Duration of treatment Indefinite v Sample Clauses

Duration of treatment Indefinite v. Adverse effects Nausea, vomiting, weakness, tachycardia, somnolence, headache, dizziness, vertigo, pain, parasthesia, neutropaenia and alterations in liver function tests. Transient increases in ALT can occur in the first 3 months of treatment, with levels returning to below twice the upper limit of normal after 2 to 6 months while treatment continues. vi. Monitoring Requirements LFT and FBC before and during therapy, every month for 3 months, then every 3 months for a further 9 months, and annually thereafter. ALT levels should be measured more frequently in patients who develop elevated ALT levels. Riluzole should be discontinued if ALT levels increase to five times the ULN. There is limited experience with dose reduction or re-challenge in these patients. Patients should be warned to report any febrile illness to their physicians. White blood cell counts should be checked and riluzole discontinued if WBC <3.5 or neutrophils < 2.0. Patients should be warned to report respiratory symptoms to their physician. Chest radiography should be performed and in case of findings suggestive of interstitial lung disease, riluzole should be discontinued immediately. vii. Clinically relevant drug interactions No clinical data available but since riluzole is extensively metabolised by the enzyme cytochrome P450 1A2, inhibitors (e.g. theophylline, quinolones) and inducers (e.g. rifampicin, omeprazole) of this enzyme could potentially affect the rate of elimination. Consult product literature for more details. viii. Contraindication Hepatic disease or baseline transaminases greater than 3 times the Upper Limit of Normal (ULN). Renal impairment, pregnancy, breast feeding