Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Adapalene Topical Solution 0.1% is supplied in the following size: 60 mL glass bottle – NDC 71297-410-02 Storage: Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]; NDC 71297-410-02 Rx Only Adapalene Topical Solution, 0.1% For External Use Only Not for Ophthalmic Use; Carton Carton
- HOW SUPPLIED: Adapalene Topical Solution 0.1% is supplied in the following size: 60 mL glass bottle – NDC 71297-410-02 Storage: Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]
- NDC 71297-410-02 Rx Only Adapalene Topical Solution, 0.1% For External Use Only Not for Ophthalmic Use
- Carton Carton
Overview
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 28 H 28 O 3 and molecular weight is 412.52. Adapalene is represented by the following structural formula: structure
Indications & Usage
: Adapalene Topical Solution 0.1% is indicated for the topical treatment of acne vulgaris.
Dosage & Administration
: 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.
Warnings & Precautions
WARNINGS: 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.
Contraindications
: 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.
Adverse Reactions
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 Allegis Holding, LLC at 1-866-633-9033 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
As Adapalene Topical Solution 0.1% has the potential to produce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohols, astringents, spices or lime) should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with Adapalene Topical Solution 0.1%. If these preparations have been used, it is advisable not to start therapy with Adapalene Topical Solution 0.1% until the effects of such preparations in the skin have subsided.
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