Applies to the following strength(s): 50 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Amyotrophic Lateral Sclerosis
50 mg orally every 12 hours.
No increased benefit can be expected from higher daily doses, but adverse events are increased.
Riluzole tablets should be taken at least an hour before, or two hours after, a meal to avoid a food-related decrease in bioavailability.
Renal Dose Adjustments
It is not known if dosage adjustments are needed in patients with renal dysfunction. However, because riluzole metabolites and a small amount of the drug itself are eliminated via the kidney, caution is advised if riluzole is prescribed to a patient with renal dysfunction.
Liver Dose Adjustments
The manufacturer states that riluzole therapy should not be started in patients presenting with elevated baseline liver function tests (i.e. alanine aminotransferase, aspartate aminotransferase, gamma-glutamate transferase and/or bilirubin).
Riluzole is extensively metabolized in the liver. Riluzole should be prescribed cautiously to patients with a current or past history of liver disease. Clinical trials that have been published excluded patients with liver disease, hence there is no information for dosage adjustments in these patients.
If a patient is currently taking riluzole and develops ALT values less than 5 times the upper limit of normal, therapy may be continued with caution. There is no clinical experience with patients whose ALT has exceeded 5 times the upper limit of normal. The risk-to-benefit ratio of continued riluzole therapy should be considered by the clinician, patient and/or caregiver(s). If riluzole therapy is to continue, the manufacturer recommends weekly monitoring of complete liver function. Therapy should be discontinued if the ALT rises above 10 times the upper limit of normal.
Rechallenge in patients who have previously discontinued riluzole due to elevations of ALT has not been done.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Data not available.
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Other brands: Rilutek