HYDROCORTISONE ACETATE suppository

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Rising Pharma Holdings, Inc.

طريقة التعاطي:

RECTAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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.

ملخص المنتج:

Hydrocortisone acetate suppositories 25 mg are white to off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 16571-676-21 Box of 24 suppositories, NDC 16571-676-42 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Excursions permitted to 15°-30°C (59°-86°F). Store away from heat. Protect from freezing. Avoid contact with eyes. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Rx Only Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52030 Rev.01/21

الوضع إذن:

unapproved drug other

خصائص المنتج

HYDROCORTISONE ACETATE - HYDROCORTISONE ACETATE SUPPOSITORY
RISING PHARMA HOLDINGS, INC.
_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 to