Brand Names: Rilutek

Generic Name: riluzole (Pronunciation: RILL you zole)

• What is riluzole (Rilutek)?
• What are the possible side effects of riluzole (Rilutek)?
• What is the most important information I should know about riluzole (Rilutek)?
• What should I discuss with my healthcare provider before taking riluzole (Rilutek)?
• How should I take riluzole (Rilutek)?
• What happens if I miss a dose (Rilutek)?
• What happens if I overdose (Rilutek)?
• What should I avoid while taking riluzole (Rilutek)?
• What other drugs will affect riluzole (Rilutek)?
• Where can I get more information?

What is riluzole (Rilutek)?

Riluzole affects muscles and nerves in the body. The exact way that it works is unknown.

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

Riluzole may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of riluzole (Rilutek)?

If you experience any of the following serious side effects, contact your doctor immediately or seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
• a fever, chills or other signs of infection; or
• liver problems (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, severe fatigue).

Other, less serious side effects may be more likely to occur. Continue to take riluzole and talk to your doctor if you experience

• weakness;
• drowsiness;
• dizziness; or
• nausea, vomiting, diarrhea, constipation or decreased appetite.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about riluzole (Rilutek)?

Rarely, riluzole may cause serious blood problems. Notify your doctor immediately if you develop a fever, chills or other signs of infection which may be an early sign of potential blood problems.

Use caution when driving, operating machinery, or performing other hazardous activities. Riluzole may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol with caution while taking riluzole. Alcohol may increase the risk of liver problems caused by riluzole.

What should I discuss with my healthcare provider before taking riluzole (Rilutek)?

Before taking this medication, tell your doctor if you

• have liver disease; or
• have kidney disease.

You may not be able to take riluzole, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Riluzole is in the FDA pregnancy category C. This means that it is not known whether riluzole will be harmful to an unborn baby. Do not take riluzole without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether riluzole passes into breast milk. Do not take riluzole without first talking to your doctor if you are breast-feeding a baby.

How should I take riluzole (Rilutek)?

Take riluzole exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Riluzole should be taken at least an hour before or two hours after a meal.

Riluzole is usually taken twice a day, every twelve hours. It should be taken at the same time each day.

Your doctor may want you to have blood tests during treatment with riluzole. It is important for your doctor to know how much riluzole is in the blood and how well the liver is working.

Store riluzole at room temperature away from moisture, heat, and bright light.

What happens if I miss a dose (Rilutek)?

If you miss a dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose (Rilutek)?

Seek emergency medical treatment.

Symptoms of a riluzole overdose have not been reported.

What should I avoid while taking riluzole (Rilutek)?

Use caution when driving, operating machinery, or performing other hazardous activities. Riluzole may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously while taking riluzole. Alcohol may increase the risk of liver problems caused by riluzole.

What other drugs will affect riluzole (Rilutek)?

Before taking this medication, tell your doctor if you are taking any of the following medicines:

• theophylline (Theo-Dur, Slo-Bid, Elixophyllin, Bronkodyl, Aerolate, Slo-Phyllin, Theovent, Theoclear, Uniphyl, Uni-Dur, Respbid,), and many others;
• allopurinol (Lopurin, Zyloprim);
• methyldopa (Aldomet);
• sulfasalazine (Azulfidine);
• omeprazole (Prilosec);
• amitriptyline (Elavil, Endep, others);
• caffeine-containing products;
• fluoroquinolone antibiotics, such as ciprofloxacin (Cipro), ofloxacin (Floxin), lomefloxacin (Maxaquin), or norfloxacin (Norflex); or
• rifampin (Rifadin, Rimactane).

Drugs other than those listed here may also interact with riluzole. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

Your pharmacist has additional information about riluzole written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others and use this medication only for the condition prescribed.

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Last Updated: April 12, 2009