Febuxostat Tablet 40 mg
- Febuxostat Tablets 40 mg
Therapeutic Class: Anti-arthritis
Dosage Forms: Tablets
Brand Name: Febuconex-40™
How it works?
Uses of Febuxostat Tablet 40 mg
Febuxostat Tablet 40 mg is primarily used to treat gout and hyperuricemia (high uric acid levels in the blood). It works by lowering uric acid production, helping prevent painful gout attacks and long‑term complications.
Important Uses of Febuxostat Tablet 40 mg
- Treatment of Gout
- Prevents uric acid crystal buildup in joints.
- Reduces pain, swelling, and inflammation caused by gout attacks.
- Management of Hyperuricemia.
- Controls high uric acid levels in patients who cannot tolerate or do not respond to allopurinol.
- Helps avoid complications like kidney stones and urate deposits.
- Safer in Kidney Impairment.
- Suitable for patients with mild to moderate kidney dysfunction, since it is not heavily cleared by kidneys.
Precautions of Febuxostat Tablet 40 mg
Precautions While Taking Febuxostat Tablet 40 mg
- Cardiovascular disorders
- Not recommended in patients with ischemic heart disease or congestive heart failure.
- Allergy / Hypersensitivity
- Rare but serious reactions reported: Stevens‑Johnson Syndrome, toxic epidermal necrolysis, and anaphylaxis.
- Patients should be advised of warning signs.
- Treatment must be stopped immediately if severe reactions occur.
- Febuxostat must not be restarted in such patients.
- Acute gout attacks
- Do not start treatment until an acute attack has fully subsided.
- Gout flares may occur during initiation due to shifting uric acid levels.
- Prophylaxis with NSAIDs or colchicine for at least 6 months is recommended.
- If a flare occurs during therapy, continue febuxostat and manage the flare separately.
- Xanthine deposition
- Not recommended in patients with Lesch‑Nyhan Syndrome (no clinical experience available).
- Drug interactions
- Contraindicated with mercaptopurine or azathioprine.
- Inhibition of xanthine oxidase can cause severe toxicity due to increased plasma levels of these drugs.
- Liver disorders
- Mild liver function abnormalities were observed in ~5% of patients. Liver function tests are recommended before starting therapy and periodically thereafter.
- Thyroid disorders
- Increased TSH values (> 5.5 μIU/mL) were reported in ~5.5% of long‑term users.
- Use with caution in patients with thyroid dysfunction.
- Organ transplant recipients
- No clinical experience available.
- Use is not recommended in transplant patients
Dosages administration of Febuxostat Tablet 40 mg
Dosage Guidelines for Febuxostat Tablet 40 mg
- Recommended dose: 40 mg once daily (with or without food).
- If serum uric acid remains > 6 mg/dL (357 μmol/L) after 2–4 weeks → dose may be increased up to 120 mg daily.
- Retesting of uric acid can be done after 2 weeks.
- Therapeutic goal: maintain serum uric acid below 6 mg/dL (357 μmol/L).
- Prophylaxis for gout flares should continue for at least 6 months.
Elderly patients
- No dose adjustment required.
- Renal impairment
- Mild to moderate impairment: no adjustment needed.
- Severe impairment (creatinine clearance < 30 mL/min): efficacy and safety not fully established.
Hepatic impairment
- Mild impairment: recommended dose is 80 mg daily.
- Moderate impairment: limited data available.
- Severe impairment (Child‑Pugh Class C): not studied.
Pediatric population
- Safety and efficacy not established in children under 18 years.
- No data available.
- Directions for use
- For oral use only.
- Tablets can be taken with or without food.
Side effects of Febuxostat Tablet 40 mg
Side Effects of Febuxostat Tablet 40 mg
Common Side Effects
- Gout flares (especially during the first months of treatment)
- Elevated liver enzymes (abnormal liver function tests)
- Nausea or mild stomach upset
- Skin rash or itching
- Joint pain or stiffness
- Headache and dizziness
Serious Side Effects of Febuxostat Tablet 40 mg
- Cardiovascular risks: heart attack, stroke, or cardiovascular death (reported in some studies)
- Severe liver problems: yellowing of eyes/skin, dark urine, persistent nausea, abdominal pain
- Serious skin reactions: blistering, peeling, Stevens‑Johnson syndrome, toxic epidermal necrolysis
- Severe allergic reactions: swelling of face/throat, difficulty breathing, hives
- Kidney issues: reduced urine output, swelling, or pain in the lower back
Storage instruction of Febuxostat Tablet 40 mg
Store below 30°C and protect from light.
Keep the medicine out of reach of children.
Packing details of Febuxostat Tablet 40 mg
10 x 10 Alu/PVC blister pack
Febuxostat tablets, 40 mg, are available in an Alu/PVC blister of 10 tablets. Such as 10 blisters in a unit carton with a package insert.
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Premium Febuxostat Tablet 40 mg Manufacturer
Conical Pharmaceutical manufactures premium Febuxostat 40 mg tablets at its WHO-GMP-certified facility in India, ensuring global quality compliance. We are available to export across CIS, Latin America, and African regions; we are now expanding further to export across Myanmar | Philippines | the United Arab Emirates | Bangladesh| Saudi Arabia| Canada| and the United States. We provide full regulatory dossier support for new partners, including GMP, Certificate of Analysis, Free Sale Certificate, and COPP, tailored to country requirements.
CUSTOM PACKAGING
Options available in size and style to meet your exact specifications and branding needs
SAMPLES AVAILABLE
Test before committing to bulk orders with complimentary samples for quality verification
LEAD TIME
45–60 days for timely delivery, ensuring reliable supply chain management
SHELF LIFE
18 months when stored below 30°C, ensuring maximum stability and viability
Quality & Regulatory Certifications
WHO-GMP Certified Facility • FDA Approved (Jordan) • Full Regulatory Dossier Support • Certificate of Analysis • Free Sale Certificate • COPP Documentation
Frequently Asked Questions
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Conical Pharmaceutical manufactures Premium Febuxostat 40 mg tablets in India, backed by WHO-GMP certification for global quality compliance.
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