Adapalene Gel, 0.1%

Rx Only

Adapalene gel 0.1%, containing adapalene USP, is used for the topical treatment of acne vulgaris. Each gram of adapalene gel 0.1% contains adapalene USP 0.1% (1 mg) in a vehicle consisting of carbomer homopolymer, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide.

The chemical name of adapalene USP is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. Adapalene USP is a white to off-white powder which is sparingly soluble in tetrahydrofuran, very slightly soluble in diethyl ether. The molecular formula is C₂₈H₂₈O₃ and molecular weight is 412.52. Adapalene USP is represented by the following structural formula:

Adapalene is a chemically stable, retinoid-like compound. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris.

Mechanistically, adapalene binds to specific retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein. Although the exact mode of action of adapalene is unknown, it is suggested that topical adapalene may normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.

Adapalene gel, 0.1% is indicated for the topical treatment of acne vulgaris.

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

Use of adapalene gel should be discontinued if hypersensitivity to any of the ingredients is noted. Patients with sunburn should be advised not to use the product until fully recovered.

Some adverse effects such as erythema, scaling, dryness, pruritus, and burning will occur in 10-40% of patients. Pruritus or burning immediately after application also occurs in approximately 20% of patients. The following additional adverse experiences were reported in approximately 1% or less of patients: skin irritation, burning/stinging, erythema, sunburn, and acne flares. These are most commonly seen during the first month of therapy and decrease in frequency and severity thereafter. All adverse effects with use of adapalene gel during clinical trials were reversible upon discontinuation of therapy.

Adapalene gel is intended for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. The acute oral toxicity of adapalene gel in mice and rats is greater than 10 mL/kg. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.

Adapalene gel 0.1% should be applied once a day to affected areas after washing in the evening before retiring. A thin film of the gel should be applied, avoiding eyes, lips, and mucous membranes.

During the early weeks of therapy, an apparent exacerbation of acne may occur. This is due to the action of the medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after eight to twelve weeks of treatment.

Adapalene gel, 0.1% is supplied in the following size:

45 g laminate tube NDC 42546-720-45

Manufactured by:

Glenmark Pharmaceuticals Ltd.
Colvale-Bardez, Goa 403 513, India

Manufactured for:

PruGen Pharmaceuticals
Scottsdale, AZ 85255

Questions? (866) 696-8525
www.prugen.com

June 2015

PE304260914-1

NDC 42546-720-45
Rx only

PRUGEN™
PHARMACEUTICALS

ADAPALENE Gel 0.1%

45 grams

For External Use Only. Not For Ophthalmic Use.