HYDROCORTISONE cream

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

זמין מ:

Actavis Pharma, Inc.

INN (שם בינלאומי):

HYDROCORTISONE

הרכב:

HYDROCORTISONE 10 mg in 1 g

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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.

leaflet_short:

Hydrocortisone Cream USP, 1% 1 oz (28. 4 g) tube NDC 0472-0321-26 Store at controlled room temperature 15° to 30°C (59° to 86°F). Avoid freezing. Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 7/2020

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

HYDROCORTISONE- HYDROCORTISONE CREAM
ACTAVIS PHARMA, INC.
----------
HYDROCORTISONE CREAM USP, 1%
TOPICAL CORTICOSTEROID
RX ONLY
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-inflammatory
and anti-pruritic agents. Hydrocortisone, USP is included in this
class of synthetic corticosteroid.
Chemically, hydrocortisone, USP is
pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11ß)- its molecular
formula is C
H O ; its molecular weight is 362.46; its Chemical Abstract Service
(CAS) registry
number is 50-23-7; and its structural formula is:
Each gram of Hydrocortisone Cream USP, 1% provides 10 mg of
hydrocortisone, USP in a non-
staining water washable cream base consisting of stearyl alcohol,
glyceryl monostearate, polyoxyl 40
stearate, isopropyl palmitate, paraffin, sorbitan monostearate,
glycerin, lactic acid, potassium sorbate
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).
21
30
5
Once absorbed through the