FEXOTA-40

Composition:Each tablet contains: Febuxostat IP 40 mg Excipients q.s.

DRUGORTHO
CompositionComposition:Each tablet contains: Febuxostat IP 40 mg Excipients q.s.
PackingALU ALU - 10*10 Tablets (ALU-ALU Packing)
MRP₹94

Product Overview

FEXOTA-40 is a modern, non-purine selective xanthine oxidase inhibitor containing 40mg of Febuxostat, designed for effective management of chronic hyperuricemia in gout. It offers clear clinical advantages over older therapies, providing dependable uric acid control without requiring routine dose adjustments for mild-to-moderate renal impairment. It stands as a premium, high-intent product for orthopaedic and internal medicine portfolios.

Indications

FEXOTA-40 is indicated for:

  • Chronic Hyperuricemia: Long-term management of elevated blood uric acid levels in adult patients diagnosed with symptomatic gout.
  • Gout Flare Prevention: Lowering systemic urate burden to reduce the frequency and severity of painful joint inflammation.
  • Allopurinol Intolerance: Serving as an effective, first-line alternative for patients who show poor clinical response or hypersensitivity to allopurinol.

Dosage & Administration

Adults: The recommended initial dose is 1 tablet (40 mg) taken once daily, with or without food. If serum uric acid levels remain above 6 mg/dL after 2 to 4 weeks of continuous therapy, the dose may be escalated to 80 mg once daily under medical supervision.

Adverse Effects

Commonly reported clinical side effects include:

  • Acute gout flares (frequently observed during early phases of therapy as urate stores shift)
  • Liver function test abnormalities (elevated transaminases)
  • Nausea or localized diarrhea
  • Arthralgia (joint discomfort) and mild skin rashes
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Contraindications

Contraindicated in patients with known hypersensitivity to febuxostat or any formulation excipients. Do not use in patients undergoing concurrent treatment with purine analogues such as azathioprine or mercaptopurine.

Warnings & Precautions

Not recommended for asymptomatic hyperuricemia. Monitor for signs of cardiovascular events and track hepatic enzyme levels before and periodically during therapy. Concurrent prophylactic therapy with an NSAID or colchicine is highly recommended when initiating treatment to manage acute gout flares.

Drug Interactions

Inhibition of xanthine oxidase by febuxostat can significantly increase the plasma concentrations of azathioprine, mercaptopurine, and theophylline, potentially leading to severe hematological toxicities.

Storage Instructions

Store below 30°C in a dry place. Keep the container tightly sealed and protected from light.

FEXOTA-40
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