Febuxostat (Febulas 40): A green color diamond shape film-coated tablet.
Febuxostat (Febulas 80): An orange color diamond shape film-coated tablet.
Each film-coated tablet contains Febuxostat INN 40 mg or 80 mg, Green Lake Color Ph. Gr. 0.05 mg.
Febuxostat (Febulas) is a FDA approved xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. Febuxostat (Febulas) is not recommended for the treatment of asymptomatic hyperuricemia.
Febuxostat (Febulas) is recommended at 40 mg or 80 mg once daily. The recommended starting dose of Febuxostat (Febulas) is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after 2 weeks with 40 mg, Febulas 80 mg is recommended.
Febuxostat (Febulas) can be administered without regard to food or antacid use.
Limit the dose of Febulas to 40 mg once daily in patients with severe renal impairment.
Febuxostat (Febulas) was studied in healthy patients in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities.
Febuxostat (Febulas) is contraindicated in patients being treated with azathioprine or mercaptopurine.
Gout Flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Febuxostat (Febulas). If a gout flare occurs during treatment, Febuxostat (Febulas) 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: Monitor for signs and symptoms of MI and stroke and discuss with physician.
Use in Children: Safety and effectiveness of Febuxostat (Febulas) in pediatric patients have not been established.
Limited available data with Febuxostat (Febulas) use in pregnant women are insufficient to informed drug associated risk of adverse developmental outcomes.
There are no data on the presence of febuxostat in human milk.
The most common side effects of Febuxostat (Febulas) include: liver problems, nausea, gout flares, joint pain, rash.
Concomitant administration of Febuxostat (Febulas) with XO substrate drugs, azathioprine or mercaptopurine could increase plasma concentrations of these drugs resulting in severe toxicity.
Store at a temperatures not exceeding 30°C.
M04AA03 - febuxostat ; Belongs to the class of preparations inhibiting uric acid production. Used in the treatment of gout.
Febulas 40 FC tab 40 mg
30's
Febulas 80 FC tab 80 mg
30's
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