HALOBETASOL PROPIONATE- halobetasol propionate ointment

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

Halobetasol Propionate (UNII: 91A0K1TY3Z) (Halobetasol - UNII:9P6159HM7T)

제공처:

Cosette Pharmaceuticals, Inc.

INN (International Name):

Halobetasol Propionate

구성:

Halobetasol Propionate .5 mg in 1 g

관리 경로:

TOPICAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Halobetasol Propionate Ointment 0.05% is a super-high potency corticosteroid indictated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children 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. Halobetasol Propionate Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

제품 요약:

Halobetasol Propionate Ointment, 0.05% is supplied in the following tube sizes: 15 g (NDC 0713-0639-15) 50 g (NDC 0713-0639-86) Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured by: G&W Laboratories, Inc. 111 Coolidge St. South Plainfield, NJ 07080 8-0639GW2 Rev. 04/2015

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

HALOBETASOL PROPIONATE - HALOBETASOL PROPIONATE OINTMENT
COSETTE PHARMACEUTICALS, INC.
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HALOBETASOL PROPIONATE OINTMENT, 0.05%
FOR DERMATOLOGICAL USE ONLY.
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Halobetasol Propionate Ointment, 0.05% contains halobetasol
propionate, a synthetic corticosteroid for
topical dermatological use. The corticosteroids constitute a class of
primarily synthetic steroids used
topically as an anti-inflammatory and antipruritic agent.
Chemically halobetasol propionate is 21-chloro-6α, 9-difluoro-11β,
17-dihydroxy-16β-methylpregna-
1, 4-diene-3-20-dione, 17-propionate, C
H ClF O . It has the following structural formula:
Halobetasol propionate has the molecular weight of 485. It is a white
crystalline powder insoluble in
water.
Each gram of Halobetasol Propionate Ointment contains 0.5 mg/g of
halobetasol propionate in a base of
aluminum stearate, beeswax, pentaerythritol cocoate, petrolatum,
propylene glycol, sorbitan
sesquioleate, and stearyl citrate.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, halobetasol propionate has
anti-inflammatory, antipruritic and
vasoconstrictive actions. The mechanism of the anti-inflammatory
activity of the topical
corticosteroids, 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 .
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 have not been demonstrated to
increase penetration; however,
occlusion of hydrocortisone for 96 hours markedly enhances
penetration. Top