FEBO-G Tablet

For the chronic management of hyperuricemia in patients with gout.

Dosage and administration

For treatment of hyperuricemia in patients with gout.

40-80mg once daily.

The recommended starting dose is 40mg once daily. For patients who do not achieve a serum uric acid less than 6mg/dL after 2 weeks with 40mg, Febo-G 80mg is recommended.

Febo-G can be taken without regard to food or antacid use.

See the package insert about the details below:

- Renal insufficiency

- Hepatic insufficiency

- Hypersensitivity to the active substance or to any of the excipients.

- Being treated with azathioprine, mercaptopurine, or theophylline.

- Asymptomatic hyperuricemia.

Common

Headache, Diarrhea, Nausea, Rash, LFT Abnormalities.

Uncommon

Blood amylase increase, platelet count decrease, blood creatinine increase, hemoglobin decrease, blood urea increase, LDH increase, triglycerides increase, dizziness, paraesthesia, somnolence, altered taste, abdominal pain, gastro-oesophageal reflux disease, vomiting, dry mouth, dyspepsia, constipation, frequent stools, flatulence, gastrointestinal discomfort, nephrolithiasis, hematuria, pollakisuria, dermatitis, urticaria, pruritus, arthralgia, arthritis, myalgia, muscle cramp, musculoskeletal pain, weight increase, increased appetite, hypertension, flushing, hot flush, fatigue, edema, influenza like symptoms, libido decreased.

Rare

Palpitations, renal insufficiency, asthenia, thirst, nervousness, insomnia.

See the package insert about the details below:

- Naproxen and other inhibitors of glucuronidation

- Inducers of glucuronidation

Should not be usd.

- Treatment with febuxostat in patients with ischemic heart disease or congestive heart failure is not recommended.

- After initiation of febuxostat, an increase in gout flares is frequently observed. This increase is due to reduction in serum uric acid levels resulting in mobilization of urate from tissue deposits. In order to prevent gout flares when febuxostat is initiated, concurrent prophylactic treatment with an NSAID or colchicine is recommended.

- As with other urate lowering medicinal products, in patients in whom the rate of urate formation is greatly increased (e.g. malignant disease and its treatment, Lesch-Nyhan syndrome) the absolute concentration of xanthine in urine could, in the urinary tract. As there has been no experience with febuxostat, its use in these populations is not recommended.

- Laboratory assessment of liver function is recommended at, for example 2-4 months following initiation of febuxostat and periodically thereafter.

Febuxostat is a potent, non-purine, selective inhibitor of xanthine oxidase that achieves its therapeutic effect of decreasing serum uric acid by selectively inhibiting xanthine oxidase. Uric acid is the end product of purine metabolism and is generated in the cascade of hypoxanthine→xanthine→furic acid. Both steps in the transformation are catalyzed by xanthine oxidase. At therapeutic concentrations febuxostat does not inhibit other enzymes involved in purine or pyrimidine metabolism, namely, guanine deaminase, hypoxanthine guanine phosphoribosyltransferase, orotate phosphoribosyltransferase, orotidine monophosphate phosphoribosyltransferase, orotidine monophosphate decarboxylase or purine nucleoside phosphorylase.