lacebo
(n=167) UROXATRAL
10 mg
(n=170) Placebo
(n=152) UROXATRAL
10 mg
(n=137) Placebo
(n=150) UROXATRAL
10 mg
(n=151)
*
Difference between baseline and week 12.
Total symptom score
Baseline 18.2
(6.4) 18.2 (6.3) 17.7
(4.1) 17.3 (3.5) 17.7
(5.0) 18.0 (5.4)
Change* -1.6
(5.8) -3.6 (4.8) -4.9
(5.9) -6.9 (4.9) -4.6
(5.8) -6.5 (5.2)
p-value 0.001 0.002 0.007
Figure 2 — Mean Change from Baseline in IPSS Total Symptom Score: Trial 1
Figure 3 — Mean Change from Baseline in IPSS Total Symptom Score: Trial 2
Figure 4 — Mean Change from Baseline in IPSS Total Symptom Score: Trial 3
Peak urinary flow rate was increased statistically significantly from baseline to last assessment (Week 12) versus placebo in trials 1 and 2 (Table 5 and Figures 5, 6, and 7).
Table 5 — Mean (SD) Change from Baseline to Week 12 in Peak Urine Flow Rate (mL/sec) in Three Randomized, Controlled, Double-Blind Trials Trial 1 Trial 2 Trial 3
Placebo
(n=167) UROXATRAL
10 mg
(n=170) Placebo
(n=147) UROXATRAL
10 mg
(n=136) Placebo
(n=150) UROXATRAL
10 mg
(n=151)
*
Difference between baseline and week 12.
Mean Peak flow rate
Baseline 10.2 (4.0) 9.9 (3.9) 9.2 (2.0) 9.4 (1.9) 9.3 (2.6) 9.5 (3.0)
Change* 0.2 (3.5) 1.7 (4.2) 1.4 (3.2) 2.3 (3.6) 0.9 (3.0) 1.5 (3.3)
p-value 0.0004 0.03 0.22
Figure 5 — Mean Change from Baseline in Peak Urine Flow Rate (mL/s): Trial 1
Figure 6 — Mean Change from Baseline in Peak Urine Flow Rate (mL/s): Trial 2
Figure 7 — Mean Change from Baseline in Peak Urine Flow Rate (mL/s): Trial 3
Mean total IPSS decreased at the first scheduled observation at Day 28 and mean peak flow rate increased starting at the first scheduled observation at Day 14 in trials 2 and 3 and Day 28 in trial 1.
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16 HOW SUPPLIED/STORAGE AND HANDLING
UROXATRAL is supplied as follows:
Package NDC Number
Bottles of 100 0024-4200-10
UROXATRAL (alfuzosin HCl) extended-release tablet 10 mg is available as a round, three-layer tablet: one white layer between two yellow layers, debossed with X10.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Protect from light and moisture.
Keep UROXATRAL out of reach of children.
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17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling
17.1 Hypotension/Syncope
Patients should be told about the possible occurrence of symptoms related to postural hypotension, such as dizziness, when beginning UROXATRAL, and they should be cautioned about driving, operating machinery, or performing hazardous tasks during this period. This is important for those with low blood pressure or who are taking antihypertensive medications or nitrates [see Warnings and Precautions (5.1)].
17.2 Intraoperative Floppy Iris Syndrome
Patients should be instructed to tell their ophthalmologist about their use of UROXATRAL before cataract surgery or other procedures involving the eyes, even if the patient is no longer taking UROXATRAL [see Warnings and Precautions (5.6)].
17.3 Priapism
Patients should be advised about the possibility of priapism resulting from treatment with UROXATRAL and medications in the same class. Although this reaction is extr |
