ALOSETRON (ORAL)

(a LO ze tron) Brand: Lotronex

What is the most significant information I must know about alosetron?

• Alosetron is accessible only under a particular program called the Prometheus Prescribing Program. You should be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

• Do not start taking alosetron if you are constipated. If you have constipation while taking alosetron, stop taking the medicine and call your doctor right away.

• Serious or fatal side effects on the stomach and intestines have occurred in some people taking 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 constipation does not improve or if it gets worse, do not start taking alosetron again before you conversation to your doctor.

• 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 treatment. If you stop taking alosetron, do not start taking it again without your doctor's advice.

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 must be used only in women who have tried another IBS treatments without success. Alosetron has not been shown to be effective in men with IBS.

• Alosetron may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking alosetron?

• Do not use alosetron if you have:

· constipation (especially if it is your main IBS symptom);

· a history of severe or ongoing constipation;

· obstruction or perforation of your intestines;

· Crohn's malady, ulcerative colitis, or diverticulitis;

· blood clots, or circulation problems affecting your intestines;

· severe liver malady; or

· if you are also taking fluvoxamine (Luvox) to treat obsessive-compulsive disorder.

• Tell your doctor if you have ever had any of the conditions listed above.

• FDA pregnancy category B. Alosetron is not expected to harm an unborn child. Speak 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 child. 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 medication must not be given to a baby younger than 18 years old.

How must I take alosetron?

• Take exactly as predesigned by your doctor. Do not take in larger or less amounts or for longer than recommended. Follow the directions on your prescription label.

• Take this medication with a full glass of water.

• Alosetron may be taken with or without food.

• Stop taking alosetron and call your doctor if you become constipated while taking alosetron.

• Alosetron is not a cure for irritable bowel syndrome. If you stop taking alosetron, symptoms may return within one week.

• Stop taking alosetron if your IBS symptoms do not improve after 4 weeks of treatment. If you stop taking alosetron, do not start taking it again without your doctor's advice.

• Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

• Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking alosetron?

• Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of alosetron?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, lips, tongue, or throat.

• Stop taking alosetron and call your doctor at once if you have a serious side effect such as:

· new or worsening stomach pain;

· bleeding from your rectum or blood in your stools; or

· quick or uneven heartbeats.

• Smaller serious side effects may include:

· mild stomach discomfort, bloating, or nausea;

· mild constipation;

· burping with heartburn;

· rectal hemorrhoids;

· bloating or gas;

· headache; or

· skin rash.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect alosetron?

• Do not take alosetron if you are also taking fluvoxamine (Luvox) to treat obsessive-compulsive disorder.

• Speak your doctor about all another medicines you use, especially:

· cimetidine (Tagamet);

· ketoconazole (Nizoral), itraconazole (Sporanox), voriconazole, (VFEND);

· isoniazid (for treating tuberculosis);

· hydralazine (BiDil);

· procainamide (Procanbid, Procan SR, Pronestyl);

· HIV medicines such as 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), clarithromycin (Biaxin), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), or telithromycin (Ketek).

• This list is not complete and another drugs may interact with alosetron. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about alosetron.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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