HYDROCORTISONE ACETATE- hydrocortisone acetate suppository

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Preferred Pharmaceuticals, Inc.

INN (International namn):

HYDROCORTISONE ACETATE

Sammansättning:

HYDROCORTISONE ACETATE 25 mg

Administreringssätt:

RECTAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

For use in inflamed hemorrhoids, post irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani. Hydrocortisone acetate suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components. Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

Produktsammanfattning:

Hydrocortisone acetate suppositories are easy to open, color coded and available in cartons of: 12's NDC 68788-9662-1 Store at controlled room temperature 15° to 30°C (59° to 86°F). Protect from freezing.

Bemyndigande status:

unapproved drug other

Produktens egenskaper

HYDROCORTISONE ACETATE- 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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HYDROCORTISONE ACETATE
SUPPOSITORIES 25 MG
DESCRIPTION
Each suppository for rectal administration contains 25 mg
hydrocortisone acetate USP in a
hydrogenated cocoglyceride base. Hydrocortisone acetate is a
corticosteroid.
Chemically, hydrocortisone acetate is pregn-4-ene-3, 20 dione, 21-
(acetyloxy)-11, 17-dihydroxy-,
(11β)- with the following structural formula:
CLINICAL PHARMACOLOGY
In normal subjects, about 26 percent 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, antipruritic and
vasoconstrictive action.
INDICATIONS AND USAGE
For use in inflamed hemorrhoids, post irradiation (factitial)
proctitis, as an adjunct in the treatment of
chronic ulcerative colitis, cryptitis, other inflammatory conditions
of the anorectum, and pruritus ani.
CONTRAINDICATIONS
Hydrocortisone acetate suppositories are contraindicated in those
patients with 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
corticosteroid should be discontinued
until the infection has been adequately controlled.
No long-term studies in animals have been performed to evaluate the
carcinogenic potential of
corticosteroid suppositories.
PREGNANCY CATEGORY C
In laboratory animals, topical steroids have been associated with