HYDROCORTISONE ACETATE suppository

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

SI Pharmaceuticals, LLC

INN (Nome Internazionale):

HYDROCORTISONE ACETATE

Composizione:

HYDROCORTISONE ACETATE 25 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

HYDROCORTISONE ACETATE- HYDROCORTISONE ACETATE SUPPOSITORY
SI PHARMACEUTICALS, LLC
_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._
----------
HYDROCORTISONE ACETATE 25MG
Hydrocortisone acetate is a corticosteroid designed chemically as
pregn-4-ene-3, 20-dione, 21-
(acetyloxy)-11, 17-dihydroxy-(11ß) with the following structural
formula:
C23H32O6
Each suppository for rectal administration contains hydrocortisone
acetate, USP 25 mg in a specially
blended hydrogenated vegetable base.
In normal subjects, about 26% 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, anti-
pruritic and vasoconstrictive action.
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, 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.
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.
CARCINOGENES IS :
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