Europe — EMA
Adenuric
Adenuric is a prescription febuxostat tablet used to lower uric acid and manage gout and hyperuricemia in the EU.
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What is Febuxostat?
Adenuric is a prescription medication that contains the active ingredient febuxostat, supplied as oral tablets. It belongs to the xanthine oxidase inhibitor class and is marketed in the European Union. The product is designed to lower uric acid levels in the body, helping to manage conditions related to elevated uric acid. As a non‑purine selective inhibitor, Adenuric targets the enzyme responsible for uric acid production.
What is Febuxostat used for?
Adenuric is indicated for the long‑term management of disorders associated with excess uric acid. It is commonly prescribed to reduce the risk of gout attacks and to maintain target serum urate concentrations.
- Treatment of chronic gout in adults. - Management of hyperuricemia associated with gout. - Prevention of gout flares during urate‑lowering therapy. - Adjunct therapy when allopurinol is not tolerated or ineffective. - Use in patients requiring a non‑purine xanthine oxidase inhibitor.
What are the side effects of Febuxostat?
Adverse reactions to Adenuric have been reported in clinical use and post‑marketing surveillance. They can be grouped by frequency and severity, and most are mild and reversible, while rare events may require medical attention. Patients are advised to report any new or worsening symptoms promptly, and clinicians may monitor liver function and renal parameters during therapy.
Common: - Headache - Nausea or vomiting - Diarrhea - Elevated liver enzymes - Mild rash or pruritus - Dizziness - Fatigue - Abdominal pain - Insomnia - Back pain
Serious: - Severe hypersensitivity reactions (e.g., Stevens‑Johnson syndrome) - Acute renal failure - Cardiovascular events such as myocardial infarction - Hepatotoxicity with jaundice - Severe liver injury - Anaphylaxis - Thromboembolic events - Severe hypotension
What precautions apply to Febuxostat?
When prescribing Adenuric, healthcare professionals should carefully consider several precautionary measures to ensure safe use.
- Assess baseline liver enzymes and renal function before initiating therapy. - Use caution in patients with a history of cardiovascular disease. - Adjust dose or avoid use in severe hepatic impairment. - Monitor serum urate levels regularly to achieve target reduction. - Review concomitant medications that may affect uric acid metabolism. - Educate patients about signs of hypersensitivity and liver injury. - Avoid use during pregnancy unless potential benefit justifies risk.
What does Febuxostat interact with?
Adenuric may interact with other medicines, altering its effectiveness or increasing the risk of adverse events. The following categories summarize known interactions.
Avoid: - Strong CYP2C9 inhibitors (e.g., fluconazole) that may increase febuxostat plasma concentrations. - Azathioprine or mercaptopurine, as febuxostat can raise their levels and risk toxicity. - High-dose aspirin, which can interfere with uric acid excretion. - Concomitant use with ribavirin, which may increase hepatotoxic risk.
Use with caution: - Warfarin, because febuxostat may enhance anticoagulant effect. - Statins, particularly simvastatin, due to potential increased risk of myopathy. - Diuretics (thiazides), which may affect serum urate levels. - NSAIDs, as they can mask gout flare symptoms.
Frequently asked questions
What is the active ingredient in Adenuric?+
How does Adenuric help patients with gout?+
Is Adenuric available over the counter?+
Can Adenuric be used in patients with kidney disease?+
What monitoring is recommended while taking Adenuric?+
Are there any dietary restrictions with Adenuric?+
What should I do if I miss a dose of Adenuric?+
Can Adenuric be taken with allopurinol?+
Is it safe to use Adenuric during pregnancy?+
What are common side effects of Adenuric?+
What serious adverse reactions have been reported with Adenuric?+
How should Adenuric be stored?+
Product details
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