In a retrospective analysis of the safety and tolerability of FLOMAX 0.4 mg in 574 younger (age range 42 to 64) and older (age range 65 to 83) men with symptomatic BPH:
- The incidence of drug-related adverse events and discontinuations due to adverse events was similar in the older and younger patients treated with FLOMAX, and was not significantly different from placebo1
- There was no statistically significant difference in the incidence of abnormal ejaculation (retrograde ejaculation, delayed ejaculation or decreased volume of ejaculate) between patients treated with FLOMAX and patients treated with placebo in either age group1
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. Chapple CR, Baert L, Thind P, Höfner K, Khoe GSS, Spångberg A, for the European Tamsulosin Study Group. Tamsulosin 0.4 mg once daily: tolerability in older and younger patients with lower urinary tract symptoms suggestive of benign prostatic obstruction (symptomatic BPH). Eur Urol. 1997;32:462-470.
