adapalene 0.1% cream generic differin

Uses

Acne Vulgaris

Adapalene is used topically for the treatment of acne vulgaris. Therapy for acne vulgaris must be individualized and frequently modified depending on the types of acne lesions that predominate and the patient's response to therapy.

Adapalene has been shown to be more effective than placebo in reducing acne lesion counts in patients with mild to moderate acne vulgaris. In 2 placebo-controlled clinical studies, once-daily application of adapalene 0.1% topical cream for 12 weeks resulted in a 30-34% reduction in the total number of lesions compared with a 15-18% reduction achieved with vehicle placebo. In comparative studies in patients with mild to moderate facial acne, adapalene 0.1% topical gel was at least as effective as tretinoin 0.025% topical gel in reducing the number of comedonal, inflammatory, and noninflammatory lesions, as well as the total number of acne lesions and generally was better tolerated (less local irritation).

A decrease in the number and severity of lesions generally occurs within 8-12 weeks following initiation of topical adapalene therapy.

Dosage and Administration

Administration

Adapalene is applied topically to the skin as a 0.1% cream or 0.1% gel.

Prior to application of the cream or gel, the affected areas should be cleansed and dried. A transient feeling of pruritus or burning may occur immediately after application of adapalene cream or gel. If increased sensitivity or irritation occurs, patients should be instructed to reduce the frequency of application or, depending on the severity of the reaction, discontinue use of the drug.

Patients should be advised not to use adapalene cream or gel in amounts larger than instructed or more often than instructed, since such use of the drug will not lead to more rapid or better results but may result in marked erythema, peeling, or discomfort.

Care should be taken not to get adapalene cream or gel into the eyes. In addition, contact of the drug with the lips, mouth, angles of the nose, and mucous membranes should be avoided. If contact with the eye(s) occurs, the eye(s) should be washed with large amounts of water; patients should consult a clinician if ocular irritation persists.

Patients receiving topical adapalene therapy should be cautioned to minimize exposure to sunlight or other UV rays, including sunlamps, unless deemed medically necessary; in such cases, exposure should be minimized during the use of adapalene. Patients with sunburn should not use adapalene until full recovery occurs. In addition, patients should be cautioned to inform their clinician if they are using other drugs that potentially could increase the sensitivity of their skin to sunlight (e.g., fluoroquinolone anti-infectives, thiazide diuretics, sulfonamides, phenothiazines). Patients who may be subjected to considerable sun exposure because of their occupation and those with inherent sensitivity to the sun should be especially cautious; when exposure cannot be avoided, use of sunscreens and protective clothing over treated areas may be prudent. Weather extremes (e.g., wind, cold) may be irritating to patients receiving topical adapalene therapy. Moisturizers may be used if necessary; however, products containing alpha-hydroxy or glycolic acids should be avoided. The manufacturer states that adapalene cream, gel, or solution should not be applied to abraded, eczematous, or sunburned skin.

Patients should be advised that use of adapalene with other topical medications that have a strong skin-drying effect should be undertaken with caution. In patients who have used such agents, sufficient time should elapse for the effects of these drugs to subside before initiating adapalene therapy. Use of topical preparations with high concentrations of alcohol, menthol, spices, or lime rind, such as shaving lotions, astringents, and perfume, also should be used with caution or avoided if possible. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with adapalene cream, gel, or solution. Patients also should avoid the use of irritating cosmetics (e.g., toners, peeling [desquamating] agents), permanent wave solutions, electrolysis, hair depilatories, or other preparations or processes that might dry or irritate the skin during topical therapy with adapalene.

Dosage

The manufacturer states that safety and efficacy of adapalene in children younger than 12 years of age have not been established.

For the topical treatment of acne vulgaris, a thin film of adapalene 0.1% cream or 0.1% gel should be applied to the cleansed affected area once daily in the evening at bedtime. During the early weeks of therapy with adapalene, an apparent exacerbation of acne may occur. This effect is attributable to the action of the drug on previously unseen lesions and should not be considered a reason to discontinue therapy. Improvement usually is detectable within 8-12 weeks of initiating topical therapy with the drug. Most reported experience to date has been for treatment periods that did not exceed 12 weeks.