Astellas Pharma


Zuellig Pharma
Concise Prescribing Info
Chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus &/or gouty arthritis). Prevention & treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of tumor lysis syndrome (TLS).
Dosage/Direction for Use
Gout 80 mg once daily. If serum uric acid is >6 mg/dL (357 micromol/L) after 2-4 wk, may be increased to 120 mg once daily. Mild hepatic impairment 80 mg. Tumor lysis syndrome 120 mg once daily. Start 2 days before initiation of cytotoxic therapy & continue for a min of 7 days. May be prolonged up to 9 days according to chemotherapy duration.
May be taken with or without food.
Special Precautions
Discontinue use if allergic/hypersensitivity reactions occurs. Severe renal & hepatic impairment. Ischaemic heart disease & CHF; exacerbation &/or onset of CV disease. Cardiac monitoring in patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of tumor lysis syndrome. Do not start treatment until acute attack of gout has completely subsided. Flare prophylaxis for at least 6 mth w/ an NSAID or colchicine at treatment initiation is recommended. Patients w/ Lesch-Nyhan syndrome & alteration of thyroid function. Concomitant use w/ mercaptopurine/azathioprine. Organ transplant recipients. Perform liver function test prior to treatment, & periodically thereafter. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Caution before driving, using machinery or participating in dangerous activities. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Gout flares; headache; diarrhoea, nausea; liver function abnormalities; rash; oedema.
Drug Interactions
Increased plasma conc of mercaptopurine/azathioprine. Increased metabolism & decreased efficacy w/ potent inducers of UGT enzymes. Delayed absorption & decrease in Cmax w/ antacids.
ATC Classification
M04AA03 - febuxostat ; Belongs to the class of preparations inhibiting uric acid production. Used in the treatment of gout.
Feburic FC tab 80 mg
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