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:

Rebel Distributors Corp

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Hydrocortisone valerate cream USP, 0.2%, is supplied in 15 g (NDC 21695-730-15). Store below 26°C (78°F).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCORTISONE VALERATE- HYDROCORTISONE VALERATE CREAM
REBEL DISTRIBUTORS CORP
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HYDROCORTISONE VALERATE CREAM USP, 0.2%
HYDROCORTISONE VALERATE OINTMENT USP, 0.2%
RX ONLY
FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION
Hydrocortisone valerate cream USP, 0.2% and hydrocortisone valerate
ointment USP, 0.2%, contain
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, propylene
glycol, purified water, sodium lauryl sulfate, steareth-2,
steareth-100, stearyl alcohol and white
petrolatum.
Each gram of hydrocortisone valerate ointment USP, 0.2% contains 2 mg
hydrocortisone valerate in a
hydrophilic base composed of carbomer 934P, dibasic sodium phosphate,
methylparaben, mineral oil,
propylene glycol, purified water, sodium lauryl sulfate, steareth-2,
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 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 inhibiti