HYDROCORTISONE ACETATE suppository

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

GRAXCELL PHARMACEUTICAL, LLC.

Via di somministrazione:

RECTAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Hydrocortisone acetate suppositories are indicated for the 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 puritus 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 dependece have not been reported in patients treated with Hydrocortisone acetate suppositories.

Dettagli prodotto:

Hydrocortisone Acetate suppositories 25mg are white,cyclinder shaped, with one end tapered. Package of 12 NDC 70795-2412-1 and Package of 24 NDC 70795-2412-2

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

HYDROCORTISONE ACETATE- HYDROCORTISONE ACETATE SUPPOSITORY
GRAXCELL PHARMACEUTICAL, 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 SUPPOSITORY 25MG, 70795-2412
GRAXCELL PHARMACEUTICAL, LLC.
DISCLAIMER: THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND
EFFECTIVE,
AND THIS LABELLING HAS NOT BEEN APPROVED BY FDA.
HYDROCORTISONE ACETAE, 25MG.
RECTAL SUPPOSITORIES.
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:
Each rectal suppository contains hydrocortisone acetate, USP 25 mg in
a specially
blended hydrogenated vegetable oil base
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 vasconstrictive action.
Hydrocortisone acetate suppositories are indicated for the 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
puritus ani.
Hydrocortisone Acetate suppositories are contraindicated in those
patients having a
history of hypersensitivity to hydrocortisone acetate or any of the
components
Do not use 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, the
corticosteroid should be
discontinued until the infection has been adequately controlled.
Carcinogenic: No long-term studies in animals have b