Dotinurad Dotinurad Dotinurad 2 mg Gout Hyperuricemia Dotinurad 100 tablets

Dotinurad is a highly selective urate transporter 1 (URAT1) inhibitor developed by Fuji Pharmaceuticals and Eisai of Japan. It is mainly used to treat hyperuricemia and gout, especially for people with renal impaired function or intolerance to traditional drugs.

1. Basic information of the drug

1. Generic name : Dotinurad; Dotinurad ; Dotinurad
2. Product name : ユリス (Fuji Soup)
3. Dosage form : Oral tablet
4. Indications : Drug for the treatment of hyperuricemia, drug for inhibiting uric acid transporters, used for gout ( DS: H01532 ).
5. Element :
• Composition formula: C₁₄ H₉ Cl₂ NO₄ S
• Molecular weight: 358.20
6. Properties : /

2. Usage and Dosage

Adults: The usual dose is 0.5 mg per day, after which the dose is gradually increased as needed, while checking the blood uric acid level. The maintenance dose is usually 2 mg per day, which can be adjusted according to the patient's condition, but the maximum dose should be 4 mg per day.

3. Taboo

It is contraindicated for those who are allergic to the ingredients of this product.

This medicine is not recommended for patients with hyperuricemia caused by excessive uric acid production.

Use with caution in pregnant and lactating women.

IV. Precautions

Special populations: It can be used by patients with mild to moderate renal impairment; patients with severe renal impairment should use it with caution and adjust the dosage according to the doctor's advice.

Medication guidance: Maintain adequate drinking water to promote uric acid excretion. It is recommended to monitor blood uric acid levels and renal function indicators.

Drug storage: Avoid high temperature and humidity, store in a cool and dry place.

5. Adverse Reactions

Common (incidence ≥ 1% ): abnormal liver function (elevated AST , ALT ), nausea, diarrhea

Uncommon: rash, itching, edema

Rare: severe liver damage, anaphylactic shock (need to stop the drug and treat urgently).

6. Drug Interactions

When used in combination with other uric acid-lowering drugs (such as benzbromarone, febuxostat), changes in uric acid levels should be closely monitored.

When nephrotoxic drugs (such as NSAIDs ) are used simultaneously, renal function should be monitored more closely.

Combination use with diuretics may reduce the effectiveness of this drug.

7. Pharmacological Action

Mechanism of action : By inhibiting the uric acid transporter SLC22A12 ( URAT1 ), it reduces uric acid reabsorption and lowers blood uric acid levels.

8. Pharmacokinetics

Absorption: Rapidly absorbed after oral administration, reaching peak value in approximately 1 hour.

Distribution: High plasma protein binding ( >98% )

Metabolism: Mainly metabolized in the liver

Excretion: Mainly excreted through bile, partially excreted through kidneys

Half-life: approximately 10 hours, supporting once-daily dosing.

IX. Clinical Research

In a Japanese Phase III clinical trial, Dotinurad 1 mg/ day treatment for 12 weeks significantly reduced serum uric acid levels and was superior to the placebo group.

Compared with benzbromarone, it has comparable efficacy in uric acid control but is less hepatotoxic.

In patients with mild to moderate renal impairment, the efficacy is still good and the drug is well tolerated.

10. Packaging specifications

0.5mg 100 tablets.

1mg 100 tablets.

2mg 100 tablets.

11. Production Information

Manufacturer : Fuji Pharmaceutical Co., Ltd.