HYDROCORTISONE ACETATE suppository

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvPAK

INN (International Name):

Hydrocortisone Acetate

Composition:

Hydrocortisone Acetate 25 mg

Administration route:

RECTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Hydrocortisone acetate suppositories 25mg are off-white, smooth surfaced and bullet shaped with one pointed end. Box of 12 suppositories, NDC 50268-411-12 Box of 24 suppositories, NDC 50268-411-24 Box of 100 suppositories NDC 50268-411-01

Authorization status:

unapproved drug other

Summary of Product characteristics

HYDROCORTISONE ACETATE- HYDROCORTISONE ACETATE SUPPOSITORY
AVPAK
_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, 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 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 PATIENTS
Stai