Monday, May 24, 2010

Adapalene

U.S. BRAND NAMES — Differin®

PHARMACOLOGIC CATEGORY
Acne Products
Topical Skin Product, Acne

DOSING: ADULTS — Acne: Topical: Apply once daily before bedtime; results appear after 8-12 weeks of therapy.

DOSING: PEDIATRIC — Children >12 years: Refer to adult dosing.

(For additional information see "Adapalene: Pediatric drug information")

DOSING: ELDERLY — Refer to adult dosing.

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, topical:
Differin®: 0.1% (15 g, 45 g)

Gel, topical:
Differin®: 0.1% (15 g, 45 g) [alcohol free]; 0.3% (45 g) [alcohol free]

DOSAGE FORMS: CONCISE
Cream, topical:
Differin®: 0.1% (15 g, 45 g)

Gel, topical:
Differin®: 0.1% (15 g, 45 g); 0.3% (45 g)

GENERIC EQUIVALENT AVAILABLE — No

USE — Treatment of acne vulgaris

ADVERSE REACTIONS SIGNIFICANT
>10%: Dermatologic: Erythema, scaling, dryness, pruritus, burning, pruritus or burning immediately after application

<1% (Limited to important or life-threatening): Acne flares, conjunctivitis, contact dermatitis, dermatitis, eczema, eyelid edema, skin discoloration, skin irritation, stinging, sunburn, rash (topical cream)

CONTRAINDICATIONS — Hypersensitivity to adapalene or any component in the vehicle gel

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Photosensitivity: Use is associated with increased susceptibility/sensitivity to UV light; avoid sunlamps or excessive sunlight exposure. Daily sunscreen use and other protective measures recommended. Skin irritation: Certain cutaneous signs and symptoms such as erythema, dryness, scaling, burning, or pruritus may occur during treatment; these are most likely to occur during the first 2-4 weeks and will usually lessen with continued use.

Disease-related concerns: Eczema: Use with caution in patients with eczema.

Special populations: Pediatrics: Safety and efficacy have not been established in children <12 years of age.

Other warnings/precautions: Appropriate use: For external use only; avoid contact with abraded skin, mucous membranes, eyes, mouth, angles of the nose.

DRUG INTERACTIONS
Vitamin A: May enhance the adverse/toxic effect of Retinoid-like Compounds. Risk D: Consider therapy modification

PREGNANCY RISK FACTOR — C (show table)

PREGNANCY IMPLICATIONS — There are no adequate and well-controlled studies in pregnant women. Use only if benefit outweighs the potential risk to fetus.

LACTATION — Excretion in breast milk unknown/use caution

PRICING — (data from drugstore.com)
Cream (Differin)
0.1% (45): $189.50

Gel (Differin)
0.1% (45): $185.59
0.3% (45): $177.06

CANADIAN BRAND NAMES — Differin®; Differin® XP

INTERNATIONAL BRAND NAMES — Aclene (KP); Acure (TW); Adaferin (CR, DO, GT, HN, IN, MX, NI, PA, SV); Adaferin Gel (IL); Beautyface (TW); Butipalen (KP); Deriva (MY); Differin (AR, AU, BR, CL, CN, EE, FI, HK, HN, KP, MY, NO, PE, PH, PL, PY, SG, TH, TW, UY, VE, ZA); Differin Gel (AT, BE, CH, DE, GB, IE, IL, IT, SE); Differine (CZ, ES, FR); Elibel (KP); Evalen (ID); Klenzit (PH); Panalene (AR); Pindome (TW); Redap (DK); Rozac (IN)

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 / KINETICS
Absorption: Topical: Minimal

Excretion: Bile

PATIENT INFORMATION — Thoroughly wash hands after applying. Avoid hydration of skin immediately before application. Minimize exposure to sunlight. Avoid washing face more frequently than 2-3 times/day. If severe irritation occurs, discontinue medication temporarily and adjust dose when irritation subsides. Avoid using topical preparations with high alcoholic content during treatment period. Do not exceed prescribed dose.

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