Febus 40mg

Tablet
Febuxostat
ACI Pharmaceuticals

Other Strength:
- Febustat 40mg
- Febus 80mg

Alternative:
- Eburic 40mg
- Goustat 40mg
- Febustat 40mg
- Feluric 40mg
- Febux 40mg
- Feburen 40mg



Febus
Description
Febus®, a novel non-purine selective inhibitor of xanthine oxidase, isindicatedfor the management of hyperuricaemia in patients with gout.Febuxostatis advantageousover allopurinol in its potency in lowering uric acid level, eliminating the need to adjust dosing in patients with renal impairment, and solely inhibiting xanthine oxidase without interrupting other enzyme system.Febuxostatgreatlyexpands the treatment options for refractory or allopurinol-intolerant gout.

Indications and usage
Febuxostat is indicated for treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred.

Dosage and administration
Febuxostatis recommended at 40 mg or 80 mg once daily. The recommendedstarting dose ofFebuxostatis 40 mg once daily. For patients who do not achieve a serum uric acid (SUA) less than 6 mg per dL after 2 weeks with40 mg,Febuxostat80 mg is recommended.Febuxostatcan be administered without regardto food or antacid use.No dose adjustment is necessary when administeringFebuxostattopatientswith mild to moderate renal or hepatic impairment.

Use in pregnancy and lactation
Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women.Febuxostatshould be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.It is not known whetherFebuxostatdrug is excreted in human milk.Anima; studies have shown excretion of this substance in breast milk and impaired development of suckling pulp. A risk to suckling infant cannot be excluded.Febuxostatshould not be used while breast feeding.

Precautions
Gout Flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, includingFebuxostat. If a gout flare occurs during treatment,Febuxostatneed not be discontinued. Prophylactic therapy (i.e., non-steroidal anti-inflammatory drugs(NSAIDs) or colchicines upon initiation of treatment) may be beneficial for up to six months.Cardiovascular Events: A higher rate of cardiovascular thromboembolic events was observed in patients treated withFebuxostatthan allopurinol in randomized controlledtrials. A causal relationship withFebuxostathas not established.Monitor for signs and symptoms of MI and stroke.Liver Enzyme Elevation: Transaminase elevations have been observed inFebuxostat-treated patients. Liver function testsis recommended priorto initiation of therapy withFebuxostatandperiodically.

Side effects
Inrandomized controlled studies, adverse reactions occurring in at least 1% ofFebuxostat-treated patients, and,at least 0.5% greater than placebo. Common side effectsare liver function abnormalities, nausea, arthralgia, and rash.

Drug interactions
Febuxostat is aXanthine Oxidase (XO)inhibitor. Drug interaction studies ofFebuxostatwith drugs that are metabolized by XO (e.g.,theophylline, mercaptopurine, azathioprine) have not been conducted. Inhibition of XO byFebuxostatmaycause increased plasma concentrations of these drugs leading to toxicity.

Contraindications
Febuxostat is contraindicated to those patients who have known hypersensitivity to any component of the formulation. Febuxostatis contraindicated in patients being treated with azathioprine, mercaptopurine, or theophylline.

Overdose
Febuxostatwas studied in healthy subjects in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities. No overdose ofFebuxostatwas reported in clinical studies. Patients should be managed by symptomatic and supportive care should there be an overdose.

Pharmaceutical precautions
Store in a cool,dry place. Protect from light.

Presentation
Febus®40tablet: Each tablet contains Febuxostat INN 40mgFebus®80tablet: Each tablet contains Febuxostat INN 80mg

Package quantities
Febus®40 tablet: Cartoon of 30 tablets in blister pack.
Febus®80 tablet: Cartoon of 30 tablets in blister pack.

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