BETAMETHASONE VALERATE aerosol, foam

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Mylan Pharmaceuticals Inc.

INN:

BETAMETHASONE VALERATE

composition:

BETAMETHASONE VALERATE 1.2 mg in 1 g

administration_route:

TOPICAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Betamethasone valerate foam 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 is contraindicated in patients who are hypersensitive to betamethasone valerate, to other corticosteroids, or to any ingredient in this preparation.

leaflet_short:

Betamethasone Valerate Foam, 0.12% contains 1.2 mg of betamethasone valerate, USP per gram. It is available as follows: NDC 0378-8180-50 50 g aluminum can NDC 0378-8180-99 100 g aluminum can Store at 20° to 25°C (68° to 77°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). Questions: Call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX). Side effects should be reported to this number. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: DPT Laboratories, Ltd. San Antonio, TX 78215 140880-0317 Revised: 3/2017 DPT:BETA:R1p

authorization_status:

New Drug Application Authorized Generic

SPC

BETAMETHASONE VALERATE- BETAMETHASONE VALERATE AEROSOL, FOAM
MYLAN PHARMACEUTICALS INC.
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FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Betamethasone foam contains betamethasone valerate, 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-fluoro11ß,17,
21-trihydroxy-16ß-methylpregna-1, 4-diene-3, 20-dione 17-
valerate, with the molecular formula C
H FO , a molecular weight of 476.58. The following is the
chemical structure:
BETAMETHASONE VALERATE
Betamethasone valerate, USP 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, 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 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 of percutaneous absorption
of topical corticosteroids is determined by many