HYDROCORTISONE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

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: 1 oz. (28 g) tube (NDC 68788-9922-3)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCORTISONE- HYDROCORTISONE CREAM
PREFERRED PHARMACEUTICALS INC.
----------
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
21
3O 5
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 a