HYDROCORTISONE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

STAT Rx USA LLC

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.

Product summary:

Hydrocortisone Cream USP 1%   1 oz (28. 4 g) tube NDC # 16590-121-30 Manufactured by Actavis Mid Atlantic LLC 1877 Kawai Road Lincolnton, NC 28092 USA FORM NO. 0321/1326 Rev.8/06 VC2901

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCORTISONE - HYDROCORTISONE CREAM
STAT RX USA LLC
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DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-inflammatory
and anti-pruritic agents. Hydrocortisone is included in this class of
synthetic corticosteroid.
Chemically, hydrocortisone is
pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11ß)- its molecular
formula is C
H O ; its molecular weight is 362.46; its Chemical Abstract Service
(CAS) registry
number is 50-23-7; and its structural formula is:
Each gram of Hydrocortisone Cream USP 1% provides 10 mg of
hydrocortisone in a non-staining water
washable cream base consisting of stearyl alcohol, glyceryl
monostearate, polyoxyl 40 stearate,
isopropyl palmitate, paraffin, sorbitan monostearate, glycerin, lactic
acid, potassium sorbate and
purified water.
Each gram of Hydrocortisone Ointment USP 1% provides 10 mg of
hydrocortisone in a white
petrolatum base.
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 absor