Febustat

Febustat80 mg

Tablet

Febuxostat

Incepta Pharmaceuticals Ltd.

Product Code : 6556
MRP 220.00
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Medicine overview

Indications of Febustat 80 mg

Febustat 80 mg is indicated for the chronic management of hyperuricemia in patients with gout. Febustat 80 mg is not recommended for the treatment of asymptomatic hyperuricemia.

Theropeutic Class

Drugs used in Gout

Pharmacology

Febustat 80 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. Febustat 80 mg is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.

Dosage & Administration of Febustat 80 mg

Febustat 80 mg is recommended at 40 mg or 80 mg once daily. The recommended starting dose of Febustat 80 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, Febustat 80 mg 80 mg is recommended. Febustat 80 mg can be administered without regard to food or antacid use. No dose adjustment is necessary when administering Febustat 80 mg to patients with mild to moderate renal or hepatic impairment.

Dosage of Febustat 80 mg

Febustat 80 mg is recommended at 40 mg or 80 mg once daily. The recommended starting dose of Febustat 80 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, Febustat 80 mg 80 mg is recommended. Febustat 80 mg can be administered without regard to food or antacid use. No dose adjustment is necessary when administering Febustat 80 mg to patients with mild to moderate renal or hepatic impairment.

Interaction of Febustat 80 mg

Concomitant administration of Febustat 80 mg with azathioprine, mercaptopurine or theophylline could increase plasma concentrations of these drugs resulting in severe toxicity.

Contraindications

Febustat 80 mg is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.

Side Effects of Febustat 80 mg

The most common adverse events associated with the use of Febustat 80 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. Febustat 80 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 Febustat 80 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 Febustat 80 mg. If a gout flare occurs during treatment, Febustat 80 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 Febustat 80 mg than allopurinol in clinical trials. Monitor for signs and symptoms of MI and stroke.Liver Enzyme Elevation: Transaminase elevations have been observed in Febustat 80 mg -treated patients. Monitor liver function tests periodically.

Overdose Effects of Febustat 80 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

Febustat 80 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. Febustat 80 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. Febustat 80 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 Febustat 80 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
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.