Zelnorm
® (
tegaserod maleate) is a prescription medicine that was licensed for the treatment of irritable bowel syndrome (IBS) with
constipation, as well as constipation that has lasted longer than six months with no apparent cause.
In March 2007, Zelnorm was taken off the market in the United States because it was shown to increase the risk for a heart attack, angina, or stroke. In July 2007, the United States Food and Drug Administration (FDA) announced that Zelnorm will be available to people who meet certain criteria through a special program called a "treatment IND" (see Zelnorm Recall for more information). However, as of April 2, 2008, Zelnorm is no longer available under the treatment IND program, although it may still be available in certain emergency situations.
It is manufactured by Novartis Pharmaceuticals Corporation.
What Is Zelnorm Used For?
Specific uses of the drug include:
- Short-term treatment of IBS with constipation in women.
- Treatment of chronic idiopathic constipation in people less than 65 years of age. Chronic constipation is constipation lasting at least six months. Idiopathic constipation means constipation not due to other diseases or drugs.
It is not meant to treat people with IBS who have
diarrhea as the main symptom.
(Click Zelnorm Uses for more information on what the medication is used for, including possible off-label uses.)
Zelnorm works by stimulating certain serotonin receptors in the digestive tract. This helps the muscles of the digestive tract to move food through more quickly, which helps to treat and prevent
constipation. It also helps to make the nerves in the digestive tract less sensitive, leading to decreased feelings of pain and bloating.
There have been several studies looking at how well Zelnorm treats IBS with constipation and chronic idiopathic constipation.
Irritable Bowel Syndrome (IBS) With Constipation
Several studies have looked at using Zelnorm for IBS with constipation in women. In these studies, women were asked to rate their symptoms of IBS as: completely relieved, considerably relieved, somewhat relieved, unchanged, or worse. In these studies, 31 to 35 percent of women who took Zelnorm felt completely or considerably relieved after the first month, compared to 17 to 22 percent of women who did not take it. More women (both those who took it and those who did not) felt completely or considerably relieved after three months of treatment.
Two studies have looked at Zelnorm as a possible IBS medication in men. These studies did not show any difference between the men who took Zelnorm and the men who did not. This could mean that it is not effective for IBS in men, or it could mean that the studies did not look at enough men to be able to notice a difference.
Chronic Idiopathic Constipation
Two studies have looked at using Zelnorm for long-term constipation with no apparent cause in people less than 65 years old. In these studies, 43 to 45 percent of people who took it had at least one normal bowel movement per week, compared to only 25 to 28 percent of people who did not take Zelnorm. People who took it also had less straining, bloating, and pain.
When the drug was looked at for chronic idiopathic constipation in people age 65 and older, these studies did not show any difference between people who took Zelnorm and people who did not. This could mean that it is not effective for
constipation relief in people 65 and older, or it could mean that the studies did not look at enough people ages 65 and older to be able to notice a difference. Zelnorm has not been studied as a treatment for
constipation in children or for infant constipation.
When and How to Take Zelnorm
Some general considerations for when and how to take Zelnorm include:
- The medication comes in tablet form. It is usually taken by mouth twice a day before meals (on an empty stomach).
- For IBS, Zelnorm is taken for four to six weeks. If it is working for you, your healthcare provider may keep you on Zelnorm for an additional four to six weeks.
- Zelnorm should be taken at the same times each day to maintain an even level of the drug in your blood.
- For Zelnorm to work properly, it must be taken as prescribed. It will not work if you stop taking it.
Dosing
The dose that your healthcare provider recommends will vary depending on a number of factors, including:
- Your age
- The medical condition you are being treated for
- Other medical conditions you may have
- Other medications you may be currently taking.
As with any medication, do not adjust your Zelnorm dose unless your healthcare provider specifically instructs you to do so.
As with any medicine, there are possible side effects. However, not everyone who takes Zelnorm will experience side effects. In fact, most people tolerate it well. When side effects do occur, they are often minor and either require no treatment or can easily be treated by you or your healthcare provider. Serious side effects are less common.
The most common side effects include:
(Click Zelnorm Side Effects to learn about the specific side effects of Zelnorm, including serious side effects to look out for.)
You can also read about other possible side effects by clicking on the following eMedTV links:
Drug Interactions With Zelnorm
Zelnorm is unlikely to interact with most medications. For the few medications that do interact with it, the interaction is not severe enough to cause any problems or require any change in dosages.
What Should I Tell My Healthcare Provider?
You should talk with your healthcare provider before taking Zelnorm if you have:
Also let your healthcare provider know if you:
Tell your healthcare provider about all the medicines you currently take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
People who take too much Zelnorm may have overdose symptoms that could include:
- Diarrhea
- Headache
- Abdominal pain (or stomach pain)
- Low blood pressure causing lightheadedness, dizziness, or fainting when standing up (orthostatic hypotension).
If you happen to overdose, seek medical attention immediately.
The medication should be stored at room temperature and away from moisture or heat. Zelnorm tablets should be kept in an airtight container.
Keep Zelnorm and all medications out of the reach of children.
What Should I Do If I Miss a Dose?
If you do not take your Zelnorm as scheduled, take your next dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose.
Zelnorm tablets are available in two strengths:
- Zelnorm 2 mg
- Zelnorm 6 mg.
There is currently no over-the-counter Zelnorm available.
There is currently no generic Zelnorm licensed for sale.
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