Febuxostat and Diacerein tablet is indicated in reducing acute gout flares, inflammation, and in reducing clinical symptoms in patients with refractory gout. Febuxostat and Diacerein tablet is indicated in adults.
Adults (aged over 18 years): The recommended oral dose of Febuxostat is 80 mg once or twice daily. If serum uric acid is > 6 mg/dL (357 μmol/L) after 2-4 weeks, Febuxostat 120 mg daily may be considered. Febuxostat works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. As some patients may experience loose stools or diarrhea, the recommended starting dose of Diacerein is 50 mg once daily with evening meal for the first 2 to 4 weeks of treatment, after which the recommended daily dose is 50 mg twice daily. The treatment should be taken with food, one tablet with breakfast and the other tablet with evening meal. Elderly and Renal impairment: In the elderly, and in moderate renal impairment, there is no need to change the dosage. In patients older than 65 years, caution should be exercised during use of this medicine; close supervision and monitoring of adverse reactions should be performed. In severe renal insufficiency (creatinine clearance below 30 ml/min), the daily dosage are to be halved. Paediatric population: This product is not recommended to be used in children below the age of 18 years.
Febuxostat: The most commonly reported adverse reactions in clinical trials (dose from 10 mg to 300 mg) 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. Diacerein: The most commonly reported adverse reactions are diarrhea, abdominal pain, frequent bowel movements, flatulence, pruritus, rash and eczema. As a rule, these effects abate with continuing treatment. In some cases, diarrhea was severe with complications such as dehydration and disorders of fluid and electrolyte balance. Cases of acute liver injury, including elevated serum hepatic enzymes and cases of hepatitis have been reported with diacerein. Most of them occurred during the first months of treatment. Patients should be monitored for signs and symptoms of hepatic injury.
Febuxostat: Cardio-vascular disorders: Treatment of chronic hyperuricaemia Treatment with febuxostat 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. Acute gouty attacks (gout flare): Febuxostat 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 flare prophylaxis for at least 6 months with an NSAID or colchicine is recommended. If a gout flare occurs during febuxostat treatment, it should not be discontinued. The gout flare should be managed concurrently as appropriate for the individual patient. Continuous treatment with febuxostat 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 is not recommended. Mercaptopurine/azathioprine: Febuxostat 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 (5.0 %). Liver function test is recommended prior to the initiation of therapy with febuxostat 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 is used in patients with alteration of thyroid function. Diacerein: Diarrhea: Intake of diacerein frequently leads to diarrhea (see chapter 4.8) that can consequently lead to dehydration and hypokalemia. In patients receiving diuretics, caution should be exercised because dehydration and hypokalemia may occur. Particular caution should also be exercised in case of hypokalemia in patients treated with cardiac glycosides (digitoxin, digoxin). Concomitant intake of laxatives should be avoided. Hepatotoxicity: Elevated serum hepatic enzyme levels and symptomatic acute hepatic injury have been reported with diacerein in the post-marketing phase. Before treatment with diacerein is initiated, the doctor should question the patient about any possible comorbidities, and past or current liver disease and screen for major causes of active hepatic disease. A diagnosis of liver disease is a contraindication to diacerein use. Patients should be advised to limit their alcohol intake while on treatment with diacerein.
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
3 x 10 Alu/PVC blister pack Febuxostat and Diacerein tablet (GOTA-D 80/100) is available in an Alu/PVC blister of 10 tablets. Such 03 blisters in a unit carton with package insert.