HYDROCORTISONE VALERATE cream

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Cosette Pharmaceuticals, Inc.

INN (الاسم الدولي):

Hydrocortisone Valerate

تركيب:

Hydrocortisone Valerate 2 mg in 1 g

طريقة التعاطي:

TOPICAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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.

ملخص المنتج:

Hydrocortisone Valerate Cream USP, 0.2% is supplied in the following tube sizes: 15 g NDC 0713-0668-15 45 g NDC 0713-0668-37 60 g NDC 0713-0668-60 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

HYDROCORTISONE VALERATE- HYDROCORTISONE VALERATE CREAM
COSETTE PHARMACEUTICALS, INC.
----------
HYDROCORTISONE
VALERATE CREAM USP, 0.2%
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
RX ONLY
DESCRIPTION
Hydrocortisone valerate cream USP, 0.2% contains 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 940, 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,
antipruritic and vasoconstrictive properties. The mechanism of the
anti-inflammatory
activity of the topical steroids, in general, is unclear. However,
corticosteroids are
26
38
6
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 to 24 hours hav