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:

Rebel Distributors Corp.

INN (mednarodno ime):

Betamethasone Dipropionate

Sestava:

Betamethasone Dipropionate 0.05 mg in 1 g

Pot uporabe:

TOPICAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Betamethasone Dipropionate Ointment is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older. Betamethasone Dipropionate Ointment is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in these preparations.

Povzetek izdelek:

Betamethasone Dipropionate Ointment 0. 05% is available in 45 gram (1. 59 oz) tubes. Store between 15°-30°C (59°-86°F). Manufactured by: Actavis Mid Atlantic LLC 1877 Kawai Road Lincolnton, NC 28092 USA Repackaged by: Rebel Distributors Corp. Thousand Oaks, CA 91320 FORM NO. 0381 Rev. 2/06 VC2796

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE OINTMENT
REBEL DISTRIBUTORS CORP.
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BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05%
(POTENCY EXPRESSED AS BETAMETHASONE)
FOR DERMATOLOGIC USE ONLY –
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Betamethasone Dipropionate Ointment contains betamethasone
dipropionate USP, a synthetic
adrenocorticosteroid, for dermatologic use. Betamethasone, an analog
of prednisolone, has high
corticosteroid activity and slight mineralocorticoid activity.
Betamethasone dipropionate is the 17,21-
dipropionate ester of betamethasone.
Chemically, betamethasone dipropionate is 9-Fluoro-11 β,
17,21-trihydroxy-16β-methylpregna-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 Betamethasone Dipropionate Ointment 0.05% contains: 0.64
mg betamethasone
dipropionate USP (equivalent to 0.5 mg betamethasone) in an ointment
base consisting of mineral oil 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.
Betamethasone dipropionate, a corticosteroid, has been shown to have
topical (dermatologic) and
systemic pharmacologic and metabolic effects characteristic of this
class of drugs.
PHARMACOKINETICS: The extent of percutaneous absorption of to