HYDROCORTISONE cream

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Actavis Pharma, Inc.

Designació comuna internacional (DCI):

HYDROCORTISONE

Composición:

HYDROCORTISONE 25 mg in 1 g

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

Hydrocortisone Cream USP, 2.5% 20 g (0.7 oz) tube NDC 0472-0337-20 30 g (1.1 oz) tube NDC 0472-0337-30 Store at controlled room temperature 15° to 30°C (59° to 86°F). Do not freeze. Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 7/2020

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

HYDROCORTISONE- HYDROCORTISONE CREAM
ACTAVIS PHARMA, INC.
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HYDROCORTISONE CREAM USP, 2.5%
FOR EXTERNAL 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 is a member of this
class. Hydrocortisone cream
contains the synthetic steroid hydrocortisone (Pregn-4-ene-3,20-dione,
11, 17, 21-trihydroxy-, (11ß)-)
which has a molecular formula of C
H O , a molecular weight of 362.46 and CAS Registry Number
50-23-7.
Each gram of the 2.5% cream contains 25 mg of hydrocortisone, USP in a
cream base of cetyl alcohol,
citric acid, glyceryl stearate, isopropyl myristate, methylparaben,
polyoxyl 40 stearate, polysorbate 60,
propylene glycol, propylparaben, purified water, sodium citrate,
sorbic acid, sorbitan monostearate,
stearyl alcohol, white wax and citric acid solution and sodium citrate
solution to adjust pH.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritic 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 to 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.
21
30
5
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 d