Adapalene

Adapalene gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Wash affected areas gently with a non-medicated soap. Apply a thin film of adapalene gel to the entire face and any other affected areas of the skin once daily in the evening. Avoid application to the areas of skin around eyes, lips, and mucous membranes. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of adapalene gel. 

Instruct patients to minimize sun exposure and to use moisturizers for relief of dry skin or irritation.

If therapeutic results are not noticed after 12 weeks of treatment, therapy should be re-evaluated. 

For topical use only. Not for ophthalmic, oral or intravaginal use.

Each gram of adapalene gel USP, 0.3% contains 3 mg adapalene, USP in an off-white aqueous gel.

Available data from clinical trials with adapalene gel use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 40 and 81 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively.  

No malformations were observed in rats treated with oral adapalene doses of 0.15 to 5.0 mg/kg/day, up to 8 times the MRHD based on a mg/m²comparison. However, malformations were observed in rats and rabbits when treated with oral doses of ≥ 25 mg/kg/day adapalene (40 and 81 times the MRHD, respectively, based on a mg/m²comparison). Findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits.

Dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6.0 mg/kg/day (9.7 and 19.5 times the MRHD, respectively, based on a mg/m²comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits).

• Allergic/ Hypersensitivity Reactions:
  Allergy/hypersensitivity reactions include anaphylaxis angioedema, face edema, eyelid edema, lip swelling, and pruritis. Discontinue adapalene gel in the event of an allergic/hypersensitivity reaction. (
  5.1 Allergic/ Hypersensitivity Reactions

  Adverse reactions including anaphylaxis angioedema, face edema, eyelid edema, lip swelling, and pruritus that sometimes required medical treatment have been reported during postmarketing use of adapalene. Advise a patient to stop using adapalene gel and seek medical attention if experiencing allergic or anaphylactoid/anaphylactic reactions during treatment.
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• Ultraviolet Light and Environmental Exposure:
  Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided (
  5.2 Ultraviolet Light and Environmental Exposure

  Exposure to sunlight, including sunlamps, should be minimized during use of adapalene 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 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 adapalene gel.
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• Local Cutaneous Reactions:
  Erythema, scaling, dryness, and stinging/burning were reported with use of adapalene gel. 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 alcohol, astringents, spices, or lime) should be approached with caution. (
  5.3 Local Cutaneous Reactions

  Cutaneous signs and symptoms such as erythema, scaling, dryness, and stinging/burning were reported with use of adapalene gel. These were most likely to occur during the first four weeks of treatment, were mostly mild to moderate in intensity, and usually lessened with continued use of the medication. Depending upon the severity of these side effects, patients should be instructed to either use a moisturizer, reduce the frequency of application of adapalene gel or discontinue use.

  Avoid application to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of "waxing" as a depilatory method should be avoided on skin treated with adapalene.

  As adapalene gel has the potential to induce 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 alcohol, astringents, spices, or lime) should be approached with caution.
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