LOTRONEX® is a medicine only for some women with severe chronic IBS whose:
Main problem is diarrhea and
IBS symptoms have not been helped enough by other treatments
LOTRONEX may be right for you if all of these things are true about you:
Your doctor has told you that your symptoms are due to IBS
Your IBS bowel problem is diarrhea
Your IBS has gone on for a long time, 6 months or longer
You have tried other IBS treatments and they haven't given you the relief you need
Prescription and nonprescription medicines
Supplements
Herbal remedies
Please list any other treatments that you've tried
Your IBS is severe
You can tell that your IBS is severe if at least one of the following is true for you:
You have lots of painful stomach cramps or bloating
You often can't control the need to have a bowel movement or have "accidents" where your underwear gets dirty from diarrhea or bowel movements
You can't lead a normal home or work life because you need to be near a bathroom.
You can use this page as a guideline to talk with your doctor. For a clearer version, simply click access printable PDF and print. Once printed, you can easily check off the boxes that apply to you. Then, bring the page with you to your next appointment and ask your doctor if LOTRONEX is right for you. Only your doctor can decide if LOTRONEX is right for you.
IMPORTANT PRODUCT INFORMATION FOR PATIENTS
What is the most important information I should know about LOTRONEX?
LOTRONEX is a medicine only for some women with severe chronic IBS whose:
main problem is diarrhea and
IBS symptoms have not been helped enough by other treatments.
Some patients have developed serious bowel side effects while taking
LOTRONEX. Serious bowel (intestine) side effects can happen suddenly,
including the following two:
Serious complications of constipation: About 1 out of every 1,000 women who take
LOTRONEX 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 constipation problems 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.
Ischemic colitis (reduced blood flow to the bowel): About 3 out of every 1,000 women
who take LOTRONEX over a 6-month period may get a serious problem where blood
flow to parts of the large bowel is reduced. This is called ischemic colitis. 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.
To lower your chances of getting serious complications of ischemic colitis,
stop taking LOTRONEX and call your doctor right away if you get:
new or worse pain in your stomach area (abdomen) or
blood in your bowel movements.
Is LOTRONEX right for you?
LOTRONEX may be right for you if all of these things are true about you:
Your doctor has told you that your symptoms are due to IBS.
Your IBS bowel problem is diarrhea.
Your IBS has lasted for 6 months or longer.
You tried other IBS treatments and they didn't give you the relief you need.
Your IBS is severe.
You can tell if your IBS is severe ifat least 1 of the following is true for you:
You have lots of painful stomach cramps or bloating.
You often can't control the need to have a bowel movement, or you have "accidents"
where your underwear gets dirty from diarrhea or bowel movements.
You can't lead a normal home or work life because you need to be near a bathroom.
Enough testing has not been done to confirm LOTRONEX works in men or children under age 18.
There is a special prescribing program for LOTRONEX.
Only doctors who have signed up with the company that makes LOTRONEX should write prescriptions for LOTRONEX. As part of signing up, these doctors have said that they understand about IBS and the possible side effects of LOTRONEX. They have agreed to use a special sticker on all prescriptions for LOTRONEX, so the pharmacist will know that the doctors have signed up with the company.
You may be taught about LOTRONEX by your doctor or healthcare provider under a doctor's direction. Your doctor will ask you to sign a Patient-Physician Agreement after you read this Medication Guide for the first time. Signing the Agreement means that you understand the benefits and risks of LOTRONEX and that you have read and understand this Medication Guide.
What is LOTRONEX?
LOTRONEX is a medicine only for some women with severe chronic IBS whose:
main problem is diarrhea and
IBS symptoms have not been helped enough by other treatments.
LOTRONEX does not cure IBS, and it may not help every person who takes it. For those who are helped, LOTRONEX reduces lower stomach area (abdominal) pain and discomfort, the sudden need to have a bowel movement (bowel urgency), and diarrhea from IBS. If you stop taking LOTRONEX, your IBS symptoms may return within 1 or 2 weeks.
Who should not take LOTRONEX?
LOTRONEX is not right for everyone. Do not take LOTRONEX if any of the following apply to you:
Your main IBS problem is constipation or you are constipated most of the time.
You have had a serious problem from constipation.
You have had serious bowel blockages.
You have had blood flow problems to your bowels, such as ischemic colitis.
You have had blood clots.
You have had Crohn's disease, ulcerative colitis, diverticulitis, or severe liver disease.
You do not understand this Medication Guide or the Patient-Physician Agreement, or you
are not willing to follow them.
You are allergic to LOTRONEX or any of its ingredients. (See the list of ingredients at the
end of this Medication Guide.)
You are taking fluvoxamine (LUVOX®).
If you are constipated now, do not start taking LOTRONEX.
What should I talk about with my doctor before taking LOTRONEX?
Talk with your doctor:
about the possible benefits and risks of LOTRONEX.
about how much of a problem IBS is in your life and what treatments you have tried.
about any other illnesses you have and medicines you take or plan to take. These
include prescription and non-prescription medicines, supplements, and herbal remedies.
Certain illnesses and medicines can increase your chance of getting serious side effects
while taking LOTRONEX. Other medicines may interact with how the body handles
LOTRONEX.
if you are pregnant, planning to get pregnant, or breastfeeding.
How should I take LOTRONEX?
Take LOTRONEX exactly as your doctor prescribes it. You can take LOTRONEX
with or without food.
Begin with 0.5 mg two times a day for 4 weeks to see how LOTRONEX affects you.
You and your doctor may decide that you should keep taking this dose if you are doing well.
Check with your doctor 4 weeks after starting LOTRONEX:
If you try 0.5 mg two times a day for 4 weeks, it may not control your symptoms. If
you do not get constipation or other side effects from LOTRONEX, your doctor may
increase your dose up to 1 mg two times a day.
If 1 mg two times a day does not work after 4 weeks, LOTRONEX is not likely to help
you. You should stop taking it and call your doctor.
If you miss a dose of LOTRONEX, just skip that dose. Do not take 2 doses the next
time. Wait until the next time you are supposed to take it and then take your normal dose.
Follow the important instructions in the section "What is the most important
information I should know about LOTRONEX?" about when you must stop taking
the drug and when you should call your doctor.
If you see other doctors about your IBS or side effects from LOTRONEX, let the
doctor who prescribed LOTRONEX know.
What are the possible side effects of LOTRONEX?
Constipation is the most common side effect among women with IBS who take LOTRONEX. Some patients have developed serious bowel side effects while taking LOTRONEX. Read the section "What is the most important information I should know about LOTRONEX?" at the beginning of this Medication Guide for information about the serious side effects you may get with LOTRONEX.
This Medication Guide does not tell you about all the possible side effects of LOTRONEX. Your doctor or pharmacist can give you a more complete list.
General information about the safe and effective use of LOTRONEX
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you have any questions or concerns about LOTRONEX, ask your doctor. Do not use LOTRONEX for a condition for which it was not prescribed. Do not share your medicine with other people. It may harm them.
Your doctor or pharmacist can give you more information about LOTRONEX that was written for healthcare professionals. You can also contact the company that makes LOTRONEX (toll free) at 1-888-423-5227 or at www.lotronex.com.
What are the ingredients of LOTRONEX?
Active Ingredient: alosetron hydrochloride
Inactive Ingredients: lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The white film-coat for the 0.5-mg tablet contains hypromellose, titanium dioxide, and triacetin. The blue film-coat for the 1-mg tablet contains hypromellose, titanium dioxide, triacetin, and indigo carmine.
This Medication Guide has been approved by the US Food and Drug Administration.
Please click here for important product information about LOTRONEX: Medication Guide.
