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Adapalene - Topical Gel 0.1%


Category:

Antiacne agent (topical)

Composition :

Each 1 gram of adapalene gel contains 1 mg adapalene

Chemistry :

molecular formula: C28H28O3

Mechanism of Action:

Adapalene exhibits some retinoic acid-like activity but it also has additional effects. It is thought that adapalene reduces important features of the pathology of acne vulgaris by normalizing the differentiation of follicular epithelial cells and keratinization to prevent microcomedone formation, similar to the mechanism of retinoic acid. It is hypothesized that by selectively binding to certain nuclear retinoic acid receptors and not others, adapalene enhances keratinocyte differentiation without inducing epidermal hyperplasia and severe irritation, such as is seen with retinoic acid. Also, adapalene may help reduce cell-mediated inflammation, an effect demonstrated by in vitro studies. Adapalene decreases formation of comedones and inflammatory and non inflammatory acne lesions.

Pharmacokinetics:

Absorption: Low absorption through skin. Onset of action: Although clinical response may be detected in 1 to 2 weeks, an optimal response is typically seen after 8 to 12 weeks. Elimination: Fecal (biliary)

Indications:

Adapalene is indicated for the treatment of acne vulgaris. It is most effective for treating mild to moderate acne vulgaris.

Contraindications:

Adapalene gel should not be administered to individuals who are hypersensitive to adapalene or any of the components of this product.

Warnings:

Hypersensitivity: Use of adapalene gel should be discontinued if hypersensitivity to any of the ingredients is noted. Burnt skin: Patients with sunburn should be advised not to use the product until fully recovered. Usage in pregnancy: It is recommended that pregnant women do not use adapalene, based on data for other topical retinoids. As a general precaution, women of reproductive age may want contraception counseling before initiating treatment. FDA Pregnancy Category C. Breast-feeding: It is not known whether adapalene is distributed into breast milk. Pediatrics: Safety and efficacy in children up to 12 years age have not been established.

Precautions:

Carcinogenicity / Tumorigenicity: Although no photo carcinogenicity studies were conducted with adapalene, other topical retinoids have shown increased risk of tumorigenicity in animals when they were exposed to sunlight or ultraviolet irradiation, But not in all test systems. The significance , in humans is not known.

Drug Interactions:

  • Acne products, or topical products containing a peeling agents, such as: Clindamycin , Erythromycin, Benzoyl peroxide, Resorcinol, Salicylic acid ,Sulfur.
  • Alcohol-containing products or products containing strong drying agents, such as: After-shave lotions, Astringents, Cosmetics or soaps with a strong drying effect , Shaving creams or lotions.
  • Hair products, skin irritating, such as: hair permanents or hair removal products
  • Products containing lime or spices, topical soaps or skin cleansers, abrasive: Concurrent use with adapalene may cause a cumulative irritating or drying effect resulting in irritation of the skin and/or sensitivity to the sun.if these effects occur, adapalene should be discontinued or initiation of treatment delayed until skin irritation has subsided. Use of benzoyl peroxide or topical antibiotics with adapalene on the same area of the skin at the same time is not recommended. A physical incompatibility between the medications or a change pH may reduce adapalene's efficacy if used simultaneously. When used together for clinical effect, it is recommended that these medications be used at different times of the day, such as morning and night, to minimize possible skin irritation. If irritation results, the dose of adapalene may need to be reduced or temporarily discontinued until the skin is less sensitive.

Side effects:

  • Incidence more frequent: Burning sensation or stinging of skin, erythema, pruritus, scaling.
  • Incidence rare: Acne flare

Dosage and Administration

  • Usual adult and adolescent dose: Topical, to the involved areas of the skin, once a day as a thin film applied to clean, dry skin at least one hour before bedtime.
  • Usual pediatric dose: Safety and efficacy have not been established.
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