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:

Par Pharmaceutical, 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 and

Product summary:

Alosetron hydrochloride tablets, 0.5 mg (0.562 mg alosetron HCl equivalent to 0.5 mg alosetron) are white, oval, film-coated tablets debossed with “P” on one side and 819 on the other side. Bottles of 30 (NDC 49884-819-11) with child-resistant closures. Alosetron hydrochloride tablets, 1 mg (1.124 mg alosetron HCl equivalent to 1 mg alosetron), are blue, oval, film-coated tablets debossed with “P” on one side and 820 on the other side. Bottles of 30 (NDC 49884-820-11) with child-resistant closures. Store at 20˚ to 25˚C (68˚ to 77˚F) (USP Controlled Room Temperature). Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Par Pharmaceutical, Inc.
----------
MEDICATION GUIDE
MEDICATION
GUIDE
Alosetron
Hydrochloride Tablets
(a-LOE-se-tron HYE-
droe-KLOR-ide)
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:
•
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 months is
not known.
Ischemic colit

Summary of Product characteristics

ALOSETRON HYDROCHLORIDE- ALOSETRON HYDROCHLORIDE TABLET
PAR PHARMACEUTICAL, 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. 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
SEVEREDIARRHEA-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 Tabletsare a selective serotonin 5-HT
antagonist indicated only for women with severe diarrhea-
predominant irritable bowel syndrome (IBS) who have: (1)
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: (1)
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 hydrochl