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 used to treat irritable bowel syndrome with constipation (IBS-C) in women less than 65 years of age. Tegaserod increases the movement of stools (bowel movement) through the bowels. It also decreases pain and discomfort in the stomach area, bloating, and constipation. However, this medicine does not cure irritable bowel syndrome. If you stop using tegaserod, your symptoms may return in 1 to 2 weeks.

Tegaserod is also used to treat women younger than 55 years of age who have chronic constipation with an unknown cause.

This medicine was withdrawn from the U.S. market on March 30, 2007, due to an increased risk of heart attack, stroke, and worsening chest pain that can become a heart attack in patients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 medicine is available only with your doctor's prescription and for use in emergency situations.

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—

Appropriate studies have not been performed on the relationship of age to the effects of tegaserod in the pediatric population. Safety and efficacy have not been established.

Older adults—

This medicine is not for use in women 65 years of age or older.

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 (scar tissues that form on the organs in the stomach area), history of or
• Angina (chest pain), history of or
• Bowel blockage, history of or
• Gallbladder disease, history of or
• Heart attack, history of or
• Ischemic colitis (not enough blood flow to the bowels), history of or
• Kidney disease, severe (eg, end-stage kidney disease) or
• Liver disease, moderate or severe or
• Sphincter of Oddi dysfunction (muscle in the upper bowels that cannot contract and relax normally), suspected, history of or
• Stroke, including transient ischemic attack, history of—Should not be used in patients with these conditions.

• Depression or
• Heart disease—Use with caution. May make these conditions worse.

• Diabetes or
• Diarrhea, now or frequent or
• Hypertension (high blood pressure) or
• Hyperlipidemia (high amount of cholesterol in the blood) or
• Obesity—Use with caution. May increase risk for more side effects.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine on an empty stomach, at least 30 minutes before meals.

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—6 milligrams (mg) 2 times a day before meals. Your doctor will decide how long you should continue to take this medicine.
    • Children—Use and dose must be determined by your doctor.
  • For irritable bowel syndrome with constipation:
    • Adults 65 years of age and older—Should not be used in women within this age group.
    • Adults less than 65 years of age—6 milligrams (mg) 2 times a day before meals for 4 to 6 weeks.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, 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:

It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you use this medicine, to make sure it is working properly. Blood and urine tests may be needed to check for unwanted effects.

Call your doctor if your symptoms do not improve or if they get worse.

This medicine may increase your risk of having a heart attack or stroke. Check with your doctor right away if you are having chest pain or discomfort, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, trouble breathing, slurred speech, or weakness.

Check with your doctor right away if you have rectal bleeding, severe or bloody diarrhea, or new or worsening stomach pain. These may be symptoms of a serious condition called ischemic colitis (swelling and injury of the bowels caused by not enough blood flow to the bowels).

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

Do not take this medicine if you have diarrhea now or have diarrhea often.

Do not use this medicine if you are smoking.

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

Bleeding from the rectum

bloody stools

dizziness or lightheadedness

feeling of constant movement of self or surroundings

headache, severe and throbbing

pale skin

sensation of spinning

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

Rare

Chest pain or discomfort

confusion

difficulty in speaking

double vision

headache

inability to move the arms, legs, or facial muscles

inability to speak

nausea

pain or discomfort in the arms, jaw, back, or neck

slow speech

sweating

thoughts or attempts at killing oneself

vomiting

Incidence not known

Blurred vision

confusion

constipation

cough

dark urine

difficulty swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast heartbeat

hives, itching, skin rash

indigestion

light-colored stools

new or worsening stomach pain

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

severe diarrhea

severe nausea or vomiting

stomach pain, usually after eating a meal

stomach tenderness

sweating

tightness in the chest

upper right abdominal pain

yellow eyes and skin

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 the stomach or bowels

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

Belching

difficulty in moving

heartburn

increased appetite

indigestion

lack or loss of strength

muscle pain or stiffness

pain, swelling, or redness in the joints

stomach discomfort or upset

Incidence not known

Thinning or loss of hair

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.