Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)
Galderma Laboratories, L.P.
FLUOCINOLONE ACETONIDE
FLUOCINOLONE ACETONIDE 1 mg in 1 mg
TOPICAL
PRESCRIPTION DRUG
Capex® Shampoo is a low to medium potency corticosteroid indicated for the treatment of seborrheic dermatitis of the scalp. This product has not been proven to be effective in other corticosteroid-responsive dermatoses. Capex® Shampoo is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Capex® Shampoo is supplied as a two component package: a capsule which contains the active component fluocinolone acetonide, and a separate package of liquid shampoo. The pharmacist must mix the content of the capsule into the base at the time of dispensing. Capex® Shampoo is dispensed to the patient in a 6 ounce bottle. Shake well before using. Store at controlled room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C) in tightly closed containers. Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USA Made in Canada. P52306-3 GALDERMA is a registered trademark. Revised: December 2015
New Drug Application
CAPEX- FLUOCINOLONE ACETONIDE GALDERMA LABORATORIES, L.P. ---------- CAPEX® SHAMPOO (FLUOCINOLONE ACETONIDE) TOPICAL SHAMPOO, 0.01% FOR TOPICAL USE ONLY RX ONLY NOT FOR OPHTHALMIC USE NDC 0299-5500-04 DESCRIPTION: Capex Shampoo 0.01% is supplied as a shampoo formulation with a 12 mg fluocinolone acetonide capsule which is emptied into the shampoo base by the pharmacist at the time of dispensing. After mixing, Capex Shampoo contains fluocinolone acetonide(6α,9-Difluoro-11β,16α, 17,21- tetrahydroxypregna-1,4-diene-3, 20-dione cyclic 16,17-acetal with acetone), a synthetic fluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an anti-inflammatory and antipruritic agents. Chemically, Capex Shampoo mixture is C H F O . It has the following structural formula: Fluocinolone acetonide in Capex Shampoo has the molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light and melts at 270°F with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each fluocinolone capsule contains 12 mg of fluocinolone acetonide, 548 mg of dibasic calcium phosphate dihydrate USP, and 240 mg of talc USP. The shampoo base contains aluminum acetate dibasic, benzalkonium chloride solution, boric acid, citric acid anhydrous, cocamido-ether-sulfate complex, cocoamine oxide, lauramide DEA, magnesium aluminum silicate, methylparaben, oat flour, propylene glycol, propylparaben, purified water, and fragrances, with D&C Yellow #10 and FD&C Blue #1 as coloring. CLINICAL PHARMACOLOGY: Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic and ® ® ® 24 30 2 6 ® vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However corticosteroids are thought to act by the induction of phospholipase A inhibitory proteins, collectively called lipocortins. It is postu Les hele dokumentet