Efficacy has not been established for less than once-daily dosing frequencies.
During the early weeks of therapy, an apparent increase in number and exacerbation of inflammatory acne lesions may occur. This is due, in part, to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after two to three weeks, but more than six weeks of therapy may be required before definite beneficial effects are seen. Patients treated with AVITA® Gel may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied (see PRECAUTIONS Section).
AVITA® (tretinoin gel) Gel, 0.025% is supplied as:
Storage Conditions: Store below 30°C (86°F). Avoid freezing. Rx Only
Mylan Pharmaceuticals Inc. Morgantown, WV 26505. REVISED 08/2011This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/4/2017
Additional Avita Information
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