Zelnorm

• Gastrointestinal Agents
• ATC:A03AE02

• SDZ HTF 919
• Tegaserod maleate
• Tegaserod [Usan:Inn:Ban]
• Zelmac
• Zelnorm

• No information avaliable

C₁₆H₂₃N₅O

http://www.rxlist.com/cgi/generic3/zelnorm.htm

Zelnorm FDA

Zelnorm MSDS

No information avaliable

301.387 g/mol

155 ^oC

No information avaliable

Solid

3.753

Tablet

Provides relief from the symptoms of irritable bowel syndrome including chronic idiopathic constipation.

Tegaserod is indicated for the short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation. Irritable bowel syndrome with constipation and chronic idiopathic constipation are both lower gastrointestinal dysmotility disorders. Clinical investigations have shown that both motor and sensory functions of the gut appear to be altered in patients suffering from irritable bowel syndrome (IBS), while in patients with chronic idiopathic constipation, reduced intestinal motility is the predominant cause of the condition. Both the enteric nervous system, which acts to integrate and process information in the gut, and 5-hydroxytryptamine (5-HT, serotonin) are thought to represent key elements in the etiology of both IBS and idiopathic constipation. Approximately 95% of serotonin is found throughout the gastrointestinal tract, primarily stored in enterochromaffin cells but also in enteric nerves acting as a neurotransmitter. Serotonin has been shown to be involved in regulating motility, visceral sensitivity and intestinal secretion. Investigations suggest an important role of serotonin Type-4 (5-HT₄) receptors in the maintenance of gastrointestinal functions in humans. 5-HT₄ receptor mRNA has been found throughout the human gastrointestinal tract.

Rapidly absorbed after oral administration, with an absolute bioavailability of approximately 10%.

Oral LD₅₀ in rat is 2000 mg/kg.

Zelnorm^®

(tegaserod maleate)

Tablets

(pronounced ZEL-norm, te-gas-a-rod mal- -ate)

Read this information carefully before you start taking Zelnorm^® (ZEL-norm). Read the information you get each time you get more Zelnorm. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

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

If you get new or worse abdominal (stomach) pain, or blood in your stools, stop taking Zelnorm right away and tell your doctor. Your doctor may need to do tests to find out if you have a serious problem with your bowel that may require special treatment or hospitalization.

Sometimes Zelnorm causes diarrhea. Stop taking Zelnorm and call your doctor right away if you get so much diarrhea that you get lightheaded, dizzy, or faint.

What is Zelnorm?

Zelnorm is a medicine for:

• the short-term treatment of women who have irritable bowel syndrome (IBS) with constipation (not enough or hard bowel movements) as their main bowel problem. Zelnorm does not work for all women who use it. Zelnorm has not been shown to work in men with IBS with constipation.
• the treatment of patients less than 65 years of age with chronic idiopathic constipation. Chronic constipation means constipation lasting over 6 months. Idiopathic constipation means constipation not due to other diseases or drugs. Zelnorm has not been shown to work in patients with chronic idiopathic constipation who are 65 years of age or older. Zelnorm increases the movement of stools (bowel movement) through the bowels. Zelnorm does not cure IBS with constipation or chronic idiopathic constipation. For those with IBS with constipation who are helped, Zelnorm reduces pain and discomfort in the abdominal area, bloating, and constipation. For those with chronic idiopathic constipation, Zelnorm increases bowel movements, reduces straining, bloating and abdominal discomfort If you stop taking Zelnorm, your symptoms may return within 1 or 2 weeks.

Who should not take Zelnorm?

You should not start taking Zelnorm if:

• You now have diarrhea or have diarrhea often.
• You have bad kidney or liver disease.
• You have ever had bowel obstruction (intestinal blockage), symptomatic gallbladder disease, or abdominal adhesions causing pain and/or intestinal blockage.
• You are allergic to Zelnorm or any of its ingredients. The active ingredient in Zelnorm is tegaserod maleate. The inactive ingredients are listed at the end of this leaflet.

Zelnorm may not be right for you. Tell your doctor if you:

• Are pregnant or plan to become pregnant. Zelnorm is not recommended for use by pregnant women.
• Are breast-feeding. Do not breast-feed while you are taking Zelnorm. The drug is likely to pass into breast milk.
• Are taking or planning to take any other medicines, including those you can get without a prescription.

How should I take Zelnorm?

• You should take Zelnorm twice a day on an empty stomach shortly before you eat a meal, or as your doctor prescribes it.
• For IBS with Constipation: You should take Zelnorm for 4 to 6 weeks to treat your IBS symptoms. If you feel better, your doctor may prescribe an additional 4 to 6 weeks of Zelnorm.
• For Chronic Idiopathic Constipation: You should talk to your doctor regularly about whether you need to stay on Zelnorm.
• If you miss a dose of Zelnorm, just skip that dose. Do not take two tablets to make up the missed dose. Instead, just wait until the next time you are supposed to take it and then take your normal dose.

What are the possible side effects of Zelnorm?

Headache and diarrhea were the most common side effects seen with Zelnorm.

Diarrhea was an occasional side effect of treatment with Zelnorm. Most people who got diarrhea had it during the first week after starting Zelnorm. Typically, diarrhea went away with continued therapy. If you get bad diarrhea, or if you get diarrhea together with bad cramping, abdominal pain, fainting, or dizziness, tell your doctor. Your doctor may tell you to stop taking Zelnorm or suggest other ways to manage your diarrhea.

There have been rare cases of rectal bleeding and severe abdominal pain in patients treated with Zelnorm. Some of these problems were related to insufficient blood flow to part of the bowel. It is not known if this was related to Zelnorm use.

In studies a very small number of patients were reported to have abdominal surgery. In IBS with constipation studies there were a few more reports of abdominal surgery in patients taking Zelnorm than in patients taking a sugar pill. Most of these were related to the gallbladder. It is not known if Zelnorm may increase your chance of abdominal surgery. Gallbladder surgery has been reported to occur more often in IBS patients than in the general population.

This list is not complete. Your doctor or pharmacist can give you a more complete list of possible side effects. Talk to your doctor about any side effects you may have.

General information about the safe and effective use of Zelnorm

Keep Zelnorm at room temperature. Do not use Zelnorm past the expiration date shown on the package.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Zelnorm for a condition for which it was not prescribed. Do not give Zelnorm to other people, even if they have the same symptoms that you have. This leaflet summarizes the most important information about Zelnorm. For more information, talk with your doctor. You can ask your doctor or pharmacist for information about Zelnorm that is written for health professionals. You can also contact the company that makes Zelnorm at 1-866-427-6682 or www.zelnorm.com.

Inactive Ingredients

Zelnorm is available for oral use in the following tablet formulations:

• 2 mg and 6 mg tablets (blister packs) containing the following inactive ingredients: crospovidone, glyceryl monostearate, hypromellose, lactose monohydrate, poloxamer 188, and polyethylene glycol 4000
• 6 mg tablets (bottles) containing the following inactive ingredients: crospovidone, glyceryl behenate, hypromellose, lactose monohydrate, colloidal silicon dioxide.

Humans and other mammals