Avita Cream

The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication dosing frequency should be adjusted temporarily to a level the patient can tolerate. However, efficacy has not been established for lower dosing frequencies. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of AVITA® Cream. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with AVITA® Cream. Adverse effects of AVITA® Cream have been reversible upon discontinuation of therapy (see DOSAGE AND ADMINISTRATION).

AVITA® Cream, a topical retinoid, contains tretinoin 0.025% by weight in a hydrophilic cream vehicle of stearic acid, polyolprepolymer-2, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-transretinoic acid (C20H2802; molecular weight 300.44 vitamin A acid) and has the following structural formula:

In one vehicle-controlled clinical trial, AVITA® (tretinoin cream) Cream 0.025%, applied once daily was more effective than vehicle in the treatment of facial acne vulgaris of mild to moderate severity. Percent reductions in lesion count after treatment for 12 weeks in this study are shown in the following table:

If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A.

AVITA® (tretinoin cream) Cream, 0.025% is supplied as:

Storage Conditions: Store below 30°C (86°F). Avoid freezing.

Keep this and all medications out of the reach of children.

Rx Only

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Revised November 2013
023.5
Patent #: 5,650,171

• Acanya
• Accutane
• BenzaClin
• Differin Cream
• Differin Gel .1
• Differin Gel .3
• Differin Lotion .1
• Duac

• Finacea
• MetroCream
• Retin-A
• Retin-A Micro
• Sumadan
• Sumaxin Cleansing Pads
• Sumaxin Wash and Topical Solution

© Avita Cream Patient Information is supplied by Cerner Multum, Inc. and Avita Cream Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.