These highlights do not include all the information needed to use tamsulosin hydrochloride safely and effectively. See full prescribing information for tamsulosin hydrochloride. Tamsulosin Hydrochloride Capsules USP*, 0.4 mg Initial U.S. App | TAMSULOSIN HYDROCHLORIDE
|
BODY SYSTEM/ ADVERSE EVENT |
TAMSULOSIN HYDROCHLORIDE CAPSULES GROUPS 0.4 mg 0.8 mg n=502 n=492 |
PLACEBO n=493 |
|
|---|---|---|---|
| BODY AS WHOLE |
|
|
|
| Headache |
97 (19.3%) |
104 (21.1%) |
99 (20.1%) |
| Infection2
|
45 (9.0%) |
53 (10.8%) |
37 (7.5%) |
| Asthenia |
39 (7.8%) | 42 (8.5%) | 27 (5.5)% |
| Back Pain |
35 (7.0%) |
41 (8.3%) | 27 (5.5%) |
| Chest Pain |
20 (4.0%) | 20 (4.1%) | 18 (3.7%) |
| NERVOUS SYSTEM |
|
|
|
| Dizziness |
75 (14.9%) | 84 (17.1%) | 50 (10.1%) |
| Somnolence |
15 (3.0%) | 21 (4.3%) | 8 (1.6%) |
| Insomnia |
12 (2.4%) |
7 (1.4%) | 3 (0.6%) |
| Libido Decreased |
5 (1.0%) |
10 (2.0%) |
6 (1.2%) |
| RESPIRATORY SYSTEM |
|
|
|
| Rhinitis3
|
66 (13.1%) |
88 (17.9%) | 41 (8.3%) |
| Pharyngitis |
29 (5.8%) | 25 (5.1%) | 23 (4.7%) |
| Cough Increased |
17 (3.4%) |
22 (4.5%) |
12 (2.4%) |
| Sinusitis |
11 (2.2%) |
18 (3.7%) |
8 (1.6%) |
| DIGESTIVE SYSTEM |
|
|
|
| Diarrhea |
31 (6.2%) |
21 (4.3%) | 22 (4.5%) |
| Nausea |
13 (2.6%) |
19 (3.9%) | 16 (3.2%) |
| Tooth Disorder |
6 (1.2%) |
10 (2.0%) | 7 (1.4%) |
| UROGENITAL SYSTEM |
|
|
|
| Abnormal Ejaculation |
42 (8.4%) |
89 (18.1%) | 1 (0.2%) |
| SPECIAL SENSES |
|
|
|
| Blurred vision |
1 (0.2%) |
10 (2.0%) | 2 (0.4%) |
| Pharmacokinetic 0.4 mg QD to healthy volunteers; m=23 0.8 mg QD to healthy volunteers; n=22 Parameter (age range 18 to 32 years) (age range 18 to 32 years) Light Breakfast Fasted Light Breakfast High-Fast Breakfast Fasted |
|||||
|---|---|---|---|---|---|
| Cmin (ng/mL) |
4.0 ± 2.6 |
3.8 ± 2.5 |
12.3 ± 6.7 |
13.5 ± 7.6 |
13.3 ± 13.3 |
| Cmax (ng/mL) |
10.1 ± 4.8 |
17.1 ± 17.1 |
29.8 ± 10.3 |
29.1 ± 11.0 |
41.6 ± 15.6 |
| Cmax/Cmin Ratio |
3.1 ± 1.0 |
5.3 ± 2.2 |
2.7 ± 0.7 |
2.5 ± 0.8 |
3.6 ± 1.1 |
| Tmax (hours) |
6.0 |
4.0 |
7.0 |
6.6 |
5.0 |
| T1/2 (hours) |
- |
- |
- |
- |
14.9 ± 3.9 |
| AUCτ (ng•hr/mL) |
151 ± 81.5 |
199 ± 94.1 |
440 ± 195 |
449 ± 217 |
557 ± 257 |
|
|
Total AUA Symptom Score
Mean Baseline Value |
Mean Change |
Peak Urine Flow Rate Mean Baseline Value |
Mean Change |
|---|---|---|---|---|
| Study 1 † |
|
|
|
|
| Tamsulosin hydrochloride capsules 0.8 mg once daily |
19.9 ± 4.9 n=247 |
-9.6* ± 6.7 n=237 |
9.57 ± 2.51 n=247 |
1.78* ± 3.35 n=247 |
| Tamsulosin hydrochloride capsules 0.4 mg once daily |
19.8 ± 5.0 n=254 |
-8.3* ± 6.5 n=246 |
9.46 ± 2.49 n=254 |
1.75* ± 3.57 n=254 |
| Placebo | 19.6 ± 4.9 n=254 |
-5.5 ± 6.6 n=246 |
9.75 ± 2.54 n=254 |
0.52 ± 3.39 n=253 |
| Study 2 ‡ |
|
|
|
|
| Tamsulosin hydrochloride capsules 0.8 mg once daily |
18.2 ± 5.6 n=244 |
-5.8* ± 6.4 n=238 |
9.96 ± 3.16 n=244 |
1.79* ± 3.36 n=237 |
| Tamsulosin hydrochloride capsules 0.4 mg once daily |
17.9 ± 5.8 n=248 |
-5.1* ± 6.4 n=244 |
9.94 ± 3.14 n=248 |
1.52 ± 3.64 n=244 |
| Placebo | 19.2 ± 6.0 n=239 |
-3.6 ± 5.7 n=235 |
9.95 ± 3.12 n=239 |
0.93 ± 3.28 n=235 |
Manufacturer
WOCKHARDT USA LLC
Active Ingredients
Source
- U.S. National Library of Medicine
- DailyMed
- Last Updated: 18 May 2013
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