BETAMETHASONE DIPROPIONATE gel

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Betamethasone Dipropionate (UNII: 826Y60901U) (Betamethasone - UNII:9842X06Q6M)

Mevcut itibaren:

Taro Pharmaceuticals U.S.A., Inc.

INN (International Adı):

Betamethasone Dipropionate

Kompozisyon:

Betamethasone 0.5 mg in 1 g

Uygulama yolu:

TOPICAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Betamethasone dipropionate gel (augmented) is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dose should not exceed 50 g per week because of potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. This product is not recommended for use in pediatric patients under 12 years of age. Betamethasone dipropionate gel (augmented) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Ürün özeti:

Betamethasone Dipropionate Gel (Augmented), 0.05% is supplied as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE GEL
TARO PHARMACEUTICALS U.S.A., INC.
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BETAMETHASONE DIPROPIONATE
GEL (AUGMENTED*), 0.05%
(POTENCY EXPRESSED AS BETAMETHASONE)
*VEHICLE AUGMENTS THE PENETRATION OF THE STEROID.
FOR DERMATOLOGICAL USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Betamethasone dipropionate gel (augmented), 0.05%, contains
betamethasone dipropionate, USP, a
synthetic fluorinated corticosteroid for topical dermatologic use.
Betamethasone dipropionate is
included in a class of compounds consisting primarily of synthetic
corticosteroids for use topically as
anti-inflammatory and anti-pruritic agents.
Chemically, betamethasone dipropionate is
9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-
diene-3,20-dione 17,21-dipropionate, with the molecular formula C
H FO , a molecular weight of
504.6, and the following structural formula:
Betamethasone dipropionate is a white to creamy white, odorless
crystalline powder, insoluble in
water.
Each gram of betamethasone dipropionate gel (augmented) contains: 0.64
mg betamethasone
dipropionate, USP (equivalent to 0.5 mg betamethasone), in an
augmented gel base of carbomer
homopolymer type C, propylene glycol, purified water and sodium
hydroxide.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, betamethasone dipropionate has
anti-inflammatory, anti-pruritic, 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 pre-cursor, arachidonic acid. Arachidonic
acid is released from membrane
phospholipids by phospholipase A .
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PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many factor