Precautions

Important Precautions Precaution on Special Populations Precaution Concerning Dosage & Administration (N/A) Precaution Concerning Use

Important Precautions

1) In patients with lower urinary-tract obstructive disease, including benign prostatic hyperplasia, the volume of residual urine should be measured prior to treatment with this product, and special examinations should be performed if necessary. The patients should be monitored carefully throughout the treatment, with attention to increased volume of residual urine.

2) Since this product may induce eye accommodation disorder (including photophobia, blurred vision and eye abnormality), dizziness and sleepiness, patients should be instructed to operate potentially hazardous machinery, such as a car, with caution.

3) This product is not indicated for patients with dementia or cognitive dysfunction who cannot clearly recognize symptoms of overactive bladder.

4) When no satisfactory efficacy is observed, treatment with this product should not be continued chronically, and an alternative appropriate therapy should be considered.

5) Prior to use of this product, clinical symptoms of patients should be confirmed with an appropriate interview, and diagnosis by exclusion of some other diseases with similar symptoms, including urinary tract infection, urinary calculus, and lower urinary tract neoplasm such as bladder cancer and prostate cancer, should be made by performing appropriate examinations such as urinalysis. In addition, special examinations should be considered to conduct, if necessary.

6) In patients complicated with lower urinary tract obstructive disease, including benign prostatic hypertrophy, treatment of the complication should be given priority.

7) An increase in hepatocellular adenoma was reported in 300 mg/kg groups of both males and females in the carcinogenicity study in mice for 2 years (at the oral doses of 30, 100, and 300 mg/kg), while increase in hepatocellular adenoma was not reported in the carcinogenicity study in rats for 2 years (at the oral doses of 3, 7, 15, and 30 mg/kg).


Precautions on Special Populations

lmidafenacin (UritosĀ®) should be administered with care in the following patients.

1) Patients with dysuria [Symptoms may be aggravated due to the anticholinergic effect of this product.]

2) Patients with arrhythmia [Symptoms may be aggravated due to the anticholinergic effect of this product.]

3) Patients with hepatic dysfunction [Adverse reactions may occur since this product are primarily metabolized in the liver]

4) Patients with renal dysfunction [Renal excretion may be delayed.]

5) Patients with dementia or cognitive dysfunction [Symptoms may be aggravated due to the anticholinergic effect of this product.]

6) Patients with Parkinsonian symptoms or cerebrovascular disorder [Symptoms may be aggravated or psychoneurotic symptoms may occur.]

7) Patients with ulcerative colitis [Toxic megacolon may occur.]

8) Patients with hyperthyroidism [Sympathetic excitation including tachycardia may be aggravated due to the anticholinergic effect of this product.]

USE IN THE ELDERLY

Since physiological functions are generally reduced in the elderly, this product should be administered with care.

PEDIATRIC USE

Safety of this product has not been established in low birthweight babies, neonates, nursing infants, infants, or children (no clinical experience).


Precaution Concerning Use

For drugs supplied in a press-through package (PTP), patients should be instructed to remove the drugs from the package prior to administration. [It has been reported that, if the PTP sheet is swallowed mistakenly, the sharp edge of the sheet may perforate the esophageal mucosa, resulting in serious complications such as mediastinitis.]