Dotfix Tablet

Dotfix is indicated for the treatment of gout and hyperuricemia.

Dotinurad is a URAT1-selective urate reabsorption inhibitor that selectively inhibits URAT1 and inhibits urate reabsorption, thereby increasing urinary urate excretion and lowering serum urate levels. In addition, since it has weak inhibitory effects on ABCG2, OAT1 and OAT3 other than URAT143,44, it is expected to effectively lower serum uric acid levels without affecting uric acid secretion via these transporters. Thus, Dotinurad is a selective urate reabsorption inhibitor (SURI) that inhibits the reabsorption pathway mediated by URAT1 without inhibiting the uric acid secretion pathway mediated by ABCG2, OAT1 and OAT3 because of its high URAT1 selectivity.

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

Salicylic acid preparations Aspirin: Salicylic acid preparations are known to suppress uric acid excretion and may antagonize the promotion of uric acid excretion by Dotfix.

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

The most commonly reported side effects gouty arthritis, limb discomfort (1% to less than 5%). (Loose stools, increased y-GTP, arthralgia, kidney stones, nephrocalcinosis, increased urinary y2 macroglobulin, increased blood creatinine, increased urine albumin/creatinine ratio, positive urine albumin) has been reported in less than 1% patients.

During pregnancy, Dotinurad should only be treated if the therapeutic benefits are judged to outweigh the risks. This drug is excreted in breast milk. Consult your doctor before breastfeeding.

Gouty Arthritis: Dotfix is a uric acid-lowering drug and lowering the blood uric acid level at the onset of gouty arthritis (gouty attack) may exacerbate gouty arthritis (gouty attack). If gouty arthritis (gout attack) is observed before administration of Dotfix, administration of Dotfix should not be started until the symptoms subside. In addition, if gouty arthritis (gouty attack) occurs during administration of Dotfix, administration should be continued without changing the dose of Dotfix and colchicine, non-steroidal anti-inflammatory drugs, corticosteroids etc. may be administered depending on the symptoms. Use together.

Patients with urolithiasis: Do not administer unless it is judged to be unavoidable for treatment. The pharmacological action of Dotfix may exacerbate the symptoms of urinary calculi due to increased urinary uric acid excretion.

Patients with renal impairment: Consider treatment with other agents. Since Dotfix acts in the renal proximal tubule, its efficacy may be reduced depending on the degree of renal dysfunction. In particular, administration of Dotfix should be avoided in patients with oliguria or anuria, as its efficacy cannot be expected.

Patients with hepatic impairment: Careful follow-up should be performed. Serious liver damage has been observed with other uricosuric agents.

Drugs used in Gout, Urate reabsorption inhibitor

Store below 30°C and dry place, away from light. Keep out of the reach of children.