Continuous treatment with febuxostat decreases frequency and intensity of gout flares.In patients in whom the rate of urate formation is greatly increased (e.g. Some, but not all of these patients reported renal impairment and/or previous hypersensitivity to allopurinol.
329958-overview
colcrys-mitigare-colchicine-342812
Mild to Moderate Renal Dysfunction: No adjustment recommendedMild to Moderate Liver Dysfunction (Child-Pugh Class A and B): No adjustment recommendedTherapeutic target is to decrease and maintain serum uric acid levels below 6 mg/dLAlways consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.
For renally impaired subjects who were randomized to allopurinol, the dose was capped at 100 mg QD.
Patients who had 3 consecutive sUA levels >6.0 mg/dL were withdrawn.Serum urate levels were maintained over time (i.e. A total of 1,086 patients were enrolled: Febuxostat 80 mg QD (n=649), febuxostat 120 mg QD (n=292) and allopurinol 300/100 mg QD (n=145). INR and Factor VII activity were also not affected by the co- administration of febuxostat.Febuxostat was shown to be a weak inhibitor of CYP2D6 Concomitant ingestion of an antacid containing magnesium hydroxide and aluminium hydroxide has been shown to delay absorption of febuxostat (approximately 1 hour) and to cause a 32% decrease in CData on a very limited number of exposed pregnancies have not indicated any adverse effects of febuxostat on pregnancy or on the health of the foetus/new born child. Febuxostat works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks.
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Flares increased following the prophylaxis period and gradually decreased over time. 62% of patients required no dose adjustment to maintain sUA <6 mg/dL and 38% of patients required a dose adjustment to achieve a final stable dose.The proportion of patients with serum urate levels of <6.0 mg/dL (357 µmol/L) at the final visit was greater than 80% (81-100%) at each febuxostat dose.During the phase 3 clinical studies, mild liver function test abnormalities were observed in patients treated with febuxostat (5.0%).
Gout flare prophylaxis is recommended (see section 4.2 and 4.4).Reporting suspected adverse reactions after authorisation of the medicinal product is important.
-Gout flares may occur due to increased urate mobilization from tissue deposits, especially during initiation; gout flare prophylaxis with a NSAID or colchicine is recommended an…
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development or parturition (see section 5.3). It belongs to the group of medications called xanthine oxidase inhibitors. No data are available.Febuxostat should be taken by mouth and can be taken with or without food.Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.8).Treatment with febuxostat in patients with ischaemic heart disease or congestive heart failure is not recommended.A numerical greater incidence of investigator-reported cardiovascular APTC events (defined endpoints from the Anti-Platelet Trialists' Collaboration (APTC) including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) was observed in the febuxostat total group compared to the allopurinol group in the APEX and FACT studies (1.3 vs. 0.3 events per 100 Patient Years (PYs)), but not in the CONFIRMS study (see section 5.1 for detailed characteristics of the studies).
In combination with docetaxel, the recommended dose of XELODA is 1250 mg/m2twice daily for 2 weeks followed by a 1-week rest period, combined with docetaxel at 75 mg/m2as a 1-hour intravenous infusion every 3 weeks. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.
Febuxostat treatment should be immediately stopped if serious allergic/hypersensitivity reactions, including Stevens-Johnson-Syndrome, occur since early withdrawal is associated with a better prognosis. 4.5 Interaction with other medicinal products and other forms of interaction6.6 Special precautions for disposal and other handling9. There was no significant increase in any other tumour type in either male or female mice or rats. Identified risk factors among these patients were a medical history of atherosclerotic disease and/or myocardial infarction, or of congestive heart failure.Rare reports of serious allergic/hypersensitivity reactions, including life-threatening Stevens-Johnson-Syndrome, Toxic epidermal necrolysis and acute anaphylactic reaction/shock, have been collected in the post-marketing experience.
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