ANUCORT-HC 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:

Preferred Pharmaceuticals, Inc

INN (International Name):

Hydrocortisone Acetate

Composition:

Hydrocortisone Acetate 25 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

ANUCORT-HC- HYDROCORTISONE ACETATE SUPPOSITORY
PREFERRED PHARMACEUTICALS, 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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ANUCORT-HC
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 & 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.
TM
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
Staining of fabric