Atralin Information
Atralin (Tretinoin) Indications And Usage
Atralin (Tretinoin) Gel is a retinoid indicated for topical treatment of acne vulgaris.
Atralin (Tretinoin) Dosage And Administration
Atralin (Tretinoin) Gel should be applied once daily, before bedtime, to the skin where acne lesions appear, using a thin layer to cover the entire affected area. Atralin (Tretinoin) 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 (Tretinoin) Gel may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied.
Atralin (Tretinoin) Dosage Forms And Strengths
0.05% weight/weight topical gel, in 45 gram tubes
Atralin (Tretinoin) Contraindications
Atralin (Tretinoin) Warnings And Precautions
The skin of certain individuals may become dry, red, or exfoliated while using Atralin (Tretinoin) Gel. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use all together. Efficacy at reduced frequencies of application has not been established. If a reaction suggesting sensitivity occurs, use of the medication should be discontinued. Mild to moderate skin dryness may also be experienced; if so, use of an appropriate moisturizer during the day may be helpful.
Tretinoin has been reported to cause severe irritation on eczematous or sunburned skin and should be used with caution in patients with these conditions.
Topical over-the-counter acne preparations, concomitant topical medication, medicated cleansers, topical products with alcohol or astringents, when used with Atralin (Tretinoin) Gel, should be used with caution. .
Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Atralin (Tretinoin) Gel. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas is recommended when exposure cannot be avoided.
Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin.
Atralin (Tretinoin) Drug Interactions
When treating with Atralin (Tretinoin) Gel, caution should be exercised with the use of concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid. Allow the effects of such preparations to subside before use of Atralin (Tretinoin) Gel is begun.
Atralin (Tretinoin) Use In Specific Populations
Safety and effectiveness in children below the age of 10 have not been established.
A total of 381 pediatric subjects (aged 10 to 16 years), treated with Atralin (Tretinoin) Gel were enrolled into the two clinical studies. Across these two studies, comparable safety and efficacy were observed between pediatric and adult subjects.
Atralin (Tretinoin) Description
Atralin (Tretinoin) Gel is a translucent to opaque, pale yellow topical gel containing 0.05% tretinoin, by weight. Other components of this formulation are benzyl alcohol, butyl paraben, butylated hydroxytoluene, carbomer 940, ethyl paraben, fish collagen hydrolyzates, glycerin, iso-butyl paraben, methylparaben, octoxynol 9, phenoxyethanol, propylparaben, purified water, sodium hyaluronate, and trolamine.
Chemically, tretinoin is all--retinoic acid, also known as (all-)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds, and a metabolite of Vitamin A. Tretinoin has a molecular weight of 300.44. Tretinoin has the following structure:
The contribution to efficacy of individual components of the vehicle has not been evaluated.
Atralin (Tretinoin) Clinical Pharmacology
Tretinoin is a metabolite of Vitamin A 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 a tretinoin-containing topical drug product.
Although tretinoin activates three members of the retinoid acid (RAR) nuclear receptors (RARα, RARβ, and RARγ) 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.
Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.
In two (2) studies, the plasma levels of tretinoin and its major metabolites (13-cis-retinoic acid and 4-oxo-13-cis-retinoic acid) were investigated in a total of 14 patients (age: 13 – 25 years) with severe acne, who applied 4 g ± 0.5 g (range 3.5 g – 4.5 g) of Atralin (Tretinoin) Gel once daily to face, back and chest, as compared to a mean of 0.71 g (range of 0.07 – 3.71 g) applied in the controlled clinical trials. Blood samples were taken at baseline and immediately prior to treatment on days 1, 5, 10 and 14. On Day 14, the final study day, samples also were taken 1, 2, 4, 6, 8, 10, 12, 16, and 24 hours, post-treatment.
The plasma concentrations of tretinoin and its metabolites could be measured (LOQ = 0.5 ng/mL for all three analytes) in all patients at all time points. The range of plasma concentrations of tretinoin and its metabolites, 13-cis-retinoic acid and all-trans-4-oxo-retinoic acid at baseline and after multiple once daily applications of Atralin (Tretinoin) Gel, 0.05% for 14 days are given in Table 2 (below). Although some patients had increased concentrations of tretinoin or its metabolites over baseline values, no consistent increase in these concentrations were observed across patients.
Atralin (Tretinoin) Clinical Studies
The safety and efficacy of Atralin (Tretinoin) Gel used once daily before bedtime for the treatment of mild to moderate acne vulgaris were assessed in two 12-week prospective, multi-center, randomized, controlled studies. Subjects in these two studies ranged from 10 to 65 years of age, were approximately 52% female, 48% male, and were 74% Caucasian, 15% Black or African American, 3% Asian, and 8% Other.
Efficacy results at Week 12 are presented in Table 3. Success on the 6-point Global Severity Score is defined as a score of 0 (clear) or 1 (very mild). In Study 2, subjects were also required to have at least two grades reduction from baseline for success. 'Very mild' acne is defined as: The database was not large enough to assess whether there were differences in effects in age, gender, or race subgroups.
Atralin (Tretinoin) How Supplied/storage And Handling
Atralin (Tretinoin) Gel, 0.05% is available as:
Atralin (Tretinoin) Patient Counseling Information
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Warn patients of the drying and irritation effects often seen during treatment. Direct patients to continue use of the medication if these effects are tolerable.
Caution patients against application of Atralin (Tretinoin) Gel around the eyes, mouth, paranasal creases, and mucous membranes as this skin is especially prone to irritation.
Instruct patients to clean the affected areas with an appropriate cleanser before applying Atralin (Tretinoin) 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 (Tretinoin) Gel. However, they should be instructed to remove the cosmetics and clean the area thoroughly before applying Atralin (Tretinoin) Gel.
Atralin (Tretinoin)
Atralin (Tretinoin)
