AMLODIPINE BESYLATE - amlodipine besylate tablet
WOCKHARDT LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use amlodipine besylate tablets safely and effectively. See full prescribing information for amlodipine besylate tablets.
Amlodipine Besylate Tablets for oral administration Initial U.S. Approval: 1987 INDICATIONS AND USAGEAmlodipine besylate is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
DOSAGE AND ADMINISTRATION
Important Limitation: Doses in excess of 5 mg daily have not been studied in pediatric patients. (2.2) (2) DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSMost common adverse reactions are headache and edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are headache, fatigue, nausea, abdominal pain, and somnolence. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Wockhardt USA LLC. at 1-800-346-6854 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONS
Revised: 10/2011 |
Adverse Event
| 2.5 mg N=275 | 5 mg N=296 | 10 mg N=268 | Placebo N=520 |
Edema
| 1.8
| 3.0
| 10.8
| 0.6
|
Dizziness
| 1.1
| 3.4
| 3.4
| 1.5
|
Flushing
| 0.7
| 1.4
| 2.6
| 0.0
|
Palpitation | 0.7
| 1.4
| 4.5
| 0.6
|
Other adverse experiences that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following:
| Amlodipine Besylate (%) (N=1730) | Placebo (%) (N=1250) |
Headache | 7.3 | 7.8 |
Fatigue | 4.5 | 2.8 |
Nausea | 2.9 | 1.9 |
Abdominal Pain | 1.6 | 0.3 |
Somnolence | 1.4 | 0.6 |
For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with amlodipine treatment as shown in the following table:
| Amlodipine Besylate | Placebo |
||
Adverse Event
| Male=% (N=1218) | Female=% (N=512) | Male=% (N=914) | Female=% (N=336) |
Edema | 5.6 | 14.6 | 1.4 | 5.1 |
Flushing | 1.5 | 4.5 | 0.3 | 0.9 |
Palpitations | 1.4 | 3.3 | 0.9 | 0.9 |
Somnolence | 1.3 | 1.6 | 0.8 | 0.3 |
Clinical Outcomes N (%) | Amlodipine Besylate (N=663) | Placebo (N=655) | Risk Reduction (p-value) |
---|---|---|---|
Composite CV Endpoint | 110 (16.6) | 151
(23.1) | 31%
(0.003) |
Hospitalization for Angina* | 51 (7.7) | 84 (12.8) | 42% (0.002) |
Coronary Revascularization* | 78 (11.8) | 103 (15.7) | 27% (0.033) |
AMLODIPINE BESYLATE
amlodipine besylate tablet |
|||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||
|
AMLODIPINE BESYLATE
amlodipine besylate tablet |
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
AMLODIPINE BESYLATE
amlodipine besylate tablet |
|||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||
|
Labeler - WOCKHARDT LIMITED (650069115) |