Riluzole is used to treat amyotrophic lateral sclerosis, also known as ALS or Lou Gehrig's disease.

Riluzole is not a cure for ALS, but it may delay progression of the disease and prolong your life.

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

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take riluzole on an empty stomach, at least 1 hour before or 2 hours after a meal.

Riluzole may also be given through a PEG feeding tube.

Read and follow all Instructions for Use. Ask your doctor or pharmacist if you need help.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

You will need frequent medical tests.

Store at room temperature away from moisture, heat, and light. Keep the liquid medicine upright and do not freeze. Throw away any unused liquid after 15 days.

Usual Adult Dose for Amyotrophic Lateral Sclerosis:

50 mg orally every 12 hours

Comments:
-This drug should be taken on an empty stomach, 1 hour before or 2 hours after eating.
-This drug may be taken via a percutaneous endoscopic gastronomy tube (PEG-tube).

Use: For the treatment of amyotrophic lateral sclerosis.

You should not use riluzole if you are allergic to it.

Tell your doctor if you have ever had:

• liver disease.

Riluzole may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using riluzole.

Not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness, confusion, problems with thinking or memory, coma, tremors, or blue lips or fingers.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from light and excess heat and moisture (not in the bathroom). Do not freeze the suspension. Be sure to store the suspension bottle upright. Be sure to use the suspension within 15 days of opening the bottle and discard any remaining medication after 15 days.

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

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.

Avoid eating charcoal-broiled foods.

Avoid smoking. Smoking cigarettes may make riluzole less effective.

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

Riluzole may cause serious side effects. Stop using riluzole and call your doctor at once if you have:

• sudden chest pain, wheezing, feeling short of breath;

• dry cough, or cough with mucus;

• low white blood cell counts--fever, mouth sores, skin sores, sore throat; or

• liver problems--nausea, loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, jaundice (yellowing of the skin or eyes).

Side effects may be more likely to occur in people of Japanese descent.

Common side effects of riluzole may include:

• increased blood pressure;

• numbness or tingling around your mouth;

• weakness;

• dizziness;

• stomach pain, nausea; or

• breathing problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Riluzole can harm your liver, especially if you also use certain medicines for infections, birth control, high cholesterol, seizures, pain, or arthritis (including Advil).

Other drugs may affect riluzole, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to riluzole.

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.