Indications of Febus 40 mg
Febus 40 mg is indicated for the chronic management of hyperuricemia in patients with gout. Febus 40 mg is not recommended for the treatment of asymptomatic hyperuricemia.
Theropeutic Class
Drugs used in Gout
Pharmacology
Febus 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. Febus 40 mg is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.
Dosage & Administration of Febus 40 mg
Febus 40 mg is recommended at 40 mg or 80 mg once daily. The recommended starting dose of Febus 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, Febus 40 mg 80 mg is recommended. Febus 40 mg can be administered without regard to food or antacid use. No dose adjustment is necessary when administering Febus 40 mg to patients with mild to moderate renal or hepatic impairment.
Dosage of Febus 40 mg
Febus 40 mg is recommended at 40 mg or 80 mg once daily. The recommended starting dose of Febus 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, Febus 40 mg 80 mg is recommended. Febus 40 mg can be administered without regard to food or antacid use. No dose adjustment is necessary when administering Febus 40 mg to patients with mild to moderate renal or hepatic impairment.
Interaction of Febus 40 mg
Concomitant administration of Febus 40 mg with azathioprine, mercaptopurine or theophylline could increase plasma concentrations of these drugs resulting in severe toxicity.
Contraindications
Febus 40 mg is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.
Side Effects of Febus 40 mg
The most common adverse events associated with the use of Febus 40 mg may include liver function abnormalities, nausea, arthralgia, and rash.
Pregnancy & Lactation
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Febus 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 Febus 40 mg is administered to a nursing woman.
Precautions & Warnings
Gout Flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Febus 40 mg. If a gout flare occurs during treatment, Febus 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 Febus 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 Febus 40 mg -treated patients. Monitor liver function tests periodically.
Overdose Effects of Febus 40 mg
Febustat was studied in healthy subjects in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities.
Storage Conditions
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Use In Special Populations
Pediatric Use: Safety and effectiveness in pediatric patients under 18 years of age have not been established
Drug Classes
Drugs used in Gout
Mode Of Action
Febus 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. Febus 40 mg is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.
Pregnancy
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Febus 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 Febus 40 mg is administered to a nursing woman.
Pediatric Uses
Pediatric Use: Safety and effectiveness in pediatric patients under 18 years of age have not been established