HYDROCORTISONE VALERATE cream HYDROCORTISONE VALERATE ointment

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

Hydrocortisone Valerate (UNII: 68717P8FUZ) (Hydrocortisone - UNII:WI4X0X7BPJ)

Verfügbar ab:

Taro Pharmaceuticals U.S.A., Inc.

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Hydrocortisone valerate cream, 0.2% and hydrocortisone valerate ointment, 0.2% are medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients. Hydrocortisone valerate cream, 0.2% and hydrocortisone valerate ointment, 0.2% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Produktbesonderheiten:

Hydrocortisone valerate cream USP, 0.2%, is supplied in 15 g (NDC 51672-1290-1), 45 g (NDC 51672-1290-6), 60 g (NDC 51672-1290-3) tube sizes. Hydrocortisone valerate ointment USP, 0.2% is supplied in 15 g (NDC 51672-1292-1), 45 g (NDC 51672-1292-6), 60 g (NDC 51672-1292-3) tube sizes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

HYDROCORTISONE VALERATE- HYDROCORTISONE VALERATE CREAM
HYDROCORTISONE VALERATE- HYDROCORTISONE VALERATE OINTMENT
TARO PHARMACEUTICALS U.S.A., INC.
----------
HYDROCORTISONE VALERATE
CREAM USP, 0.2%
HYDROCORTISONE VALERATE
OINTMENT USP, 0.2%
RX ONLY
FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION
Hydrocortisone valerate cream USP, 0.2% and hydrocortisone valerate
ointment USP,
0.2%, contain hydrocortisone valerate,
11,21-dihydroxy-17-[(1-oxopentyl)oxy]-(11β)-
pregn-4-ene-3,20-dione, a synthetic corticosteroid for topical
dermatologic use. The
corticosteroids constitute a class of primarily synthetic steroids
used topically as anti-
inflammatory and antipruritic agents. Chemically, hydrocortisone
valerate is C
H
O . It
has the following structural formula:
Hydrocortisone valerate has a molecular weight of 446.58. It is a
white, crystalline solid,
soluble in ethanol and methanol, sparingly soluble in propylene glycol
and insoluble in
water.
Each gram of hydrocortisone valerate cream USP, 0.2% contains 2 mg
hydrocortisone
valerate in a hydrophilic base composed of carbomer homopolymer type
C, dibasic
sodium phosphate, methylparaben, polyoxyl 2 stearyl ether, propylene
glycol, purified
water, sodium lauryl sulfate, steareth-100, stearyl alcohol and white
petrolatum.
Each gram of hydrocortisone valerate ointment USP, 0.2% contains 2 mg
hydrocortisone valerate in a hydrophilic base composed of carbomer
homopolymer type
B, dibasic sodium phosphate, methylparaben, mineral oil, polyoxyl 2
stearyl ether,
propylene glycol, purified water, sodium lauryl sulfate, steareth-100,
stearyl alcohol and
26
38
6
propylene glycol, purified water, sodium lauryl sulfate, steareth-100,
stearyl alcohol and
white petrolatum.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, hydrocortisone valerate 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 induct