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Febuxostat Dosage

Applies to the following strength(s): 80 mg ; 40 mg

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

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

Comments:
-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 non-steroidal anti-inflammatory 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: Chronic management of symptomatic hyperuricemia in patients with gout.

Renal Dose Adjustments

Mild and Moderate Renal Impairment (CrCl 30 to 89 mL/min) No adjustment recommended.
Severe Renal Impairment (CrCl less than 30 mL/min): Use with caution.
End-Stage Renal Impairment on Dialysis: Data not available

Liver Dose Adjustments

Mild to Moderate Liver Impairment (Child-Pugh Class A and B): No adjustment recommended.
Severe Liver Impairment (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 both ALT levels greater than 3 x ULN and bilirubin greater than 2 x ULN: Therapy should be discontinued.

Dose Adjustments

Gout:
-Therapeutic target is to decrease and maintain serum uric acid levels below 6 mg/dL.
-If a patient does not achieve a serum uric acid level of less than 6 mg/dL after 2 to 4 weeks, a dose increase is warranted.
-Maximum dose: 80 mg/day

Concomitant use with mercaptopurine/azathioprine is contraindicated.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

End-Stage Renal Impairment on Dialysis: Data not available

Other Comments

Administration advice:
-May be taken with or without food.

Storage requirements:
-Protect from light.

General:
-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.

Monitoring:
-Liver test panels should be obtained 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).
-Serum uric acid may be measured as soon as 2 weeks after starting this drug.

Patient advice:
-Patients should speak with a healthcare provider before starting any new medications, including over the counter medications.
-Patients should be instructed to report signs/symptoms of hypersensitivity reactions (rash, chest pain, shortness of breath, neurological symptoms).
-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 healthcare provider if pregnant, intend to become pregnant, or are breastfeeding.

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