NEOMED PHARMACEUTICAL- hydrocortisone acetate suppository

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

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05-03-2018

Bahan aktif:

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

Boleh didapati daripada:

Neomed Pharmaceutical

Laluan pentadbiran:

RECTAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Hydrocortisone 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 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 suppositories.

Ringkasan produk:

Hydrocortisone acetate suppositories 25mg are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 24 suppositories, NDC 70898-204-24

Status kebenaran:

unapproved drug other

Ciri produk

                                NEOMED PHARMACEUTICAL- HYDROCORTISONE ACETATE SUPPOSITORY
NEOMED PHARMACEUTICAL
_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 25MG
Hydrocortisone acetate suppositories 25mg
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––(11 β) with the following
structural formula:
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 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 suppositories are contraindicated in those patients
having a history of hypersensitivity
to hydrocortisone acetate or any of the components.
PRECAUTIONS:
Do not use Hydrocortisone 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 suppository should be
discontinued until the
infection has been adequately controlled.
CARCINOGENES IS :
No long term studies in animals have been performed to evaluate the
carcin
                                
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