ALOSETRON HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rising Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alosetron hydrochloride 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 hydrochloride 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 hydrochloride tablets in men. Alosetron hydrochloride tablets should not be initiated in patien

Product summary:

Alosetron HCl Tablet, USP 0.5 mg is white to off white colored, oval, biconvex, film coated tablet debossed with "Cipla" on one side and "198" on the other side and available in bottles of 30 (64980-453-03) and bottles of 500 (64980-453-50). Alosetron HCl Tablet, USP 1 mg is blue colored, oval, biconvex, film coated tablet debossed with "Cipla" on one side and "199" on the other side and available in bottles of 30 (64980-454-03) and bottles of 500 (64980-454-50). Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ALOSETRON HYDROCHLORIDE - ALOSETRON HYDROCHLORIDE TABLET
Rising Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
ALOSETRON (a-LOW-zeh-tron) Hydrochloride Tablet, USP
Read the Medication Guide you get with each refill for alosetron
hydrochloride 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
hydrochloride tablets?
Alosetron hydrochloride tablets are 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 hydrochloride 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
hydrochloride tablets.
•
To lower your chances of getting serious complications of
constipation, do the following:
•
If you are constipated, do not start taking alosetron hydrochloride
tablets.
•
If you get constipated while taking alosetron hydrochloride tablets,
stop taking it right
away and call your doctor.
•
If your constipation does not get better after stopping alosetron
hydrochloride tablets, call
your doctor again.
•
If you stopped taking alosetron hydrochloride tablets, do not start
taking alosetron
hydrochloride 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 hydrochloride tablets for more than 6 mo

Summary of Product characteristics

ALOSETRON HYDROCHLORIDE - ALOSETRON HYDROCHLORIDE TABLET
RISING PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALOSETRON
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ALOSETRON HYDROCHLORIDE TABLETS.
ALOSETRON HYDROCHLORIDE 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 TABLETS. THESE EVENTS, INCLUDING
ISCHEMIC COLITIS AND
SERIOUS COMPLICATIONS OF CONSTIPATION, HAVE RESULTED IN
HOSPITALIZATION AND, RARELY,
BLOOD TRANSFUSION, SURGERY, AND DEATH.
ALOSETRON HYDROCHLORIDE 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 HYDROCHLORIDE TABLETS IMMEDIATELY IN PATIENTS
WHO DEVELOP
CONSTIPATION OR SYMPTOMS OF ISCHEMIC COLITIS. DO NOT RESUME ALOSETRON
HYDROCHLORIDE
TABLETS IN PATIENTS WHO DEVELOP ISCHEMIC COLITIS. (2.1, 5.1, 5.2)
INDICATIONS AND USAGE
Alosetron hydrochloride 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