HYDROCORTISONE ACETATE suppository

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

APNAR PHARMA LP

Rute administrasi :

RECTAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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; and 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.

Ringkasan produk:

Boxes of 12 suppositories NDC 24689-102-01 Boxes of 12 suppositories NDC 24689-103-01

Status otorisasi:

unapproved drug other

Karakteristik produk

HYDROCORTISONE ACETATE- HYDROCORTISONE ACETATE SUPPOSITORY
APNAR PHARMA LP
_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
DESCRIPTION
Hydrocortisone Acetate is a corticosteroid designated chemically as
pregn-4-ene 3, 20-
dione, 21- (acetyloxy)-11,17-dihydroxy-(11ß)
with the following structural formula:
Each rectal suppository contains hydrocortisone acetate, 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 acetate suppositories are indicated for 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
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 evaluate the
carcinogenic
potential of corticosteroid suppositories.
INFORMATION FOR PATIEN