Febuxostat (Febuxosaph 40) 40mg Film Coated Tablet 30's

Certainly! Here is the detailed information for Febuxostat (Febuxosaph 40) 40mg Film Coated Tablet 30's:

Product Description:

Febuxostat (Febuxosaph 40) is a xanthine oxidase inhibitor used to lower uric acid levels in the blood. It works by reducing the production of uric acid, which is a byproduct of purine metabolism. Excessive uric acid can lead to the formation of uric acid crystals that accumulate in the joints and tissues, resulting in gout and hyperuricemia (elevated uric acid levels in the blood).

Febuxosaph 40 is available as 40mg film-coated tablets, with each pack containing 30 tablets. It is typically used in the management of gout and hyperuricemia in patients with gout, particularly when other treatments are not effective or suitable.

Indications:

Febuxosaph 40 (Febuxostat) is indicated for the following:

1. Hyperuricemia in Gout: For the treatment of gout and to prevent gout flares by reducing the levels of uric acid in the blood.

2. Chronic Hyperuricemia: In patients with chronic hyperuricemia, particularly those who are at risk of developing gout or other complications related to high uric acid levels, such as kidney stones or joint damage.

Febuxosaph 40 is usually prescribed when allopurinol, another uric acid-lowering drug, is not effective or is poorly tolerated by the patient.

Dosage:

The recommended dosage for Febuxosaph 40 (Febuxostat) varies based on the patient's condition, but typical dosing is as follows:

• Adults (for Gout or Hyperuricemia):

  • Starting Dose: 40mg once daily.

  • Dose Adjustment: After 2 weeks, the dose may be increased to 80mg once daily if target uric acid levels are not reached. Some patients may require up to 120mg daily to control their uric acid levels effectively.

  • It is recommended to take the tablet with or without food, at the same time each day, for consistency.

• Renal Impairment:

  • No dose adjustment is typically needed for patients with mild to moderate renal impairment. However, Febuxostat should be used with caution in patients with severe renal impairment or end-stage renal disease.

• Hepatic Impairment:

  • For patients with moderate to severe hepatic impairment, the starting dose should be 40mg daily, and further dose adjustments should be made based on response.

Side Effects:

As with any medication, Febuxosaph 40 (Febuxostat) can cause side effects. Common and less common side effects include:

Common Side Effects:

• Liver function abnormalities: Slight increases in liver enzymes (AST/ALT) are common.

• Nausea or vomiting.

• Rash or skin reactions.

• Headache.

• Gastrointestinal discomfort, such as abdominal pain or diarrhea.

Serious Side Effects:

• Cardiovascular Issues: Rarely, Febuxostat has been associated with an increased risk of cardiovascular events, including heart attacks, strokes, and unstable angina, especially in patients with pre-existing heart conditions. It is recommended to assess the cardiovascular risk before prescribing.

• Severe liver problems: Symptoms such as yellowing of the skin or eyes (jaundice), dark urine, and persistent nausea.

• Severe allergic reactions: This can include swelling of the face, lips, or throat, difficulty breathing, and anaphylaxis (a severe allergic reaction requiring emergency medical attention).

• Kidney problems: Rarely, Febuxostat can cause kidney-related issues such as acute kidney injury or interstitial nephritis.

If you experience any of the above serious side effects, seek medical attention immediately.

Contraindications:

Febuxosaph 40 (Febuxostat) should not be used in the following conditions:

• Hypersensitivity to Febuxostat or any of its ingredients: Patients who are allergic to Febuxostat or any excipients in the tablet should avoid taking this medication.

• Severe Liver Disease: Febuxostat is contraindicated in patients with severe hepatic impairment or active liver disease.

• Uncontrolled Gout Flares: During an acute gout flare, Febuxostat should not be initiated until the flare is resolved. Starting Febuxostat during an acute flare may worsen symptoms.

• Pregnancy: Febuxostat is not recommended during pregnancy. There is limited safety data, and it is advised to use alternative treatments for gout during pregnancy.

• Breastfeeding: It is unknown whether Febuxostat is excreted in human milk. Therefore, it is not recommended to use Febuxostat during breastfeeding unless clearly needed.

Precautions:

• Cardiovascular Risk: Febuxostat should be used with caution in patients with pre-existing cardiovascular disease or risk factors for heart disease. Monitoring for cardiovascular side effects is recommended.

• Liver Function Monitoring: Liver function should be monitored periodically during treatment, especially if any symptoms of liver dysfunction (such as jaundice or dark urine) occur.

• Kidney Function Monitoring: While Febuxostat does not require significant dose adjustments in mild to moderate renal impairment, kidney function should still be monitored in patients with any kidney issues.

• Alcohol Use: Chronic alcohol consumption can increase uric acid levels and should be avoided in conjunction with Febuxostat. Patients should be advised to limit alcohol intake.

• Allergic Reactions: Patients should be informed about potential allergic reactions, including rash, itching, or swelling, and should seek immediate medical attention if they develop such symptoms.

Drug Interactions:

Febuxostat (Febuxosaph 40) may interact with several other medications, including:

• Azathioprine and Mercaptopurine: These drugs are metabolized by the same enzyme as Febuxostat (xanthine oxidase). Using them together may lead to elevated levels of azathioprine or mercaptopurine, which increases the risk of toxicity. Febuxostat should not be combined with these drugs.

• Theophylline: Like azathioprine, Theophylline is also metabolized by xanthine oxidase, so Febuxostat may increase the levels of theophylline, which can cause side effects such as toxicity. Doses of theophylline should be monitored and adjusted if necessary.

• Warfarin: Febuxostat can interact with warfarin (a blood thinner), potentially affecting its blood-thinning effects. Regular monitoring of INR (International Normalized Ratio) is recommended if used together.

• Diuretics: Diuretics (especially thiazide diuretics) may reduce the efficacy of Febuxostat in lowering uric acid levels. If used together, additional monitoring may be required.

Summary:

Febuxostat (Febuxosaph 40) is a xanthine oxidase inhibitor that is used to lower uric acid levels in the blood and manage gout and chronic hyperuricemia. The typical starting dose is 40mg once daily, which may be increased based on the patient's response.

The most common side effects include gastrointestinal symptoms such as nausea and headache, while more serious side effects may include liver dysfunction, cardiovascular events, and severe allergic reactions. Febuxostat is contraindicated in patients with severe liver disease and should not be used during an acute gout flare.

It is important to monitor liver function and cardiovascular health during treatment, particularly for those with pre-existing conditions. Additionally, Febuxostat should not be used during pregnancy and breastfeeding, and should be avoided in patients with a known allergy to the medication.

Always follow the prescribed dosage and consult a healthcare provider for guidance, especially if taking other medications or dealing with pre-existing medical conditions.