Hydrocortisone Valerate Cream

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 C26H38O6. 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.

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 A2 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 A2.

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 demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Studies performed with Hydrocortisone Valerate Cream USP, 0.2% indicate that it is in the medium range of potency as compared with other topical corticosteroids.

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)

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Manufactured by Perrigo

Bronx, NY 10457

Distributed By Perrigo

Allegan, MI 49010 • www.perrigo.com

Rev 05-15

: 2H500 RC JX1