BETAMETHASONE DIPROPIONATE cream

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)

Verfügbar ab:

Cosette Pharmaceuticals, Inc.

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Produktbesonderheiten:

Betamethasone Dipropionate Cream USP, 0.05% is supplied as follows: 15 g tube (NDC 0713-0659-15) 45 g tube (NDC 0713-0659-37) Store at 25°C, excursions permitted between 15° and 30°C. Protect from light and freezing. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Rev. 06/2022 8-0659CPLNC2     VC7631

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM
COSETTE PHARMACEUTICALS, INC.
----------
BETAMETHASONE DIPROPIONATE CREAM, USP 0.05%
(POTENCY EXPRESSED AS BETAMETHASONE)
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Betamethasone Dipropionate Cream USP, 0.05% contains betamethasone
dipropionate
USP, a synthetic adrenocorticosteroid, for dermatologic use.
Betamethasone, an analog
of prednisolone, has a high degree of glucocorticoid activity and a
slight degree
of mineralocorticoid activity.
Betamethasone dipropionate is a white to almost white powder insoluble
in water.
Chemically, it is
9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione
17,21-dipropionate. The structural formula is:
Molecular Formula: C
H
FO
Molecular Weight: 504.60
Each gram of the 0.05% Cream contains 0.64 mg betamethasone
dipropionate
(equivalent to 0.5 mg betamethasone) in a soft,white to off white,
hydrophilic cream of
purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl
ether, cetyl alcohol,
stearyl alcohol, monobasic sodium phosphate, chlorocresol is present
as a preservative.
Sodium hydroxide or phosphoric acid solution to adjust pH, if
required.
28
37
7
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritic and
vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical
corticosteroids is unclear.
Various laboratory methods, including vasoconstrictor assays, are used
to compare and
predict potencies and/or clinical efficacies of the topical
corticosteroids. There is some
evidence to suggest that a recognizable correlation exists between
vasoconstrictor
potency and therapeutic efficacy in man.
PHARMACOKINETICS:The extent of percutaneous absorption of topical
corticosteroids is
determined by many factors including the vehicle, the integrity of the
epidermal barrier,
and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin.
Inflammation and/or
other disease processes in the