ADENURIC 80mg Tablets/Film-coated

What is ADENURIC 80mg

ADENURIC 80mg is a prescription medication primarily used to treat chronic gout and hyperuricemia (high levels of uric acid in the blood). The active ingredient in ADENURIC is Febuxostat, a xanthine oxidase inhibitor that helps reduce uric acid production in the body. Elevated uric acid can lead to gout attacks, joint inflammation, and potential kidney damage, making control of uric acid levels critical in affected patients.

• Belongs to a class of drugs called xanthine oxidase inhibitors.
• Primarily indicated for long-term management of hyperuricemia in patients with gout.
• Helps prevent gout flares by maintaining lower uric acid levels.
• Available as film-coated tablets for oral administration.
• ADENURIC 80mg tablets typically come in packs of 28 tablets, often packaged as two blister strips of 14 tablets each.

Febuxostat is often prescribed when patients are intolerant or have inadequate response to allopurinol, another common uric acid-lowering drug. It is essential to follow the prescribed dosage and duration strictly to avoid complications.

How to use ADENURIC 80mg

Proper usage of ADENURIC 80mg is crucial to ensure its effectiveness and minimize side effects. Below are detailed guidelines on how to take this medication:

• Dosage Schedule: Take ADENURIC once daily, preferably at the same time each day to maintain steady drug levels.
• Administration: Swallow the film-coated tablet whole with water. It can be taken with or without food.
• Starting Dose: Typically, treatment starts at 40 mg daily, but your doctor may adjust the dose to 80 mg depending on your uric acid levels and clinical response.
• Duration: Long-term treatment may be necessary to maintain uric acid control and prevent gout attacks.
• Missed Dose: If you miss a dose, take it as soon as you remember unless it is almost time for the next dose. Do not double the dose to catch up.
• Regular Monitoring: Periodic blood tests to monitor uric acid levels and liver function are recommended during treatment.
• Do not stop abruptly: Discontinuing ADENURIC suddenly may result in a rebound increase in uric acid and gout flare-ups.

Always follow your healthcare provider’s instructions carefully and report any unusual symptoms or concerns promptly.

Mode of Action ADENURIC 80mg

ADENURIC contains febuxostat, which works through a specific biochemical mechanism to lower uric acid levels:

• Xanthine Oxidase Inhibition: Febuxostat selectively inhibits xanthine oxidase, an enzyme responsible for converting hypoxanthine and xanthine into uric acid.
• Reduced Uric Acid Production: By blocking this enzyme, febuxostat decreases the formation of uric acid, thereby reducing its concentration in blood and tissues.
• Improvement in Gout Symptoms: Lower uric acid levels prevent the formation and deposition of urate crystals in joints and tissues, which are responsible for gout pain and inflammation.
• Selective and Potent: Febuxostat has a high affinity for xanthine oxidase with minimal effect on other enzymes, which contributes to its efficacy and tolerability.
• Renal and Hepatic Metabolism: The drug is metabolized in the liver and excreted via both the kidneys and bile, allowing flexibility in use even in some patients with mild-to-moderate renal impairment (under medical supervision).

Overall, the mode of action targets the biochemical root cause of gout by controlling uric acid synthesis, offering effective management of chronic gout and hyperuricemia.

ADENURIC 80mg Interactions ADENURIC 80mg

When taking ADENURIC (febuxostat), it’s important to be aware of potential drug interactions that may affect efficacy or safety:

• Azathioprine and Mercaptopurine: Febuxostat can increase plasma concentrations of these immunosuppressants, raising the risk of toxicity. Dose adjustments and careful monitoring are necessary.
• Theophylline: Febuxostat may increase theophylline levels, requiring monitoring for toxicity.
• Warfarin and Anticoagulants: Febuxostat can enhance the effects of warfarin and other anticoagulants, increasing bleeding risk; INR should be monitored closely.
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Colchicine: Often used to manage gout flares, concomitant use is generally safe but should be supervised by a doctor.
• Other Xanthine Oxidase Inhibitors: Avoid concurrent use with allopurinol or other xanthine oxidase inhibitors to prevent excessive uric acid reduction and adverse effects.
• Febuxostat and Liver Enzyme Inducers: Drugs that induce or inhibit liver enzymes (e.g., rifampin, fluconazole) may alter febuxostat metabolism and require dose adjustment.

