Lotronex (Alosetron)

They need to know if you have any of these conditions: -constipation -Crohn's disease -diverticulitis -history of ischemic colitis, impaired intestinal circulation, bleeding, or blood clots -history of a stomach, bowel, or intestine problems -kidney disease or liver disease -toxic megacolon -ulcerative colitis -an unusual or allergic reaction to alosetron, other medicines, foods, dyes, or preservatives -pregnant or trying to get pregnant -breast-feeding

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. 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 -enoxacin -fluvoxamine -mexiletine -zileuton This medicine may also interact with the following medications: -certain antibiotics like ciprofloxacin, clarithromycin, erythromycin or troleandomycin -cimetidine -hydralazine -isoniazid, INH -medicines for fungal infections like ketoconazole, itraconazole and voriconazole -medicines for HIV or AIDS -procainamide

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 -constipation -dark urine -hemorrhoids -fever -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): -anxiety -difficulty sleeping -dry mouth -frequent urination -gas -headache -nausea -restlessness

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.