HYDROCORTISONE VALERATE cream

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Cosette Pharmaceuticals, Inc.

Droga podania:

TOPICAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Hydrocortisone valerate cream USP, 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 USP, 0.2% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Podsumowanie produktu:

Hydrocortisone Valerate Cream USP, 0.2%, is supplied in the following tube sizes: 15 g NDC 0713-0720-15 45 g NDC 0713-0720-37 60 g NDC 0713-0720-60 STORAGE Store between 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature].

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

HYDROCORTISONE VALERATE- HYDROCORTISONE VALERATE CREAM
COSETTE PHARMACEUTICALS, INC.
----------
RX ONLY
HYDROCORTISONE VALERATE CREAM USP, 0.2%
FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION
Hydrocortisone valerate cream USP, 0.2% contains hydrocortisone
valerate, 11,2l-
dihydroxy-17-[(l-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 to off white,
crystalline powder, soluble in ethanol, chloroform and acetone,
slightly soluble in
isopropanol and insoluble in water.
Each gram of hydrocortisone valerate cream USP, 0.2% contains 2mg
hydrocortisone
valerate in a hydrophilic base composed of carbomer 980, dibasic
sodium phosphate,
methylparaben, polyoxyl 2 stearyl ether, 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,
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38
6
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
The extent of percutaneous absorption of topical corticosteroids is
determined by many
factors including the vehicle and the integrity of the epidermal
barrier. Occlusive
dressings with hydrocortisone for up