ALOSETRON HYDROCHLORIDE- alosetron hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE, Inc.

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: - 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 should not be initiated in patients with constipation [see Warnings an

Product summary:

Alosetron hydrochloride tablets, 0.5 mg (0.562 mg alosetron hydrochloride 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 42291-123-30 with child-resistant closures. Alosetron hydrochloride tablets, 1 mg (1.124 mg alosetron hydrochloride 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 42291-124-30 with child-resistant closures. . Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ALOSETRON HYDROCHLORIDE- ALOSETRON HYDROCHLORIDE TABLET, FILM COATED
AvKARE, Inc.
----------
MEDICATION GUIDE
Alosetron (a-LO-ze-tron) Hydrochloride Tablets
Before using alosetron hydrochloride tablets for the
first time, you
should:
•
Understand that alosetron hydrochloride tablets
have serious risks for some
people.
•
Read and follow the directions in this
Medication
Guide.
Carefully 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.
1. What is the most important information I should know about
alosetron hydrochloride tablets?
A. 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.
B. Some patients have developed serious bowel side effects while
taking alosetron hydrochloride tablets.
Serious bowel (intestine) side effects can happen suddenly, including
the following:
1. Serious complications of constipation: About 1 out of every 1,000
women who take alosetron
hydrochloride tablets may get 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

Summary of Product characteristics

ALOSETRON HYDROCHLORIDE- ALOSETRON HYDROCHLORIDE TABLET, FILM COATED
AVKARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
ALOSETRON HYDROCHLORIDE
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. 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 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)
Discontinue a