AMLODIPINE BESYLATE
-
amlodipine besylate tablet
Med Health Pharma, LLC
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|
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 |
Amlodipine besylate USP is a white or almost white powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets are formulated as white to off-white tablets equivalent to 2.5, 5, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.
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) |
Med-Health Pharma, LLC
North Las Vegas, NV 89032
MHP LB-60025 rev00
AMLODIPINE BESYLATE
amlodipine besylate tablet |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA078021 | 01/05/2011 |
AMLODIPINE BESYLATE
amlodipine besylate tablet |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA078021 | 01/05/2011 |
AMLODIPINE BESYLATE
amlodipine besylate tablet |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA078021 | 01/05/2011 |
Labeler - Med Health Pharma, LLC (962603812) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Aurobindo Pharma Limited | 918917642 | MANUFACTURE |
Revised: 09/2011 Med Health Pharma, LLC