HYDROCORTISONE - hydrocortisone cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

Hydrocortisone

Composition:

Hydrocortisone 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCORTISONE - HYDROCORTISONE CREAM
PD-RX PHARMACEUTICALS, INC.
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HYDROCORTISONE CREAM USP, 1%
RX ONLY
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Hydrocortisone Cream USP, 1% contains hydrocortisone
[pregn-4-ene-3,20-dione, 11,17,21-
trihydroxy-, (11ß)-], with the molecular formula C
H O and molecular weight 362.47. Each gram
contains 10 mg of hydrocortisone in a base containing glyceryl
monostearate, polyoxyl 40 stearate,
glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan
monostearate, benzyl alcohol,
potassium sorbate, lactic acid, and purified water.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic and
vasoconstrictive actions. The
mechanism of anti-inflammatory activity of the topical corticosteroids
is unclear. Various laboratory
methods, including vasoconstrictor assays, are used to compare and
predict potencies and/or clinical
efficacies of the topical corticosteroids. There is some evidence to
suggest that a recognizable
correlation exists between vasoconstrictor potency and therapeutic
efficacy in man.
PHARMACOKINETICS: The extent of percutaneous absorption of topical
corticosteroids is determined by
many factors including the vehicle, the integrity of the epidermal
barrier, and the use of occlusive
dressings. Topical corticosteroids can be absorbed from normal intact
skin. Inflammation and/or other
disease processes in the skin increase percutaneous absorption.
Occlusive dressings substantially
increase the percutaneous absorption of topical corticosteroids. Thus,
occlusive dressings may be a
valuable therapeutic adjunct for treatment of resistant dermatoses.
(See DOSAGE AND
ADMINISTRATION). Once absorbed through the skin, topical
corticosteroids are handled through
pharmacokinetic pathways similar to systemically administered
corticosteroids. Corticosteroids are
bound to plasma proteins in varying degrees. Corticosteroids are
metabolized primarily in the liver and
then are excreted by the kidneys. Some of the topical corticos