Febuxostat Tablet 40 mg
- Febuxostat 40 mg Extended Release Tablets
Therapeutic Class: Anti-arthritis
Dosage Forms: Tablets
Brand Name: Gota 40ER™
How it works?
Uses of Febuxostat Tablet 40 mg
Uses of Febuxostat 40 mg Extended Release Tablets
Gout Management
- Febuxostat is indicated for the chronic management of hyperuricemia in adults with gout.
- It reduces uric acid production, preventing the formation of urate crystals that cause painful gout attacks.
- Helps lower the risk of long‑term complications such as joint damage and kidney stones.
Hyperuricemia Treatment
- Prescribed for patients with high uric acid levels who are intolerant to or inadequately controlled by allopurinol.
- Not recommended for asymptomatic hyperuricemia (high uric acid without symptoms).
Tumor Lysis Syndrome Prophylaxis
- In some cases, higher doses of Febuxostat are used to prevent tumor lysis syndrome in patients undergoing chemotherapy for blood cancers.
- This condition occurs when cancer cells break down rapidly, releasing uric acid into the bloodstream.
Precautions of Febuxostat Tablet 40 mg
Precautions While Taking Febuxostat 40 mg ER
Cardiovascular Disorders
- Treatment of chronic hyperuricemia with Febuxostat is 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, anaphylaxis.
- Patients should be advised of warning signs and monitored closely.
- Febuxostat must be stopped immediately if severe reactions occur.
- Once discontinued due to hypersensitivity, Febuxostat must not be restarted.
- Do not start Febuxostat until an acute gout 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.
- Continuous treatment reduces the frequency and intensity of flares over time.
Dosages administration of Febuxostat Tablet 40 mg
Dosage & Administration of Febuxostat 40 mg ER
Gout
- Recommended oral dose: 80 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 to 120 mg daily.
- Febuxostat acts quickly, allowing retesting after 2 weeks.
- Therapeutic target: maintain serum uric acid below 6 mg/dL (357 μmol/L).
- Gout flare prophylaxis: 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 evaluated.
Hepatic Impairment
- Mild impairment: recommended dose 80 mg daily.
- Moderate impairment: limited data available.
- Severe impairment (Child‑Pugh Class C): not studied.
Pediatric Population
- Safety and efficacy not established in patients under 18 years.
- No data available.
Directions for Use
- For oral use only.
- Tablets may be taken with or without food.
Side effects of Febuxostat Tablet 40 mg
Side Effects of Febuxostat 40 mg ER
Common Side Effects
- Gout flares often occur during initiation of treatment.
- Liver function abnormalities – raised liver enzymes detected in blood tests.
- Diarrhea – mild gastrointestinal disturbance.
- Nausea – feeling sick or queasy.
- Headache – mild to moderate intensity.
- Skin rash – allergic skin reaction.
- Edema (swelling) – fluid retention, usually mild.
Uncommon Side Effects
- Blood thyroid‑stimulating hormone (TSH) increases – detected in lab tests, usually without symptoms.
Rare Side Effects
- Blood & lymphatic disorders:
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- Pancytopenia – reduction in all blood cell types.
- Thrombocytopenia – low platelet count, risk of bleeding.
- Agranulocytosis – severe drop in white blood cells, risk of infection.
- Immune system disorders:
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- Anaphylactic reaction – severe allergic reaction, potentially life‑threatening.
- Drug hypersensitivity – systemic allergic response.
- Eye disorders:
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- Blurred vision – temporary or persistent visual disturbance.
Serious Hypersensitivity Reactions
- Rare but severe allergic reactions reported, including:
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- Stevens‑Johnson Syndrome (SJS)
- Toxic epidermal necrolysis (TEN)
- Acute anaphylactic shock
These require immediate discontinuation of febuxostat and urgent medical care.
Storage instruction of Febuxostat Tablet 40 mg
Store below 30°C. Protect from light and moisture.
Keep out of reach of children.
Packing details of Febuxostat Tablet 40 mg
3 x 10 Alu/PVC blister pack
Febuxostat Extended Release Tablets (GOTA 40ER) is available in an Alu/PVC blister of 10 tablets. Such 03 blisters in a unit carton with package insert.
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Top‑Rated GMP Certified Febuxostat Tablet 40 mg Manufacturer
Conical Pharmaceuticals makes and exports Febuxostat 40 mg tablets from its GMP certified factory in Ahmedabad, India, under the brand name Febuxostat Extended Release Tablets 40mg (40ER). Premium quality Febuxostat 40 mg tablets are already registered in Myanmar and is being supplied widely in Central Africa and Central America. We are also expanding our reach to countries like Sri Lanka, Nepal, UAE, Bangladesh, Nigeria, the Philippines, South Africa, Saudi Arabia, Australia, the UK, the USA, CIS countries, Iran, Indonesia, and Cambodia. Importers receive all the necessary documents, including GMP certification, Certificate of Analysis, Free Sale Certificate, and COPP, to ensure smooth and legal entry into their markets. As a trusted large-scale contract manufacturer, Conical Pharmaceuticals works with distributors, international importers, retail chains, pharmacies, private label brands, and companies creating custom formulations. We supply large quantities for hospitals, tenders, and Large scale distributors, supported by strong research and development to deliver reliable and effective products. Our private label services allow partners to sell the product under their own brand, while custom formulas can be created to meet specific needs. We maintain consistent quality across all markets, making us a dependable supplier of bulk pharmaceuticals worldwide.
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 Pharmaceuticals is a Febuxostat Tablet 40 mg ER private label third‑party contract manufacturer, offering bulk supply, custom formulations, and brand development support for distributors, pharmacies, and hospital tenders worldwide.
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