HYDROCORTISONE VALERATE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Padagis Israel Pharmaceuticals Ltd

INN (International Name):

HYDROCORTISONE VALERATE

Composition:

HYDROCORTISONE VALERATE 2 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Hydrocortisone Valerate Cream USP, 0.2% is available as follows: 15 g tube (NDC 45802-455 -35) 45 g tube (NDC 45802-455 -42) 60 g tube (NDC 45802-455 -37)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCORTISONE VALERATE- HYDROCORTISONE VALERATE CREAM
PADAGIS ISRAEL PHARMACEUTICALS LTD
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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 2mg
hydrocortisone
valerate in a hydrophilic base composed of amphoteric-9, carbomer
homopolymer type
C, dibasic sodium phosphate, propylene glycol, purified water, sodium
lauryl sulfate,
sorbic acid, 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
26
38
6
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 to 24 hours have not been