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Careful Administration (Urief Tablets should be administered with care in the following patients): Patients with orthostatic hypotension. [The symptoms may be aggravated.]
Patients with impaired hepatic function. [Elevated plasma drug concentrations may occur. (See Precautions under Dosage & Administration.)]
Patients with impaired renal function. [Elevated plasma drug concentrations have been reported. (See Precautions under Dosage & Administration.)]
Patients treated with phosphodiesterase-5 inhibitors. (See INTERACTIONS.)
Important Precautions: Abnormal ejaculation (e.g. retrograde ejaculation) has been reported. Therefore, Urief Tablets should be used after obtaining the understanding of patients by carefully explaining the risk of abnormal ejaculation. (See ADVERSE REACTIONS.)
Orthostatic hypotension may occur. Therefore, caution should be exercised regarding fluctuations in blood pressure due to changes in body posture.
The symptom such as dizziness may occur. Therefore, the patient should be advised to exercise caution when engaging in hazardous activities such as working at heights or driving a car.
Prior to commencement of treatment with Urief Tablets, the patient should be asked whether they are taking any hypotensive drugs and, in the event that any hypotensive drug are used, attention should be paid to changes in blood pressure while using Urief Tablets. If a decrease in blood pressure occurs, appropriate therapeutic actions, such as a dosage reduction or discontinuation of treatment, should be taken.
It should be borne in mind that treatment with Urief Tablets does not eliminate the cause of the disease, but gives symptomatic relief. If treatment with Urief Tablets does not result in the expected effect, consideration should be given to other appropriate therapeutic measures such as surgery.
Precautions concerning use: Precaution in dispensing: Patients should be instructed to press the tablet out of a press-through package (PTP) and take it.
[It has been reported that, if the PTP sheet is swallowed, the hard and sharp corners of the sheet may puncture the esophageal mucosa, resulting in severe complications such as mediastinitis.]
Other precautions: Intraoperative Floppy Iris Syndrome (IFIS): IFIS (a variant of small pupil syndrome) has been observed during cataract surgery in some patients on α1-blockers or previously treated with α1-blockers. During pre-operative assessment, eye surgeons and ophthalmic teams should consider whether patients scheduled for cataract surgery are being or have been treated with Urief Tablets, in order to ensure that appropriate measures will be in place to manage IFIS during surgery.
In a 104-week administration study in mice, it has been reported that the frequency of seminal vesicle dilatation was increased at doses of 20 mg/kg/day or more.
In a study on fertility and early embryogenesis until implantation in rats, it has been reported that deciduation of sperm cells in seminiferous tubules was observed at doses of 200 mg/kg/day or more and atrophy/degeneration of seminiferous tubules as well as decreased sperm survival and sperm count were observed at a dose of 600 mg/kg/day.
Use in the Elderly: In a patient with impaired hepatic function or renal function, it should take into account to start treatment at a low dose (2 mg daily) of URIEF while observing a patient's condition. Geriatric patient have generically reduced physiological function.
