HYDROCORTISONE ACETATE suppository

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Vitruvias Therapeutics

Droga podania:

RECTAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 the anorectum, and pruritus ani. Drug abuse and dependence has not been reported in patients treated with hydrocortisone acetate suppositories.

Status autoryzacji:

unapproved drug other

Charakterystyka produktu

HYDROCORTISONE ACETATE- HYDROCORTISONE ACETATE SUPPOSITORY
VITRUVIAS THERAPEUTICS
_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 25MG
RECTAL SUPPOSITORIES
DESCRIPTION
Each Rectal Suppository contains 25 mg hydrocortisone acetate in a
hydrogenated
vegetable oil base.
Hydrocortisone acetate is a corticosteroid. Chemically, hydrocortisone
acetate is pregn–
4–ene–3, 20–dione, 21–(acetyloxy)–11, 17–dihydroxy
(11ß)– 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,
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, other inflammatory conditions of the anorectum,
and pruritus ani.
CONTRAINDICATION
Hydrocortisone suppositories are contraindicated in those patients
with a history of
hypersensitivity to any of the components.
PRECAUTIONS
1. Do not use unless adequate proctologic examination is made.
2. If irritation develops, the product should be discontinued and
appropriate therapy
instituted.
3. 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.
CARCINOGENIC
No long–term studies in animals have been performed to evaluate the
carcinogenic
potential of corticosteroid suppositories.
INFORMATION FOR PATIENTS