Thursday, January 31, 2008

Adapalene

U.S. BRAND NAMES — Differin®
CANADIAN BRAND NAMES — Differin® XP; Differin®
SYNONYMS — CD271
THERAPEUTIC CATEGORY Acne Products
DOSING — Topical: Children >12 years and Adults: Apply topically once daily in the evening
(For additional information see "Adapalene: Drug information")
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, topical: 0.1% (15 g, 45 g)
Gel, topical: 0.1% (15 g, 45 g) [alcohol free]
Pledget, topical: 0.1% (60s) [DSC]
Solution, topical: 0.1% (30 mL) [DSC]
GENERIC AVAILABLE — No
ADMINISTRATION — Topical: After cleansing the affected area with mild or soapless cleanser, using gloves, apply a thin film of medication (cream or gel) before retiring in the evening. Avoid contact with eyes, angles of the nose, lips and mucous membranes.
USE — Topical treatment of acne vulgaris
ADVERSE REACTIONS Dermatologic: Erythema, scaling, dry skin, skin irritation, pruritus, acne flares, photosensitivity, sunburn, skin discoloration
Local: Pruritus or burning immediately after application
Ophthalmic: Eyelid edema, conjunctivitis
CONTRAINDICATIONS — Hypersensitivity to adapalene or any component; sunburn
PRECAUTIONS — Use with caution in patients with eczema
WARNINGS — Avoid excessive exposure to sunlight and sunlamps; avoid contact with abraded skin, mucous membranes, eyes, mouth, or angles of the nose
DRUG INTERACTIONS — Topical sulfur, benzoyl peroxide, salicylic acid, and resorcinol potentiate adverse reactions seen with adapalene; other topical products containing alcohol, astringents, or lime may increase drying effects
PREGNANCY RISK FACTOR — C (show table)
MONITORING PARAMETERS — Reduction in lesion size and/or inflammation; reduction in the number of lesions
STABILITY — Store at controlled room temperature
MECHANISM OF ACTION — Retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris
PHARMACODYNAMICS — Onset of action: 8-12 weeks
PHARMACOKINETICS Absorption: Absorption through the skin is very low; only trace amounts have been measured in serum after chronic application
Elimination: Primarily in bile
PATIENT INFORMATION — For external use only; apply using gloves; avoid contact with eyes, mouth, mucous membranes, or open wounds. Do not apply occlusive dressing. Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided. Wax epilation should not be performed on treated skin due to the potential for skin erosions. Transient burning or stinging immediately after applying may occur. Mild to moderate redness, dryness, scaling, burning or itching are likely to occur during the first 2-4 weeks and will usually lessen with continued use; report worsening of condition or skin redness, dryness, peeling, or burning that persists between applications to the healthcare provider. May cause photosensitivity reactions (eg, exposure to sunlight may cause severe sunburn, skin rash, redness, or itching); avoid exposure to sunlight and artificial light sources (sunlamps, tanning booth/bed); wear protective clothing, wide-brimmed hats, sunglasses, and lip sunscreen (SPF 15); use a sunscreen [broad-spectrum sunscreen or physical sunscreen(preferred) or sunblock with SPF 15]; contact physician if reaction occurs.

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