DrugindexOnline^{2nd edition}

Generic Name: Alosetron (a-LOE-se-tron)
Brand Name: Lotronex

Serious intestinal problems, which may be life-threatening, have occurred with Alosetron . Stop taking Alosetron and contact your doctor at once if constipation, rectal bleeding, bloody diarrhea, bloody stools, or new or worsening stomach pain occurs. If constipation occurs, Alosetron should only be restarted on the advice of your doctor. After discussing Alosetron with your doctor, you must read, initial, and sign a consent form before taking Alosetron . Do not sign the consent form if there is anything you do not understand.

Alosetron is used for:

Treating women with severe irritable bowel syndrome (IBS) accompanied by severe diarrhea (usually lasting for 6 months or more). It is only prescribed to women who do not respond to other medicines and is not to be used by women whose main IBS problem is constipation. Certain stomach or intestinal disorders must be ruled out before Alosetron is prescribed.

Alosetron is a selective 5HT₃ receptor antagonist. It works by blocking the action of serotonin on the intestinal system. This reduces the cramping, stomach pain, stomach discomfort, urgency, and diarrhea caused by IBS.

Do NOT use Alosetron if:

• you are allergic to any ingredient in Alosetron
• you are constipated
• you have a history of severe liver problems, blood-clotting or circulation problems; blood vessel inflammation; severe or long-term constipation; Crohn disease; diverticulitis; ischemic colitis; enlarged colon; perforation of the stomach, intestine, or bowel; paralysis of the intestinal tract; narrowing, growths, scarring, or obstructions of the intestine; reduced blood circulation in the intestine; or ulcerative colitis
• you are taking fluvoxamine
• you are unable to understand or follow the patient-physician agreement for Alosetron

Contact your doctor or health care provider right away if any of these apply to you.

Before using Alosetron :

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver problems or rectal bleeding

Some MEDICINES MAY INTERACT with Alosetron . Tell your health care provider if you are taking any of the following medicines:

• Cimetidine, clarithromycin, fluvoxamine, HIV protease inhibitors (eg, ritonavir), imidazole antifungals (eg, ketoconazole, itraconazole), quinolone antibiotics (eg, ciprofloxacin), telithromycin, or voriconazole because they may increase the risk of Alosetron 's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Alosetron may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Alosetron :

Use Alosetron as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Alosetron comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Alosetron refilled.
• Alosetron may be taken with or without food.
• Your doctor will fully counsel you on the risks and benefits of taking Alosetron before your prescription is written. You must sign a consent form stating you will follow your doctor's instructions before you can take Alosetron . This will be necessary each time you get your prescription refilled.
• Your pharmacist cannot fill your prescription unless it has a program sticker attached to it.
• Take Alosetron regularly to receive the most benefit from it.
• If you miss a dose of Alosetron , skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Alosetron .

Important safety information:

• It may take up to 4 weeks for Alosetron to work. Contact your doctor if you have not experienced any improvement in your condition after 4 weeks.
• Caution is advised when using Alosetron in the ELDERLY because they may be more sensitive to the effects of constipation, if it occurs.
• Use Alosetron with extreme caution in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Alosetron during pregnancy. It is unknown if Alosetron is excreted in breast milk. If you are or will be breast-feeding while you are using Alosetron , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Alosetron :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; heartburn; hemorrhoids; indigestion; nausea; stomach discomfort and pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; bloody diarrhea; bloody stools; constipation; depression; new or worsening stomach discomfort or pain; rectal bleeding; unexplained fever; unusually fast pulse.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include loss of coordination; seizures; tremors; trouble breathing.

Proper storage of Alosetron :

Store Alosetron at 77 degrees F (25 degrees C) in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Alosetron out of the reach of children and away from pets.

General information:

• If you have any questions about Alosetron , please talk with your doctor, pharmacist, or other health care provider.
• Alosetron is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Alosetron . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.