LOTRONEX- 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:

Sebela Pharmaceuticals Inc.

INN (International Name):

ALOSETRON HYDROCHLORIDE

Composition:

ALOSETRON 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LOTRONEX 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 LOTRONEX, 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 LOTRONEX in men. LOTRONEX should not be initiated in patients with constipation [see Warnings and Precautions ( 5.1)]

Product summary:

LOTRONEX 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 65483-894-03) with child-resistant closures. LOTRONEX 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 65483-895-03) with child-resistant closures. Store at 20-25°C (68-77°F) (USP Controlled Room Temperature). Protect from light and moisture.

Authorization status:

New Drug Application

Patient Information leaflet

Sebela Pharmaceuticals Inc.
----------
MEDICATION GUIDE
LOTRONEX ® (LOW-trah-nex)
(alosetron hydrochloride)
Tablets
Read the Medication Guide you get with each refill for LOTRONEX. 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 LOTRONEX?
LOTRONEX is a meeicine only for some women with severe chronic
irritable bowel syndrome (IBS)
whose:
•
main problem is darrhea and
•
IBS symptoms have not been helped enough by other treatments.
Some people have developed serious bowel side effects while taking
LOTRONEX. 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 LOTRONEX.
To lower your chances of getting serious complications of
constipation, do the following:
•
If you are constipated, do not start taking LOTRONEX.
•
If you get constipated while taking LOTRONEX, stop taking it right
away and call your doctor.
•
If your constipation does not get better after stopping LOTRONEX, call
your doctor again.
•
If you stopped taking LOTRONEX, do not start taking LOTRONEX 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 LOTRONEX 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 LOTRONEX and call your doctor or get medical help if you
have symptoms of ischemic
colitis such as new or worsening stomach-area (abdominal) pain, bloody
diarrhea or blood in

Summary of Product characteristics

LOTRONEX- ALOSETRON HYDROCHLORIDE TABLET
SEBELA PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LOTRONEX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LOTRONEX.
LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLETS
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 LOTRONEX.
THESE EVENTS, INCLUDING ISCHEMIC COLITIS AND SERIOUS COMPLICATIONS OF
CONSTIPATION, HAVE RESULTED IN
HOSPITALIZATION AND, RARELY, BLOOD TRANSFUSION, SURGERY, AND DEATH.
LOTRONEX IS INDICATED ONLY FOR WOMEN WITH SEVERE DIARRHEA-PREDOMINANT
IRRITABLE BOWEL SYNDROME
(IBS) WHO HAVE NOT RESPONDED ADEQUATELY TO CONVENTIONAL THERAPY. ( 1)
DISCONTINUE LOTRONEX IMMEDIATELY IN PATIENTS WHO DEVELOP CONSTIPATION
OR SYMPTOMS OF ISCHEMIC
COLITIS. DO NOT RESUME LOTRONEX IN PATIENTS WHO DEVELOP ISCHEMIC
COLITIS. ( 2.1, 5.1, 5.2)
INDICATIONS AND USAGE
LOTRONEX 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 LOTRONEX in patients who have not had adequate control of
IBS symptoms after 4 weeks of treatment
with 1 mg twice a day. ( 2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: