Serious intestinal problems, which may be life-threatening, have occurred with Alosetron . These problems may lead to hospitalization and, in some cases, blood transfusions, surgery, and even death.
Stop taking Alosetron and contact your doctor at once if you develop constipation. If constipation occurs, Alosetron should only be restarted on the advice of your doctor.
Stop taking Alosetron and contact your doctor at once if you experience rectal bleeding, bloody diarrhea, bloody stools, or new or worsening abdominal pain. These could be signs of a condition called ischemic colitis, in which the blood flow to parts of your intestine is reduced. If this condition occurs, Alosetron should not be restarted.
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.
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 5-HT3 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.
Contact your doctor or health care provider right away if any of these apply to you.
Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Alosetron . Tell your health care provider if you are taking any other medicines, especially any of the following:
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.
Use Alosetron as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use 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:
Nausea; mild stomach discomfort and pain.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; bloody diarrhea; bloody stools; constipation; mental or mood changes; new or worsening stomach discomfort or pain; rectal bleeding; severe or persistent nausea; unexplained fever; unusually fast pulse; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), 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.
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.