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 mgInitial U.S. Approval: 1997
RECENT MAJOR CHANGES SECTION
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Orthostasis
5.2 Drug Interactions
5.3 Priapism
5.4 Screening for Prostate Cancer
5.5 Intraoperative Floppy Iris Syndrome
5.6 Sulfa Allergy
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
| 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%) |
- The adverse event occurred for the first time after initial dosing with double-blind study medication.
- The adverse event was present prior to or at the time of initial dosing with double-blind study medication and subsequently increased in severity during double-blind treatment; or
- The adverse event was present prior to or at the time of initial dosing with double-blind study medication, disappeared completely, and then reappeared during double-blind treatment.
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Cytochrome P450 Inhibition
7.2 Other Alpha Adrenergic Blocking Agents
7.3 PDE5 Inhibitors
7.4 Warfarin
7.5 Nifedipine, Atenolol, Enalapril
7.6 Digoxin and Theophylline
7.7 Furosemide
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
| 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 |
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
| Study 1 † | ||||
| Tamsulosin hydrochloride capsules0.8 mg once daily | 19.9 ± 4.9n=247 | -9.6* ± 6.7n=237 | 9.57 ± 2.51n=247 | 1.78* ± 3.35n=247 |
| Tamsulosin hydrochloride capsules 0.4 mg once daily | 19.8 ± 5.0n=254 | -8.3* ± 6.5n=246 | 9.46 ± 2.49n=254 | 1.75* ± 3.57n=254 |
| Placebo | 19.6 ± 4.9 n=254 | -5.5 ± 6.6n=246 | 9.75 ± 2.54n=254 | 0.52 ± 3.39n=253 |
| Study 2 ‡ | ||||
| Tamsulosin hydrochloride capsules0.8 mg once daily | 18.2 ± 5.6 n=244 | -5.8* ± 6.4n=238 | 9.96 ± 3.16n=244 | 1.79* ± 3.36n=237 |
| Tamsulosin hydrochloride capsules0.4 mg once daily | 17.9 ± 5.8n=248 | -5.1* ± 6.4n=244 | 9.94 ± 3.14n=248 | 1.52 ± 3.64n=244 |
| Placebo | 19.2 ± 6.0n=239 | -3.6 ± 5.7n=235 | 9.95 ± 3.12n=239 | 0.93 ± 3.28n=235 |
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Hypotension
17.2 Priapism
17.3 Screening for Prostate Cancer
17.4 Intraoperative Floppy Iris Syndrome
17.5 Administration
17.6 FDA-approved Patient Labeling
INFORMATION FOR PATIENTS SECTION
- Tamsulosin hydrochloride capsules are not for women.
- Tamsulosin hydrochloride capsules are not for children.