ATRALIN- tretinoin gel
DESCRIPTION
Atralin (tretinoin) Gel, 0.05% is translucent to opaque, pale yellow gel containing 0.05% tretinoin, by weight for topical administration.
Chemically, tretinoin is all-trans -retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is member of the retinoid class of compounds, and metabolite of Vitamin A. Tretinoin has molecular weight of 300.44, molecular formula of C20 H28 O2
Other components of this formulation are benzyl alcohol, butyl paraben, butylated hydroxytoluene, carbomer 940, ethylparaben, fish collagen hydrolyzates, glycerin, iso-butyl paraben, methylparaben, octoxynol 9, phenoxyethanol, propylparaben, purified water, sodium hyaluronate, and trolamine. The contribution to efficacy of individual components of the vehicle has not been evaluated.
Mechanism of Action
Tretinoin is metabolite of Vitamin that binds with high affinity to specific retinoic acid receptors located in both the cytosol and nucleus, but cutaneous levels of tretinoin in excess of physiologic concentrations occur following application of tretinoin-containing topical drug product.
Although tretinoin activates three members of the retinoid acid (RAR) nuclear receptors (RAR?, RAR?, and RAR?) which act to modify gene expression, subsequent protein synthesis, and epithelial cell growth and differentiation, it has not been established whether the clinical effects of tretinoin are mediated through activation of retinoic acid receptors, other mechanisms, or both.
INDICATIONS AND USAGE
Atralin Gel is indicated for topical treatment of acne vulgaris.
2 DOSAGE AND ADMINISTRATION
For topical use only. Not for ophthalmic, oral, or intravaginal use.
Atralin Gel should be applied once daily, before bedtime, to the skin where acne lesions appear, using thin layer to cover the entire affected area. Atralin Gel should be kept away from the eyes, the mouth, paranasal creases, and mucous membranes. Application of excessive amounts of gel will not provide incremental efficacy.
Patients treated with Atralin Gel may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied.
When treating with Atralin Gel, caution should be exercised with the use of concomitant topical over-the-counter preparations, topical medications, medicated or abrasive soaps and cleansers, products that have strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime. Particular caution should be exercised with acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Allow the effects of such preparations to subside before use of Atralin Gel has begun.
3 DOSAGE FORMS AND STRENGTHS
Gel, 0.05%
Each gram of Atralin Gel contains 0.5 mg (0.05%) tretinoin in translucent to opaque, pale yellow topical gel.
Pregnancy
Pregnancy Category C
Storage and Handling: Store at controlled room temperature 20? 25?C (68? 77?F) with excursions permitted between 15?-30?C (59?-86?F). Protect from freezing. Keep out of reach of children.
PATIENT COUNSELING info.
See FDA-Approved Patient Labeling (Patient info.)
Instruct patients to clean the affected areas with an appropriate cleanser before applying Atralin Gel.
Patients may use moisturizers that are non-comedogenic, and should avoid products that could be drying or irritating.
Patients may also wear cosmetics while being treated with Atralin Gel; however, they should be instructed to remove the cosmetics and clean the area thoroughly before applying Atralin Gel.
Warn patients of the drying and irritation effects often seen during treatment. Continue use of the medication if these effects are tolerable.
Caution patients against application of Atralin Gel around the eyes, mouth, paranasal creases, and mucous membranes as the skin is especially prone to irritation.
Minimize exposure to sunlight, including sunlamps. Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided.
