BETAMETHASONE VALERATE aerosol, foam

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Betamethasone Valerate (UNII: 9IFA5XM7R2) (Betamethasone - UNII:9842X06Q6M)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

INN (International Name):

Betamethasone Valerate

Composition:

Betamethasone Valerate 1.2 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Betamethasone valerate foam, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp. Betamethasone valerate foam, 0.12% is contraindicated in patients who are hypersensitive to betamethasone valerate, to other corticosteroids, or to any ingredient in this preparation.

Product summary:

Betamethasone Valerate Foam, 0.12% is supplied in 50 gram (NDC 51672-4188-3) and 100 gram (NDC 51672-4188-7) aluminum cans. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE VALERATE- BETAMETHASONE VALERATE AEROSOL, FOAM
TARO PHARMACEUTICALS U.S.A., INC.
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BETAMETHASONE VALERATE
FOAM, 0.12%
Rx Only
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Betamethasone Valerate Foam, 0.12% contains betamethasone valerate,
USP, a synthetic corticosteroid,
for topical dermatologic use. The corticosteroids constitute a class
of primarily synthetic steroids used
topically as anti-inflammatory agents.
Betamethasone valerate is 9-fluoro11β,17,
21-trihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-
valerate, with the empirical formula C
H FO , a molecular weight of 476.58. The following is the
chemical structure:
Betamethasone valerate
Betamethasone valerate is a white to practically white, odorless
crystalline powder, and is practically
insoluble in water, freely soluble in acetone and in chloroform,
soluble in alcohol, and slightly soluble
in benzene and in ether.
Betamethasone valerate foam, 0.12%, contains 1.2 mg betamethasone
valerate, USP, per gram in a
thermolabile hydroethanolic foam vehicle consisting of alcohol
(60.4%), cetyl alcohol, citric acid
anhydrous, polysorbate 60, potassium citrate, propylene glycol,
purified water, and stearyl alcohol
pressurized with a hydrocarbon (propane/butane) propellant.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, betamethasone valerate foam has
anti-inflammatory, antipruritic, and
vasoconstrictive properties. The mechanism of the anti-inflammatory
activity of the topical steroids, in
general, is unclear. However, corticosteroids are thought to act by
the induction of phospholipase A
inhibitory proteins, collectively called lipocortins. It is postulated
that these proteins control the
biosynthesis of potent mediators of inflammation such as
prostaglandins and leukotrienes by inhibiting
the release of their common precursor arachidonic acid. Arachidonic
acid is released from membrane
phospholipids by phospholipase A .
PHARMACOKINETICS
Topical corticosteroids can be absorbed from intact healthy skin. The
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