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Dotinurad

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Dotinurad, developed by Japan's Fuji Pharmaceutical Co., Ltd., is a drug used to treat hyperuricemia and gout.

1. Drug name

1. Common name: Dotinurad

2. Trade name: UreceT ablets)

3. Specifications:0.5mg, 1mg, 2mg

2. Indications

Used to treat gout and hyperuricemia (except those with excessive uric acid production).

3. Specifications and properties

1. Specifications: Each tablet contains 0.5mg, 1mg or 2mg of dotinaide.

2. Characteristics:

0.5 mg: white to light yellow-white tablets, about 6.5mm in diameter and 2.8mm in thickness, identification code FY321.

1mg: White plain tablet with a score on one side.

2mg: very light red tablet, diameter about 8.0mm, thickness about 3.8mm, identification code FY323, with a notch on one side.

IV. Main ingredients

1. Each tablet contains 0.5mg, 1mg or 2mg of dotenadine.

2. Excipients include: Lactose hydrate, D-mannitol, microcrystalline cellulose, hypromellose, carboxymethylcellulose, magnesium stearate (2mg specification also contains iron oxide).

V. Usage and Dosage

1. Routine dosage for adults: Take orally once a day, the starting dose is 0.5 mg, and gradually increase according to the blood uric acid level.

2. Maintenance dose: Usually 2 mg per day, which can be adjusted according to the patient's condition. The maximum dose is 4 mg per day.

3. Dose adjustment: In the initial stage of treatment, the dose needs to be increased slowly to avoid gout attacks:

Weeks 1-2: 0.5mg/day

Weeks 3-6: 1mg/day

From week 7: 2mg/day, it can be increased to 4mg/day if necessary.

6. Medication Precautions

1. Before and after meals: It can be taken with food or on an empty stomach. Food will slightly delay the peak time but does not affect absorption.

2. Missed dose: If you miss a dose, you should take it as soon as possible. If it is close to the next dose time, skip it. Do not double the dose.

3. Vomiting: If you vomit after taking the medicine, you need to judge whether to take more medicine according to the time of vomiting, and consult a doctor if necessary.

4. Others: It is necessary to drink enough water and alkalize urine to prevent urinary tract stones.

7. Medication for special groups

1. Renal insufficiency:

(1.) Avoid use in patients with severe renal impairment (eGFR<30mL/min/1.73m²);

(2.) Mild to moderate patients need careful monitoring.

2. Liver insufficiency: People with mild to severe liver damage need to be closely observed and have their liver function checked regularly.

3. Elderly people: The pharmacokinetics are not significantly different from those of young people, so there is no need to adjust the dose.

4. Pregnant women and lactation periods:

Pregnant women should only use it when the benefits outweigh the risks (animal experiments show the risk of skeletal deformities);

During lactation period, the necessity of medication needs to be weighed, as drugs can enter breast milk.

8. Adverse reactions

Common side effects include:

(1.) Gouty arthritis (≥5%), joint pain, and limb discomfort (1-5%);

(2. ) Abnormal liver function (increased γ-GTP, ALT, AST);

(3.) Gastrointestinal reactions (soft stool, diarrhea, nausea);

(4.) Abnormal renal function-related indicators (kidney stones, elevated blood creatinine, etc.).

9. Contraindications

1. It is prohibited for those who are allergic to the ingredients of this product;

2. In principle, it is prohibited for patients with urinary tract stones (unless necessary and closely monitored).

10. Drug interactions

1. Pyrazinamide: may weaken the uric acid-lowering effect of this product;

2. Salicylic acid preparations (such as aspirin): may antagonize the effect of this product;

3. Oxabutynin: Combined use may increase the plasma concentration of dotenadine.

11. Storage method

Store at room temperature and avoid moisture; valid for 3 years.

12. Manufacturer

Manufacturer: Fuji Pharmaceutical Co., Ltd. (Fuji Pharmaceuticals).