BETAMETHASONE DIPROPIONATE lotion

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Padagis Israel Pharmaceuticals Ltd

INN (Nome Internazionale):

BETAMETHASONE DIPROPIONATE

Composizione:

BETAMETHASONE 0.5 mg in 1 g

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Betamethasone Dipropionate Lotion USP, 0.05% is available as follows: 60 mL bottle (NDC 45802-021 -46) Shake well before using.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE LOTION
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
RX ONLY
BETAMETHASONE DIPROPIONATE LOTION USP, 0.05%
(Potency expressed as Betamethasone)
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
DESCRIPTION
Betamethasone Dipropionate Lotion USP, 0.05% 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-11β,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 Lotion USP, 0.05% contains
0.64 mg
betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a
lotion base of
carbomer homopolymer type B, isopropyl alcohol, and purified water.
Sodium hydroxide
is used to adjust pH.
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,
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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