HYDROCORTISONE cream

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

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

INN (Internationale Bezeichnung):

hydrocortisone

Zusammensetzung:

hydrocortisone 10 mg in 1 g

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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.

Produktbesonderheiten:

Hydrocortisone Cream USP, 1%, a white cream, is supplied as follows: NDC 0168-0015-31 28.35 g (1 Oz) tubes NDC 0168-0015-16 453.6 g (1 lb) jars Store at controlled room temperature 15°-30°C (59°-86°F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I21531H/IF21504H R11/11 #190

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

HYDROCORTISONE- HYDROCORTISONE CREAM
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
----------
HYDROCORTISONE CREAM USP, 1%
RX ONLY
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Hydrocortisone Cream USP, 1% contains hydrocortisone
[pregn-4-ene-3,20-dione,
11,17,21-trihydroxy-, (11ß)-], with the molecular formula C
H
O and molecular
weight 362.47. Each gram contains 10 mg of hydrocortisone in a base
containing
glyceryl monostearate, polyoxyl 40 stearate, glycerin, paraffin,
stearyl alcohol, isopropyl
palmitate, sorbitan monostearate, benzyl alcohol, potassium sorbate,
lactic acid, 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 similar to systemically
administered
21
30
5
corticosteroids. Corticosteroids are bound to plasma proteins in
varying degrees.
Corticosteroids are metabolized primarily in the liver and then are
excreted by the