Generic Name

Composition

Therapeutic Category

Division

Febuxostat

Febuxostat 40 mg Tablet

Febuxostat 80 mg Tablet

Anti-gout

NEXUS

    Pharmacodynamic 

    Febuxostat is a xanthine oxidase inhibitor which selectively inhibits xanthine oxidase, the enzyme responsible for the conversion of hypoxanthine to xanthine to uric acid thereby decreasing uric acid. At therapeutic concentration does not inhibit other enzymes involved in purine and pyrimidine synthesis.

     

    Pharmacokinetics

    • Absorption: ≥ 49 %
    • Distribution: Protein Binding: 99.2 % (primarily to albumin)
    • Metabolism: Extensively metabolized by conjugation via uridine diphosphate glucuronosyltransferase (UDPGT) enzyme system and oxidation via cytochrome P450 (CYP) system.
    • Elimination: Eliminated by both hepatic and renal pathways

    Indication

    For the chronic management of hyperuricemia in patients with gout.

    Dose

    For Chronic Gout

    Initial Dose: 40 mg OD

     Increased to 80 mg OD after 2 weeks if serum uric acid 

    Gout flare prophylaxis of at least 6 months is recommended.

    Patient Group

    Dose Consideration

    • Elderly

    No dose adjustment required

    • Renal impairment

    No dose adjustment is necessary in patients with mild or moderate renal impairment.

     

    • Hepatic impairment

    Mild hepatic impairment: 80 mg.

    Moderate hepatic impairment: limited information available

     

    • Pediatric population

    Safety and efficacy in children aged below the age of 18 years have not been established.

     

     Side Effects

    Nausea, Arthralgia, Rash & Liver function abnormalities

     Pregnancy Category : C

     Contraindications

    Contraindicated in patient being treated with azathioprine or mercaptopurine

     Warning & Precautions:

    • History of Major Cardiovascular Disease A higher rate of cardiovascular thromboembolic events was observed in patients treated with febuxostat who has history of major cardiovascular disease. Monitor for signs and symptoms of MI and stroke
    • Gout flares Increase in gout flares can be observed frequently during the initiation of febuxostat. In order to prevent this concurrent prophylactic treatment with an NSAID or colchicine is recommended
    • Hepatic Effects Liver enzymes can be elevated significantly. Measure liver tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice

    Storage

    Store below 25◦C

    Missed Dose

    • Take the missed dose as soon as you remember.
    • Skip the missed dose if it is almost time for your next scheduled dose.
    • Do not take extra medicine to make up the missed dose.

     Presentation:

    • Febumin 40 Each box contains: 10 strips X 10 Tabs. ALU-ALU Packing
    • Febumin 80 Each box contains: 10 strips X 10 Tabs. ALU-ALU Packing