ALOSETRON tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 tablets should not be initiated in patients with constipation [see Warnings and Precautions (5.1)] . Alosetron tablets are co

Product summary:

NDC: 63629-2517-1: 30 Tablets in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Bryant Ranch Prepack
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MEDICATION GUIDE
Alosetron (a-LOE-se-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 is 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 taking alosetron tablets and call your doctor or get medical help
if you have symptoms of ischemic
coliti

Summary of Product characteristics

ALOSETRON- ALOSETRON TABLET
BRYANT RANCH PREPACK
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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 TABLETS. THESE EVENTS, INCLUDING ISCHEMIC COLITIS AND
SERIOUS
COMPLICATIONS OF CONSTIPATION, HAVE RESULTED IN HOSPITALIZATION AND,
RARELY, BLOOD
TRANSFUSION, SURGERY, AND DEATH.
ALOSETRON TABLETS ARE INDICATED ONLY FOR WOMEN WITH SEVERE
DIARRHEA-PREDOMINANT
IRRITABLE BOWEL SYNDROME (IBS) WHO HAVE NOT RESPONDED ADEQUATELY TO
CONVENTIONAL
THERAPY. (1)
DISCONTINUE ALOSETRON TABLETS IMMEDIATELY IN PATIENTS WHO DEVELOP
CONSTIPATION OR
SYMPTOMS OF ISCHEMIC COLITIS. DO NOT RESUME ALOSETRON TABLETS IN
PATIENTS WHO
DEVELOP ISCHEMIC COLITIS. (2.1, 5.1, 5.2)
INDICATIONS AND USAGE
Alosetron tablets are 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 adequate
control of IBS symptoms after 4
weeks of treatment with 1 mg twice a day. (2.1)
DO