HYDROCORTISONE ACETATE suppository

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Доступно од:

Syntenza Pharmaceuticals LLC

Пут администрације:

RECTAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani. Hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components. Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

Резиме производа:

Rx only. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Store away from heat. Protect From Freezing.

Статус ауторизације:

unapproved drug other

Карактеристике производа

HYDROCORTISONE ACETATE- HYDROCORTISONE ACETATE SUPPOSITORY
SYNTENZA PHARMACEUTICALS LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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HYDROCORTISONE ACETATE, 25 MG
RECTAL SUPPOSITORIES
DESCRIPTION
Hydrocortisone Acetate is a corticosteroid designated chemically as
pregn-4-ene 3, 20-dione, 21-
(acetyloxy)-11, 17-dihydroxy-(11β) with the following structural
formula:
MW 404.51
Each rectal suppository contains hydrocortisone acetate, USP 25 mg in
a specially blended
hydrogenated vegetable oil base.
CLINICAL PHARMACOLOGY
In normal subjects, about 26% of hydrocortisone acetate is absorbed
when the suppository is applied to
the rectum. Absorption of hydrocortisone acetate may vary across
abraded or inflamed surfaces.
Topical steroids are primarily effective because of their
anti-inflammatory, anti-pruritic and
vasoconstrictive action.
INDICATIONS AND USAGE
Hydrocortisone acetate suppositories are indicated for use in inflamed
hemorrhoids, post-irradiation
(factitial) proctitis; as an adjunct in the treatment of chronic
ulcerative colitis; cryptitis; and other
inflammatory conditions of anorectum and pruritus ani.
CONTRAINDICATIONS
Hydrocortisone acetate suppositories are contraindicated in those
patients having a history of
hypersensitivity to hydrocortisone acetate or any of the components.
PRECAUTIONS
Do not use hydrocortisone acetate suppositories unless adequate
proctologic examination is made.
If irritation develops, the product should be discontinued and
appropriate therapy instituted.
In the presence of an infection, the use of an appropriate antifungal
or antibacterial agent should be
instituted. If a favorable response does not occur promptly,
hydrocortisone acetate should be
discontinued until the infection has been adequately controlled.
CARCINOGENES IS
No long term studies in animals have been performed to evaluate the
carcinogenic potential of
corticosteroi