Dotin

• Hyperuricemia: Treatment of hyperuricemia with or without gout.
• Gout: Used to lower serum uric acid levels to prevent gout attacks.
• Urate nephropathy prevention: May be used to reduce urate levels in patients at risk of uric acid nephropathy.

Route: Oral

Adults:

• Initial dose: 0.5 mg once daily
• Maintenance dose: Titrate gradually based on serum uric acid levels, usually 1–2 mg once daily
• Maximum dose: Up to 4 mg daily depending on response and tolerability
• Dose adjustment is recommended based on renal function and uric acid levels

Elderly:

• Start at low dose; adjust cautiously

Renal Impairment:

• Dose adjustments recommended in moderate to severe renal impairment; monitor renal function closely

Pediatrics:

• Safety and efficacy not established

Administration Notes:

• Take with or without food
• Maintain adequate hydration to reduce risk of uric acid stone formation

Dotinurad is a selective urate reabsorption inhibitor (SURI) that inhibits the urate transporter 1 (URAT1) in the proximal renal tubules. By blocking URAT1, dotinurad reduces renal reabsorption of uric acid, thereby increasing its excretion in urine and lowering serum uric acid concentrations. This uricosuric effect helps to prevent deposition of urate crystals and subsequent gout flares.

• Absorption: Well absorbed orally; peak plasma concentration within 2–4 hours.
• Distribution: Moderate plasma protein binding.
• Metabolism: Primarily metabolized hepatically via conjugation; minor involvement of CYP enzymes.
• Half-life: Approximately 10–14 hours, supporting once-daily dosing.
• Elimination: Excreted mainly via urine as metabolites and unchanged drug.

• Pregnancy: No well-controlled human studies; animal studies show no teratogenicity at clinical doses. Use only if clearly needed.
• Lactation: Unknown if excreted in human milk; caution advised and breastfeeding should be avoided or discontinued during treatment.

• Primary class: Uricosuric agent
• Subclass: Selective urate transporter 1 (URAT1) inhibitor

• Known hypersensitivity to dotinurad or formulation components
• History of urolithiasis or uric acid kidney stones without adequate hydration
• Severe renal impairment (relative contraindication)
• Concomitant use with drugs causing hyperuricemia without monitoring

• Monitor for signs of kidney stones; ensure adequate hydration.
• Caution in patients with renal impairment.
• Risk of hypersensitivity reactions.
• Monitor liver function tests periodically.
• Use cautiously in patients with a history of cardiovascular disease.
• Serum uric acid levels should be regularly monitored.
• Discontinue if severe rash or allergic reaction occurs.

Common:

• Elevated liver enzymes
• Increased urination
• Gastrointestinal discomfort (nausea, diarrhea)
• Headache

Less common:

• Rash or mild allergic reactions
• Dizziness
• Elevated serum creatinine

Rare / Serious:

• Severe hypersensitivity reactions
• Urolithiasis (kidney stones)
• Acute gout flare at treatment initiation

• May increase serum levels of concomitant uric acid lowering drugs; monitor closely.
• Avoid combination with other uricosurics without supervision.
• Potential interaction with warfarin and other anticoagulants; monitor coagulation parameters.
• No significant CYP450 induction or inhibition reported.

• Recent clinical trials support dotinurad as an effective and well-tolerated urate-lowering therapy.
• Guidelines now include selective URAT1 inhibitors as alternatives to traditional uricosurics or xanthine oxidase inhibitors.
• Ongoing post-marketing surveillance for long-term safety data.
• Recommendations emphasize dose titration to target serum urate <6 mg/dL.

• Store at 20°C to 25°C (68°F to 77°F)
• Protect from moisture and light
• Keep container tightly closed
• Avoid exposure to freezing temperatures
• Keep out of reach of children