RECTACORT - HC- hydrocortisone acetate suppository

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Acino Products, LLC.

INN (Διεθνής Όνομα):

HYDROCORTISONE ACETATE

Σύνθεση:

HYDROCORTISONE ACETATE 25 mg

Οδός χορήγησης:

RECTAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Hydrocortisone acetate suppositories are indicated for the 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 puritus ani. 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. Drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

Περίληψη προϊόντος:

Hydrocortisone acetate suppository is off-white, smooth surfaced and rod shaped with one pointed end. Box of 12, 24, 50, 100 suppositories. Store between 15°-30°C(59°-86°F). Protect from freezing

Καθεστώς αδειοδότησης:

unapproved drug other

Αρχείο Π.Χ.Π.

RECTACORT - HC - HYDROCORTISONE ACETATE SUPPOSITORY
ACINO PRODUCTS, 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._
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DESCRIPTION:
HYDROCORTISONE ACETATE, 25 mg
Rectal Suppositories
DESCRIPTION: Hydrocortisone Acetate is a corticosteroid designated
chemically as pregn-4-ene-3,
20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β) 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
vasconstrictive action.
INDICATIONS AND USAGE:
Hydrocortisone acetate suppositories are indicated for the 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 puritus ani.
CONTRAINDICATIONS:
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.
PRECAUTIONS:
Do not use hydrocortisone acetate suppositories unless a 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.
Carcinogenesis: No long term