CAPEX- fluocinolone acetonide kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)

Available from:

Galderma Laboratories, L.P.

INN (International Name):

FLUOCINOLONE ACETONIDE

Composition:

FLUOCINOLONE ACETONIDE 1 mg in 1 mg

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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

Authorization status:

New Drug Application

Summary of Product characteristics

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