Urief Special Precautions

Careful Administration [Silodosin (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].
Patients with impaired renal function [Elevated plasma drug concentrations have been reported].
Patients treated with phosphodiesterase-5 inhibitors.
Important Precautions: Abnormal ejaculation (e.g., retrograde ejaculation) has been reported. Therefore, this drug 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.
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 Silodosin (Urief) the patient should be asked whether they are taking any hypotensive drugs and, in the event that any hypotensive drug is used, attention should be paid to changes in blood pressure while using Silodosin (Urief). If a decrease in blood pressure occurs, appropriate therapeutic actions, such as dosage reduction or discontinuation of treatment, should be taken.
It should be borne in mind that treatment with this drug does not eliminate the cause of the disease, but gives symptomatic relief. If treatment with Silodosin (Urief) does not result in the expected effect, consideration should be given to other appropriate therapeutic measures such as surgery.
Since benign prostatic hyperplasia (BPH) and prostate carcinoma may present the same symptoms and can co-exist, patients thought to have BPH should be examined prior to starting therapy with Silodosin (Urief), to rule out the presence of carcinoma of the prostate. Digital rectal examination and, when necessary, determination of prostate specific antigen (PSA) should be performed before treatment and at regular intervals afterwards.
Other Precautions: This drug is associated with a high incidence of adverse reactions and abnormal ejaculation is reported frequently as a characteristic adverse reaction. Silodosin (Urief) should be used after careful consideration is given to the risks associated with its use and carefully explaining the adverse reactions to the patient.
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.
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 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: 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, such as start administration at a low dose (2 mg/dose).