Generic Name: alosetron (a-LOE-se-tron)
Brand Name: Lotronex
Serious intestinal problems, which may be life-threatening, have occurred with Lotronex. These problems may lead to hospitalization and, in some cases, blood transfusions, surgery, and even death.
Stop taking Lotronex and contact your doctor at once if you develop constipation. If constipation occurs, Lotronex should only be restarted on the advice of your doctor.
Stop taking Lotronex 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, Lotronex should not be restarted.
After discussing Lotronex with your doctor, you must read, initial, and sign a consent form before taking Lotronex. Do not sign the consent form if there is anything you do not understand.
Lotronex 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 Lotronex is prescribed.
Lotronex 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.
Do NOT use Lotronex if:
- you are allergic to any ingredient in Lotronex
- you are constipated, you have a history of severe or long-term constipation, or your main IBS problem is constipation
- you have a history of blood flow problems to your intestine or bowels (eg, ischemic colitis)
- you have a history of severe liver problems, blood-clotting, or circulation problems; blood vessel inflammation; Crohn disease; diverticulitis; enlarged colon; perforation of the stomach, intestine, or bowel; paralysis of the intestinal tract; narrowing, growths, or scarring of the intestine; blockage of the bowel or intestine; or ulcerative colitis
- you are unable to understand or follow the patient-physician agreement for Lotronex
- you are taking fluvoxamine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Lotronex:
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
- if you have very poor health
Some MEDICINES MAY INTERACT with Lotronex. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Cimetidine, clarithromycin, fluvoxamine, HIV protease inhibitors (eg, ritonavir), imidazole antifungals (eg, itraconazole, ketoconazole), quinolone antibiotics (eg, ciprofloxacin), telithromycin, or voriconazole because they may increase the risk of Lotronex's side effects
This may not be a complete list of all interactions that may occur. Ask your health care provider if Lotronex 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 Lotronex:
Use Lotronex as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Lotronex comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Lotronex refilled.
- Take Lotronex by mouth with or without food.
- Your doctor will fully counsel you on the risks and benefits of taking Lotronex before your prescription is written. You must sign a consent form stating you will follow your doctor's instructions before you can take Lotronex.
- Your pharmacist cannot fill your prescription unless it has a program sticker attached to it.
- Lotronex works best if it is taken at the same time each day.
- If you miss a dose of Lotronex, 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 Lotronex.
Important safety information:
- It may take up to 4 weeks for Lotronex to work. Contact your doctor if you have not experienced any improvement in your condition after 4 weeks.
- Tell your doctor or dentist that you take Lotronex before you receive any medical or dental care, emergency care, or surgery.
- Use Lotronex with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation, if it occurs.
- Lotronex should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lotronex while you are pregnant. It is not known if Lotronex is found in breast milk. If you are or will be breast-feeding while you are using Lotronex, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Lotronex:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Nausea; mild stomach discomfort and pain.
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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include loss of coordination; seizures; tremors; trouble breathing.Proper storage of Lotronex:
Store Lotronex 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 Lotronex out of the reach of children and away from pets.
- If you have any questions about Lotronex, please talk with your doctor, pharmacist, or other health care provider.
- Lotronex 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Lotronex or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Lotronex. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Lotronex. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Lotronex.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.