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(3) an increase in pulse rate of . 20 bpm upon standing with a standing pulse rate . 100 bpm during the orthostatic test; and (4) the presence of clinical symptoms (faintness, lightheadedness/ lightheaded, dizziness, spinning sensation, vertigo, or postural hypotension) upon standing during the orthostatic test. Following the first dose of double-blind medication in Study 1, a positive orthostatic test result at 4 hours post-dose was observed in 7% of patients (37 of 498) who received FLOMAX capsules 0.4 mg once daily and in 3% of the patients (8 of 253) who received placebo. At 8 hours post-dose, a positive orthostatic test result was observed for 6% of the patients (31 of 498) who received FLOMAX capsules 0.4 mg once daily and 4% (9 of 250) who received placebo (Note: patients in the 0.8 mg group received 0.4 mg once daily for the first week of Study 1). Text Continues Below
In Studies 1 and 2, at least one positive orthostatic test result was observed during the course of these studies for 81 of the 502 patients (16%) in the FLOMAX capsules 0.4 mg once daily group, 92 of the 491 patients (19%) in the FLOMAX capsules 0.8-mg once daily group and 54 of the 493 patients (11%) in the placebo group. Because orthostasis was detected more frequently in FLOMAX capsule-treated patients than in placebo recipients, there is a potential risk of syncope (see WARNINGS). Abnormal Ejaculation: Abnormal ejaculation includes ejaculation failure, ejaculation disorder, retrograde ejaculation and ejaculation decrease. As shown in Table 3, abnormal ejaculation was associated with FLOMAX capsules administration and was dose-related in the U. S. studies. Withdrawal from these clinical studies of FLOMAX capsules because of abnormal ejaculation was also dose-dependent with 8 of 492 patients (1.6%) in the 0.8 mg group, and no patients in the 0.4 mg or placebo groups discontinuing treatment due to abnormal ejaculation. Post-Marketing Experience Allergic-type reactions such as skin rash, pruritus, angioedema of tongue, lips and face and urticaria have been reported with positive rechallenge in some cases. Priapism has been reported rarely. Infrequent reports of palpitations, constipation and vomiting have been received during the post-marketing period. Page: << Prev | 1 | 2
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