Uroxatral Side Effects, and Drug Interactions - Alfuzosin HCl

Uroxatral Side Effects, and Drug Interactions - Alfuzosin HCl

SIDE EFFECTS

The incidence of treatment-emergent adverse events has been ascertained from 3 placebo-controlled clinical trials involving 1,608 men in which daily doses of 10 and 15 mg alfuzosin were evaluated. In these 3 trials, 473 men received UROXATRAL (alfuzosin HCl 10 mg extended release tablets). In these studies, 4% of patients taking UROXATRAL (alfuzosin HCl extended release tablets) 10 mg tablets withdrew from the study due to adverse events, compared with 3% in the placebo group.

Table 4 summarizes the treatment-emergent adverse events that occurred in 2% of patients receiving UROXATRAL, and at an incidence numerically higher than that of the placebo group. In general, the adverse events seen in long-term use were similar in type and frequency to the events described below for the 3-month trials.

The following adverse events, reported by between 1% and 2% of patients receiving UROXATRAL and occurring more frequently than with placebo, are listed alphabetically by body system and by decreasing frequency within body system:

Body as a whole: pain

Gastrointestinal system: abdominal pain, dyspepsia, constipation, nausea

Reproductive system: impotence

Respiratory system: bronchitis, sinusitis, pharyngitis

The following adverse events have also been reported in postmarketing experience: rash, tachycardia, chest pain, priapism.

Signs and Symptoms of Orthostasis in Clinical Studies: The adverse events related to orthostasis that occurred in the double-blind phase 3 studies with alfuzosin 10 mg are summarized in Table 5. Approximately 20% to 30% of patients in these studies were taking antihypertensive medication.

Multiple testing for blood pressure changes or orthostatic hypotension was conducted in the three controlled studies at each scheduled clinic visit (Days 14, 28, 56, and 84). Patients with a decrease in systolic blood pressure of >20 mm Hg after 2 minutes standing following being supine were excluded from the three trials. These tests were considered positive for blood pressure decrease if (1) supine systolic blood pressure was £90 mm Hg, with a decrease ³20 mm Hg versus baseline, and/or (2) supine diastolic blood pressure was £50 mm Hg, with a decrease 15 mm Hg versus baseline. The tests were considered positive for orthostatic hypotension if there was a decrease in systolic blood pressure of ³20 mm Hg upon standing from the supine position during the orthostatic tests. According to these definitions, decreased systolic blood pressure was observed in none of the 674 placebo patients and 1 (0.2%) of the 469 UROXATRAL patients. Decreased diastolic blood pressure was observed in 3 (0.4%) of the placebo patients and in 4 (0.9%) of the UROXATRAL patients. A positive orthostatic test was seen in 52 (7.7%) of placebo patients and in 31 (6.6%) of the UROXATRAL patients.

No vital sign measurements were obtained following first dose administration in the phase 3 studies, except for a subset of patients in study 1 who had blood pressure measurements 12 to 16 hours after the first dose to assess the potential to produce orthostatic hypotension. None of these 35 UROXATRAL treated patients showed a positive test for systolic, diastolic or orthostatic blood pressure change.

DRUG INTERACTIONS

No specific information available.