Urece Special Precautions

Precautions Concerning Indications: Patients should be selected for application of URECE in reference to the disease type and the latest treatment guidelines. [See Pharmacology: Pharmacodynamics: Clinical Studies under Actions.]
Precautions Concerning Dosage and Administration: Since gouty arthritis (gout attack) may be induced by a rapid decrease in blood uric acid level in the early stage of treatment with urate-lowering drugs, the dosage of URECE should be started at 0.5 mg once daily, followed by a gradual dose increase, for instance, to 1 mg once daily after the first 2 weeks of treatment and then to 2 mg once daily after 6 weeks of treatment. Patients should be carefully monitored after a dose increase. [See as follows and Pharmacology: Pharmacodynamics: Clinical Studies under Actions.]
Important Precautions: URECE, a urate-lowering drug, may exacerbate gouty arthritis (gout attack) due to a decrease in blood uric acid level when used during gouty arthritis (gout attack). Treatment with URECE should not be started in patients with gouty arthritis (gout attack) until the symptoms have disappeared.
If gouty arthritis (gout attack) occurs during treatment with URECE, treatment should be continued without changing the dose level, and colchicine, non-steroidal anti-inflammatory drugs, and/or corticosteroids should be added according to the patient's condition. [See as follows.]
The pharmacological action of URECE causes an increase in uric acid excretion, especially in the early stages of administration, and if the urine is acidic, the patient may develop urinary calculus and resultant symptoms such as hematuria and renal colic. Urinary calculus should be prevented by increasing the water intake and thus increasing urine output, and by trying to alkalinize the urine. In this case, attention should be paid to the patient's acid-base balance.
Since serious liver disorder has been reported with other uricosurics, patients should be carefully monitored through periodic liver function testing, etc., during administration of URECE. [See as follows.]
Precautions Concerning Patients With Specific Backgrounds: Patients with Complication or History of Diseases, etc.: Patients with urinary calculus: Do not administer unless deemed unavoidable for the sake of treatment. URECE may exacerbate symptoms of urinary calculus by increasing the urinary excretion of uric acid due to its pharmacological effects. URECE has not been administered to patients with urinary calculus in clinical studies.
Patients with Renal Impairment: Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²): Alternative treatment should be considered. Since URECE acts in the renal proximal tubules, its efficacy may be reduced depending on the severity of the renal impairment. In particular, URECE should not be administered in patients with oliguria or anuria, since it is not expected to be effective.
Patients with an eGFR < 30 mL/min/1.73 m² were excluded from clinical studies.
Patients with Hepatic Impairment: Patients should be closely monitored. Serious liver disorder has been observed with other uricosurics.
Patients with serious liver disease or an AST or ALT ≧100 IU/L were excluded from clinical studies. [See as previously mentioned.]
Precautions For Co-Administration (URECE should be administered with care when co-administered with the following drugs.) (See Table 12.)

Click on icon to see table/diagram/image

Precautions Concerning Use: Precautions when Dispensing the Drug: For drugs that are dispensed in a press-through package (PTP), patients should be instructed to remove the drug from the package prior to use. If part of the PTP sheet is swallowed, the sharp corners of the sheet may puncture the esophageal mucosa, resulting in severe complications such as mediastinitis.
Effects on ability to drive and use machines: Not applicable.