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TEVA-FEBUXOSTAT is a brand name for Febuxostat, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions Patients with gout and established cardiovascular (CV) disease treated with febuxostat had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study (See WARNING AND PRECAUTIONS, Cardiovascular).
Consider the risks and benefits of TEVA-FEBUXOSTAT when deciding to prescribe or continue patients on TEVA-FEBUXOSTAT. TEVA-FEBUXOSTAT should only be used in patients who have an inadequate response or intolerance to allopurinol, or for whom treatment with allopurinol is inappropriate (See INDICATIONS).
General Gout Flare TEVA-FEBUXOSTAT treatment should not be started until an acute attack of gout has completely subsided. After initiation of TEVA-FEBUXOSTAT therapy, an increase in gout flares is frequently observed. In order to reduce the likelihood of gout flares when TEVA-FEBUXOSTAT is initiated, concurrent flare prophylactic treatment with drugs such as a non-steroidal anti- inflammatory drug (NSAID) or colchicine is recommended.
Flare prophylactic therapy may be beneficial for up to six months (see CLINICAL TRIALS). If a gout flare occurs during TEVA-FEBUXOSTAT treatment, TEVA-FEBUXOSTAT should not be discontinued. The gout flare should be managed concurrently, as appropriate for the individual patient.
, malignant disease and its treatment, Lesch-Nyhan syndrome). No studies have been conducted in these populations. Febuxostat has not been studied in organ transplant recipients. The use of TEVA-FEBUXOSTAT in these patients with secondary hyperuricemia is not recommended.
73]. 21]. Febuxostat was similar to allopurinol for nonfatal MI, nonfatal stroke and unstable angina with urgent coronary revascularization (see CLINICAL TRIALS). 53)]. A potential increased risk of cardiac failure has also been reported in patients with pre-existing cardiovascular disease and/or risk factors for cardiovascular disease.
Treatment with febuxostat is not recommended in patients with ischemic heart disease or congestive heart failure. Monitor for signs and symptoms of myocardial infarction (MI), stroke and cardiac failure. Consider the risks and benefits of TEVA-FEBUXOSTAT when deciding to prescribe or continue patients on TEVA-FEBUXOSTAT.
Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. Gastrointestinal TEVA-FEBUXOSTAT tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactase malabsorption should not take TEVA-FEBUXOSTAT.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Febuxostat in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Hepatic/Biliary/Pancreatic There have been postmarketing reports of fatal and non-fatal hepatic failure in patients taking febuxostat, although the reports contain insufficient information necessary to establish the probable cause.
During randomized controlled studies, transaminase elevations greater than three times the upper limit of normal (ULN) were observed (AST: 2%, 2% and ALT: 3%, 2% in febuxostat and allopurinol-treated patients, respectively). No dose-effect relationship for these transaminase elevations was noted.
Laboratory assessment of liver function is recommended prior to the initiation of TEVA-FEBUXOSTAT therapy and periodically thereafter (see ADVERSE REACTIONS, Abnormal Hematologic and Clinical Chemistry Findings). Obtain a liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin) as a baseline before initiating TEVA- FEBUXOSTAT.
Measure liver tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. In this clinical context, if the patient is found to have abnormal liver tests (ALT greater than three times the upper limit of the reference range), TEVA-FEBUXOSTAT treatment should be interrupted and investigation done to establish the probable cause.
TEVA-FEBUXOSTAT should not be restarted in these patients without another explanation for the liver test abnormalities. Patients who have serum ALT greater than three times the reference range with serum total bilirubin greater than two times the reference range without alternative etiologies are at risk for severe drug-induced liver injury and should not be restarted on TEVA-FEBUXOSTAT.
For patients with lesser elevations of serum ALT or bilirubin and with an alternate probable cause, treatment with TEVA-FEBUXOSTAT can be used with caution. TEVA-Febuxostat Page 6 of 32 Hypersensitivity See Skin. Skin Serious skin and hypersensitivity reactions, including Stevens-Johnson Syndrome, DRESS and Toxic Epidermal Necrolysis have been reported in patients taking febuxostat.
Many of these patients had reported previous […]