alosetron – oral, Lotronex

WARNING: Alosetron has rarely caused serious, sometimes fatal intestinal side effects including constipation and ischemic colitis. Do 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 diarrhea is the major symptom. 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.

USES: This medication treats severe cases of irritable bowel syndrome (IBS) in women with diarrhea as a major symptom. Alosetron is not effective in men with IBS. This medication is not recommended for use in children due to serious side effects seen in adults.

HOW TO USE: 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 for your pharmacy to dispense 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.

SIDE EFFECTS: Headache, stomach upset, or hemorrhoids may occur. If these effects persist or worsen, notify your doctor promptly. Many people using this medication do not have serious side effects. Tell your doctor immediately 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. Seek immediate medical attention if you experience a serious allergic reaction. This is not a complete list of possible side effects. Contact your doctor or pharmacist for more information and to report any additional side effects.

PRECAUTIONS: 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 that can cause allergic reactions or other problems. Talk to your pharmacist for more details. Do not use this medication if you have certain medical conditions such as certain intestinal disorders, Crohn’s disease, ulcerative colitis, diverticulitis, severe liver disease, or blood disorders. Caution is advised when using this drug in the elderly. This medication may be used during pregnancy if clearly needed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

DRUG INTERACTIONS: Consult your healthcare professionals before starting, stopping, or changing the dosage of any medicine. This drug should not be used with certain medications because serious interactions may occur. Tell your doctor or pharmacist about all prescription and nonprescription/herbal products you use. Other medications can affect the removal of alosetron from your body, which may affect how alosetron works. 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 of all your medicines because they may contain ingredients that can cause constipation. This document does not contain all possible interactions. Keep a list of all your medications and share it with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. Symptoms of overdose may include difficulty breathing, loss of coordination, tremors, and seizures.

QUESTION

NOTES: 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. Store at room temperature, away from light and moisture. Properly discard this product when it is expired or no longer needed. Information last revised March 2013. Report negative side effects of prescription drugs to the FDA.

CONDITIONS OF USE: The information in this database is intended to supplement the expertise and judgment of healthcare professionals. It is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. A healthcare professional should be consulted before taking any drug, changing any diet, or commencing or discontinuing any course of treatment.

Selected from data included with permission and copyrighted by First Databank, Inc. This material has been downloaded from a licensed data provider and is not for distribution, except as authorized by the applicable terms of use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

CONDITIONS OF USE: The information in this database is intended to supplement the expertise and judgment of healthcare professionals. It is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. A healthcare professional should be consulted before taking any drug, changing any diet, or commencing or discontinuing any course of treatment.