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:

West-Ward Pharmaceuticals Corp.

INN (International Name):

ALOSETRON HYDROCHLORIDE

Composition:

ALOSETRON 0.5 mg

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: Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following: 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 patients with constipation [see Warnings and Precautions (5.1) ]. Alosetron hydrochloride tablets are contraindicated in patients with a history of the following: Concomitant administration of alosetron hydrochloride tablets with fluvoxamine is contraindicated. Fluvoxamine, a known strong inhibitor of CYP1A2, has been shown to increase mean alosetron plasma concentrations (AUC) approximately 6

Product summary:

Alosetron Hydrochloride Tablets USP 0.5 mg (0.562 mg alosetron HCl equivalent to 0.5 mg alosetron) tablets are supplied as white to off-white, round, biconvex tablets with product identification “54” over “628” debossed on one side and plain on the other side. NDC 0054-0295-13: Bottle of 30 Tablets with child-resistant closures. 1 mg (1.124 mg alosetron HCl equivalent to 1 mg alosetron) tablets are supplied as white to off-white, round, biconvex tablets with product identification “54” over “974” debossed on one side and plain on the other side. NDC 0054-0296-13: Bottle of 30 Tablets with child-resistant closures. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

West-Ward Pharmaceuticals Corp.
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Medication Guide
Alosetron (a-LOW-zeh-tron) Hydrochloride Tablets USP
Rx only
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 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 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:
o
If you are constipated, do not start taking alosetron hydrochloride
tablets.
o
If you get constipated while taking alosetron hydrochloride tablets,
stop taking it right away and call
your doctor.
o
If your constipation does not get better after stopping alosetron
hydrochloride tablets, call your doctor
again.
o
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
months is not known. Ischemic
colitis may lead to a hospit

Summary of Product characteristics

ALOSETRON HYDROCHLORIDE- ALOSETRON HYDROCHLORIDE TABLET
WEST-WARD PHARMACEUTICALS CORP.
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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.
•
•
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:
•
•
•
Severe IBS includes diarrhea and 1 or more of the following:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 0.5 and 1 mg (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
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)
3
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)
frequent and severe abdominal pain/discomfort,
frequent bowel urgency or fecal incontinence,
disability or restriction of daily activities due to IBS. (1)
Starting dose is 0.5 m