Alosetron has rarely caused serious, sometimes fatal intestinal side effects including constipation and ischemic colitis. You should not use this medication if you have ever had problems from blocked blood flow to the bowel (ischemic colitis).
This medication should only be used in women with severe cases of irritable bowel syndrome (IBS) where the major symptom is diarrhea. If you experience constipation, new or worsening bowel pains, or blood in your diarrhea or stool, stop taking this drug and seek immediate medical attention.
Before your doctor can prescribe this medication for you, your doctor must have completed the Prescribing Program for Lotronex (PPL).
Only carefully selected patients may use this medication. Consult your doctor or pharmacist for more information about the risks and benefits of using this medication.Who should not take alosetron?
This medication is used to treat severe cases of irritable bowel syndrome (IBS) in women who have diarrhea as a major symptom.
Alosetron is not effective in men with IBS.
This medication is not recommended for use in children because of the serious side effects that have been seen in adults.
Read and complete the Patient-Physician Agreement form provided by your doctor. Read the Medication Guide provided by your pharmacist before you start using alosetron and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. Your prescription must have a sticker affixed to it in order for your pharmacy to dispense you a supply of this medicine.
Take this medication by mouth with or without food as directed by your doctor. Do not begin this medication if you are currently constipated. Contact your doctor for further instructions.
Headache, stomach upset, or hemorrhoids may occur. If these effects persist or worsen, notify your doctor promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any of these unlikely but serious side effects: bloating, depression.
Stop taking this medication and seek immediate medical attention if any of these unlikely but serious side effects occur: constipation, bloody stools, unexplained fever, unusually fast pulse, new or sudden worsening of stomach/abdominal/bowel pain.
This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking alosetron, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain intestinal disorders (e.g., ileus, ischemic colitis, impaired intestinal circulation, constipation or its complications, obstruction, megacolon, stricture/adhesions, or perforation), Crohn's disease, ulcerative colitis, diverticulitis, severe liver disease, blood disorders (e.g., history of blood clots).
Before using this medication, tell your doctor your medical history, including: liver disease.
Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of constipation if it occurs.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.
This drug should not be used with the following medications because very serious interactions may occur: apomorphine, fluvoxamine.
If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting alosetron.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergics/antispasmodics (e.g., atropine, dicyclomine), antidiarrheals (e.g., kaolin-pectin, loperamide), hydralazine, isoniazid, narcotics (e.g., codeine, diphenoxylate).
Other medications can affect the removal of alosetron from your body, which may affect how alosetron works. Examples include cimetidine, quinolone antibiotics such as ciprofloxacin, among others.
Constipation can be a serious side effect of this medication. Discuss with your doctor or pharmacist before using any medications that may slow down the gut. Check the labels on all your medicines (e.g., allergy, cough-and-cold, sleep products) because they may contain ingredients that can cause constipation. Ask your pharmacist about the safe use of those products.
The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include difficulty breathing, loss of coordination, tremors, and seizures.
Do not share this medication with others.
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature, 77 degrees F (25 degrees C), away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.
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