AMLODIPINE BESYLATE - amlodipine besylate tablet
Aurobindo Pharma Limited
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use amlodipine besylate safely and effectively. See full prescribing information for amlodipine besylate tablets, USP.
Amlodipine Besylate Tablets, USP for oral administration Initial U.S. Approval: 1987 INDICATIONS AND USAGEAmlodipine besylate tablets, USP are 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) 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% are headache, fatigue, nausea, abdominal pain, and somnolence. (6) 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 INTERACTIONS
USE IN SPECIFIC POPULATIONS
See 17 for FDA-approved patient labeling. Revised: 12/2011 |
Adverse Event | 2.5 mg N=275 | 5 mg N=296 | 10 mg N=268 | Placebo N=520 |
---|---|---|---|---|
Edema
| 1.8
| 3
| 10.8
| 0.6
|
Dizziness
| 1.1
| 3.4
| 3.4
| 1.5
|
Flushing
| 0.7
| 1.4
| 2.6
| 0
|
Palpitation | 0.7
| 1.4
| 4.5
| 0.6 |
Placebo-Controlled Studies | ||
---|---|---|
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 |
Adverse Event | Amlodipine Besylate | Placebo | ||
---|---|---|---|---|
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 |
Coadministration of amlodipine besylate with digoxin did not change serum digoxin levels or digoxin renal clearance in normal volunteers.
Clinical Outcomes N (%) | Amlodipine Besylate (N=663) | Placebo (N=655) | Risk Reduction (p-value) |
---|---|---|---|
* Total patients with these events |
|||
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 |
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AMLODIPINE BESYLATE
amlodipine besylate tablet |
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AMLODIPINE BESYLATE
amlodipine besylate tablet |
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Labeler - Aurobindo Pharma Limited (650082092) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Aurobindo Pharma Limited | 918917642 | MANUFACTURE, ANALYSIS |