Hydrocortisone Valerate Cream USP, 0.2%  Rx only  For Dermatologic Use only. Not for Ophthalmic Use.

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

HYDROCORTISONE VALERATE (UNII: 68717P8FUZ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Tilgjengelig fra:

Glenamrk Pharmaceuticals Inc., USA

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Hydrocortisone Valerate Cream USP, 0.2%, is supplied in the following tube sizes: 15 g – NDC 68462-575-17 45 g – NDC 68462-575-47 60 g – NDC 68462-575-65

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

HYDROCORTISONE VALERATE- HYDROCORTISONE VALERATE CREAM
GLENAMRK PHARMACEUTICALS INC., USA
---------- HYDROCORTISONE VALERATE CREAM USP, 0.2% RX ONLY FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION
Hydrocortisone Valerate Cream USP, 0.2% contains hydrocortisone
valerate, USP, pregn-4-ene-3,20-
dione, 11,21-dihydroxy-17-[(1-oxopentyl)oxy]-, (11β)-;cortisol
17-valerate or 11β,17,21-
Trihydroxypregn-4-ene-3,20-dione 17-valerate, 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, USP is C
H O . It has the following structural formula:
Hydrocortisone valerate, USP has a molecular weight of 446.58. It is a
white or almost white
crystalline powder, freely soluble in acetone and dichloromethane;
soluble in alcohol; insoluble in
water.
Each gram of Hydrocortisone Valerate Cream USP, 0.2% contains 2 mg
hydrocortisone valerate, USP
in a hydrophilic base composed of citric acid monohydrate,
methylparaben, polyoxyl 2 stearyl ether,
propylene glycol, purified water, sepineo P 600, steareth-100, stearyl
alcohol, sodium lauryl sulfate
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 induction of phospholipase A
26
38
6
2
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
The extent of percutaneous absorption of topical corticosteroids is
determined by many factors
including