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Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat Tablets 40 mg Tablets is indicated in adults.
Dosage
Gout: The recommended oral dose of Febuxostat is 40 mg once or twice daily without regard to food. If serum uric acid is > 6 mg/dL (357 μmol/L) after 2-4 weeks, Febuxostat 120 mg daily may be considered. Febuxostat Tablets 40 mg 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.
Elderly: No dose adjustment is required in the elderly
Renal impairment: The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance < 30 mL/min). No dose adjustment is necessary in patients with mild or moderate renal impairment.
Hepatic impairment: The efficacy and safety of Febuxostat Tablets 40 mg have 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.
Paediatric population: The safety and efficacy ofFebuxostat Tablets 40 mg Tablets in children aged below the age of 18 years have not been established. No data are available.
Directions for Use
For oral use only. Febuxostat Tablets 40 mgTablets should be taken by mouth and can be taken with or without food.
The most commonly reported adverse reactions in clinical trials (4,072 subjects treated at least with a dose from 10 mg to 300 mg) and post-marketing experience in gout patients are gout flares, liver function abnormalities, diarrhoea, nausea, headache, rash and oedema. These adverse reactions were mostly mild or moderate in severity. Rare serious hypersensitivity reactions to febuxostat, some of which were associated to systemic symptoms, have occurred in the post-marketing experience. Gout flares, Liver function abnormalities, Uncommon: Cholelithiasis, Rare: Hepatitis, jaundice, liver injury, Rash (including various types of rash reported with lower frequencies), Uncommon: Dermatitis, urticaria, pruritus, skin discolouration, skin lesion, petechiae, rash macular, rash maculopapular, rash popular, Rare: Toxic epidermal necrolysis, Stevens-Johnson Syndrome, angioedema, drug reaction with eosinophilia and systemic symptoms, generalized rash (serious), erythema, exfoliative rash, rash follicular, rash vesicular, rash pustular, rash pruritic, rash erythematous, rash morbillifom, alopecia, hyperhidrosis
Cardio-vascular disorders
Treatment of chronic hyperuricaemia
Treatment with Febuxostat Tablets 40 mg in patients with ischaemic heart disease or congestive heart failure is not recommended.
Medicinal product allergy / hypersensitivity
Rare serious allergic/hypersensitivity reactions, including life-threatening Stevens-Johnson Syndrome, Toxic epidermal necrolysis and acute anaphylactic reaction/shock, have been reported. Patients should be advised of the signs and symptoms and monitored closely for symptoms of allergic/hypersensitivity reactions. Febuxostat Tablets 40 mg treatment should be immediately stopped if serious allergic/hypersensitivity reactions, including Stevens-Johnson Syndrome, occur since early withdrawal is associated with a better prognosis and febuxostat must not be re-started in this patient at any time.
Acute gouty attacks (gout flare)
Febuxostat Tablets 40 mg treatment should not be started until an acute attack of gout has completely subsided. Gout flares may occur during initiation of treatment due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits. At treatment initiation with Febuxostat Tablets 40 mg flare prophylaxis for at least 6 months with an NSAID or colchicine is recommended. If a gout flare occurs during Febuxostat Tablets 40 mg treatment, it should not be discontinued. The gout flare should be managed concurrently as appropriate for the individual patient. Continuous treatment with Febuxostat Tablets 40 mg decreases frequency and intensity of gout flares.
Xanthine deposition
As there has been no experience with febuxostat, its use in patients with Lesch-Nyhan Syndrome isnot recommended.
Mercaptopurine/azathioprine
Febuxostat Tablets 40 mg use is not recommended in patients concomitantly treated with mercaptopurine/ azathioprine as inhibition of xanthine oxidase by febuxostat may cause increased plasma concentrations of mercaptopurine/azathioprine that could result in severe toxicity.
Liver disorders
During the combined phase 3 clinical studies, mild liver function test abnormalities were observed in patients treated with Febuxostat Tablets 40 mg (5.0 %). Liver function test is recommended prior to the initiation of therapy with Febuxostat Tablets 40 mg and periodically thereafter based on clinical judgment.
Thyroid disorders
Increased TSH values (> 5.5 μIU/mL) were observed in patients on long-term treatment with febuxostat (5.5 %) in the long term open label extension studies. Caution is required when Febuxostat Tablets 40 mg is used in patients with alteration of thyroid function.
Organ transplant recipients
As there has been no experience in organ transplant recipients, the use of Febuxostat Tablets 40 mg in such patients is not recommended.
Store below 30°C, protect from light.
Keep the medicine out of reach of children.
10 x 10 Alu/PVC blister pack
Febuconex-40 is available in an Alu/PVC blister of 10 tablets. Such 10 blisters in a unit carton with package insert.
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