CLOBETASOL PROPIONATE cream

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

Clobetasol Propionate (UNII: 779619577M) (Clobetasol - UNII:ADN79D536H)

Saadav alates:

Proficient Rx LP

Manustamisviis:

TOPICAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Clobetasol Propionate Cream, USP 0.05% 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 preparations. Safety and effectiveness of clobetasol propionate cream in pediatric patients has not been established. Use in children under 12 years of age is not recommended. Because of a higher ratio of skin

Toote kokkuvõte:

Clobetasol Propionate Cream, USP 0.05% is supplied in:   15 g tubes (NDC 71205-151-15) Store at 20°– 25°C (68°–77°F) [see USP Controlled Room Temperature]. Do not refrigerate. Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Relabeled by: . Proficient Rx, Lp.. Thousand Oaks, CA 91320 Rev. 04/2015 8-0665ACT2

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
PROFICIENT RX LP
REFERENCE LABEL SET ID: A188664A-8FA1-479F-9493-0DA4A6C592F7
----------
CLOBETASOL PROPIONATE CREAM, USP 0.05%
FOR TOPICAL DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE
RX ONLY
DESCRIPTION
Clobetasol Propionate Cream, USP 0.05% 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.
Chemically, clobetasol propionate 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:
Clobetasol propionate has the molecular formula C
H ClFO and a molecular weight of 466.97. It is
a white to cream-colored crystalline powder insoluble in water.
Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in
a cream base of propylene
glycol, glyceryl monostearate, cetostearyl alcohol, glyceryl stearate
SE, PEG 100 stearate, white wax,
chlorocresol, sodium citrate, citric acid, 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 A
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 A .
25
32
5
2
2
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
h