Atenolol Tablets, USPRx only
DESCRIPTION
CLINICAL PHARMACOLOGY
Pharmacokinetics and Metabolism
Pharmacodynamics
Atenolol Geriatric Pharmacology
INDICATIONS AND USAGE
Hypertension
Angina Pectoris Due to Coronary Atherosclerosis
Acute Myocardial Infarction
CONTRAINDICATIONS
WARNINGS
Cardiac Failure
In Patients Without a History of Cardiac Failure
Cessation of Therapy with Atenolol
Concomitant Use of Calcium Channel Blockers
Bronchospastic Diseases
Anesthesia and Major Surgery
Diabetes and Hypoglycemia
Thyrotoxicosis
Untreated Pheochromocytoma
Pregnancy and Fetal Injury
PRECAUTIONS
General
Impaired Renal Function
Drug Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal Toxicology
Usage in Pregnancy
Nursing Mothers
Pediatric Use
Geriatric Use
Hypertension and Angina Pectoris Due to Coronary Atherosclerosis
Acute Myocardial Infarction
ADVERSE REACTIONS
| Volunteered(U.S. Studies) | Total - Volunteered and Elicited(Foreign+U.S. Studies) | |||
| Atenolol(n=164)% | Placebo(n=206)% | Atenolol(n=399)% | Placebo(n=407)% | |
| CARDIOVASCULAR | ||||
| Bradycardia | 3 | 0 | 3 | 0 |
| Cold Extremities | 0 | 0.5 | 12 | 5 |
| Postural Hypotension | 2 | 1 | 4 | 5 |
| Leg Pain | 0 | 0.5 | 3 | 1 |
| CENTRAL NERVOUS SYSTEM/NEUROMUSCULAR | ||||
| Dizziness | 4 | 1 | 13 | 6 |
| Vertigo | 2 | 0.5 | 2 | 0.2 |
| Lightheadedness | 1 | 0 | 3 | 0.7 |
| Tiredness | 0.6 | 0.5 | 26 | 13 |
| Fatigue | 3 | 1 | 6 | 5 |
| Lethargy | 1 | 0 | 3 | 0.7 |
| Drowsiness | 0.6 | 0 | 2 | 0.5 |
| Depression | 0.6 | 0.5 | 12 | 9 |
| Dreaming | 0 | 0 | 3 | 1 |
| GASTROINTESTINAL | ||||
| Diarrhea | 2 | 0 | 3 | 2 |
| Nausea | 4 | 1 | 3 | 1 |
| RESPIRATORY (see WARNINGS) | ||||
| Wheeziness | 0 | 0 | 3 | 3 |
| Dyspnea | 0.6 | 1 | 6 | 4 |
Acute Myocardial Infarction
| Conventional TherapyPlus Atenolol(n=244) | Conventional TherapyAlone(n=233) | |||
| Bradycardia | 43 | (18%) | 24 | (10%) |
| Hypotension | 60 | (25%) | 34 | (15%) |
| Bronchospasm | 3 | (1.2%) | 2 | (0.9%) |
| Heart Failure | 46 | (19%) | 56 | (24%) |
| Heart Block | 11 | (4.5%) | 10 | (4.3%) |
| BBB + Major Axis Deviation | 16 | (6.6%) | 28 | (12%) |
| Supraventricular Tachycardia | 28 | (11.5%) | 45 | (19%) |
| Atrial Fibrillation | 12 | (5%) | 29 | (11%) |
| Atrial Flutter | 4 | (1.6%) | 7 | (3%) |
| Ventricular Tachycardia | 39 | (16%) | 52 | (22%) |
| Cardiac Reinfarction | 0 | (0%) | 6 | (2.6%) |
| Total Cardiac Arrests | 4 | (1.6%) | 16 | (6.9%) |
| Nonfatal Cardiac Arrests | 4 | (1.6%) | 12 | (5.1%) |
| Deaths | 7 | (2.9%) | 16 | (6.9%) |
| Cardiogenic Shock | 1 | (0.4%) | 4 | (1.7%) |
| Development of Ventricular Septal Defect | 0 | (0%) | 2 | (0.9%) |
| Development of Mitral Regurgitation | 0 | (0%) | 2 | (0.9%) |
| Renal Failure | 1 | (0.4%) | 0 | (0%) |
| Pulmonary Emboli | 3 | (1.2%) | 0 | (0%) |
| Reasons for Reduced Dosage | ||||
| IV Atenolol Reduced Dose(< 5 mg)* | Oral Partial Dose | |||
| Hypotension/Bradycardia | 105 | (1.3%) | 1168 | (14.5%) |
| Cardiogenic Shock | 4 | (.04%) | 35 | (.44%) |
| Reinfarction | 0 | (0%) | 5 | (.06%) |
| Cardiac Arrest | 5 | (.06%) | 28 | (.34%) |
| Heart Block (> first degree) | 5 | (.06%) | 143 | (1.7%) |
| Cardiac Failure | 1 | (.01%) | 233 | (2.9%) |
| Arrhythmias | 3 | (.04%) | 22 | (.27%) |
| Bronchospasm | 1 | (.01%) | 50 | (.62%) |
POTENTIAL ADVERSE EFFECTS
OVERDOSAGE
DOSAGE AND ADMINISTRATION
Hypertension
Angina Pectoris
Acute Myocardial Infarction
Elderly Patients or Patients with Renal Impairment
| Creatinine Clearance(mL/min/1.73 m2) | Atenolol Elimination Half-Life(h) | Maximum Dosage |
| 15-35 | 16-27 | 50 mg daily |
| <15 | >27 | 25 mg daily |