HYDROCORTISONE BUTYRATE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCORTISONE BUTYRATE (UNII: 05RMF7YPWN) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

Oceanside Pharmaceuticals

INN (International Name):

HYDROCORTISONE BUTYRATE

Composition:

HYDROCORTISONE BUTYRATE 1 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrocortisone Butyrate Ointment, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. None.

Product summary:

Hydrocortisone Butyrate Ointment, 0.1% is supplied in tubes containing:         15 g  (NDC 68682-271-15)         45 g  (NDC 68682-271-45)

Authorization status:

New Drug Application

Summary of Product characteristics

HYDROCORTISONE BUTYRATE- HYDROCORTISONE BUTYRATE OINTMENT
OCEANSIDE PHARMACEUTICALS
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HYDROCORTISONE BUTYRATE
OINTMENT, 0.1%
FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC USE.
DESCRIPTION
Hydrocortisone Butyrate Ointment, 0.1% contains the topical
corticosteroid, hydrocortisone butyrate, a
non-fluorinated hydrocortisone ester. It has the chemical name:
11β,17,21-Trihydroxypregn-4-ene-3,20-
dione 17-butyrate; 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 Ointment contains 1 mg of
hydrocortisone butyrate in a base
consisting of mineral oil and polyethylene.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic, and
vasoconstrictive actions. The
mechanism of anti-inflammatory activity of topical corticosteroids is
unclear. Various laboratory
methods, including vasoconstrictor assays, are used to compare and
predict potencies and/or clinical
efficacies of 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.
25
36
6
Once absorbed through the skin, topical corticosteroids are handled
through pharmacokinetic pathways
similar to systemically administered corticosteroids. Corticosteroids
are bound to plasma proteins in
varying degrees. Corticosteroids are metabolized primarily in the
liver and are then excreted by the
kidneys. Some of the topical corticosteroids and their metabolites are
also excreted int