Dotinurad is indicated for the treatment of gout and hyperuricemia (elevated uric acid levels).

Dotinurad is a selective inhibitor of URAT1, a transporter responsible for urate reabsorption in the kidneys. By blocking URAT1, it reduces urate reabsorption and enhances urinary excretion of uric acid, thereby lowering serum uric acid levels. It has minimal inhibitory activity on other transporters such as ABCG2, OAT1, and OAT3, which are involved in uric acid secretion. Due to this high selectivity, Dotinurad effectively lowers serum uric acid without significantly interfering with uric acid excretion pathways mediated by these transporters.

The usual adult dosage is 0.5 mg of Dotinurad, administered orally once daily. After that, gradually increase the dose as necessary while checking the blood uric acid level. The maintenance dose is usually 2 mg once a day, and the dose may be adjusted according to the patient's condition but the maximum dose should be 4 mg once a day.

Precautions Related to Dosage and Administration: In the early stages of treatment with urate-lowering drugs, gouty arthritis (gout attack) may be induced by a rapid decrease in blood uric acid levels. The dose should be gradually increased to 1 mg once a day after 2 weeks and 2 mg once a day after 6 weeks. Patients should be carefully monitored after the dose is increased.

Missing dose: If you miss a dose, take the missed dose as soon as possible when you remember. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Never take two doses at once. Do not stop taking this medicine without your doctor's advice.

Overdose: If you accidentally take too much, consult your doctor or pharmacist.

Pyrazinamide: The effect of dotinurad may be weakened. Pyrazinamide is known to suppress uric acid secretion in the renal tubules and may antagonize the promotion of uric acid excretion by dotinurad.

Salicylic Acid Preparations (Aspirin): Salicylic acid preparations are known to suppress uric acid excretion and may antagonize the promotion of uric acid excretion by dotinurad.

Dotinurad is contraindicated in patients with known hypersensitivity to any component of the drug.

The most frequently observed adverse effects include gouty arthritis and limb discomfort (occurring in about 1% to less than 5% of patients). Other reported effects such as loose stools, elevated γ-GTP, joint pain, kidney stones, nephrocalcinosis, increased urinary β2-macroglobulin, raised blood creatinine, and elevated urine albumin/creatinine ratio have been noted in less than 1% of patients.

During pregnancy, Dotinurad should be used only if the anticipated therapeutic benefits outweigh potential risks. The drug is excreted into breast milk; therefore, medical advice should be sought before breastfeeding.

Gouty arthritis: As this medicine lowers uric acid levels, it may initially trigger or worsen gout attacks. If a gout flare is present before starting therapy, treatment should be delayed until symptoms subside. If an attack occurs during treatment, therapy may be continued along with medications such as colchicine, NSAIDs, or corticosteroids to manage symptoms.

Patients with urolithiasis: Use should be avoided unless clearly necessary, as increased urinary uric acid excretion may worsen symptoms of urinary stones.

Patients with renal impairment: Alternative treatments should be considered, as efficacy may decrease depending on renal function. Avoid use in patients with oliguria or anuria.

Patients with hepatic impairment: Careful monitoring is recommended, as liver-related adverse effects have been reported with similar drugs.

Agents used in gout; selective urate reabsorption inhibitors

Store below 30°C in a dry place, protected from light. Keep out of reach of children.