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:

Amneal Pharmaceuticals LLC

INN (International Name):

ALOSETRON HYDROCHLORIDE

Composition:

ALOSETRON 0.5 mg

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 withalosetron 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 hydrochloride should not be initiated in patients with constipation [see Warnings and Precautions (5.1)] . Alosetron hydrochlori

Product summary:

Alosetron tablets USP, 0.5 mg (0.562 mg alosetron hydrochloride, USP 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 65162-248-03 with child-resistant closures. Bottles of 500:                        NDC 65162-248-50 with child-resistant closures. Alosetron tablets USP, 1 mg (1.124 mg alosetron hydrochloride, USP 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 65162-249-03 with child-resistant closures. Bottles of 500:                        NDC 65162-249-50 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

Amneal Pharmaceuticals LLC
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
documents.amneal.com/mg/alosetron.pdf
Alosetron (a-LO-ze-
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 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 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
ta

Summary of Product characteristics

ALOSETRON HYDROCHLORIDE- ALOSETRON HYDROCHLORIDE TABLET, FILM COATED
AMNEAL PHARMACEUTICALS LLC
----------
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 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 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 alosetron tablets in patients who have not had adequate
control of