Febustad 40 (3 blisters x 10 tablets/box)

Indications

• Indicated for the chronic management of hyperuricemia in patients with gout.
• Febuxostat is not recommended for the treatment of asymptomatic hyperuricemia.

Contraindications

• Know hypersensitive to any ingredient in the formulation.
• Concomitant therapy with azathioprine, mercaptopurine, or theophylline.

Compositon/Ingredients

Dosage and administration

• The recommended initial dosage of febuxostat for the management of hyperuricemia in patients with gout is 40 mg once daily.
  The dosage of febuxostat may be increased to 80 mg once daily in patients who do not achieve serum urate concentrations of less than 6 mg/dL following 2 weeks of therapy with febuxostat 40 mg once daily.
• Dosage adjustment is not needed in patients with mild to moderate renal impairment or hepatic impairment.
• Pediatric: Safety and efficacy of febuxostat have not been established in pediatric patients younger than 18 years of age.
• Geriatric: Dosage adjustment based on age is not needed.

Precaution

• Gout flare: An increase in gout flare 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 (i.e., nonsteroidal anti-inflammatory drug (NSAID) or colchicine upon initiation of treatment) may be beneficial for up to six months.
• Cardiovascular events: Treatment with febuxostat in patients with ischaemic heart disease or congestive heart failure is not recommended. A higher rate of cardiovascular thromboembolic events was observed in patients treated with febuxostat than allopurinol in clinical trials. Monitor for signs and symptoms myocardial infarction (MI) and stroke.
• Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. If liver injury is detected, promptly interrupt febuxostat and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart febuxostat if liver injury is confirmed and no alternate etiology can be found.
• Medicinal product allergy/hypersensitivity: Patients should be advised of the signs and symptoms and monitored closely for symptoms of allergic/hypersensitivity reactions. Febuxostat treatment should be immediately stopped if serious allergic/hypersensitivity reactions, including Stevens-Johnson syndrome. If patient has developed allergic/hypersensitivity reactions including Stevens-Johnson syndrome and acute anaphylactic reaction/shock, febuxostat must not be restarted in this patient any time.
• Thyroid disorders: Increased TSH values (> 5.5 μIU/ml) were observed in patients on long-term treatment with febuxostat (5.5%). Caution is required when febuxostat is used in patients with alteration of thyroid function.
• Febustad 80 contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Febuxostat should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when febuxostat is administered to a nursing woman.
• Efficacy and safety of the drug have not been established in children under 18 years of age.
• Patients should be aware of how they react to drug before driving or operating machinery.

Storage

Store at temperature below 30°C, protect from light.