HYDROCORTISONE- hydrocortisone cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc

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, 2.5% is supplied in 28.35 g tubes - 68788-9715-2 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCORTISONE- HYDROCORTISONE CREAM
PREFERRED PHARMACEUTICALS, INC
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HYDROCORTISONE
CREAM USP, 1%
CREAM USP, 2.5%
FOR DERMATOLOGICAL USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-inflammatory
and anti-pruritic agents. Hydrocortisone Cream USP, 1% and
Hydrocortisone Cream USP, 2.5% contain
hydrocortisone. Hydrocortisone is a white to practically white
crystalline powder. Chemically,
hydrocortisone is pregn-4-ene-3,20-dione, 11,17, 21-trihydroxy-,
(11ß)-. Hydrocortisone has the
molecular formula C
H O and molecular weight of 362.47. The structural formula is:
Hydrocortisone
Hydrocortisone Cream USP, 1% (Each gram contains 10 mg of
Hydrocortisone); Hydrocortisone
Cream USP, 2.5% (Each gram contains 25 mg of Hydrocortisone) in a base
containing cetyl alcohol,
isopropyl palmitate, methylparaben, mineral oil and lanolin alcohol,
polyoxyl 40 stearate, polysorbate
60, propylene glycol monostearate, propylene glycol, propylparaben,
purified water, sorbic acid, and
sorbitan monostearate.
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
21
30
5
processes in the skin increase percutaneous absorption.
Occlusive dressings substantially increase the percutaneous absorptio