HYDROCORTISONE ACETATE suppository

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Cameron Pharmaceuticals, LLC

Via de administração:

RECTAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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, 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.

Resumo do produto:

Hydrocortisone acetate suppositories 25mg are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 42494-301-12 Box of 24 suppositories, NDC 42494-301-24

Status de autorização:

unapproved drug other

Características técnicas

HYDROCORTISONE ACETATE- HYDROCORTISONE ACETATE SUPPOSITORY
CAMERON 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 SUPPOSITORIES, 25 MG
FOR RECTAL ADMINISTRATION
RX ONLY
DESCRIPTION
Hydrocortisone acetate is a corticosteroid designed chemically as
pregn-4-ene-3, 20-
dione, 21-(acetyloxy)-11, 17-dihydroxy-(11ß) with the following
structural formula:
Each suppository for rectal administration contains hydrocortisone
acetate, USP 25 mg
in a specially blended hydrogenated vegetable base.
CLINICAL PHARMACOLOGY:
In normal subjects, about 26% of hydrocortisone acetate is absorbed
when the
hydrocortisone acetate 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, 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.
CARCINOGENESIS:
No long-term studies in animals have been performed