Urief Special Precautions

Urief is associated with a high incidence of adverse reactions and abnormal ejaculation is reported frequently as a characteristic adverse reaction. Urief tablet should be used after careful consideration is given to the risks associated with its use and carefully explaining the adverse reactions to the patient. (See Adverse Reactions.)
The plasma concentration of silodosin may be elevated in patients with impaired hepatic function. It has been reported that plasma concentration of silodosin is increased in patients with impaired renal function. Therefore, starting treatment at a low dose (2 mg/dose) while observing the condition of the patient, for instance, should be considered. (See Pharmacology: Pharmacokinetics under Actions.)
Careful Administration: Urief should be administered with care in the following patients: Patients with orthostatic hypotension. Symptoms may be aggravated.
Patients with impaired hepatic function. Elevated plasma drug concentrations may occur as previously mentioned.
Patients with impaired renal function. Elevated plasma drug concentrations have been reported as previously mentioned.
Patients treated with phosphodiesterase-5 inhibitors. (See Interactions.)
Important Precautions: Abnormal ejaculation (eg, retrograde ejaculation) has been reported. Therefore, Urief 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.
Prior to commencement of treatment with Urief, the patient should be asked whether they are taking any hypotensive drugs and, in the event that any hypotensive drugs are used, attention should be paid to changes in blood pressure while using Urief. If a decrease in blood pressure occurs, appropriate therapeutic actions eg, a dosage reduction or discontinuation of treatment should be taken.
It should be borne in mind that treatment with Urief does not eliminate the cause of the disease, but gives symptomatic relief. If treatment with Urief does not result in the expected effect, consideration should be given to other appropriate therapeutic measures eg, surgery.
Other Precautions: It has been reported that intraoperative floppy iris syndrome (IFIS) attributable to α1-blocking effect had been observed in patients who are currently receiving treatment with an α1-blocker or who have previously received such treatment.
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.
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 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.
Effects on the Ability to Drive or Operate Machinery: The symptom eg, dizziness may occur. Therefore, the patient should be advised to exercise caution when engaging in hazardous activities eg, working at heights or driving a car.
Use in pregnancy & lactation: Not applicable as silodosin is intended for male patients only.
Use in the elderly: The elderly often have reduced physiological function. If hepatic or renal function is reduced, the elderly should be treated while carefully monitoring the condition of the patient eg, start administration at a low dose (2 mg/dose). (See Dosage & Administration.)