HYDROCORTISONE cream

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Quality Care Products LLC

INN (Kansainvälinen yleisnimi):

HYDROCORTISONE

Koostumus:

HYDROCORTISONE 25 mg in 1 g

Antoreitti:

TOPICAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

Hydrocortisone Cream USP, 2.5% is available as follows: 55700-321-30 Hydrocortisone Ointment USP, 2.5% is available as follows:

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

HYDROCORTISONE- HYDROCORTISONE CREAM
QUALITY CARE PRODUCTS 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
21
3O 5
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 absorb