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:

Actavis Pharma, Inc.

INN (International Name):

ALOSETRON HYDROCHLORIDE

Composition:

ALOSETRON 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alosetron hydrochloride is 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, 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 in men. Alosetron hydrochloride should not be initiated in patients with constipation

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 GX EX1 on one face. Bottles of 30 (NDC 45963-479-03) 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 GX CT1 on one face. Bottles of 30 (NDC 45963-480-03) with child-resistant closures. Store at 20-25˚C (USP Controlled Room Temperature). Protect from light and moisture.

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

ALOSETRON HYDROCHLORIDE- ALOSETRON HYDROCHLORIDE TABLET
Actavis Pharma, Inc.
----------
MEDICATION GUIDEALOSETRON HYDROCHLORIDE (a-LOE-se-tron
HYE-droe-KLOR-ide)
TABLETS
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 is 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, do not start taking
alosetron hydrochloride 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
ACTAVIS PHARMA, 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 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 is 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 hydrochloride in pati