Product Details

Drug Category: Anti gout

Presentation:

• APPOSTAT-40 Each film coated tablet contains: Febuxostat 40 mg Pack Size : 10 X 10 Tablet
• APPOSTAT-80 Each film coated tablet contains: Febuxostat 80 mg Pack Size : 10 X 10 Tablet

Mechanism of Action:

Febuxostat selectively inhibits xanthine oxidase, the enzyme that catalyses the conversion of hypoxanthine to xanthine to uric acid, thereby decreasing serum concentration of the uric acid.

Indication:

Febuxostat is indicated for the chronic management of hyperuricemia in patients with gout.

Dosage & Administration

Recommended at 40 mg or 80 mg once daily. The recommended starting dose 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, 80 mg is recommended.

Contraindication & Precaution

• Febuxostat is contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.
• Gout Flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Febuxostat. If a gout flare occurs during treatment, Febuxostat need not be discontinued. Prophylactic therapy may be beneficial for up to six months.
• Cardiovascular Events: A higher rate of cardiovascular thromboembolic events was observed in patients treated with febuxostat than allopurinol in clinical trials. Liver Enzyme Elevation: Transaminase elevations have been observed in febuxostat -treated patients.

Side Effect:

The most common adverse events associated with the use of Febuxostat may include liver function abnormalities, nausea, arthralgia, & rash.

Drug Interaction:

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

Use in Pregnancy & Lactation

Pregnancy Category C: Febuxostat 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 Febuxostat is administered to a nursing woman.

Use in Children:

The safety & efficacy of Febuxostat in children (under 18 years of age) has not been established.

Source: Drug.com