In the U.S.—

• Amyotrophic lateral sclerosis (ALS) therapy agent

Riluzole (RIL-yoo-zole) is used to treat patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Riluzole is not a cure for ALS, but it may extend survival in the early stages of the disease, and/or may extend the time until a tracheostomy may be needed.

Riluzole is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For riluzole, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to riluzole. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies with riluzole have not been done in pregnant women. Some unwanted effects have been reported in animal studies. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Riluzole has been shown to pass into the milk of nursing animals. It may also pass into human milk and may cause unwanted effects in nursing babies. It may be necessary for you to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of riluzole in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of riluzole in the elderly with use in other age groups, this medicine has been used in elderly patients and is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your doctor and pharmacist if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Kidney disease or
• Liver disease—Higher blood levels of riluzole may occur, increasing the chance of side effects

Riluzole should be taken on a regular basis and at the same time of the day (for example, in the morning and the evening).

Riluzole should be taken on an empty stomach. Take this medicine at least one hour before meals or two hours after meals.

Dosing—

The dose of riluzole will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of riluzole. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For ALS:
    • Adults—Oral, 50 milligrams (mg) every twelve hours.
    • Children up to 18 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and bright light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

If you become ill with a fever, report this to your doctor promptly. Fever may be a sign of infection.

This medicine may cause dizziness or drowsiness. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

Avoid drinking alcoholic beverages. It is not known if drinking alcohol while taking riluzole may cause liver problems.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Diarrhea;  nausea;  vomiting;  worsening of some symptoms of ALS, including spasticity and tiredness or weakness 
  
  

• Less common
  • Difficulty in breathing;  increased cough ;  pneumonia 
  
  

• Rare
  • Bloody or cloudy urine, frequent urge to urinate, or painful or difficult urination;  convulsions (seizures);  fast or pounding heartbeat;  fever, chills, or continuing sores in mouth;  hypertension (high blood pressure);  increased thirst, irregular heartbeat, mood or mental changes, or muscle cramps, pain, or weakness;  lack of coordination;  lack of energy ;  mental depression;  pain, tenderness, bluish color, or swelling of foot or leg;  redness, scaling, or peeling of the skin;  swelling of eyelids, mouth, lips, tongue, and/or throat;  swelling of face;  trouble in swallowing;  yellow eyes or skin 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Abdominal pain or gas;  dizziness;  drowsiness;  loss of appetite;  numbness or tingling around the mouth 
  
  

• Less common
  • Back or muscle pain or stiffness;  constipation ;  general feeling of discomfort or illness;  hair loss;  headache;  irritation or soreness of mouth;  runny nose;  skin rash or itching;  trouble in sleeping  
  
  

This medicine may also cause the following side effect that your doctor will watch for:

• More common
  • Liver problems 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.