Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).
ADENURIC is indicated in adults.
The recommended oral dose of ADENURIC is 80 mg once daily without regard to food. If serum uric acid is >6 mg/dL (357 μmol/L) after 2-4 weeks, ADENURIC 120 mg once daily may be considered.
ADENURIC works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 μmol/L).
Gout flare prophylaxis of at least 6 months is recommended (see section 4.4).
No dose adjustment is required in the elderly (see section 5.2).
The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance <30 mL/min, see section 5.2). No dose adjustment is necessary in patients with mild or moderate renal impairment.
The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C).
The recommended dose in patients with mild hepatic impairment is 80 mg. Limited information is available in patients with moderate hepatic impairment.
The safety and the efficacy of ADENURIC in children aged below the age of 18 years have not been established. No data are available.
Oral use.
ADENURIC should be taken by mouth and can be taken with or without food.
Patients with an overdose should be managed by symptomatic and supportive care.
3 years.
This medicinal product does not require any special storage conditions.
Clear (Aclar/PVC/Aluminium or PVC/PE/PVDC/Aluminium) blister of 14 tablets.
ADENURIC 80 mg is available in pack sizes of 14, 28, 42, 56, 84 and 98 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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