Urotex Special Precautions

Careful Administration (UROTEX 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.] (See Dosage & Administration.)
Patients with impaired renal function [Elevated plasma drug concentrations have been reported.] (See Dosage & Administration and Pharmacology: Pharmacokinetics under Actions.)
Patients treated with phosphodiesterase-5 inhibitors. (See Interactions.)
Important Precautions: Abnormal ejaculation (e.g., retrograde ejaculation) has been reported. Therefore, UROTEX 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 UROTEX, 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 UROTEX. 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 UROTEX does not eliminate the cause of the disease, but gives symptomatic relief. If treatment with UROTEX does not result in the expected effect, consideration should be given to other appropriate therapeutic measures such as surgery.
Since 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, 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: 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.
Effects on ability to drive and use machines: 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.