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HYDROCORTISONE CREAM USP, 2.5%
HYDROCORTISONE OINTMENT 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 2.5% and Hydrocortisone Ointment 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-, (11β)-. The structural formula of hydrocortisone is:

Each gram of the 2.5% Cream contains 25 mg of hydrocortisone in a base of glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin, stearyl alcohol, isopropyl palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate, lactic acid and purified water.

Each gram of the 2.5% Ointment contains 25 mg of hydrocortisone in a base of white petrolatum and mineral oil.

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.

INDICATIONS AND USAGE

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS

ADVERSE REACTIONS

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are uled in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

OVERDOSAGE

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Apply to the affected area as a thin film 2 to 4 times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

Hydrocortisone Cream USP, 2.5%Hydrocortisone Ointment USP, 2.5%
a white cream is available as follows:a white ointment is available as follows:
NDC 0168-0080-3130 g tubesNDC 0168-0146-3028.35 g (1 oz) tubes
NDC 0168-0080-16453.6 g (1 Lb) jarsNDC 0168-0146-16453.6 g (1 Lb) jars

Store at controlled room temperature 15° - 30°C (59° - 86°F).

E. FOUGERA & CO.

a division of Altana Inc.

MELVILLE, NEW YORK 11747

I280B / IF280A
#545
R8/98

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