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:

Cosette Pharmaceuticals, Inc.

INN (International Name):

HYDROCORTISONE VALERATE

Composition:

HYDROCORTISONE VALERATE 2 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrocortisone valerate ointment 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 ointment 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 ointment USP, 0.2% is supplied in 15 g (NDC 0713-0669-15), 45 g (NDC 0713-0669-37), 60 g (NDC 0713-0669-60) tube sizes. Store at 20° – 25°C (68° – 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCORTISONE VALERATE- HYDROCORTISONE VALERATE OINTMENT
COSETTE PHARMACEUTICALS, INC.
----------
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, 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 ointment USP, 0.2% contains 2 mg
hydrocortisone valerate in a hydrophilic base composed of carbomer
homopolymer type
B, dibasic sodium phosphate, methylparaben, mineral oil, 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
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 wit