AMLODIPINE - amlodipine besylate tablet
Macleods Pharmaceuticals Limited
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Amlodipine besylate tablets USP safely and effectively. See full prescribing information for Amlodipine besylate tablets.
Amlodipine Besylate Tablets USP 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: •Hypertension (1.1) •Coronary Artery Disease (1.2) o Chronic Stable Angina o Vasospastic Angina (Prinzmetal’s or Variant Angina) o Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% DOSAGE AND ADMINISTRATION• Adult recommended starting dose: 5 mg once daily with maximum dose 10 mg once daily. (2.1) o Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily. (2.1) • Pediatric starting dose: 2.5 mg to 5 mg once daily. (2.2) Important Limitation: Doses in excess of 5 mg daily have not been studied in pediatric patients. (2.2) DOSAGE FORMS AND STRENGTHS• 5 mg, and 10 mg Tablets (3) CONTRAINDICATIONS• Known sensitivity to amlodipine (4) WARNINGS AND PRECAUTIONS• Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, because of the gradual onset of action, acute hypotension is unlikely. (5.1) • Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine besylate, particularly in patients with severe obstructive coronary artery disease. (5.2) • Titrate slowly when administering calcium channel blockers to patients with severe hepatic impairment. (5.4) 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 AB Pharmaceuticals, LLC at 314814-2833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS• If simvastatin is co-administered with amlodipine, do not exceed doses greater than 20 mg daily of simvastatin. (7.7) USE IN SPECIFIC POPULATIONS• Pregnancy: Use only if the potential benefit justifies the potential risk. (8.1) • Nursing: Discontinue when administering amlodipine besylate. (8.3) • Pediatric: Effect on patients less than 6 years old is not known. (8.4) • Geriatric: Start dosing at the low end of the dose range, due to the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. (8.5) See 17 for PATIENT COUNSELING INFORMATION. Revised: 04/2012 |
Chronic Stable Angina
Amlodipine besylate is indicated for the symptomatic treatment of chronic stable angina. Amlodipine besylate may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetal's or Variant Angina)
Amlodipine besylate is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine besylate may be used as monotherapy or in combination with other antianginal agents.
In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate is indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure.
Adverse Event
| 2.5 mg N=275 | 5.0 mg N=296 | 10.0 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 |
Placebo – Controlled Studies
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| Amlodipine besyalate (%)
| PLACEBO (%)
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| (N = 1730)
| (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 |
| Amlodipine besyalate
| PLACEBO
|
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Adverse Event
| Male=%
| Female=%
| Male=%
| Female=%
|
| (N=1218)
| (N=512)
| (N=914)
| (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 |
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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
amlodipine tablet |
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AMLODIPINE
amlodipine tablet |
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Labeler - Macleods Pharmaceuticals Limited (862128535) |