HYDROCORTISONE lotion

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

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

INN (Alþjóðlegt nafn):

HYDROCORTISONE

Samsetning:

HYDROCORTISONE 25 mg in 1 mL

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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.

Vörulýsing:

Hydrocortisone Lotion USP, 2.5% is supplied in a 59 mL (2 Fl Oz) bottle. Shake well before using. Store at controlled room temperature 15°- 30°C (59°- 86°F). Keep out of the reach of children. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2288C/IF2288C R10/15 #278

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

HYDROCORTISONE- HYDROCORTISONE LOTION
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
----------
HYDROCORTISONE LOTION USP, 2.5%
RX ONLY
FOR EXTERNAL USE ONLY
AVOID CONTACT WITH EYES
DESCRIPTION:
Each mL of Hydrocortisone Lotion USP, 2.5% contains 25 mg of
hydrocortisone in a
vehicle consisting of carbomer 980, propylene glycol, polysorbate 40,
propylene glycol
stearate, cholesterol and related sterols, isopropyl myristate,
sorbitan palmitate, cetyl
alcohol, triethanolamine, sorbic acid, simethicone, and purified
water.
Chemically, hydrocortisone is pregn-4-ene-3,20-dione,
11,17,21-trihydroxy-, (11β)- and
is represented by the following structural formula:
Hydrocortisone has the molecular formula C
H
O and a molecular weight of 362.47.
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
21
30
5
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 the percutaneous
absorption of topical
corticosteroids. 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
ADMI