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|Rilutek

Rilutek

Rilutek is used for:

Prolonging survival or prolonging the time before a patient with amyotrophic lateral sclerosis (ALS, Lou Gehrig disease) is placed on a ventilator or breathing machine. It may also be used for other conditions as determined by your doctor.

Rilutek is a benzothiazole. It is not known exactly how Rilutek works. It may prevent further damage to certain brain cells (motor neurons) responsible for controlling muscle function.

Do NOT use Rilutek if:

• you are allergic to any ingredient in Rilutek

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rilutek :

Some medical conditions may interact with Rilutek . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver or kidney disease, abnormal liver function tests, or low white blood cell count

Some MEDICINES MAY INTERACT with Rilutek . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Omeprazole or rifampin because the effectiveness of Rilutek may be decreased
• Amitriptyline, phenacetin, quinolones (eg, levofloxacin), tacrine, or theophylline because actions and side effects of Rilutek may be increased
• Medicines that may harm the liver (eg, acetaminophen, allopurinol, isoniazid, ketoconazole, methotrexate, methyldopa, sulfasalazine, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rilutek may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rilutek :

Use Rilutek as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Rilutek on an empty stomach, at least 1 hour before or 2 hours after eating.
• Rilutek works best if taken on a regular basis.
• Take Rilutek at the same time every day.
• If you miss a dose of Rilutek , skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Rilutek .

Important safety information:

• Rilutek may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Rilutek . Using Rilutek alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Avoid drinking excessive amounts of alcohol while taking Rilutek to reduce the risk of liver damage.
• Caffeine may increase the actions or side effects of Rilutek . Avoid large amounts of caffeine-containing foods and beverages, such as coffee, tea, cocoa, cola drinks, and chocolate.
• Cigarette smoke or charcoal-broiled food may decrease the effectiveness of Rilutek . Contact your doctor with any questions or concerns.
• Patients of Japanese descent and women may be at higher risk of developing side effects from Rilutek .
• LAB TESTS, including liver function tests, may be required to monitor progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Rilutek with caution in ELDERLY patients with liver problems because they may be more sensitive to its effects.
• Use Rilutek with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Rilutek during pregnancy. It is unknown if Rilutek is excreted in breast milk. Do not breast-feed while taking Rilutek .

Possible side effects of Rilutek :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations around the mouth; cough; diarrhea; dizziness; drowsiness; feeling of a whirling motion; headache; loss of appetite; muscle weakness; nausea; stomach pain; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breathing problems; fast or irregular heartbeat; fever, chills, or sore throat; frequent or painful urination; pneumonia; swelling of the hands or feet; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Rilutek at room temperature, between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rilutek out of the reach of children and away from pets.

General information:

• If you have any questions about Rilutek , please talk with your doctor, pharmacist, or other health care provider.
• Rilutek is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Rilutek . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.