RiteMED Febuxostat

Chronic hyperuricemia in conditions where urate deposition has already occurred (including history, or presence of, tophus &/or gouty arthritis).

Adult 40 mg once daily, depending on baseline serum uric acid (sUA) levels (40 mg if sUA >8 mg/dL; 20 mg if sUA <7.5 mg/dL). Dose may be increased to 120 mg once daily if sUA >6 mg/dL (357 micromol/L) after 2-4 wk. Gout flare prophylaxis of at least 6 mth is recommended. Patient w/ mild hepatic impairment 80 mg.

May be taken with or without food.

Hypersensitivity. Pregnancy & lactation.

Not recommended for treatment in patients w/ ischaemic heart disease or CHF. Do not start treatment until acute attack of gout has completely subsided. Gout flare that occurs during treatment should be managed concurrently as appropriate for individual patient. Not recommended in patients in whom rate of urate formation is greatly increased (eg, malignant disease & its treatment, Lesch-Nyhan syndrome). Caution in patients w/ alteration of thyroid function. Concomitant use w/ mercaptopurine/azathioprine is not recommended. Caution in patients concomitantly treated w/ theophylline; monitor theophylline levels in patients starting therapy. Efficacy & safety have not been fully evaluated in patients w/ severe renal impairment (CrCl <30 mL/min). Limited information is available in patients w/ moderate hepatic impairment. Efficacy & safety have not been studied in patients w/ severe hepatic impairment (Child Pugh class C). LFT is recommended prior to initiation of therapy & periodically thereafter. Not recommended in childn <18 yr.

Liver function abnormalities, diarrhea, headache, nausea, rash.

Inhibition of xanthine oxidase may result in an increase in levels of mercaptopurine or azathioprine; theophylline. Elimination could be affected by medicinal products that inhibit glucuronidation (eg, NSAIDs & probenecid). Increased exposure (C_max, AUC & t_1/2) w/ naproxen. Increased metabolism & decreased efficacy w/ potent inducers of UGT enzymes. Monitor anticoagulant activity in patients receiving warfarin or similar agents after initiation of febuxostat. Mean increase in AUC of desipramine (CYP2D6 substrate). Delayed absorption & decreased C_max w/ antacid containing Mg & Al hydroxide.

Hyperuricemia & Gout Preparations

M04AA03 - febuxostat ; Belongs to the class of preparations inhibiting uric acid production. Used in the treatment of gout.

Rx