HYDROCORTISONE ointment HYDROCORTISONE cream

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

hydrocortisone (UNII: WI4X0X7BPJ) (hydrocortisone - UNII:WI4X0X7BPJ)

可用日期:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN（国际名称）:

hydrocortisone

组成:

hydrocortisone 25 mg in 1 g

给药途径:

TOPICAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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.

產品總結:

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 0168-0080-31 30 g tubes NDC 0168-0146-30 28.35 g (1 oz) tubes NDC 0168-0080-16 453.6 g (1 Lb) jars NDC 0168-0146-16 453.6 g (1 Lb) jars Store at controlled room temperature 15° to 30°C (59° to 86°F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 46165000A R06/15 #145

授权状态:

Abbreviated New Drug Application

产品特点

HYDROCORTISONE- HYDROCORTISONE OINTMENT
HYDROCORTISONE- HYDROCORTISONE CREAM
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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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 USP, 2.5% and
hydrocortisone ointment USP, 2.5%
contain hydrocortisone, USP. Hydrocortisone, USP 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, USP 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, USP
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.
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
o