ALFUZOSIN HYDROCHLORIDE - alfuzosin hydrochloride tablet, film coated, extended release
Aurobindo Pharma Limited
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use alfuzosin hydrochloride safely and effectively. See full prescribing information for alfuzosin hydrochloride extended release tablets.
Alfuzosin Hydrochloride Extended Release Tablets Initial U.S. Approval: 2003 RECENT MAJOR CHANGESINDICATIONS AND USAGEAlfuzosin hydrochloride extended release tablets are an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1) Important Limitations of Use: Alfuzosin hydrochloride extended release tablets are not indicated for treatment of hypertension. (1.1) Alfuzosin hydrochloride extended release tablets are not indicated for use in the pediatric population. (1.1, 8.4, 12.3) DOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHSExtended release tablet: 10 mg (3) CONTRAINDICATIONSWARNINGS AND PRECAUTIONS
ADVERSE REACTIONSMost common adverse reactions in clinical studies (incidence ≥2% and at a higher incidence than placebo): dizziness, upper respiratory tract infection, headache, fatigue. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 8/2012 |
Adverse Reaction | Placebo (n=678) | Alfuzosin Hydrochloride Extended Release Tablets (n=473) |
---|---|---|
Dizziness | 19 (2.8%) | 27 (5.7%) |
Upper respiratory tract infection | 4 (0.6%) | 14 (3%) |
Headache | 12 (1.8%) | 14 (3%) |
Fatigue | 12 (1.8%) | 13 (2.7%) |
Symptoms | Placebo (n=678) | Alfuzosin Hydrochloride Extended Release Tablets (n=473) |
---|---|---|
Dizziness
| 19 (2.8%)
| 27 (5.7%)
|
Hypotension or postural hypotension
| 0
| 2 (0.4%)
|
Syncope
| 0
| 1 (0.2%)
|
Drug/Dose
| QT
| Fridericia method
| Population-specific method
| Subject-specific method
|
---|---|---|---|---|
*Active control | ||||
Alfuzosin 10 mg
| -5.8 (-10.2, -1.4) | 4.9 (0.9, 8.8) | 1.8 (-1.4, 5) | 1.8 (-1.3, 5) |
Alfuzosin 40 mg
| -4.2 (-8.5, 0.2) | 7.7 (1.9, 13.5) | 4.2 (-0.6, 9) | 4.3 (-0.5, 9.2) |
Moxifloxacin* 400 mg
| 6.9 (2.3, 11.5) | 12.7 (8.6, 16.8) | 11 (7, 15) | 11.1 (7.2, 15) |
a Difference between baseline and week 12. | ||||||
Symptom Score
| Trial 1
| Trial 2
| Trial 3
|
|||
Placebo
(n=167) | Alfuzosin
Hydrochloride Extended Release Tablets 10 mg (n=170) | Placebo
(n=152) | Alfuzosin
Hydrochloride Extended Release Tablets 10 mg (n=137) | Placebo (n=150) | Alfuzosin
Hydrochloride Extended Release Tablets 10 mg (n=151) |
|
Total symptom score | | | | | | |
Baseline | 18.2 (6.4) | 18.2 (6.3) | 17.7 (4.1) | 17.3 (3.5) | 17.7 (5) | 18 (5.4) |
Changeª | -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 |
ªDifference between baseline and week 12. | ||||||
| Trial 1
| Trial 2
| Trial 3
|
|||
| Placebo
(n=167) | Alfuzosin
Hydrochloride Extended Release Tablets 10 mg (n=170) | Placebo
(n=147) | Alfuzosin
Hydrochloride Extended Release Tablets 10 mg (n=136) | Placebo (n=150) | Alfuzosin
Hydrochloride Extended Release Tablets 10 mg (n=151) |
Mean Peakflow rate
| | | | | | |
Baseline | 10.2 (4) | 9.9 (3.9) | 9.2 (2) | 9.4 (1.9) | 9.3 (2.6) | 9.5 (3) |
Changeª | 0.2 (3.5) | 1.7 (4.2) | 1.4 (3.2) | 2.3 (3.6) | 0.9 (3) | 1.5 (3.3) |
p-value | 0.0004 | 0.03 | 0.22 |
Ask your doctor if you are not sure if you are taking one of these medicines.
ALFUZOSIN HYDROCHLORIDE
alfuzosin hydrochloride tablet, film coated, extended release |
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Labeler - Aurobindo Pharma Limited (650082092) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Aurobindo Pharma Limited | 918917642 | ANALYSIS(65862-249), MANUFACTURE(65862-249) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Aurobindo Pharma Limited | 918917662 | API MANUFACTURE(65862-249) |