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Film Coated Tablets
56 X 50 mg
Treatment should only be initiated by specialist physicians with experience in the management of motor neurone diseases. The recommended daily dose in adults or elderly is 100 mg (50 mg every 12 hours). No significant increased benefit can be expected from higher daily doses. Rilutek tablets should be taken at least an hour before, or two hours after a meal to avoid a food related decrease in biovailability.
Children: This product is not recommended for use in children, due to a lack of data on the safety and efficacy of riluzole in any neurodegenerative diseases occurring in children or adolescents.
Patients with impaired renal function: This product is not recommended for use in patients with impaired renal function, as studies at repeated doses have not been conducted in this population.
Elderly: based on pharmacokinetic data, there are no special instructions for the use in this population.
For full details see prescribing information.
This product is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that this product extends survival for patients with ALS. Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free. There is no evidence that this product exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. this product has not been shown to be effective in the late stages of ALS. Safety and efficacy has only been studied in ALS. Therefore, this product should not be used in patients with any other form of motor neurone disease.
Hypersensitivity to the active substance or to any of the excipients. Hepatic disease or baseline transaminases greater than 3 times the upper limit of normal. Patients who are pregnant or breast-feeding.
Liver impairment: Riluzole should be prescribed with care in patients with a history of abnormal liver function, or in patients with slightly elevated serum transaminases (ALT/SGPT; AST/SGOT up to 3 times the upper limit of the normal range (ULN)), bilirubin and/or gamma-glutamyl transferase (GGT) levels. Baseline elevations of several liver function tests (especially elevated bilirubin) should preclude the use of riluzole. Because of the risk of hepatitis, serum transaminases, including ALT, should be measured before and during therapy with riluzole. ALT should be measured every month during the first 3 months of treatment, every 3 months during the remainder of the first year, and periodically thereafter. ALT levels should be measured more frequently in patients who develop elevated ALT levels. Riluzole should be discontinued if the ALT levels increase to 5 times the ULN. There is no experience with dose reduction or rechallenge in patients who have developed an increase of ALT to 5 times ULN. Readministration of riluzole to patients in this situation cannot be recommended.
Neutropenia: Patients should be warned to report any febrile illness to their physicians. The report of a febrile illness should prompt physicians to check white blood cell counts and to discontinue riluzole in case of neutropenia.
Interstitial lung disease: Cases of interstitial lung disease have been reported in patients treated with riluzole, some of them were severe. If respiratory symptoms develop such as dry cough and/or dyspnea, chest radiography should be performed, and in case of findings suggestive of interstitial lung disease (e.g. bilateral diffuse lung opacities), riluzole should be discontinued immediately. In the majority of the reported cases, symptoms resolved after drug discontinuation and symptomatic treatment.
Renal impairment: Studies at repeated doses have not been conducted in patients with impaired renal function.
Asthenia, nausease, vomiting, headache, abdominal pain, dizziness, tachycardia, somnolence, circumoral parasthesia, neuropenia, disturbances in liver function test.
For full details see prescribing information.
There have been no clinical studies to evaluate the interactions of riluzole with other medicinal products. In vitro studies using human liver microsomal preparations suggest that CYP 1A2 is the principal isozyme involved in the initial oxidative metabolism of riluzole. Inhibitors of CYP 1A2 (e.g. caffeine, diclofenac, diazepam, nicergoline, clomipramine, imipramine, fluvoxamine, phenacetin, theophylline, amitriptyline and quinolones) could potentially decrease the rate of riluzole elimination, while inducers of CYP 1A2 (e.g. cigarette smoke, charcoal-broiled food, rifampicin and omeprazole) could increase the rate of riluzole elimination.
Pregnancy and Lactation
Pregnancy: This product is contraindicated in pregnancy. Clinical experience with riluzole in pregnant women is lacking.
Lactation: This product is contraindicated in breast-feeding women. It is not known whether riluzole is excreted in human milk.
Neurological and psychiatric symptoms, acute toxic encephalopathy with stupor, coma, and methemoglobinemia have been observed in isolated cases. In case of overdose, treatment is symptomatic and supportive.