Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF)
Galderma Laboratories, L.P.
TOPICAL
PRESCRIPTION DRUG
DIFFERIN Gel is indicated for the topical treatment of acne vulgaris. DIFFERIN Gel should not be administered to individuals who are hypersensitive to adapalene or any of the components in the vehicle gel.
DIFFERIN (adapalene gel) Gel, 0.1% is supplied in the following size: 45 g laminate tube - NDC 0299-5910-45 Store at controlled room temperature 68° - 77°F (20° - 25°C), excursions permitted between 59° and 86°F (15° - 30°C). Protect from freezing. Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USA Mfd. by: G Production Inc. Baie d’Urfe, QC, H9X 3S4 Canada Made in Canada. GALDERMA is a registered trademark. P50045-1 Revised: April 2011
New Drug Application
DIFFERIN - ADAPALENE GEL GALDERMA LABORATORIES, L.P. ---------- DIFFERIN (ADAPALENE GEL) GEL, 0.1% RX ONLY DESCRIPTION: DIFFERIN Gel, containing adapalene, is used for the topical treatment of acne vulgaris. Each gram of DIFFERIN Gel contains adapalene 0.1% (1 mg) in a vehicle consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide. May contain hydrochloric acid to adjust pH. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. Adapalene is a white to off-white powder which is soluble in tetrahydrofuran, sparingly soluble in ethanol, and practically insoluble in water. The molecular formula is C H O and molecular weight is 412.52. Adapalene is represented by the following structural formula: CLINICAL PHARMACOLOGY: Adapalene is a chemically stable, retinoid-like compound. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris. Mechanistically, adapalene binds to specific retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein. Although the exact mode of action of adapalene is unknown, it is suggested that topical adapalene may normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. _PHARMACOKINETICS:_ Absorption of adapalene through human skin is low. Only trace amounts (<0.25 ng/mL) of parent substance have been found in the plasma of acne patients following chronic topical application of adapalene in controlled clinical trials. Excretion appears to be primarily by the biliary route. INDICATIONS AND USAGE: ® ® 28 28 3 DIFFERIN Gel is indicated for the topical treatment of acne vulgaris. CONTRAINDICATIONS: DIFFERIN Gel should not be administered to individuals who are hypersensitive to adapalene or any of the components in the vehicle gel. Prečítajte si celý dokument