HYDROCORTISONE BUTYRATE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCORTISONE BUTYRATE (UNII: 05RMF7YPWN) (HYDROCORTISONE BUTYRATE - UNII:05RMF7YPWN)

Available from:

Physicians Total Care, Inc.

INN (International Name):

HYDROCORTISONE BUTYRATE

Composition:

HYDROCORTISONE BUTYRATE 1.0 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrocortisone butyrate cream USP, 0.1% is 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 Butyrate Cream, USP, 0.1% is supplied in tubes containing:           45 g         NDC 54868-6248-0

Authorization status:

New Drug Application

Summary of Product characteristics

HYDROCORTISONE BUTYRATE - HYDROCORTISONE BUTYRATE CREAM
PHYSICIANS TOTAL CARE, INC.
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HYDROCORTISONE BUTYRATE CREAM, USP, 0.1%
FOR DERMATOLOGICAL USE ONLY
DESCRIPTION
Hydrocortisone Butyrate Cream USP, 0.1% contains the topical
corticosteroid hydrocortisone butyrate,
a non-fluorinated hydrocortisone ester. It has the chemical name:
pregn-4-ene-3,20-dione, 11,21 -
dihydroxy-17-[(1-oxobutyl)oxy]-, (11β-); the molecular formula: C
H O ; the molecular weight:
432.54; and the CAS registry number: 13609-67-1.
Its structural formula is:
Each gram of hydrocortisone butyrate cream USP, 0.1% contains 1.0 mg
of hydrocortisone butyrate in a
hydrophilic base consisting of cetostearyl alcohol, ceteth-20, mineral
oil, white petrolatum, citric acid,
sodium citrate, propylparaben and butylparaben (preservatives) 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
simila