BETAMETHASONE VALERATE aerosol, foam

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M)

Tilgjengelig fra:

Ingenus Pharmaceuticals, LLC

INN (International Name):

BETAMETHASONE VALERATE

Sammensetning:

BETAMETHASONE VALERATE 1.2 mg in 1 g

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

Betamethasone Valerate Foam, 0.12% is supplied in 50 gram and 100 gram aluminum cans in carton 50 g (50742-315-50) aluminum can 100 g (50742-315-01) aluminum can Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] WARNING FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Keep out of reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C). Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Rev. 08/2018 26717 ingenus

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

BETAMETHASONE VALERATE- BETAMETHASONE VALERATE AEROSOL, FOAM
INGENUS PHARMACEUTICALS, LLC
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PRESCRIBING INFORMATION
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-fluoro-11β,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 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
cetyl alcohol, citric
acid, ethanol (60.4%), 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
27
37
6
2
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
extent