HYDROCORTISONE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals LLC

INN (International Name):

HYDROCORTISONE

Composition:

HYDROCORTISONE 25 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Product summary:

Hydrocortisone Cream USP, 2.5% is available as follows: 28 GRAM in a TUBE/1 TUBE in a CARTON (53217-197-01) Repackaged by Aidarex Pharmaceuticals, LLC Corona, CA 92880

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCORTISONE- HYDROCORTISONE CREAM
AIDAREX PHARMACEUTICALS LLC
----------
HYDROCORTISONE CREAM USP, 2.5%
HYDROCORTISONE OINTMENT USP, 2.5%
RX ONLY
DESCRIPTION
Each gram of Hydrocortisone Cream USP, 2.5% contains 25 mg of
hydrocortisone in a cream base of
cetyl alcohol, methylparaben, propylene glycol, propylparaben,
purified water, sodium lauryl sulfate,
and stearyl alcohol.
Each gram of Hydrocortisone Ointment USP, 2.5% contains 25 mg of
hydrocortisone in ointment base
of light mineral oil and white petrolatum.
Chemically, hydrocortisone is
[Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-] with the
molecular formula (C
H
0 ) and is represented by the following structural formula:
Its molecular weight is 362.47 and its CAS Registery Number is
50-23-7. The topical corticosteroids,
including hydrocortisone, constitute a class of primarily synthetic
steroids used as anti-inflammatory
and antipruritic agents.
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
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 thr