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Fostat 40 mgFostat 40 mg is indicated for the chronic management of hyperuricemia in patients with gout. Fostat 40 mg is not recommended for the treatment of asymptomatic hyperuricemia.Theropeutic ClassDrugs used in GoutPharmacologyFostat 40 mg is a non-purine, selective xanthine oxidase (XO) inhibitor. It decreases serum uric acid level by inhibiting xanthine oxidase, which is responsible for uric acid production. Xanthine oxidase breaks down hypoxanthine to xanthine and thus to uric acid. Fostat 40 mg is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.Dosage & Administration of Fostat 40 mgFostat 40 mg is recommended at 40 mg or 80 mg once daily. The recommended starting dose of Fostat 40 mg is 40 mg once daily. For patients who do not achieve a serum uric acid less than 6 mg /dL after 2 weeks with 40 mg, Fostat 40 mg 80 mg is recommended. Fostat 40 mg can be administered without regard to food or antacid use. No dose adjustment is necessary when administering Fostat 40 mg to patients with mild to moderate renal or hepatic impairment.Dosage of Fostat 40 mgFostat 40 mg is recommended at 40 mg or 80 mg once daily. The recommended starting dose of Fostat 40 mg is 40 mg once daily. For patients who do not achieve a serum uric acid less than 6 mg /dL after 2 weeks with 40 mg, Fostat 40 mg 80 mg is recommended. Fostat 40 mg can be administered without regard to food or antacid use. No dose adjustment is necessary when administering Fostat 40 mg to patients with mild to moderate renal or hepatic impairment.Interaction of Fostat 40 mgConcomitant administration of Fostat 40 mg with azathioprine, mercaptopurine or theophylline could increase plasma concentrations of these drugs resulting in severe toxicity.ContraindicationsFostat 40 mg is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.Side Effects of Fostat 40 mgThe most common adverse events associated with the use of Fostat 40 mg may include liver function abnormalities, nausea, arthralgia, and rash.Pregnancy & LactationPregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Fostat 40 mg should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Caution should be exercised when Fostat 40 mg is administered to a nursing woman.Precautions & WarningsGout Flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Fostat 40 mg. If a gout flare occurs during treatment, Fostat 40 mg 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.Cardiovascular Events: A higher rate of cardiovascular thromboembolic events was observed in patients treated with Fostat 40 mg than allopurinol in clinical trials. Monitor for signs and symptoms of MI and stroke.Liver Enzyme Elevation: Transaminase elevations have been observed in Fostat 40 mg -treated patients. Monitor liver function tests periodically.Overdose Effects of Fostat 40 mgFebustat was studied in healthy subjects in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities.Storage ConditionsKeep below 30?C temperature, away from light & moisture. Keep out of the reach of children.Use In Special PopulationsPediatric Use: Safety and effectiveness in pediatric patients under 18 years of age have not been establishedDrug ClassesDrugs used in GoutMode Of ActionFostat 40 mg is a non-purine, selective xanthine oxidase (XO) inhibitor. It decreases serum uric acid level by inhibiting xanthine oxidase, which is responsible for uric acid production. Xanthine oxidase breaks down hypoxanthine to xanthine and thus to uric acid. Fostat 40 mg is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.PregnancyPregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Fostat 40 mg should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Caution should be exercised when Fostat 40 mg is administered to a nursing woman.Pediatric UsesPediatric Use: Safety and effectiveness in pediatric patients under 18 years of age have not been established