Always inform your healthcare provider of all medications, supplements, and herbal products you are using to avoid dangerous interactions and optimize treatment safety.

Dosage of ADENURIC 80mg

The dosage of ADENURIC should be individualized based on the patient’s uric acid levels, kidney function, and clinical response. Standard dosing guidelines include:

• Initial Dose: Usually starts at 40 mg once daily.
• Maintenance Dose: May be increased to 80 mg once daily if uric acid targets are not achieved after 2 weeks.
• Maximum Dose: 80 mg daily is the highest recommended dose.
• Special Populations:
  • Renal impairment: No dose adjustment required for mild to moderate renal impairment; severe impairment requires careful monitoring.
  • Hepatic impairment: Use with caution in mild to moderate liver impairment; not recommended in severe hepatic impairment.
• Duration: Chronic therapy is usually required; therapy should not be discontinued abruptly.
• Monitoring: Serum uric acid levels should be checked regularly (every 2-5 weeks initially) to guide dose adjustments.

The goal is to maintain serum uric acid below 6 mg/dL to prevent gout attacks and complications.

Possible side effects of ADENURIC 80mg

While ADENURIC is generally well tolerated, patients may experience some side effects. It is important to recognize common and serious adverse reactions:

• Common Side Effects:
  • Headache
  • Nausea
  • Joint pain or stiffness
  • Rash or skin reactions
  • Increased liver enzymes (detected via blood tests)
• Serious Side Effects (require immediate medical attention):
  • Severe allergic reactions (anaphylaxis, Stevens-Johnson syndrome)
  • Hepatotoxicity (jaundice, severe abdominal pain)
  • Cardiovascular events (rare but observed in some patients, such as heart attack or stroke)
  • Gout flares may increase initially during therapy initiation but typically improve over time.
• Precautions: Inform your doctor if you experience persistent fatigue, dark urine, yellowing of eyes, or unusual bruising.

Regular monitoring through blood tests helps detect liver and kidney effects early, allowing timely intervention.

ADENURIC 80mg Contraindications ADENURIC 80mg

There are specific conditions and factors where ADENURIC should not be used due to safety concerns:

• Hypersensitivity: Known allergy or hypersensitivity to febuxostat or any component of the tablet formulation.
• Severe Hepatic Impairment: ADENURIC is contraindicated in patients with severe liver dysfunction due to risk of toxicity.
• Concomitant Use with Azathioprine or Mercaptopurine: Increased toxicity risk prevents combined use without dose adjustment.
• Pregnancy and Breastfeeding: Safety has not been established; use only if clearly needed and prescribed by a physician.
• Patients with Cardiovascular Disease: Use caution in those with a history of heart disease or stroke; benefits versus risks must be weighed carefully.

Always discuss your full medical history with your healthcare provider before starting ADENURIC to avoid contraindicated situations.

Storage of ADENURIC 80mg

Proper storage of ADENURIC tablets ensures their stability and efficacy:

• Store at room temperature, ideally between 20°C to 25°C (68°F to 77°F).
• Keep tablets in their original blister packaging until use to protect from moisture and light.
• Do not store in the bathroom or places with high humidity.
• Keep out of reach of children and pets to prevent accidental ingestion.
• Avoid exposure to excessive heat or direct sunlight.
• If the tablets change color, smell, or texture, do not use them and consult a pharmacist.
• Dispose of expired or unused medicine properly following local regulations or pharmacy guidelines.

Following these storage guidelines helps maintain the medication's potency and ensures safe use throughout the prescribed course.