Riluzole

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

Riluzole is not a cure for ALS, but it may help slow down the disease's progression and extend your life.

Riluzole may also be used for reasons not mentioned in this medication guide.

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.

Use only as directed. Inform your doctor if you are taking other medicines, have other medical conditions, or have allergies.

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.

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

Riluzole may cause serious side effects. Stop using riluzole and call your doctor immediately 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.

Usual Adult Dose for Amyotrophic Lateral Sclerosis:

50 mg orally every 12 hoursComments: -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.

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

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

Symptoms of an overdose may include drowsiness, confusion, trouble with thinking or memory, coma, tremors, or blue lips or fingers.

Avoid smoking. Smoking cigarettes may reduce the effectiveness of riluzole.

Sometimes it is not safe to use certain medications together. Some drugs can change the amount of other drugs in your blood, which may increase side effects or reduce how well the medications work.

Riluzole can damage your liver, especially if you also take certain medications 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. Inform your doctor about all other medicines you are using.

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