Indications
Indicated for the chronic management of hyperuricemia in patients where urate deposition has already occurred (including a history, or presence of tophus and/or gouty arthritis. Not recommended for the treatment of asymptomatic hyperuricemia.
Contraindications
Know hypersensitive to any ingredient in the formulation.
Concomitant therapy with azathioprine, mercaptopurine, or theophylline.
Compositon/Ingredients
Febuxostat 80mg
Dosage and administration
The management of hyperuricemia in patients with gout: initial dosage of 40 mg once daily, if do not achieve serum urate concentrations < 6 mg/dL: increased to 80 mg once daily. If serum uric acid is > 6 mg/dL after 2 – 4 weeks, febuxostat 120 mg once daily may be considered.
Gout flare prophylaxis of at least 6 months is recommended.
Precaution
Ischaemic heart disease/congestive heart failure: not recommended. A risk of cardiovascular thromboembolic events.
Causality cannot be excluded, do not restart febuxostat if liver injury is confirmed and no alternate etiology can be found.
Serious allergic/hypersensitivity reactions: febuxostat should be immediately stopped. If reactions have been developed (including Stevens-Johnson syndrome and acute anaphylactic reaction/shock): febuxostat must not be restarted.
Patients with alteration of thyroid function: caution is required.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pregnancy: justify the potential benefit/potential risk. Nursing woman.
Driving/using machinery.
Safety and efficacy have not been established in pediatric patients < 18 years of age.
Storage
Store at temperature below 30°C, protect from light.
