tegaserod

Generic name: tegaserod [ te-GAS-e-rod ]
Brand name: Zelnorm
Drug class: Serotoninergic neuroenteric modulators

What is tegaserod?

Tegaserod was withdrawn from the U.S. market on March 30, 2007. This medication may still be used in limited emergency situations.

Tegaserod increases the action of a chemical called serotonin in the intestines. This speeds the movement of stools through the bowels.

Tegaserod is used to treat severe, chronic, irritable bowel syndrome (IBS) in women who have constipation (and not diarrhea) as their main bowel problem.

Tegaserod is also used to treat chronic constipation in patients younger than 55 years old.

Tegaserod may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about tegaserod?

Tegaserod was withdrawn from the U.S. market on March 30, 2007. This medication may still be used in limited emergency situations.

Tegaserod is not for use in people with diarrhea as the main symptom of their irritable bowel condition.

You should not use this medication if you are allergic to tegaserod, or if you have a history of stroke or heart attack, high blood pressure, uncontrolled angina, high cholesterol or triglycerides, diabetes, depression, or anxiety.

You also should not use tegaserod if you smoke, if you are older than 55 years, if you are overweight, or if you have a history of suicidal thoughts or actions.

Before taking tegaserod, tell your doctor if you have gallbladder problems, a blockage in your intestines, other stomach or intestinal disorders, kidney disease, or liver disease.

Tegaserod has not been shown to be helpful for men with irritable bowel syndrome.

Stop taking tegaserod and call your doctor at once if you have new or worsening stomach pain, blood in your stools, ongoing diarrhea, severe stomach pain or cramps, or feel like you might pass out.

What should I discuss with my healthcare provider before taking tegaserod?

You should not use this medication if you are allergic to tegaserod, or if you have:

• a history of stroke or heart attack;

• untreated or uncontrolled angina (chest pain);

• high blood pressure;

• high cholesterol or triglycerides;

• diabetes;

• depression or anxiety;

• if you smoke;

• if you are older than 55 years;

• if you are overweight; or

• if you have a history of suicidal thoughts or actions.

Before taking tegaserod, tell your doctor if you are allergic to any drugs, or if you have:

• diarrhea or if diarrhea is your main symptom of IBS;

• gallbladder problems;

• a blockage in your intestines;

• any other stomach or intestinal disorders;

• kidney disease; or

• liver disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use tegaserod.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether tegaserod passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Tegaserod has not been shown to be helpful for men with irritable bowel syndrome.

How should I take tegaserod?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medication with a full glass of water.

Take tegaserod on an empty stomach.

Tegaserod is usually taken twice daily. Follow your doctor's instructions.

It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 to 6 weeks of treatment.

Tegaserod is not a cure for irritable bowel syndrome. If you stop taking tegaserod, your symptoms may return within 1 or 2 weeks.

Store tegaserod at room temperature away from moisture and heat.

What happens if I miss a dose?

If you miss a dose or forget to take your medicine, wait until it is time for your next dose and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include diarrhea, stomach pain, nausea, and vomiting.

What should I avoid while taking tegaserod?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using tegaserod.

Tegaserod side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking tegaserod and call your doctor at once if you have a serious side effect such as:

• new or worsening stomach pain;

• blood in your stools;

• ongoing diarrhea;

• severe stomach pain or cramps; or

• feeling like you might pass out.

Less serious side effects may include:

• headache, dizziness or migraine;

• back pain or joint pain; or

• mild stomach pain, nausea or gas.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

Tegaserod dosing information

Usual Adult Dose for Irritable Bowel Syndrome:

Tegaserod was voluntary withdrawn from the US market by the manufacturer in March, 2007 due to increased reports of serious cardiovascular adverse events, including angina, heart attacks, and stroke. However, the FDA announced on July 27, 2007 that it is allowing the restricted use of tegaserod under a treatment investigational new drug (IND) protocol to treat IBS-C and CIC in women younger than 55 who meet specific guidelines. These patients must meet strict criteria and have no known or preexisting heart complications and be in critical need of this therapy. Tegaserod will stay off the market for general use. Prescribers with IBS-C or CIC patients who meet the IND criteria should contact Novartis at 888-669-6682 or 800-QUI-NTILE. Those patients who do not qualify for the tegaserod treatment protocol may contact FDA's Division for Drug Information regarding other options at 888-463-6332.

Women:
Initial dose: 6 mg orally twice a day before meals for 4 to 6 weeks.
Maintenance dose: If patients respond to therapy after 4 to 6 weeks, an additional 4 to 6 week course may be prescribed. Efficacy beyond 12 weeks has not been established.

Men: Safety and efficacy have not been established.

Usual Adult Dose for Constipation -- Chronic:

Tegaserod was voluntary withdrawn from the US market by the manufacturer in March, 2007 due to increased reports of serious cardiovascular adverse events, including angina, heart attacks, and stroke. However, the FDA announced on July 27, 2007 that it is allowing the restricted use of tegaserod under a treatment investigational new drug (IND) protocol to treat IBS-C and CIC in women younger than 55 who meet specific guidelines. These patients must meet strict criteria and have no known or preexisting heart complications and be in critical need of this therapy. Tegaserod will stay off the market for general use. Prescribers with IBS-C or CIC patients who meet the IND criteria should contact Novartis at 888-669-6682 or 800-QUI-NTILE. Those patients who do not qualify for the tegaserod treatment protocol may contact FDA's Division for Drug Information regarding other options at 888-463-6332.

6 mg orally twice a day before meals. Efficacy beyond 12 weeks has not been established.

What other drugs will affect tegaserod?

Other drugs may interact with tegaserod. Talk your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Frequently asked questions

• Is Zelnorm back on the market?

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2023 Cerner Multum, Inc. Version: 4.01. Revision Date: 2008-04-11, 8:55:46 AM.