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Tegaserod (Oral route)

Pronunciation:

teg-a-SER-od

Brand Names:

  • Zelnorm

Dosage Forms:

  • Tablet

Classifications:

Therapeutic—

Gastrointestinal Agent

Pharmacologic—

Serotonin Receptor Agonist, 5-HT4

Uses of This Medicine:

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 55 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 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This medicine was withdrawn from the U.S. market on March 30, 2007, due to a higher chance of heart attack, stroke, and worsening chest pain that can become a heart attack in patients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 .

Before Using This Medicine:

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.

Children—

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.

Older adults—

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—

Pregnancy CategoryExplanation
All TrimestersBAnimal 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.

Breast-feeding—

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.

Other medicines—

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
  • Anxiety or
  • Bowel obstructions or intestinal blockage (or history of) or
  • Depression or
  • Diabetes or
  • Gallbladder disease or gallstones (or history of) or
  • Heart attack or stroke, history of or
  • High blood pressure or
  • Hyperlipidemia (high amount of cholesterol in the blood) or
  • Kidney disease or
  • Liver disease or
  • Obesity or
  • Sphincter of Oddi dysfunction (severe stomach pain with nausea and vomiting) or
  • Suicidal tendencies or
  • 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.

Proper Use of This Medicine:

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):
    • 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.
    • 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 While Using This Medicine:

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.

Side Effects of This Medicine:

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:

More common
Diarrhea
stomach pain
Less common
Dizziness
feeling of warmth
itching skin
redness of the face, neck, arms and occasionally, upper chest
swelling or puffiness of face
Incidence not known
Black, tarry stools
bloody diarrhea
bloody stools
constipation
fainting
indigestion
nausea
new or worsening abdominal pain
rectal bleeding
severe stomach pain with nausea and vomiting
vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
Bloated, full feeling
chills
cold sweats
confusion
dizziness, faintness, or lightheadedness when getting up from lying or sitting position
excess air or gas in stomach or intestines
headache
passing gas

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:

Less common or rare
Back pain
disease or abnormality of the joint
headache, severe and throbbing
leg pain

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.


Last Updated: 4/4/2014

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