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:

Rebel Distributors Corp

INN (International Name):

HYDROCORTISONE ACETATE

Composition:

HYDROCORTISONE ACETATE 30 mg

Administration route:

RECTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For use in inflamed hemorrhoids, postirradiation (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 any of the components. Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

Product summary:

Box of 12 suppositories - NDC 21695-731-12 Rx only. Store at 20°–25°C (68°–77°F). See USP Controlled Room Temperature. Store away from heat. Protect from freezing. For Inquiries call: 1-866-207-5636 Distributed by: County Line Pharmaceuticals, LLC Brookfield, WI 53005 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

unapproved drug other

Summary of Product characteristics

HYDROCORTISONE ACETATE- HYDROCORTISONE ACETATE SUPPOSITORY
REBEL DISTRIBUTORS CORP
_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
PROCTOCORT
Hydrocortisone Acetate
Rectal Suppositories, 25 mg
DESCRIPTION
Each Hydrocortisone Acetate 25 mg Suppository contains 25 mg
hydrocortisone acetate in a
hydrogenated vegetable oil base. Hydrocortisone acetate is a
corticosteroid. Chemically,
hydrocortisone acetate is a pregn-4-ene-3, 20-dione,
21-(acetyloxy)-11, 17-dihydroxy-(11β) with the
following structural formula:
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
For use in inflamed hemorrhoids, postirradiation (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 any of the components.
PRECAUTIONS
Do not use 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, the
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.
PREGNANCY CATEGORY C: In laboratory animals, topical stero