Generic name: LESINURAD 200mg
Dosage form: tablet, film coated
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ZURAMPIC tablets are for oral use and should be co-administered with a xanthine oxidase inhibitor, including allopurinol or febuxostat.
ZURAMPIC is recommended at 200 mg once daily. This is also the maximum daily dose. ZURAMPIC should be taken by mouth, in the morning with food and water.
ZURAMPIC may be added when target serum uric acid levels are not achieved on the medically appropriate dose of the xanthine oxidase inhibitor alone.
Use of ZURAMPIC is not recommended for patients taking daily doses of allopurinol less than 300 mg (or less than 200 mg in patients with estimated creatinine clearance (eCLcr) less than 60 mL/min). Take ZURAMPIC at the same time as the morning dose of xanthine oxidase inhibitor. If treatment with the xanthine oxidase inhibitor is interrupted, ZURAMPIC should also be interrupted. Failure to follow these instructions may increase the risk of renal events [see Warnings and Precautions (5.1)].
Patients should be instructed to stay well hydrated (eg, 2 liters [68 oz] of liquid per day).
Patients with Renal Impairment
No dose adjustment is needed in patients with mild or moderate renal impairment (eCLcr of 45 mL/min or greater). ZURAMPIC should not be initiated in patients with an eCLcr less than 45 mL/min. Assessment of renal function is recommended prior to initiation of ZURAMPIC therapy and periodically thereafter [see Warnings and Precautions (5.1)]. More frequent renal function monitoring is recommended in patients with an eCLcr below 60 mL/min. ZURAMPIC should be discontinued when eCLcr is persistently less than 45 mL/min [seeWarnings and Precautions (5.1)and Use in Specific Populations (8.6)].
Gout flares may occur after initiation of urate lowering therapy, including ZURAMPIC, due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. Gout flare prophylaxis is recommended when starting ZURAMPIC, according to practice guidelines.
If a gout flare occurs during ZURAMPIC treatment, ZURAMPIC need not be discontinued. The gout flare should be managed concurrently, as appropriate for the individual patient.
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