Febustat 40 - Tablet Febuxostat - 40mg 10 Tablet(s) / Strip Incepta Pharmaceuticals Ltd. Introduction: Febustat 40 is a medicine used to treat and prevent gout. Gout happens when there is too much uric acid in your body and it forms into crystals which can appear around your joints leading to painful and swollen joints. This medicine helps to keep uric acid levels low. Febustat 40 can be taken with or without food. You should keep taking it as recommended by your doctor even when you are not having a gout attack. If you stop, your symptoms may get worse because of the formation of more crystals in your joints. You can help yourself by... Uses of Febustat 40: Gout Side effects of Febustat 40: DiarrheaHeadacheIncreased liver enzymesNauseaSkin rashGout flares How to use Febustat 40: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Febustat 40 may be taken with or without food, but it is better to take it at a fixed time. How Febustat 40 works: Febustat 40 is a xanthine oxidase inhibitor. It works by decreasing blood uric acid, which is the chemical that causes gout. What if you forget to take Febustat 40?: If you miss a dose of Febustat 40, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose. Indication: Gout, Hyperuricemia Administration: May be taken with or without food. May be taken w/o regard to antacid use. Adult Dose: Chronic Gout 40 mg/day PO initially; maintenance: 40-80 mg/day; increased if serum uric acid is >6 mg/mL after 2 weeks Hepatic impairment Mild to moderate (Child-Pugh class A or B): Dosage adjustment not necessary Severe (Child-Pugh class C): Data not available; use with caution Child Dose: Safety and efficacy not established Renal Dose: Renal impairment Mild to moderate (CrCl 30-89 mL/min): Dosage adjustment not necessary Severe (CrCl <30 mL/min): Data not available; use with caution Contraindication: Patients being treated with azathioprine, mercaptopurine, or theophylline. Mode of Action: Febuxostat selectively inhibits xanthine oxidase, the enzyme that catalyses the conversion of hypoxanthine to xanthine to uric acid, thereby decreasing serum concentrations of uric acid. Precaution: Cardiovascular death Patients with established cardiovascular (CV) disease treated with febuxostat had a higher rate of CV death compared with those treated with allopurinol in a CV outcomes study. Evaluate risks and benefits when prescribing febuxostat or continuing treatment. Gout Flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Febustat. If a gout flare occurs during treatment, Febustat need not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months. Lactation: Unknown whether drug is excreted into breast milk; use with... Side Effect: >1% Arthralgia,Elevated liver function test (LFT) results,Liver function abnormalities,Nausea,Rash Pregnancy Category Note: Pregnancy Limited available data in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes Animal data No adverse developmental effects observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (MRHD) No adverse developmental effects observed in a pre- and postnatal development study with administration of febuxostat to pregnant rats from organogenesis through lactation at an exposure ~11 times the MRHD Lactation There are no data on... Interaction: May increase plasma conc of mercaptopurine, azathioprine. Alteration of metabolism of xanthine oxidase substrate drugs (eg theophylline).