Zelnorm

(Generic versions may still be available.)

DRUG DESCRIPTION

Zelnorm® (tegaserod maleate) tablets contain tegaserod as the hydrogen maleate salt. As the maleate salt, tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide hydrogen maleate. Its empirical formula is C16H23N5O.C4H4O4. The molecular weight is 417.47 and the structural formula is

Tegaserod as the maleate salt is a white to off-white crystalline powder and is slightly soluble in ethanol and very slightly soluble in water. Each 1.385 mg of tegaserod as the maleate is equivalent to 1 mg of tegaserod. Zelnorm (tegaserod maleate) is available for oral use in the following tablet formulations:

· 2 mg and 6 mg tablets (blister packs) containing 2 mg and 6 mg tegaserod, respectively and the following inactive ingredients: crospovidone, glyceryl monostearate, hypromellose, lactose monohydrate, poloxamer 188, and polyethylene glycol 4000

· 6 mg tablets (bottles) containing 6 mg tegaserod and the following inactive ingredients: crospovidone, glyceryl behenate, hypromellose, lactose monohydrate, colloidal silicon dioxide.

What are the possible side effects of tegaserod (Zelnorm)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking tegaserod and call your doctor at once if you have a serious side effect such as:

  • new or worsening stomach pain;
  • blood in your stools;
  • ongoing diarrhea;
  • severe stomach pain or cramps; or
  • feeling like you might pass out.

Less serious side effects may include:

  • headache, dizziness or...

Read All Potential Side Effects and See Pictures of Zelnorm »

What are the precautions when taking tegaserod maleate (Zelnorm)?

Consult your...

Read All Potential Precautions of Zelnorm »


Zelnorm Consumer (continued)

SIDE EFFECTS: Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Consult your pharmacist.


Zelnorm Patient Information Including Side Effects

Brand Names: Zelnorm

Generic Name: tegaserod (Pronunciation: te GAS e rod)

  • What is tegaserod (Zelnorm)?
  • What are the possible side effects of tegaserod (Zelnorm)?
  • What is the most important information I should know about tegaserod (Zelnorm)?
  • What should I discuss with my healthcare provider before taking tegaserod (Zelnorm)?
  • How should I take tegaserod (Zelnorm)?
  • What happens if I miss a dose (Zelnorm)?
  • What happens if I overdose (Zelnorm)?
  • What should I avoid while taking tegaserod (Zelnorm)?
  • What other drugs will affect tegaserod (Zelnorm)?
  • Where can I get more information?

What is tegaserod (Zelnorm)?

Tegaserod was withdrawn from the U.S. market on March 30, 2007. This medication may still be used in limited emergency situations.

Tegaserod increases the action of a chemical called serotonin in the intestines. This speeds the movement of stools through the bowels.

Tegaserod is used to treat severe, chronic, irritable bowel syndrome (IBS) in women who have constipation (and not diarrhea) as their main bowel problem.

Tegaserod is also used to treat chronic constipation in patients younger than 55 years old.

Tegaserod may also be used for other purposes not listed in this medication guide.

What are the possible side effects of tegaserod (Zelnorm)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking tegaserod and call your doctor at once if you have a serious side effect such as:

  • new or worsening stomach pain;
  • blood in your stools;
  • ongoing diarrhea;
  • severe stomach pain or cramps; or
  • feeling like you might pass out.

Less serious side effects may include:

  • headache, dizziness or migraine;
  • back pain or joint pain; or
  • mild stomach pain, nausea or gas.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What is the most important information I should know about tegaserod (Zelnorm)?

Tegaserod was withdrawn from the U.S. market on March 30, 2007. This medication may still be used in limited emergency situations.

Tegaserod is not for use in people with diarrhea as the main symptom of their irritable bowel condition.

You should not use this medication if you are allergic to tegaserod, or if you have a history of stroke or heart attack, high blood pressure, uncontrolled angina, high cholesterol or triglycerides, diabetes, depression, or anxiety.

You also should not use tegaserod if you smoke, if you are older than 55 years, if you are overweight, or if you have a history of suicidal thoughts or actions.

Before taking tegaserod, tell your doctor if you have gallbladder problems, a blockage in your intestines, other stomach or intestinal disorders, kidney disease, or liver disease.

Tegaserod has not been shown to be helpful for men with irritable bowel syndrome.

Stop taking tegaserod and call your doctor at once if you have new or worsening stomach pain, blood in your stools, ongoing diarrhea, severe stomach pain or cramps, or feel like you might pass out.

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