BETAMETHASONE DIPROPIONATE lotion

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Versapharm Incorporated

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Betamethasone Dipropionate Lotion, USP 0.05% w/w is a medium-potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older. Betamethasone Dipropionate Lotion, USP 0.05% w/w is contraindicated in those patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any of the components in these preparation.

Produktsammanfattning:

Betamethasone Dipropionate Lotion, USP 0.05% w/w is supplied as follows: 60 mL bottles (NDC 61748-475-60) Store at 25°C, excursions permitted between 15° and 30°C. Protect from light and freezing. Store in carton until contents are used. Marketed by: VersaPharm Inc. – An Akorn Company Lake Forest, IL 60045 Manufactured by: Hi-Tech Pharmacal Co. Inc. – An Akorn Company Amityville, NY 11701 BDL00N Rev. 02/2018

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE LOTION
VERSAPHARM INCORPORATED
----------
BETAMETHASONE DIPROPIONATE LOTION USP, 0.05% W/W
(POTENCY EXPRESSED AS BETAMETHASONE)
RX ONLY
FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Betamethasone Dipropionate Lotion, USP 0.05% w/w 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 the 17, 21-dipropionate ester of betamethasone.
Chemically, betamethasone dipropionate 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
Betamethasone dipropionate is a white to cream white odorless
crystalline powder, insoluble in water.
Each gram of Betamethasone Dipropionate Lotion, USP 0.05% w/w
contains: 0.643 mg betamethasone
dipropionate (equivalent to 0.5 mg betamethasone) in a vehicle of
isopropyl alcohol, USP (40.0%) and
purified water, USP; slightly thickened with carbomer 934P. Sodium
hydroxide solution to adjust pH, if
28
37
7
required.
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 ef