Tegaserod

Tegaserod is used in women younger than 65 years of age to treat irritable bowel syndrome with constipation (IBS-C; a condition that causes stomach pain or cramps, bloating, and infrequent or difficult passage of stools). 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 at least 30 minutes 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.

Your healthcare provider may tell you to stop using tegaserod if your symptoms do not improve within 4 to 6 weeks of treatment. Talk to your doctor about how you are feeling during your treatment.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with tegaserod and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

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 or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had ischemic colitis (decreased blood flow to the bowels), any type of blockage in your stomach or bowels, sphincter of Oddi dysfunction (blockage of bile or digestive juices flowing into the intestine that causes pain or jaundice), scar tissue that formed between the tissues and organs in the stomach area, or gallbladder, kidney, or liver disease. Also tell your doctor if you have had a stroke, mini-stroke, heart attack or have angina (ongoing chest pain or pressure that is felt when the heart does not get enough oxygen).Your doctor will probably tell you not to take tegaserod.

• tell your doctor if you have or have ever had frequent diarrhea or depression. Also tell your doctor if you smoke or are overweight or if you have high blood pressure, high blood cholesterol levels, coronary artery disease (narrowing of the blood vessels that carry blood to the heart), or diabetes,

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking tegaserod, call your doctor. Do not breastfeed while you are taking tegaserod.

• you should know that tegaserod may cause changes in your thoughts, behavior, or mental health. Some patients who took tegaserod have developed depression or psychosis (loss of contact with reality), have become violent, have thought about killing or hurting themselves, and have tried or succeeded in doing so. You or your family or caregiver should call your doctor right away if you experience any of the following symptoms: anxiety, sadness, crying spells, loss of interest in activities you used to enjoy, poor performance at school or work, sleeping more than usual, difficulty falling asleep or staying asleep, irritability, anger, aggression, changes in appetite or weight, difficulty concentrating, withdrawing from friends or family, lack of energy, feelings of worthlessness or guilt, thinking about killing or hurting yourself, acting on dangerous thoughts, or hallucinations (seeing or hearing things that do not exist). Be sure that your family members know which symptoms are serious so that they can call the doctor if you are unable to seek treatment on your own.

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

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

  • headache

  • diarrhea

  • nausea

  • gas

  • heartburn

  • dizziness

• 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 or get emergency medical treatment:

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

  • chest pain that may spread to the arms, neck, jaw, back, or stomach area; sweating; shortness of breath; or feeling sick or vomiting;

  • sudden numbness or weakness, especially on one side of the body; severe headache or confusion; or problems with vision, speech, or balance

  • bleeding from the rectum

  • new or worsening stomach pain

  • diarrhea that is bloody or that causes you to feel lightheaded or faint

• Tegaserod may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

Symptoms of overdose may include the following:

• diarrhea

• headache

• stomach pain

• gas

• nausea

• vomiting

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.