ANUSOL HC- hydrocortisone acetate suppository

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Salix Pharmaceuticals, Inc

INN (International Name):

HYDROCORTISONE ACETATE

Sammensætning:

HYDROCORTISONE ACETATE 25 mg

Indgivelsesvej:

RECTAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske 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. Drug abuse and dependence has not been reported in patients treated with Anusol-HC™ suppositories.

Produkt oversigt:

Anusol-HC™ 25 mg Suppositories are white, cylinder shaped, with one end tapered. NDC 65649-411-12 25 mg 12 suppositories NDC 65649-411-24 25 mg 24 suppositories Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store away from heat. PROTECT FROM FREEZING. Manufactured for : Salix Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA Anusol-HC is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. © Valeant Pharmaceuticals North America LLC OPENING INSTRUCTIONS Avoid excessive handling of the suppository. It is designed to melt at body temperature. 1. Separate plastic film at top opening and pull downward. 2. Continue pulling downward to almost the full length of the suppository. 3. Gently remove the suppository from the film pocket. Rev. 10/2017 9520701 2201318 9B500 9L J2

Autorisation status:

unapproved drug other

Produktets egenskaber

ANUSOL HC- HYDROCORTISONE ACETATE SUPPOSITORY
SALIX 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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ANUSOL-HC HYDROCORTISONE ACETATE RECTAL SUPPOSITORIES, 25 MG
RX ONLY
DESCRIPTION
Each Anusol-HC 25 mg 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
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
Anusol-HC 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.
INFORMATION FOR PATIENTS:
Staining of fabric may occur with use of the suppository.
Precautionary