Brand
name: TEGIBS (Tegaserod, Zelnorm)
Drug Information provided by: Micromedex
US Brand Names:* Zelnorm
Description
Tegaserod 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. Tegaserod is also used
to treat women younger than 65 years of age who have chronic constipation
with an unknown cause. Tegaserod increases the movement of stools (bowel
movement) through the bowels. Tegaserod 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 was available only with your doctor's prescription.
This medicine was withdrawn from the U.S. market on March 30, 2007,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).
This product is available in the following dosage forms: Tablet
Before Using TEGIBS (Tegaserod, Zelnorm)
In deciding to use a medicine, the risks of taking the medicine must
be weighed against the good it will do. 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 :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
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
65 years of age or older for treatment of chronic constipation.
Pregnancy
Pregnancy Category Explanation
All Trimesters 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:
* Abdominal adhesions or
* Bowel obstructions or intestinal blockage (or history of) or
* Gallbladder disease or gallstones (or history of) or
* Liver disease or
* Kidney disease or
* Sphincter of Oddi dysfunction (severe stomach pain with nausea and vomiting)—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.
Proper Use TEGIBS (Tegaserod, Zelnorm)
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.
* For oral dosage form (tablets):
o For chronic constipation:
+ 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.
o For irritable bowel syndrome:
+ 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.
Precautions
Your healthcare professional 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 healthcare professional or pharmacist
if you are taking or plan to take any prescription or over-the-counter
medicines while taking tegaserod
It is very important to tell your healthcare professional immediately
if you become pregnant
You should consult your healthcare professional 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.
Side Effects TEGIBS (Tegaserod, Zelnorm)
Along with its needed effects, a medicine may cause some unwanted
effects. 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:
Symptoms of overdose
Get emergency help immediately if any of the following symptoms of
overdose occur:
* Bloated, full feeling
* Chills
* Cold sweats
* Confusion
* Diarrhea
* Dizziness, faintness, or lightheadedness when getting up from lying or sitting
position
* Excess air or gas in stomach or intestines
* Headache
* Nausea
* Passing gas
* Stomach pain
* Vomiting
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:
