Details

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• MAL Registration Number: MAL16075031ACRZ

• Manufacturer: Pantheon France

Content

• Active Ingredient: Febuxostat 80 mg (as febuxostat hemihydrate)

• Excipients: Each tablet contains 76.5 mg of lactose (as monohydrate) and 2.275 mg of sodium.

Indications

Feburic 80mg is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred, including:

• Presence or history of tophi

• Gouty arthritis

It is also used for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of tumor lysis syndrome (TLS).

Instructions for Use

• Dosage: The recommended oral dose is 80 mg once daily, regardless of food intake.

• Adjustment: If serum uric acid levels remain above 6 mg/dL (357 µmol/L) after 2–4 weeks, the dose may be increased to 120 mg once daily.

• Administration: Swallow the tablet whole with water; do not chew, crush, or break.

• Gout Flare Prophylaxis: Prophylactic treatment with colchicine or NSAIDs is recommended for at least 6 months during the initiation of febuxostat therapy to prevent gout flares.