Riluzole

Riluzole is used to treat amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease). Riluzole is in a class of medications called benzothiazoles. It works by changing the activity of certain natural substances in the body that affect nerves and muscles.

Riluzole comes as a tablet and a suspension (liquid) to take by mouth. It also comes as an oral film to be dissolved on the tongue. It usually is taken on an empty stomach (1 hour before or 2 hours after meals) twice a day, every 12 hours. You should take it at the same times each day (usually in the morning and in the evening). Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take riluzole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the suspension well (at least 30 seconds) before each use to mix the medication evenly. Be sure to turn the bottle up and down until you do not see clear liquid at the top or any particles at the bottom of the bottle. Read the instructions for use before you start taking riluzole suspension. Be sure that you understand these directions, and ask your pharmacist if you have any questions.

To use the oral film follow these steps:

1. Wash your hands and make sure your hands are completely dry before handling the film.
2. Remove riluzole oral film from the foil patch and place on the top of the tongue.
3. Close mouth and swallow saliva normally while allowing riluzole oral film to dissolve. Do not take any liquids or chew, spit, or talk while riluzole dissolves.
4. Wash your hands after you have finished handling riluzole oral film.

Riluzole may slow progression of ALS but does not cure it. Continue to take riluzole even if you feel well. Do not stop taking riluzole without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking riluzole,

• tell your doctor and pharmacist if you are allergic to riluzole, any other medications, or any of the ingredients in riluzole tablets, suspension or oral film. Ask your pharmacist for a list of the ingredients..
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking riluzole. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• The following nonprescription or herbal products may interact with riluzole: acetaminophen. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking riluzole. Do not start any of these medications while taking riluzole without discussing you're your healthcare provider.
• tell your doctor if you are of Japanese descent and if you have or have ever had kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking riluzole, call your doctor.
• tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this drug.

Avoid eating charcoal-broiled foods.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Riluzole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• weakness
• dizziness
• dry mouth
• mouth numbness
• difficulty falling asleep or staying asleep
• drowsiness
• swelling of the hands, feet, ankles, or lower legs
• fast heart rate

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• hives
• rash
• itching
• difficulty breathing or swallowing
• dry cough
• nausea
• stomach pain
• vomiting
• extreme tiredness
• unusual bleeding or bruising
• loss of appetite
• pain in the upper right part of the stomach
• yellowing of the skin or eyes
• dark urine
• fever, chills, cough, or other signs of infection
• muscle or joint pain
• headache

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• drowsiness
• memory loss
• bluish coloring of the skin, headache, tiredness, shortness of breath, lack of energy
• hard to concentrate, involuntary movements, seizures
• coma

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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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