Febuxostat And Diacerein Tablets 80mg/50mg
- Febuxostat and Diacerein Tablets 80mg/50mg
Therapeutic Class: Others
Dosage Forms: Tablets
Brand Name: GOTA-D 80/50™
How it works?
Uses of Febuxostat And Diacerein Tablets 80mg/50mg
Uses of Febuxostat And Diacerein Tablets 80mg/50mg
- Acute gout flares → Helps reduce the frequency and severity of painful gout attacks.
- Inflammation control → Provides anti‑inflammatory action to ease swelling and joint discomfort.
- Refractory gout management → Indicated for patients with persistent or resistant gout symptoms where conventional therapy is insufficient.
- Symptom relief → Improves mobility and reduces pain, stiffness, and tenderness in affected joints.
Precautions of Febuxostat And Diacerein Tablets 80mg/50mg
Precautions While Taking Febuxostat And Diacerein Tablets 80mg/50mg
- Cardiovascular disorders → Febuxostat is not recommended in patients with ischemic heart disease or congestive heart failure.
- Allergy/hypersensitivity → Rare but serious reactions (Stevens‑Johnson Syndrome, toxic epidermal necrolysis, anaphylaxis) have been reported. Discontinue immediately if symptoms occur.
- Acute gout flares → Febuxostat should not be started during an acute attack. Flare prophylaxis with NSAIDs or colchicine for at least 6 months is recommended. If flare occurs, continue therapy and manage flare separately.
- Xanthine deposition → Febuxostat is not recommended in patients with Lesch‑Nyhan Syndrome.
- Drug interactions → Febuxostat should not be used with mercaptopurine or azathioprine due to risk of severe toxicity.
- Liver disorders → Both drugs may cause liver enzyme abnormalities. Liver function tests should be performed before initiation and periodically during treatment.
- Thyroid disorders → Febuxostat has been associated with increased TSH values; monitor thyroid function in at‑risk patients.
- Diarrhoea risk → Diacerein frequently causes Diarrhoea, which may lead to dehydration and hypokalemia. Caution in patients on diuretics or cardiac glycosides; avoid concomitant laxatives.
- Hepatotoxicity → Diacerein has been linked to acute liver injury, especially in the first months of treatment. Contraindicated in patients with liver disease.
- Alcohol intake → Patients should limit alcohol consumption while on diacerein to reduce liver risk.
Dosages administration of Febuxostat And Diacerein Tablets 80mg/50mg
Adults (≥18 years)
- Febuxostat
- Recommended dose: 80 mg once or twice daily.
- If serum uric acid remains >6 mg/dL (357 μmol/L) after 2–4 weeks → increase to 120 mg daily.
- Retesting of serum uric acid can be done after 2 weeks due to rapid action.
- Diacerein
- Starting dose: 50 mg once daily with evening meal for the first 2–4 weeks (to reduce risk of diarrhoea).
- Maintenance dose: 50 mg twice daily (one tablet with breakfast, one with evening meal).
- Always administer with food to improve tolerance.
Special Populations
- Elderly → No dosage adjustment required, but caution advised in patients >65 years; close monitoring recommended.
- Renal impairment →
- Moderate impairment: No adjustment needed.
- Severe impairment (creatinine clearance <30 ml/min): Daily dosage should be halved.
- Pediatric population → Not recommended in children <18 years due to lack of data.
Key Takeaway
- Febuxostat: 80–120 mg daily depending on uric acid response.
- Diacerein: Start at 50 mg once daily, then increase to 50 mg twice daily.
- Special care: Elderly and renal impairment require monitoring; contraindicated in children under 18.
Side effects of Febuxostat And Diacerein Tablets 80mg/50mg
- Gout flares → Often occur during initiation of febuxostat therapy.
- Liver function abnormalities → Mild elevations in hepatic enzymes observed.
- Gastrointestinal disturbances → Diarrhoea, abdominal pain, nausea, flatulence, constipation, frequent bowel movements.
- Skin reactions → Rash, pruritus, eczema.
- Neurological/general → Headache, malaise.
- Fluid imbalance → Oedema, dehydration, electrolyte disturbances (especially hypokalemia with diacerein).
Rare but Serious
- Hypersensitivity reactions → Stevens‑Johnson Syndrome, toxic epidermal necrolysis, anaphylaxis.
- Severe diarrhoea → May lead to dehydration and electrolyte imbalance.
- Acute liver injury → Elevated hepatic enzymes, hepatitis, symptomatic hepatic injury (mostly within first months of diacerein therapy).
Storage instruction of Febuxostat And Diacerein Tablets 80mg/50mg
Store below 30°C. Protect from light and moisture. Keep out of reach of children.
Packing details of Febuxostat And Diacerein Tablets 80mg/50mg
3 x 10 Alu/PVC blister pack Febuxostat And Diacerein Tablets 80mg/50mg is available in an Alu/PVC blister of 10 tablets. Such 03 blisters in a unit carton with package insert.
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Reliable GMP Certified Febuxostat And Diacerein Tablets 80mg/50mg Manufacturer
Conical Pharmaceuticals, headquartered in Ahmedabad, India, is a GMP‑certified manufacturer & exporter of Febuxostat and Diacerein Tablets 80mg/50mg, delivering premium pharmaceutical and nutraceutical solutions worldwide.
With exports planned into Central Africa, Central America, and the CIS Region, and a strong distribution network across Belize, Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panama, Cameroon, Chad, DRC, Equatorial Guinea, Gabon, and the Republic of the Congo, we ensure reliable supply and smooth market entry.
Expansion into Nigeria, Ghana, Zambia, Zimbabwe, Kenya, the Philippines, Singapore, and Afghanistan further strengthens our global footprint. Importers benefit from complete regulatory dossier support, including GMP Certification, COPP, COA, and Free Sale Certificates as per requirements.
We also provide third‑party contract manufacturing, private labelling, and custom formulation options, empowering partners to launch their own brands with tailored solutions. As a trusted contract manufacturer, Conical Pharmaceuticals supplies to international importers, large distributors, pharmacy chains, and hospitals. With advanced R&D, flexible MOQ options, and consistent quality assurance, we enable partners to expand their market presence while delivering effective, high‑quality pharmaceutical solutions 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
Shelf Life: 24 months.
Frequently Asked Questions
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Conical Pharmaceuticals, headquartered in Ahmedabad, India, is a GMP‑certified manufacturer and exporter with global distribution networks.
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