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USP DI Vol. II - TEGASEROD (Systemic)

TEGASEROD (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Zelnorm

In Canada?

  • Zelnorm

Category

  • Serotonin agonist

Description

Tegaserod (te-GAS-a-rod) is a medicine for short term treatment ofwomen who have irritable bowel syndrome (IBS) with constipation (not enoughor hard bowel movements) as their main bowel problem. Tegaserod is also usedto treat women younger than 65 years of age who have chronic constipationwith an unknown cause. Tegaserod increases the movement of stools (bowel movement)through the bowels. Tegaserod does not cure irritable bowel syndrome. Tegaseroddecreases pain and discomfort in the abdominal area, bloating, and constipation.If you stop taking tegaserod your irritable bowel syndrome symptoms may returnin one to two weeks.

This medicine is available only with your healthcare professional's prescription,in the following dosage forms:

    Oral
  • Tablets (U.S. and Canada)

Before Using This Medicine

In decidingto use a medicine, the risks of using the medicine must be weighed againstthe good it will do. This is a decision you and your healthcare professionalwill make. For tegaserod the following should be considered:

Allergies?Tell your healthcare professional if you have everhad any unusual or allergic reaction to tegaserod. Also tell your healthcareprofessional and pharmacist if you are allergic to any other substances, suchas foods, preservatives, or dyes.

Pregnancy?Tegaserod has not been studied in pregnant women.Before taking this medicine, make sure your healthcare professional knowsif you are pregnant or if you may become pregnant.

Breast-feeding?It is not known if tegaserod passes into thebreast milk. Many medicines pass into breast milk and they may cause unwantedeffects in nursing babies. Mothers who are taking this medicine and wish tobreast feed should discuss this with their healthcare professional and besure they understand the risks and benefits of the medicine.

Children?Studies on this medicine have been done only inadult patients and there is no specific information comparing the use of tegaserodin children and adolescents under the age of 18 with use in other age groups.

Older adults?Many medicines have not been specificallystudied in older people. Therefore it may not be known whether they work thesame way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing theuse of tegaserod in older patients with use in other age groups for treatmentof irritable bowel syndrome

This medicine is not approved for patients 65 years of age or older fortreatment of chronic constipation.

Note:

Studies on this medicine have only been done in women patients andthere is no specific information about the use of tegaserod in male patients.

Other medical problems?The presence of other medical problems mayaffect the use of tegaserod. Make sure you tell your healthcare professionalif 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 andvomiting)?Tegaserod should not be used if you have any of these conditions
  • Abdominal pain, new or sudden worsening of?Tegaserod shouldbe 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 shouldnot be used if you are currently experiencing or frequently experience diarrhea.

Proper Use of This Medicine

Dosing?The dose of tegaserod will be different fordifferent patients. Follow your healthcare professional'sorders or the directions on the label. The following information includesonly the average doses of tegaserod. If your dose is different,do not change it unless your healthcare professional tells you to doso.

  • For oral dosage form (tablets):
    • For chronic constipation:
      • Adults?Oral, 6 milligrams (mg) twice daily on an empty stomachshortly before you eat a meal. Your doctor will decide how long you shouldcontinue to take this medicine.
    • For irritable bowel syndrome:
      • Adults?Oral, 6 milligrams (mg) twice daily on an empty stomachshortly before you eat a meal. You will take tegaserod for 4 to 6 weeks. Ifyou feel better your healthcare professional might want to continue the medicinefor an additional 4 to 6 weeks.

Missed dose?If you miss a dose of this medicine, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store this medicine at room temperature
  • Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Your healthcare professional will want to check your progressat regular visits, especially during the first few weeks that you takethis medicine.

It is important to check with your healthcare professional or pharmacistif you are taking or plan to take any prescription or over-the-counter medicineswhile taking tegaserod

It is very important to tell your healthcare professional immediately ifyou become pregnant

You should consult your healthcare professional if you experience severediarrhea, or if the diarrhea is accompanied by severe cramping, abdominalpain, or dizziness. You should also consult your healthcare professional ifyou 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 medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

    Check with your healthcareprofessional 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 puffinessof face

      Frequency not determined

        Black, tarry stools; bloody diarrhea ; bloody stools; constipation; fainting; indigestion; nausea; new or worseningabdominal pain; rectal bleeding; severe stomach pain with nausea and vomiting; vomiting

      Symptoms of overdose

      Get emergency help immediately if any of the followingsymptoms of overdose occur

        Bloated, full feeling; chills; cold sweats; confusion; diarrhea; dizziness, faintness, or lightheadednesswhen getting up from lying or sitting position; excess air or gas in stomach or intestines; headache; nausea; passing gas; stomach pain; vomiting

    Otherside effects may occur that usually do not need medical attention. These sideeffects may go away during treatment as your body adjusts to the medicine.However, check with your healthcare professional if any of the following sideeffects continue or are bothersome.

      More common

        Bloated, full feeling; excess air orgas in stomach or intestines; headache; nausea; passing gas

      Less common or rare

        Back pain; disease or abnormality ofthe joint; headache, severe and throbbing; leg pain

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your healthcare professional.


Developed: 06/05/2003
Revised: 09/24/2004