FIBURIK 120mg Tablets/Film-coated

What is FIBURIK 120mg

FIBURIK 120 mg is a prescription medication containing 120 mg of febuxostat as the active ingredient. It is available in the form of film-coated tablets and is supplied in packs of 30 tablets (10 tablets per blister, 3 blisters per pack). Febuxostat is primarily used to manage hyperuricemia associated with gout, particularly in patients who are intolerant to or have not responded adequately to allopurinol.

Indications:

• Chronic management of hyperuricemia in gout patients
• Prevention of gout flares during urate-lowering therapy
• Management of elevated serum uric acid levels in patients with gout

How to use FIBURIK 120mg

Administration: FIBURIK 120 mg tablets should be taken orally once daily. The tablets can be ingested with or without food and should be swallowed whole with a sufficient amount of water. It is important to follow the dosing regimen prescribed by your healthcare provider.

Starting Dose: The typical starting dose is 40 mg once daily. If serum uric acid levels remain above the target after two weeks, the dose may be increased to 80 mg once daily. In some cases, a dose of 120 mg once daily may be prescribed, depending on individual patient needs and response.

Prophylactic Treatment: To minimize the risk of gout flares during the initiation of therapy, concomitant treatment with colchicine or a nonsteroidal anti-inflammatory drug (NSAID) is recommended for the first 6 months of therapy.

Mode of Action FIBURIK 120mg

Mechanism: Febuxostat is a selective inhibitor of xanthine oxidase, an enzyme responsible for the conversion of hypoxanthine to xanthine and xanthine to uric acid. By inhibiting xanthine oxidase, febuxostat decreases the production of uric acid in the body, thereby lowering serum uric acid levels and reducing the risk of gout attacks.

Pharmacodynamics: Febuxostat has a high affinity for both the oxidized and reduced forms of xanthine oxidase, leading to potent and sustained inhibition of uric acid production. This results in a significant reduction in serum uric acid levels, which is beneficial in the management of gout.

FIBURIK 120mg Interactions FIBURIK 120mg

Contraindicated Drugs:

• Mercaptopurine and Azathioprine: Febuxostat inhibits the metabolism of these drugs, leading to increased plasma concentrations and potential toxicity. Concurrent use is contraindicated.
• Theophylline: Febuxostat may decrease the clearance of theophylline, increasing its plasma concentration and risk of adverse effects. Monitor for signs of theophylline toxicity if coadministration is necessary.

Other Considerations:

• Febuxostat does not require dose adjustment for patients with mild to moderate renal impairment. However, caution is advised in patients with severe renal impairment.
• Concurrent use with other urate-lowering therapies should be done under medical supervision to avoid potential interactions and adverse effects.

Dosage of FIBURIK 120mg

Initial Dose: The recommended starting dose is 40 mg once daily. If serum uric acid levels remain above the target after two weeks, the dose may be increased to 80 mg once daily.

Maintenance Dose: Depending on the patient's response and serum uric acid levels, the dose may be further increased to 120 mg once daily. The maximum recommended dose is 120 mg per day.

Administration: FIBURIK 120 mg tablets should be taken orally once daily, with or without food. The tablets should be swallowed whole with a sufficient amount of water.

Possible side effects of FIBURIK 120mg

Common Side Effects:

• Headache
• Diarrhea
• Nausea
• Rash
• Elevated liver enzymes

Serious Side Effects:

• Severe allergic reactions (e.g., anaphylaxis)
• Severe liver problems (e.g., hepatitis, jaundice)
• Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Cardiovascular events (e.g., heart attack, stroke)

Management: If any of these serious side effects occur, discontinue use of FIBURIK 120 mg and seek immediate medical attention. Regular monitoring of liver function tests is recommended during treatment.

FIBURIK 120mg Contraindications FIBURIK 120mg

Absolute Contraindications:

• Hypersensitivity to febuxostat or any component of the formulation
• Concurrent use with mercaptopurine or azathioprine
• Severe hepatic impairment
• Pregnancy and breastfeeding (unless clearly needed and the potential benefits outweigh the risks)

Relative Contraindications:

• History of cardiovascular disease
• Renal impairment (use with caution and under medical supervision)
• Concurrent use with other urate-lowering therapies (e.g., allopurinol, probenecid)

Storage of FIBURIK 120mg

Storage Conditions:

• Store at room temperature between 15°C and 30°C (59°F and 86°F)
• Keep the tablets in their original blister packaging