Feluric® 40 mg Tablet: Each film-coated tablet contains Febuxostat INN 40 mg.
Feluric® 80 mg Tablet: Each film-coated tablet contains Febuxostat INN 80 mg.
Feluric® is an FDA-approved, non-purine, selective inhibitor of xanthine oxidase, indicated for the chronic management of hyperuricemia in patients with gout. It is not recommended for the treatment of asymptomatic or secondary hyperuricemia and is not indicated for acute gout. Feluric® reduces serum uric acid levels by inhibiting xanthine oxidase, the enzyme responsible for uric acid production. Xanthine oxidase catalyzes the conversion of hypoxanthine (a naturally occurring purine derivative) to xanthine and then to uric acid.
Feluric® is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. It is not recommended for the treatment of asymptomatic hyperuricemia.
For the treatment of hyperuricemia in gout patients:
The recommended starting dose of Feluric® is 40 mg once daily.
If the serum uric acid (sUA) level does not drop below 6 mg/dL within 2 weeks at 40 mg, the dose may be increased to 80 mg once daily.
Feluric® can be taken with or without food or antacids.
No dosage adjustment is required for patients with mild to moderate renal or hepatic impairment.
The most common side effects of Feluric® include:
Liver problems
Nausea
Gout flares
Joint pain
Rash
Gout Flares: Gout flares are common when starting anti-hyperuricemic agents, including Feluric®. If a flare occurs during treatment, Feluric® should not be discontinued. Prophylactic therapy with a non-steroidal anti-inflammatory drug (NSAID) or colchicine for up to six months may help prevent flares.
Use with caution in patients with cardiac conditions or a history of stroke, as per physician’s advice.
Regular monitoring of liver function is recommended.
Feluric® is contraindicated in patients taking:
Azathioprine
Mercaptopurine
Theophylline
Pregnancy: Feluric® is classified as Pregnancy Category C. It should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus, as there are no adequate, well-controlled studies in pregnant women.
Lactation: It is unknown whether Feluric® is excreted in human milk. Caution is advised when administering to nursing women.
The safety and efficacy of Feluric® in children under 12 years of age have not been established.
Concurrent use of Feluric® with azathioprine, mercaptopurine, or theophylline can increase plasma concentrations of these drugs, potentially resulting in severe toxicity.
In studies, healthy subjects tolerated doses of Feluric® up to 300 mg daily for seven days without evidence of dose-limiting toxicities.
Feluric® 40 mg Tablet: Each box contains 30 tablets.
Feluric® 80 mg Tablet: Each box contains 20 tablets.
Store Feluric® in a cool, dry place below 30°C. Protect from light.
Medicine: Keep out of reach of children.
