CLOBETASOL PROPIONATE cream

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)

Fáanlegur frá:

Northstar RxLLC

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Clobetasol propionate cream is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Clobetasol propionate cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Vörulýsing:

Clobetasol Propionate Cream USP, 0.05% is supplied in tamper-evident tubes as follows: 15 g (NDC 16714-730-01) 30 g (NDC16714-730-02) 45 g (NDC 16714-730-03) 60 g (NDC16714-730-04) Store at controlled room temperature 15° to 30°C (59° to 86°F). DO NOT REFRIGERATE. Manufactured for: Northstar Rx LLC., Memphis, TN 38141 Manufactured By: E.FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747. 46208621A I07-2017

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
NORTHSTAR RXLLC
----------
CLOBETASOL PROPIONATE CREAM USP, 0.05%
(POTENCY EXPRESSED AS CLOBETASOL PROPIONATE)
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
RX ONLY
DESCRIPTION:
Clobetasol propionate cream, USP contains the active compound
clobetasol propionate,
a synthetic corticosteroid, for topical dermatologic use. Clobetasol,
an analog of
prednisolone, has a high degree of glucocorticoid activity and a
slight degree of
mineralocorticoid activity.
Clobetasol propionate is a white to cream-colored crystalline powder
insoluble in water.
Chemically, it is
21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-
dione 17-propionate, and it has the following structural formula:
Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in
a cream base
of propylene glycol, glyceryl monostearate, cetostearyl alcohol,
glyceryl stearate/PEG
100 stearate, white wax, chlorocresol, sodium citrate anhydrous,
citric acid anhydrous,
and purified water.
CLINICAL PHARMACOLOGY:
Like other topical corticosteroids, clobetasol propionate has
anti-inflammatory,
antipruritic, and 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 A2 inhibitory
proteins, collectively called
lipocortins. It is postulated that these proteins control the
biosynthesis of potent
mediators of inflammation such as prostaglandins and leukotrienes by
inhibiting the
release of their common precursor, arachidonic acid. Arachidonic acid
is released from
membrane phospholipids by phospholipase A2.
PHARMACOKINETICS: The extent of percutaneous absorption of topical
corticosteroids is
determined by many factors, including the vehicle and the integrity of
the epidermal
barrier. Occlusive dressings with hydrocortisone for up to 24 hours
has not been
demonstrated to increase penetration; however, occlusion of
hydrocorti