Zelnorm is a medicine for short-term treatment of women who have irritable bowel syndrome (IBS) with constipation (not enough or hard bowel movements) as their main bowel problem.
Zelnorm is also used to treat women younger than 55 years of age who have chronic constipation with an unknown cause. Tegaserod increases the movement of stools (bowel movement) through the bowels.
Zelnorm does not cure irritable bowel syndrome. Tegaserod decreases pain and discomfort in the abdominal area, bloating, and constipation.
If you stop taking tegaserod your irritable bowel syndrome symptoms may return in one to two weeks. This medicine is available only for use in emergency situations.
This medicine was withdrawn from the U.S. market on March 30, 2007, due to a higher chance of heart attack, stroke, and worsening chest pain that can become a heart attack in patients treated with this medicine compared to placebo (sugar pills) .
On July 27, 2007, this medicine was made available under a restricted access program called treatment IND; however, as of April 2, 2008, this medicine is no longer available under a treatment IND and is only available for use in emergency situations.
For further information and to see if you qualify for treatment with tegaserod for emergency use, you should consult your doctor.
Your doctor will then contact FDA's Division for Drug Information about the emergency IND process at druginfo@fda.hhs.gov.
This product is available in the following dosage forms:
Before using Zelnorm, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.
For this medicine, the following should be considered:
Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric Population: Studies on this medicine have been done only in adult patients and there is no specific information comparing the use of tegaserod in children and adolescents under the age of 18 with use in other age groups.
Geriatric Population: Many medicines have not been specifically studied in older people. Therefore it may not be known whether they work the same way they do in younger adults or if they cause different side effects or problems in older people.
There is no specific information comparing the use of tegaserod in older patients with use in other age groups for treatment of irritable bowel syndrome. This medicine is not approved for patients 55 years of age or older.
Pregnancy: All Trimesters: Category B: Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.
Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary.
Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems: The presence of other medical problems may affect the use of this medicine.
Make sure you tell your doctor if you have any other medical problems, especially:
Sphincter of Oddi dysfunction (severe stomach pain with nausea and vomiting)
Suicidal tendencies
Unstable angina (chest pain at rest)—Tegaserod should not be used if you have any of these conditions
Abdominal pain, new or sudden worsening of—Tegaserod should be stopped immediately
Diarrhea—Serious side effects such as dizziness, lightheadedness, and dehydration can occur when using tegaserod. If you have any of these symptoms, notify your doctor immediately and stop taking this medicine. Tegaserod should not be used if you are currently experiencing or frequently experience diarrhea
3 Proper Usage
To use Zelnorm properly, you must follow all instructions given by your doctor.
Dosing: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Adults—Oral, 6 milligrams (mg) twice daily on an empty stomach shortly before you eat a meal. Your doctor will decide how long you should continue to take this medicine.
Adults—Oral, 6 milligrams (mg) twice daily on an empty stomach shortly before you eat a meal. You will take tegaserod for 4 to 6 weeks. If you feel better your healthcare professional might want to continue the medicine for an additional 4 to 6 weeks.
Missed Dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage: Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.
4 Precautions to Take
Before using Zelnorm, there are some precautions you must take. Your doctor will want to check your progress at regular visits, especially during the first few weeks that you take this medicine.
It is important to check with your doctor or pharmacist if you are taking or plan to take any prescription or over-the-counter medicines while taking tegaserod.
Do not use this medicine if you are smoking. It is very important to tell your healthcare professional immediately if you become pregnant.
You should consult your doctor if you experience severe diarrhea, or if the diarrhea is accompanied by severe cramping, abdominal pain, or dizziness.
You should also consult your healthcare professional if you experience new or worsening abdominal pain. Do not take this medication if you have diarrhea now or have diarrhea often.
This medicine may cause some people to become dizzy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy.
As with many medications, there are several potential side effects associated with Zelnorm. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine.
Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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