Chemical formula: C₂₀H₂₁N₃O Molecular mass: 319.408 g/mol PubChem compound: 6433090
Administration of these products is not recommended to pregnant women or women suspected of being pregnant. Safety of these products has not been established during pregnancy. Transfer to fetus was reported in animal studies (in rats).
Administration of these products is not recommended during breast feeding. When unavoidable, nursing mothers should discontinue breast feeding during treatment of these products. Transfer to breast milk was reported in animal studies (in rats).
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).
Since these products may induce eye accommodation disorder including photophobia, blurred vision, and eye abnormality, patients should be instructed to operate potentially hazardous machinery, such as driving a car, with caution.
Adverse reactions to these products including abnormalities in laboratory test values were reported in 533 (45.5%) of 1,172 cases evaluated. Major adverse reactions included thirst in 368 cases (31.4%), constipation in 98 cases (8.4%), photophobia in 18 cases (1.5%), blurred vision in 16 cases (1.4%), sleepiness in 16 cases (1.4%), stomach discomfort in 13 cases (1.1%), increased triglyceride in 13 cases (1.1%), and increased γ-GTP in 12 cases (1.0%) (at the time of approval).
In additional clinical studies for dosage and administration, adverse reactions including abnormalities in laboratory test values were reported in 215 (49.4%) of 435 cases evaluated. Major adverse reactions included thirst/dry mouth in 164 cases (37.7%), constipation in 59 cases (13.6%), residual urine in eight cases (1.8%), positive urinary leukocyte in seven cases (1.6%), stomach discomfort in six cases (1.4%), headache in five cases (1.1%), and dysuria in five cases (1.1%) (at the time of additional approval for dosage and administration).
In the post-marketing surveillance (drug-use-surveillance and special drug-use-surveillance), adverse reactions including abnormal laboratory test values were reported in 771 (12.7%) of 6,094 cases evaluated. Major adverse reactions included thirst/dry mouth in 321 cases (5.3%), constipation in 160 cases (2.6%). (At the end of reexamination)
(1) Acute glaucoma (incidence: 0.06%) Since incidence of acute glaucoma induced by increased intraocular pressure has been reported, patients should be monitored carefully. When such a symptom is observed, administration should be discontinued, and appropriate measures should be taken immediately.
(2) Urinary retention (incidence: 0.03%†) Since urinary retention may occur, patients should be monitored carefully. When symptoms are observed, administration should be discontinued, and appropriate measures should be taken.
(3) Hepatic dysfunction (incidence: 0.02%†) Hepatic dysfunction with elevations of aspartate aminotransferase (AST or glutamate oxaloacetate transaminase [GOT]), alanine aminotransferase (ALT or glutamate pyruvate transaminase [GPT]), or bilirubin may occur. Patients should be carefully monitored, and if any abnormalities are observed, administration of this drug should be discontinued and appropriate measures should be taken immediately.
†: The incidences of adverse reactions were calculated from the result of post-marketing surveillance (druguse surveillance and special drug-use surveillance).
(1) Ileus paralytic: Since incidence of ileus paralytic has been reported in the similar drugs (other agents for overactive bladder), patients should be monitored carefully. When symptoms including severe constipation and abdominal distention are observed, administration should be discontinued, and appropriate measures should be taken.
(2) Hallucination/delirium: Since incidence of hallucination/delirium has been reported in the similar drugs (other agents for overactive bladder), patients should be monitored carefully. When these symptoms are observed, administration should be discontinued, and appropriate measures should be taken.
(3) QT prolongation, ventricular tachycardia: Since incidence of symptoms including QT prolongation, ventricular tachycardia, atrioventricular block, and bradycardia has been reported in the similar drugs (other agents for overactive bladder), patients should be monitored carefully. When these symptoms are observed, administration should be discontinued, and appropriate measures should be taken.
| ≥ 5% | 5% > to ≥ 0.1% | 0.1% >† | |
|---|---|---|---|
| Hypersensitivity Note2 | Rash, itching, etc. | ||
| Psycho-neurologic | Sleepiness, dysgeusia, dizziness, headache | Numbness, hallucination, delirium | |
| Gastro-Intestinal | Constipation | Stomach discomfort/abdominal discomfort, nausea, abdominal pain, abdominal distention, diarrhea, anorexia, dyspepsia, gastritis, vomiting, lip dry, abnormal faeces, stomatitis | |
| Cardio-vascular | Palpitations, extrasystoles, increased blood pressure | ||
| Respiratory | Pharyngolaryngeal pain, cough, dry throat, hoarseness | ||
| Hematologic | Decreased RBC, decreased WBC, decreased platelets | ||
| Renal/urinary | Dysuria, residual urine, positive WBC and RBC urine, urinary tract infections (cystitis, pyelonephritis, etc.), positive protein urine, increased creatinine | ||
| Ophthalmologic | Photophobia, vision blurred, abnormal sensation in eye, xerophthalmia, asthenopia, eyelid edema, diplopia | ||
| Hepatic | Increased γ-GTP, increased ALP, increased AST (GOT), increased ALT (GPT), increased bilirubin | ||
| Others | Thirst/dry mouth | Increased triglyceride, edema, increased LDH, increased blood uric acid, malaise, increased cholesterol, chest pain, back pain, feeling of weakness, dry skin |
†: The incidences of adverse reactions were calculated from the result of post-marketing surveillance (drug-use surveillance and special drug-use surveillance).
Note: When any of these symptoms is observed, administration should be discontinued, and appropriate measures should be taken.
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