HYDROCORTISONE ACETATE suppository

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Cameron Pharmaceuticals, LLC

INN (International Name):

HYDROCORTISONE ACETATE

구성:

HYDROCORTISONE ACETATE 30 mg

관리 경로:

RECTAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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.

제품 요약:

Hydrocortisone acetate suppositories 30 mg are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 42494-302-12

승인 상태:

unapproved drug other

제품 특성 요약

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, 30 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 30 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.
CARCINOGENES IS :
No long-term studies in animals have been performed