betamethasone dipropionate- betamethasone dipropionate ointment

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

betamethasone dipropionate (UNII: 826Y60901U) (betamethasone - UNII:9842X06Q6M)

Dostopno od:

Warrick Pharmaceuticals Corporation

INN (mednarodno ime):

betamethasone dipropionate

Farmacevtska oblika:

OINTMENT

Sestava:

0.5 mg in 1 g

Pot uporabe:

TOPICAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Augmented Betamethasone Dipropionate Ointment is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Augmented Betamethasone Dipropionate Ointment is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

Povzetek izdelek:

Augmented Betamethasone Dipropionate Ointment 0.05% is supplied in 15-g (NDC 59930-1575-1) and 50-g (NDC 59930-1575-3) tubes; boxes of one. Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]

Lastnosti izdelka

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE OINTMENT
WARRICK PHARMACEUTICALS CORPORATION
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AUGMENTED BETAMETHASONE DIPROPIONATE
OINTMENT 0.05%
(POTENCY EXPRESSED AS BETAMETHASONE)
FOR DERMATOLOGIC USE ONLY– NOT FOR OPHTHALMIC USE
PRODUCT INFORMATION
DESCRIPTION
Augmented Betamethasone Dipropionate Ointment contains betamethasone
dipropionate, USP, a
synthetic adrenocorticosteroid, for dermatologic use. Betamethasone,
an analog of prednisolone, has a
high degree of corticosteroid activity and a slight degree of
mineralocorticoid activity. Betamethasone
dipropionate is the 17,21-dipropionate ester of betamethasone.
Chemically, betamethasone dipropionate is 9-fluoro-11β,
17,21-trihydroxy-16β-methyl-pregna-1,4-
diene-3,20-dione 17,21-dipropionate, with the empirical 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 Augmented Betamethasone Dipropionate Ointment 0.05%
contains: 0.643 mg
betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone),
in ACTIBASE , an optimized
vehicle of propylene glycol; propylene glycol stearate (55%
monoester); white wax; and white
petrolatum.
CLINICAL PHARMACOLOGY
The corticosteroids are a class of compounds comprising steroid
hormones secreted by the adrenal
cortex and their synthetic analogs. In pharmacologic doses,
corticosteroids are used primarily for their
anti-inflammatory and/or immunosuppressive effects.
Topical corticosteroids, such as betamethasone dipropionate, are
effective in the treatment of
corticosteroid-responsive dermatoses primarily because of their
anti-inflammatory, antipruritic, and
vasoconstrictive actions. However, while the physiologic,
pharmacologic, and clinical effects of the
corticosteroids are well known, the exact mechanisms of their actions
in each disease are uncertain.
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Betamethasone dipropionate, a corticosteroid, has been shown to have
topical (dermatologic