Adapalene Topical Solution

Adapalene Topical Solution 0.1%, containing adapalene is used for the topical treatment of acne vulgaris. Each mL of Adapalene Topical Solution, 0.1%, contains adapalene 0.1% (1 mg) in a vehicle consisting of polyethylene glycol 400 and alcohol, denatured, 30% (w/v).

The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. Adapalene is a white to off-white powder which is soluble in tetrahydrofuran, sparingly soluble in ethanol, and practically insoluble in water. The molecular formula is C ₂₈H ₂₈O ₃ and molecular weight is 412.52. Adapalene is represented by the following structural formula:

structure

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 is unknown, it is suggested that topical adapalene may normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.

Adapalene Topical Solution 0.1% is indicated for the topical treatment of acne vulgaris.

Adapalene Topical Solution 0.1% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the vehicle solution.

Use of Adapalene Topical Solution 0.1% 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 30-60% of patients. Pruritus or burning immediately after application also occurs in approximately 30% 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 the use of similar products during clinical trials were reversible upon discontinuation of therapy.

To report SUSPECTED ADVERSE REACTIONS, contact Rochester Pharmaceuticals at 1-866-458-1772 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Adapalene Topical Solution 0.1% 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 Topical Solution 0.1% 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.

1. Adapalene Topical Solution 0.1% should be applied once a day to affected areas.
2. Before retiring in the evening, wash and dry areas to be treated.
3. Apply a thin film of medication to the affected areas. Avoid the eyes lips, and mucous membranes.
4. Replace cap after each use.

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 Topical Solution 0.1% is supplied in the following size:

Carton containing 120 mL – NDC 49908-117-70

Storage: Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]

CAUTION: Federal law prohibits dispensing without prescription.

Distributed by:​

Rochester Pharmaceuticals

Doylestown, PA 18901

Rev. #, Date: 07/21

​NDC 49908-117-70

​Rx Only

​Adapalene Topical Solution, 0.1%

For External Use Only

Not for Ophthalmic Use

​Carton containing 120 mL

​Rochester Pharmaceuticals

Carton