Medically reviewed by Drugs.com. Last updated on Feb 15, 2022.
Applies to the following strengths: 40 mg; 80 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Gout
Initial dose: 40 mg orally once a day
-If serum uric acid level is greater than 6 mg/dL after 2 weeks, increase the dose to 80 mg orally once a day
Maintenance dose: 40 to 80 mg orally once a day
Maximum dose: 80 mg/day
-Use of this drug should occur after an acute gout flare subsides.
-Gout flares may occur due to increased urate mobilization from tissue deposits, especially during initiation; gout flare prophylaxis with a NSAID or colchicine is recommended and may be beneficial for up to 6 months.
-Uric acid levels may be checked as soon as 2 weeks after beginning this drug.
Use: For the chronic management of hyperuricemia in patients with gout who have an inadequate experience to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.
Renal Dose Adjustments
Mild to Moderate Renal Dysfunction: No adjustment recommended
Severe Renal Dysfunction (CrCl 15 to less than 30 mL/min): Maximum daily dose should be limited to 40 mg/day
ESRD (CrCl less than 15 mL/min): Data not available
Liver Dose Adjustments
Mild to Moderate Liver Dysfunction (Child-Pugh Class A and B): No adjustment recommended
Severe Liver Dysfunction (Child-Pugh Class C): Use with caution
-For patients who develop ALT levels greater than 3 times the upper limit of normal (3 x ULN): Interrupt treatment; do not restart without another explanation for ALT abnormalities.
-For patients who develop ALT levels greater than 3 x ULN AND bilirubin greater than 2 x ULN: Therapy should be discontinued and not restarted in patients without alternative etiologies.
-For patients with lesser ALT or bilirubin elevations AND with an alternate probable cause: Use with caution.
Therapeutic target is to decrease and maintain serum uric acid levels below 6 mg/dL
Concomitant use with mercaptopurine/azathioprine is contraindicated
WARNING: CARDIOVASCULAR DEATH
-Gout patients with established cardiovascular (CV) disease treated with this drug had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study.
-Consider the risks and benefits when deciding to prescribe or continue patients on this drug; therapy should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.
-Concomitant use of azathioprine or mercaptopurine
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-May be taken with or without food
-This drug may be taken without regard to antacid use
-Protect from light
-This drug is not recommended for use in patients for whom the rate of urate formation is greatly increased (e.g., malignant disease and its treatment, Lesch-Nyhan syndrome); in rare cases, the concentration of xanthine in urine could rise and deposit in the urinary tract.
-This drug should not be used to treat asymptomatic hyperuricemia.
-This drug should not be started until an acute gout flare has subsided; if gout flares occur during treatment, manage concurrently; discontinuation of this drug should not be necessary.
-Obtain liver function tests at baseline and periodically thereafter; liver tests should be conducted in patients reporting signs/symptoms of liver injury (e.g., fatigue, anemia, upper right abdominal discomfort, dark urine, jaundice).
-Monitor for signs and symptoms of myocardial infarction and stroke
-Serum uric acid may be measured as soon as 2 weeks after starting this drug
-Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
-Patients should be informed that a higher risk of cardiovascular death with this drug compared to allopurinol has been observed; they should be alert for the development of signs and symptoms of cardiovascular events and instructed on steps to take if they occur.
-Patients should speak with a healthcare provider before starting any new medications, including over the counter medications.
-Patients should be instructed to report skin or hypersensitivity reactions including rash, blistering, chest pain, shortness of breath, or neurological symptoms suggesting a stroke.
-Instruct patients to report signs/symptoms of liver injury to the health care provider.
-Inform patients that gout flares may occur, and they should not stop taking this drug if a gout flare occurs.
-Patients should be advised to speak to their healthcare provider if they are pregnant, intend to become pregnant, or are breastfeeding.
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