Medically reviewed by Drugs.com. Last updated on Jun 28, 2021.
Applies to the following strengths: 50 mg; 50 mg/10 mL
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Amyotrophic Lateral Sclerosis
50 mg orally every 12 hours
-This drug should be taken on an empty stomach, 1 hour before or 2 hours after eating.
-This drug may be taken via a percutaneous endoscopic gastronomy tube (PEG-tube).
Use: For the treatment of amyotrophic lateral sclerosis.
Renal Dose Adjustments
Use with caution
Liver Dose Adjustments
Not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times the upper limit of normal or evidence of liver dysfunction (e.g. elevated bilirubin)
Discontinue therapy if hepatic transaminases increase to greater than 5 x ULN
Discontinue therapy if there is evidence of liver dysfunction (e.g. elevated bilirubin)
-Hypersensitivity to active substance or any product components; anaphylaxis has been reported
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available.
-Take orally at least 1 hour before or 2 hours after a meal
-May administer via PEG tube, see Instructions for Use in package labeling for steps on use
-Gently shake bottle for at least 30 seconds before measuring dose
-Use within 15 days of first opening; protect from bright light; store upright; do not freeze
-Clinical studies have shown the time to tracheostomy or death was longer for patients receiving this drug compared with placebo.
-Measures of muscle strength and neurological function did not show benefit with this drug.
-Obtain baseline serum aminotransferases levels and repeat as clinically indicated
-Monitor for signs and symptoms of hepatic toxicity monthly for first 3 months, then periodically thereafter
-Monitor for signs and symptoms of neutropenia, especially in first 3 months.
-Read the US FDA-approved patient labeling (Instructions for Use).
-Patients should be instructed to contact their healthcare provider if they experience yellowing of the whites of the eyes, fever, or respiratory symptoms such as dry cough and difficult or labored breathing.
-Patients should notify their healthcare provider if they become pregnant or intend to become pregnant or are breastfeeding.
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