Riluzole (Oral route)
Central Nervous System Agent
Uses of This Medicine:
Riluzole is used to treat patients with amyotrophic lateral sclerosis (ALS), which is also known as Lou Gehrig's disease. Riluzole is not a cure for ALS, but it may extend survival for patients in the early stages of the disease or extend the time until a tracheostomy (breathing tube in the throat) is needed.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of riluzole in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of riluzole in the elderly. However, elderly patients are more likely to have age-related kidney and liver problems, which may require caution and an adjustment in the dose for patients receiving riluzole.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bone marrow problems (e.g., low white blood cells) or
- Liver disease, recent or history of or
- Lung disease (e.g., interstitial lung disease)—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
Take this medicine exactly as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine works best if there is a constant amount in the blood. To keep blood levels constant, take this medicine at the same time each day (e.g., in the morning and in the evening) and do not miss any doses.
The tablet should be taken on an empty stomach. Take the tablet at least one hour before or two hours after meals.
The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For ALS:
- Adults—50 milligrams (mg) every 12 hours.
- Children—Use and dose must be determined by your doctor.
- For ALS:
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Stop using this medicine and check with your doctor right away if you have a rash; stomach pain; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
Riluzole can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
Stop using this medicine and check with your doctor right away if you start having breathing problems, shortness of breath, a dry cough, chest pain, fever, or chills. These could be symptoms of a serious lung problem.
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 not alert.
Avoid drinking large amounts of alcoholic beverages. Alcohol taken together with riluzole may cause liver problems.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- More common
- Blurred vision
- difficulty with breathing
- difficulty with moving
- excessive muscle tone
- increased cough
- muscle pain or stiffness
- muscle tension or tightness
- pain in the joints
- pounding in the ears
- slow or fast heartbeat
- Less common
- Bladder pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- bluish lips or skin
- burning while urinating
- changes in skin color
- chest congestion
- chest pain
- cold sweats
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- cough producing mucus
- difficult, burning, or painful urination
- difficult or labored breathing
- difficulty with swallowing
- fast, pounding, or irregular heartbeat or pulse
- frequent urge to urinate
- general feeling of discomfort or illness
- increased sputum
- loss of appetite
- low blood pressure or pulse
- lower back or side pain
- muscle aches and pains
- rapid weight gain
- runny nose
- shortness of breath
- slow breathing
- sore throat
- tightness in the chest
- tingling of the hands or feet
- trouble sleeping
- troubled breathing
- unusual tiredness or weakness
- unusual weight gain or loss
- Continuing sores in the mouth
- increased thirst
- lack of coordination
- lack of energy
- mental depression
- mood or mental changes
- muscle cramps, pain, or weakness
- pain, tenderness, bluish color, or swelling of the foot or leg
- redness, scaling, or peeling of the skin
- swelling of the eyelids, mouth, lips, tongue, or throat
- swelling of the face
- yellow eyes or skin
- More common
- Abdominal or stomach pain
- acid or sour stomach
- lack or loss of strength
- numbness or tingling around the mouth
- pain or tenderness around the eyes and cheekbones
- stomach discomfort, upset, or pain
- weight loss
- Less common
- Back or muscle pain or stiffness
- cracks in the skin
- dizziness or lightheadedness
- dry mouth
- excess air or gas in the stomach or intestines
- feeling of constant movement of self or surroundings
- full feeling
- general feeling of discomfort or illness
- hair loss or thinning of the hair
- irritation or soreness of the mouth
- itching skin
- loss of heat from the body
- passing gas
- sensation of spinning
- skin rash, encrusted, scaly, and oozing
- sleepiness or unusual drowsiness
- sore mouth or tongue
- swelling or inflammation of the mouth
- tooth problems
- unable to sleep
- white patches in the mouth, tongue, or throat
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 immediately if any of the following side effects occur:
Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014