AGOUT 40mg Tablets/Film-coated

What is AGOUT 40mg

AGOUT 40mg is a prescription medicine that contains Febuxostat as its active ingredient. It belongs to a class of medications known as xanthine oxidase inhibitors. This medication is primarily used for the treatment of chronic hyperuricemia (high uric acid levels in the blood) in conditions where urate deposition has already occurred, including gouty arthritis.

• Therapeutic Use: AGOUT 40mg is indicated for patients suffering from chronic gout, especially when allopurinol is not suitable or has failed to adequately control serum uric acid levels.
• Pharmaceutical Form: Each tablet is a film-coated oral dosage form, packaged as 30 tablets (2 blisters of 15 tablets each).
• Generic Name: Febuxostat
• ATC Code: M04AA03
• Patient Population: Adults, especially those with a history of gouty attacks or visible tophi.

Unlike some older medications, Febuxostat is not a purine analog, which makes it more selective in its action and sometimes better tolerated in patients who cannot use allopurinol.

How to use AGOUT 40mg

AGOUT 40mg should be used exactly as prescribed by a healthcare professional. Misuse or abrupt discontinuation can worsen symptoms or trigger acute gout attacks.

• Dosage Form: Oral tablet, to be swallowed whole with water.
• Administration: Taken once daily, with or without food.
• Timing: It is advisable to take the medicine at the same time each day to maintain consistent blood levels.
• Initial Phase: During the first weeks of treatment, there may be an increase in gout flares. This is normal and prophylactic therapy with NSAIDs or colchicine may be recommended during the first 6 months.
• Missed Dose: If you miss a dose, take it as soon as possible unless it's nearly time for your next dose. Do not double the dose to catch up.
• Duration: Treatment is often long-term and should not be stopped without medical consultation even if symptoms improve.

Always read the patient information leaflet and consult your doctor or pharmacist for individual advice.

Mode of Action AGOUT 40mg

Febuxostat, the active ingredient in AGOUT 40mg, works by selectively inhibiting an enzyme called xanthine oxidase, which plays a crucial role in the production of uric acid.

• Enzyme Inhibition: Febuxostat blocks xanthine oxidase, which converts hypoxanthine to xanthine and then to uric acid. By doing so, it lowers blood uric acid levels.
• Uric Acid Reduction: The reduction in serum uric acid levels leads to decreased formation of urate crystals in joints and tissues, which are the primary cause of inflammation and pain in gout.
• Selective Inhibitor: Unlike allopurinol, Febuxostat is a non-purine selective inhibitor, making it less likely to interfere with other metabolic pathways.
• Therapeutic Effect: Gradual dissolution of existing urate crystals and prevention of new crystal formation.

Because of its selectivity, Febuxostat may provide a better safety profile for some patients compared to traditional urate-lowering therapies.

AGOUT 40mg Interactions AGOUT 40mg

Drug interactions can affect how AGOUT 40mg works or increase the risk of serious side effects. Always inform your healthcare provider about all medications you are taking.

• Azathioprine and Mercaptopurine: Co-administration is contraindicated due to the risk of severe toxicity. Febuxostat inhibits xanthine oxidase, which is responsible for breaking down these drugs.
• Theophylline: Use with caution. Febuxostat may increase the plasma levels of theophylline; monitor for toxicity symptoms like nausea, restlessness, and tachycardia.
• Warfarin: Febuxostat does not significantly affect INR levels in most cases, but caution is advised especially during initiation of therapy. Monitor INR closely.
• NSAIDs and Colchicine: Commonly co-prescribed during initial therapy to manage gout flares. Ensure proper monitoring to avoid gastrointestinal or renal side effects.
• Diuretics (e.g., Hydrochlorothiazide): May increase uric acid levels and counteract Febuxostat’s effect.

Herbal supplements, over-the-counter medicines, and vitamins can also affect AGOUT’s efficacy. Always seek medical advice before starting new treatments.

Dosage of AGOUT 40mg

The dosage of AGOUT 40mg depends on the patient's serum uric acid levels, clinical condition, and response to treatment.

• Starting Dose: Typically, the recommended initial dose is 40mg once daily.
• Maintenance Dose: If uric acid levels are not adequately controlled (<6 mg/dL) after two to four weeks, the dose may be increased to 80mg daily.
• Maximum Dose: 80mg per day, depending on therapeutic response and patient tolerance.
• Prophylaxis: Concomitant use of colchicine or NSAIDs is advised during the first 6 months of therapy to prevent acute gout attacks.
• Renal or Hepatic Impairment: No dose adjustment is needed in mild-to-moderate renal or hepatic dysfunction. Use with caution in severe cases.
• Children: Not recommended for pediatric use due to lack of safety data.

Always follow your healthcare provider’s instructions. Do not adjust your dose without medical advice.

Possible side effects of AGOUT 40mg

Like all medications, AGOUT 40mg (Febuxostat) can cause side effects, although not everyone experiences them. Side effects are usually mild to moderate in severity.

• Common Side Effects:
  • Gout flares (especially during initial therapy)
  • Nausea
  • Rash
  • Arthralgia (joint pain)
  • Liver enzyme elevation
• Uncommon Side Effects:
  • Diarrhea
  • Dizziness
  • Fatigue
  • Headache
• Rare but Serious Side Effects:
  • Severe allergic reactions (Stevens-Johnson Syndrome)
  • Cardiovascular events (e.g., myocardial infarction, stroke)
  • Severe hepatic injury

If you notice any unusual symptoms, seek immediate medical attention, especially if they involve chest pain, rash with fever, or difficulty breathing.

AGOUT 40mg Contraindications AGOUT 40mg

AGOUT 40mg should not be used in patients with certain health conditions due to the risk of serious adverse effects.

• Known Hypersensitivity: Contraindicated in patients allergic to Febuxostat or any of the tablet's components.
• Concomitant Use with Azathioprine or Mercaptopurine: These drugs are metabolized by xanthine oxidase. Their levels can rise dangerously when taken with Febuxostat, leading to bone marrow suppression.
• Severe Hepatic Impairment: Use is contraindicated or should be closely monitored in patients with advanced liver disease.
• Pregnancy and Lactation: Not recommended unless absolutely necessary. Safety data in pregnant or breastfeeding women is limited.
• Children and Adolescents: Safety and efficacy in pediatric populations have not been established.

A full patient history should be taken before prescribing AGOUT to ensure safety and minimize risk.

Storage of AGOUT 40mg

Proper storage of AGOUT 40mg ensures the medication retains its efficacy and remains safe for use.

• Temperature: Store at room temperature, between 20°C and 25°C (68°F to 77°F).
• Keep Away From: Moisture, heat, and direct sunlight. Do not store in bathrooms.
• Packaging: Keep in the original blister packaging until ready to use to protect from moisture and contamination.
• Child Safety: Store out of reach and sight of children.
• Do Not Use: After the expiration date printed on the pack. Dispose of expired medication appropriately.

If you are unsure about the condition of the tablets or how to dispose of them safely, consult your pharmacist.