These 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
1 INDICATIONS AND USAGE
1.1 Hypertension
1.2 Coronary Artery Disease (CAD)
2 DOSAGE AND ADMINISTRATION
2.1 Adults
2.2 Children
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypotension
5.2 Increased Angina or Myocardial Infarction
5.3 Beta-Blocker Withdrawal
5.4 Patients with Hepatic Failure
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
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:
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:
|
| 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 |
|
| 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 |
|
| 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 |
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 In Vitro Data
7.2 Cimetidine
7.3 Grapefruit Juice
7.4 Magnesium and Aluminum Hydroxide Antacid
7.5 Sildenafil
7.6 Atorvastatin
7.7 Digoxin
7.8 Ethanol (Alcohol)
7.9 Warfarin
7.10 Drug/Laboratory Test Interactions
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics and Metabolism
12.4 Pediatric Patients
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Effects in Hypertension
14.2 Effects in Chronic Stable Angina
14.3 Effects in Vasospastic Angina
14.4 Effects in Documented Coronary Artery Disease
|
| 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) |
14.5 Studies in Patients with Heart Failure
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 2.5 mg Tablets
16.2 5 mg Tablets
16.3 10 mg Tablets
16.4 Storage
SPL UNCLASSIFIED SECTION
- ever had heart disease
- ever had liver problems
- are pregnant, or plan to become pregnant. Your doctor will decide if amlodipine besylate tablets are the best treatment for you.
- are breast-feeding. Do not breast-feed while taking amlodipine besylate tablets. You can stop breast-feeding or take a different medicine.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL