Objective
A long-term (up to 6 years) clinical trial of α-blockade therapy for patients with BPH was conducted. It evaluated the effectiveness and safety of FLOMAX in patients with lower urinary tract symptoms (LUTS) due to BPH.
Design
The study enrolled 609 men after the completion of a one-year, open-label study that included patients who had previously completed up to 57 weeks of double-blind, placebo-controlled studies. Of the 609 patients who entered the four-year extension study, 159 had ≥2 years' prior experience with tamsulosin, yielding a potential 6-year experience on the medication. Of this 159-patient subset, 109 completed the 6 years. All men enrolled in the study continued maintenance doses of tamsulosin (0.4 mg/day or 0.8 mg/day).1
Important Safety Information
FLOMAX is indicated to treat the signs and symptoms of benign prostatic hyperplasia (BPH). FLOMAX is not indicated to treat hypertension. As with other alpha-adrenergic blocking agents, there is a potential risk of syncope. Patients beginning treatment with FLOMAX should be cautioned to avoid driving or hazardous tasks for 12 hours after their first dose or increase in dose should syncope occur. The most common side effects are dizziness, abnormal ejaculation, and rhinitis.
Caution should be exercised with concomitant administration of warfarin and FLOMAX. In addition, FLOMAX should be used with caution in combination with cimetidine, particularly at doses higher than 0.4 mg. FLOMAX is contraindicated in patients known to be hypersensitive to tamsulosin HCl or any component of FLOMAX.
Before prescribing FLOMAX, please see the full Prescribing Information.
1. Narayan P, Evans CP, Moon T. Long-term safety and efficacy of tamsulosin for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia. J Urol. 2003;170:498-502.
