HYDROCORTISONE VALERATE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Glenmark Pharmaceuticals Inc., USA

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Hydrocortisone Valerate Ointment USP, 0.2% is supplied in the following tube sizes: 15 g – NDC 68462-836-17 45 g – NDC 68462-836-47 60 g – NDC 68462-836-65 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCORTISONE VALERATE- HYDROCORTISONE VALERATE OINTMENT
GLENMARK PHARMACEUTICALS INC., USA
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HYDROCORTISONE VALERATE OINTMENT USP, 0.2%
RX ONLY
FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION
Hydrocortisone Valerate Ointment 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 Ointment, USP, 0.2% contains 2 mg
hydrocortisone valerate,
USP in a hydrophilic base composed of citric acid monohydrate, methyl
paraben, mineral oil, polyoxyl
stearyl ether, propylene glycol, sepineo P 600, steareth 100, stearyl
alcohol, sodium lauryl sulfate,
white petrolatum and purified water.
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
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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