ALOSETRON HYDROCHLORIDE tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

ALOSETRON HYDROCHLORIDE (UNII: 2F5R1A46YW) (ALOSETRON - UNII:13Z9HTH115)

Saadav alates:

Amneal Pharmaceuticals of New York LLC

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: - chronic IBS symptoms (generally lasting 6 months or longer), - had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and - not responded adequately to conventional therapy. Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following: - frequent and severe abdominal pain/discomfort, - frequent bowel urgency or fecal incontinence, - disability or restriction of daily activities due to IBS. Because of infrequent but serious gastrointestinal adverse reactions associated with alosetron tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable. Clinical studies have not been performed to adequately confirm the benefits of alosetron tablets in men. Alosetron hydrochloride should not be initiated in patients with constipation [see Warnings and Precautions (5.1)] . Alosetron hydrochlor

Toote kokkuvõte:

Alosetron tablets USP, 0.5 mg (0.562 mg alosetron hydrochloride, USP equivalent to 0.5 mg alosetron), are supplied as white, oval shaped, film coated tablets debossed with “AN248” on one side and plain on the other side. They are available as follows: Bottles of 30:                                     NDC 53746-248-30 with child-resistant closures. Alosetron tablets USP, 1 mg (1.124 mg alosetron hydrochloride, USP equivalent to 1 mg alosetron), are supplied as light blue, oval shaped, film coated tablets debossed with “AN249” on one side and plain on the other side. They are available as follows: Bottles of 30:                                     NDC 53746-249-30 with child-resistant closures. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

Amneal Pharmaceuticals of New York LLC
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
documents.amneal.com/mg/alosetron-in.pdf
Alosetron (a-LO-ze-tron)Tablets, USP
Read the Medication Guide you get with each refill for alosetron
tablets. There may be new information.
This Medication Guide does not take the place of talking with your
doctor.
What is the most important information I should know about alosetron
tablets?
Alosetron tablets are a medicine only for some women with severe
chronic irritable bowel syndrome
(IBS) whose:
•
main problem is diarrhea and
•
IBS symptoms have not been helped enough by other treatments.
Some people have developed serious bowel side effects while taking
alosetron tablets. Serious bowel
(intestine) side effects can happen suddenly, including the following:
•
Serious complications of constipation:
These complications may lead to a hospital stay and, in rare cases,
blood transfusions, surgery and
death. People who are older, who are weak from illness, or who take
other constipating medicines may
be more likely to have serious complications of constipation with
alosetron tablets.
To lower your chances of getting serious complications of
constipation, do the following:
•
If you are constipated, do not start taking alosetron tablets.
•
If you get constipated while taking alosetron tablets, stop taking it
right away and call your
doctor.
•
If your constipation does not get better after stopping alosetron
tablets, call your doctor again.
•
If you stopped taking alosetron tablets, do not start taking alosetron
tablets again unless your
doctor tells you to do so.
•
Inflammation and injury of the intestines caused by reduced blood flow
(ischemic
colitis): Ischemic colitis is caused by reduced blood flow to parts of
the large bowel. The chance
of getting ischemic colitis when you take alosetron tablets for more
than 6 months is not known.
Ischemic colitis may lead to a hospital stay and, in rare cases, blood
transfusions, surgery, and
death.
Stop takin

Toote omadused

ALOSETRON HYDROCHLORIDE- ALOSETRON HYDROCHLORIDE TABLET, FILM COATED
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALOSETRON TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALOSETRON
TABLETS.
ALOSETRON TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INFREQUENT BUT SERIOUS GASTROINTESTINAL ADVERSE REACTIONS HAVE BEEN
REPORTED WITH THE
USE OF ALOSETRON HYDROCHLORIDE. THESE EVENTS, INCLUDING ISCHEMIC
COLITIS AND SERIOUS
COMPLICATIONS OF CONSTIPATION, HAVE RESULTED IN HOSPITALIZATION AND,
RARELY, BLOOD
TRANSFUSION, SURGERY AND DEATH.
ALOSETRON HYDROCHLORIDE IS INDICATED ONLY FOR WOMEN WITH SEVERE
DIARRHEA-
PREDOMINANT IRRITABLE BOWEL SYNDROME (IBS) WHO HAVE NOT RESPONDED
ADEQUATELY TO
CONVENTIONAL THERAPY. (1)
DISCONTINUE ALOSETRON HYDROCHLORIDE IMMEDIATELY IN PATIENTS WHO
DEVELOP
CONSTIPATION OR SYMPTOMS OF ISCHEMIC COLITIS. DO NOT RESUME ALOSETRON
HYDROCHLORIDE
IN PATIENTS WHO DEVELOP ISCHEMIC COLITIS. (2.1, 5.1, 5.2)
INDICATIONS AND USAGE
Alosetron tablets are a selective serotonin 5-HT antagonist indicated
only for women with severe
diarrhea-predominant irritable bowel syndrome (IBS) who have:
chronic IBS symptoms (generally lasting 6 months or longer),
had anatomic or biochemical abnormalities of the gastrointestinal
tract excluded and
not responded adequately to conventional therapy. (1)
Severe IBS includes diarrhea and 1 or more of the following:
frequent and severe abdominal pain/discomfort,
frequent bowel urgency or fecal incontinence,
disability or restriction of daily activities due to IBS. (1)
DOSAGE AND ADMINISTRATION
Starting dose is 0.5 mg twice a day. (2.1)
May increase dose to 1 mg twice a day after 4 weeks if starting dosage
is well tolerated but does not
adequately control IBS symptoms. (2.1)
Discontinue alosetron tablets in patients who have not had adequa