ALOSETRON (al OH se tron) is used to treat irritable bowel syndrome (IBS) in women. It is reserved for those women who have severe diarrhea as the main symptom and who have not had success with other treatments. This medicine has not been shown to work in men with IBS. It is available only from health care providers who participate in a special Prescribing Program because this drug may cause serious side effects. Your health care provider will discuss your condition and these side effects with you prior to prescribing this drug.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
They need to know if you have any of these conditions:
history of ischemic colitis, impaired intestinal circulation, bleeding, or blood clots
history of a stomach, bowel, or intestine problems
kidney disease or liver disease
an unusual or allergic reaction to alosetron, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. This medicine is not for use in children.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
If you miss a dose, skip that dose. Do not take double or extra doses.
Do not take this medicine with any of the following medications:
antidiarrheal medicines, like Imodium, Kaopectate, or Lomotil
This medicine may also interact with the following medications:
certain antibiotics like ciprofloxacin, clarithromycin, erythromycin or troleandomycin
medicines for fungal infections like ketoconazole, itraconazole and voriconazole
medicines for HIV or AIDS
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
Constipation is a common and serious side effect of this medicine. Stop taking this medicine and call your health care provider immediately if you become constipated. Only restart this medicine if your constipation has resolved and you and your doctor have agreed to restart treatment. You should not start taking this medicine if you are already constipated or constipated most of the time.
Ischemic colitis is a serious and potentially life-threatening condition that has been rarely reported with this medicine. If you experience new or worsening abdominal pain, bloody diarrhea or blood in the stool, immediately stop taking this medicine and contact your doctor or health care professional.
This medicine may not work for all women who take it. For women who are helped by this medicine, relief may occur within the first week or within four weeks of starting the drug. If you stop taking this medicine, it is likely that your symptoms will return within one week.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Alcohol can increase drowsiness or dizziness. Avoid alcoholic drinks.
Side effects that you should report to your doctor or health care professional immediately:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
blood in stool, bloody diarrhea or rectal bleeding
irregular heart beat
unusually weak or tired
worsening of abdominal pain
yellowing of the eyes or skin
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Keep out of the reach of children.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light and moisture. Throw away any unused medicine after the expiration date.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.