Sunday, March 2, 2008

Adapalene, Differin

U.S. BRAND NAMES — Differin®
PHARMACOLOGIC CATEGORY Acne ProductsTopical 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. [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]
DOSAGE FORMS: CONCISE Cream, topical: Differin®: 0.1% (15 g, 45 g)
Gel, topical: Differin®: 0.1% (15 g, 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 — Use with caution in patients with eczema. Avoid excessive exposure to sunlight and sunlamps. Avoid contact with abraded skin, mucous membranes, eyes, mouth, angles of the nose.
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.
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): $132.93
Gel (Differin) 0.1% (45): $117.28
TOXICOLOGY / OVERDOSE COMPREHENSIVE — Toxic signs of an overdose commonly respond to drug discontinuation, and generally return to normal spontaneously within a few days to weeks. When confronted with signs of increased intracranial pressure, treatment with mannitol (0.25 g/kg I.V. up to 1 g/kg/dose repeated every 5 minutes as needed), dexamethasone (1.5 mg/kg I.V. load followed with 0.375 mg/kg every 6 hours for 5 days), and/or hyperventilation should be employed.
CANADIAN BRAND NAMES — Differin® XP; Differin®
INTERNATIONAL BRAND NAMES — Acure (HK, TW); Adaferin (CR, DO, GT, HN, IN, MX, NI, PA, SV); Adaferin Gel (IL); Differin (AR, AU, BR, CA, CL, EE, FI, HK, HU, KR, MY, NZ, PE, PH, PL, PY, SG, TH, TW, UY, VE, ZA); Differin Gel (AT, BE, CH, DE, GB, IE, IL, IT, SE); Differin XP (CA); Differine (ES, FR); Klenzit (PH); Panalene (AR); Redap (DK)
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.
(For additional information see "Adapalene: Patient drug information")

No comments: