The following information is a summary about Lotronex. It is not intended to replace a doctor's instructions.
What is alosetron?
Alosetron blocks the action of a chemical called serotonin in the intestines. This slows the
movement of stools (bowel movements) through the intestines.
Alosetron is used to treat severe, chronic irritable bowel syndrome (IBS) in women who
have had diarrhea as the main symptom for at least 6 months. Alosetron should be used only in
women who have tried other IBS treatments without success. Alosetron has not been shown to
be effective in men with IBS.
Alosetron may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about alosetron?
Do not start taking alosetron if you are constipated. If you have constipation while
taking alosetron, call your doctor right away.
Serious or fatal side effects on the stomach and intestines have occurred in some people
taking alosetron. Alosetron should be prescribed only by a qualified doctor who is enrolled in a
prescribing program specific for this drug. You will be required to read and sign a
Patient-Physician Agreement form before you get a prescription for alosetron.
In rare cases, alosetron has caused severe constipation, or ischemic colitis (caused by
reduced blood flow to the intestines). Stop taking alosetron and call your doctor right away if you
develop new or worsening constipation, stomach pain, bloody diarrhea, or blood in your stools
(bowel movements). If the constipation is severe or gets worse, and you also have increasing
stomach discomfort, stop taking alosetron and do not start taking it again until you talk to your
doctor. If your constipation does not improve after you stop taking alosetron, call your doctor
again.
Alosetron does not improve the symptoms of IBS for everyone. When alosetron does
work well, it helps reduce stomach pain and discomfort, bowel urgency, and diarrhea. Some or
all symptoms may improve within one to two weeks of treatment.
What should I discuss with my healthcare provider before taking alosetron?
Serious or fatal side effects on the stomach and intestines have occurred in some people
taking alosetron. Alosetron should be prescribed only by a qualified doctor who is enrolled in a
prescribing program specific for this drug. You will be required to read and sign a
Patient-Physician Agreement form before you get a prescription for alosetron.
Do not use alosetron if you have:
Tell your doctor if you have ever had any of the conditions listed above.
In rare cases, alosetron has caused severe constipation. Do not start taking alosetron
if you are constipated. If you have constipation while taking alosetron, call your doctor right
away. If the constipation is severe or gets worse, and you also have increasing stomach
discomfort, stop taking alosetron and do not start taking it again until you talk to your doctor. If
your constipation does not improve after you stop taking alosetron, call your doctor again.
In rare cases, alosetron has caused ischemic colitis, which is caused by reduced blood
flow to the intestines. Stop taking alosetron and call your doctor right away if you develop new
or worsening abdominal pain, bloody diarrhea, or blood in your stools (bowel movements).
FDA pregnancy category B. This medication is not expected to be harmful to an
unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether alosetron passes into breast milk or if it could harm a nursing
baby. Do not take alosetron without telling your doctor if you are breast-feeding a baby.
Older adults and those who are ill or debilitated may be more likely to have serious
complications from constipation.
This medicine should not be given to a child younger than 18 years old.
How should I take alosetron?
Take this medication exactly as it was prescribed for you. Do not take the medication in
larger amounts, or take it for longer than recommended by your doctor.
Take each dose with a full glass of water.
Alosetron can be taken with or without food.
Alosetron does not improve the symptoms of IBS for everyone. When alosetron does
work well, it helps reduce stomach pain and discomfort, bowel urgency, and diarrhea. Some or
all symptoms may improve within one to two weeks of treatment.
Stop taking alosetron if your IBS symptoms do not improve after 4 weeks of taking
this medication. If you stop taking alosetron, do not start taking it again without your doctor's
consent.
Alosetron is not a cure for irritable bowel syndrome. If you stop taking alosetron,
symptoms may return within one week.
Store alosetron at room temperature away from moisture and heat.
What happens if I miss a dose?
Skip the missed dose and take the medicine at the next regularly scheduled time. Do not take two doses at once, or take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
Symptoms of an alosetron overdose may include breathing problems, tiredness, loss of muscle control, tremors, and seizure (convulsions).
What should I avoid while taking alosetron?
There are no restrictions on food, beverages, or activity while taking alosetron, unless otherwise directed by your doctor.
Alosetron side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking alosetron and call your doctor right away if you have any of these serious side effects:
- new or worsening stomach pain;
- bleeding from your rectum or blood in your stools; or
- fast or uneven heartbeats.
Continue using alosetron and talk with your doctor if you have any of these less serious side effects:
- mild stomach discomfort, bloating, or nausea;
- burping with heartburn;
- rectal hemorrhoids; or
- bloating or gas.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect alosetron?
Do not take alosetron if you are also taking fluvoxamine (Luvox) to treat obsessive-compulsive disorder.
Before taking alosetron, tell your doctor if you are using any of the following drugs:
- cimetidine (Tagamet);
- ketoconazole (Nizoral), itraconazole (Sporanox), voriconazole, (VFEND);
- isoniazid (Nydrazid);
- hydralazine (BiDil);
- procainamide (Procanbid, Procan SR, Pronestyl);
- clarithromycin (Biaxin) or telithromycin (Ketek);
- HIV medicines such as amprenavir (Agenerase), tipranavir (Aptivus), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), atazanavir (Reyataz), or nelfinavir (Viracept); or
- an antibiotic such as ciprofloxacin (Cipro), gatifloxacin (Tequin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), or ofloxacin (Floxin).
There may be other drugs that can affect alosetron. Tell your doctor
about all the prescription and over-the-counter medications you use. This includes vitamins,
minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new
medication without telling your doctor.
Where can I get more information?
- Your pharmacist has additional information about alosetron written for health professionals that you may read.
What does my medication look like?
Alosetron is available with a prescription under the brand name Lotronex. Other brand or
generic formulations may also be available. Ask your pharmacist any questions you have about
this medication, especially if it is new to you.
- Lotronex 0.5 mg-white, oval tablets
- Lotronex 1 mg-blue, oval tablets
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
