Febuxostat Fahrenheit Special Precautions

Cardio-vascular disorders: Treatment with febuxostat in patients with ischaemic heart disease or congestive heart failure is not recommended.
Caution should be exercised for exacerbation and/or onset of cardiovascular disease when administering this drug.
Cardiovascular thromboembolic events (cardiovascular deaths, nonfatal myocardial infarctions and non fatal strokes) were reported in patients receiving febuxostat. A causal relationship with febuxostat has not been established. Patient should be monitored for signs and symptoms of myocardial infarction (MI) and stroke.
Medicinal product allergy / hypersensitivity: Rare reports of serious allergic/hypersensitivity reactions, including life-threatening Stevens-Johnson Syndrome, Toxic epidermal necrolysis and acute anaphylactic reactions/shock, have been. In most cases, these reactions occurred during the first month of therapy with febuxostat. Some, but not all of these patients reported renal impairment and/or previous hypersensitivity to allopurinol. Severe hypersensitivity reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) were associated with fever, haematological renal or hepatic involvement in some cases.
Patients should be advised of the signs and symptoms and monitored closely for symptoms of allergic/hypersensitivity reactions. Febuxostat treatment should be immediately stopped if serious allergic/hypersensitivity reactions, including Stevens-Johnson Syndrome, occur since early withdrawal is associated with better prognosis. If patient has developed allergic/hypersensitivity reactions including Stevens-Johnson Syndrome and acute anaphylatic reaction/shock, Febuxostat must not be re-started in this patient at any time.
Acute gouty attacks (gout flare): Febuxostat treatment should not be started until an acute attack of gout has completely subsided. Gout flares may occur during initiation of treatment due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. At treatment initiation with febuxostat, flare prophylaxis for at least 6 months with an NSAID or colchicine is recommended. If a gout flare occurs during febuxostat treatment, it should not be discontinued. The gout flare should be managed concurently as appropriate for the individual patients. Continuous treatment with febuxostat decreases frequency and intensity of gout flares.
Xanthine deposition: In patients in whom the rate of urate formation is greatly increased (e.g malignant disease and its treatment, Lesch-Nyhan syndrome) the absolute concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract. Febuxostat is not recommended in these patients.
Mercaptopurine/azathioprine: Febuxostat use is not recommended in patients concomitantly treated with mercaptopurine/azathioprine. Where the combination cannot be avoided patients should be closely monitored. A reduction of dosage of mercaptopurine or azathioprine is recommended in order to avoid possible haematological effects.
Organ transplant recipients: As there has been no experience in organ transplant recipients, the use of Febuxostat in such patients is not recommended.
Theophylline: Febuxostat 80 mg can be used in patients concomitantly treated with theophylline without risk of increasing theophylline plasma levels. No data is available for febuxostat 120 mg.
Liver disorders: Liver function test is recommended prior to the initiation of therapy with febuxostat and periodically thereafter based on clinical judgement.
Thyroid disorders: Caution is required when febuxostat is used in patients with alteration of thyroid function.
Lactose: Febuxostat tablet contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effects on Ability to Drive and Use Machines: Somnolence, dizziness, paraesthesia, and blurred vision have been reported with the use of febuxostat. Patients should exercise caution before driving, using machinery or participating in dangerous activities until they are reasonably certain that Febuxostat does bit adversely affect performance.