Zelnorm (Tegaserod)

(te gas' a rod)

In 2007, tegaserod was removed from the U.S. market and was made available only through a restricted distribution program from the manufacturer. Beginning in April 2008, tegaserod will no longer be available through the restricted distribution program; therefore, the U.S. Food and Drug Administration (FDA) has decided to make tegaserod available to physicians for patients in emergency situations that are life-threatening or require hospitalization. If your doctor believes that you should receive tegaserod, he or she may contact the FDA for more information. If you are receiving tegaserod through the restricted distribution program, you should talk to your doctor about switching to another treatment.

Tegaserod is used to relieve pain, bloating, and constipation caused by irritable bowel syndrome (IBS; a condition that causes stomach pain, bloating, constipation, and diarrhea) in women whose main symptom is constipation. This medication is also used to increase the frequency of bowel movements and relieve bloating, straining, and stomach pain in women and men with chronic idiopathic constipation (constipation that is not due to other diseases or medications and that has been a problem for longer than 6 months). Tegaserod is in a class of medications called serotonin agonists. It works by improving muscle movement and increasing production of fluid in the bowels.

Tegaserod comes as a tablet to take by mouth. It is usually taken twice a day on an empty stomach shortly before a meal. Take tegaserod at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tegaserod exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. If you have IBS with constipation, your doctor will probably tell you to take tegaserod for 4-6 weeks. If your symptoms improve, your doctor may tell you to take tegaserod for another 4-6 weeks. If you have chronic idiopathic constipation, you should talk to your doctor regularly to see if you should continue to take tegaserod. Be sure to tell your doctor how you are feeling, and do not take tegaserod for longer than your doctor prescribes. Tegaserod controls the symptoms of irritable bowel syndrome and chronic idiopathic constipation, but does not cure these conditions. Continue to take tegaserod even if you feel well. Do not stop taking tegaserod without talking to your doctor. If you stop taking tegaserod, your symptoms may return within 1-2 weeks.

Before taking tegaserod,
• tell your doctor and pharmacist if you are allergic to tegaserod or any other medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, herbal products, or nutritional supplements you are taking. Your doctor may need to adjust the dose of your medications or monitor you more carefully for side effects.
• tell your doctor if you have diarrhea now or if you often have diarrhea; if you have or have ever had gallbladder, kidney, or liver disease; a blockage in your intestines or unexplained stomach pain; abdominal surgery (surgery on the area between your chest and hips); jaundice (yellowing of the skin or eyes); sphincter of Oddi dysfunction (blockage of bile or digestive juices flowing into the intestine that causes pain and/or jaundice); or ischemic colitis (decreased blood flow to the intestines causing rectal bleeding, bloody diarrhea, or stomach pain).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tegaserod, call your doctor. Do not breast-feed while you are taking tegaserod.
• you may have some diarrhea, especially during your first week of taking tegaserod. However, if you have a lot of diarrhea, or if you also have severe cramping, dizziness, light-headedness, fainting, blurred vision, upset stomach or a fast heartbeat, you should stop taking tegaserod and call your doctor immediately.

Unless your doctor tells you otherwise, continue your normal diet.

You should skip the missed dose. Wait until the next time you are supposed to take tegaserod, and then take your normal dose. Do not take a double dose to make up for a missed dose.

Tegaserod may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• diarrhea
• nausea
• vomiting
• gas
• leg or back pain
• joint pain or problems
• difficulty falling asleep or staying asleep
• runny nose, congestion, or other cold symptoms

Some side effects can be serious. If you experience any of the following symptoms or the symptoms mentioned in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• rash
• hives
• itching
• swelling of the face, throat, tongue, lips, or eyes
• difficulty breathing and swallowing
• hoarseness

People with IBS may need to have abdominal surgery, especially gallbladder surgery, more often than people who do not have IBS. People with IBS who took tegaserod needed this type of surgery somewhat more often than people who did not take tegaserod. It is not known if taking tegaserod increases your chance of needing abdominal surgery. Talk to your doctor about the risk of taking this medication. You should know that tegaserod rarely may cause ischemic colitis. Tell your doctor and stop taking tegaserod right away if you have new or worsening stomach pain, bloody diarrhea, rectal bleeding, or blood in your stools. Tegaserod may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.