Urece Dotinurad Tablets

1. Indications and Usage
Gout with Hyperuricemia:
Indicated for the treatment of gout with hyperuricemia.
2. Dosage and Administration
Route of Administration:
Oral Use ONLY.
Recommended Dosage:
Initial Dose: 1 mg administered orally once daily.
Titration: The dose should be gradually increased based on serum uric acid levels.
Maintenance Dose: Generally 2 mg once daily.
Maximum Dose: 4 mg once daily.
Administration Instructions:
Increase fluid intake (at least 2L/day) to maintain adequate urine volume and alkalize urine to prevent kidney stones.
3. Mechanism of Action
Selective URAT1 Inhibition:
Dotinurad is a selective inhibitor of the Urate Transporter 1 (URAT1) in the kidney.
Promotion of Excretion:
By inhibiting URAT1, Dotinurad blocks the reabsorption of uric acid in the renal proximal tubules, thereby promoting the excretion of uric acid into the urine and lowering serum uric acid levels.
4. Safety and Warnings
Gout Flare (Acute Attack):
Contraindication for Initiation: Do not initiate treatment during an acute gout attack. Wait until symptoms subside.
Management: If a gout flare occurs during treatment, continue Dotinurad without dose adjustment and administer anti-inflammatory agents (e.g., NSAIDs, colchicine, corticosteroids) as needed.
Urolithiasis (Kidney Stones):
Increased uric acid excretion may lead to kidney stones. Monitor for hematuria or colic. Hydration is mandatory.
Renal Impairment:
Not recommended for patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²) as efficacy may be reduced.
Hepatic Impairment:
Monitor liver function tests regularly.
5. Adverse Reactions
Most Common:
Gouty arthritis (gout flare), gastrointestinal symptoms (diarrhea, soft stools), and elevated liver enzymes.
6. Drug Interactions
Pyrazinamide:
May antagonize the uricosuric effect of Dotinurad; avoid concomitant use.
Salicylates (e.g., Aspirin):
May inhibit uric acid excretion and antagonize the effect of Dotinurad.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Dotinurad.
Available strengths: 1 mg (White to pale yellowish white tablets), 2 mg (Pale red tablets).
Storage:
Store in a tightly closed container, protected from light and moisture.