Atenolol Tablets, USP
DESCRIPTION
CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE
CONTRAINDICATIONS
WARNINGS
| Cessation of Therapy with Atenolol Patients with coronary artery disease, who are being treated with atenolol, should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in angina patients following the abrupt discontinuation of therapy with beta-blockers. The last two complications may occur with or without preceding exacerbation of the angina pectoris. As with other beta-blockers, when discontinuation of atenolol is planned, the patients should be carefully observed and advised to limit physical activity to a minimum. If the angina worsens or acute coronary insufficiency develops, it is recommended that atenolol be promptly reinstituted, at least temporarily. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue atenolol therapy abruptly even in patients treated only for hypertension. (See DOSAGE AND ADMINISTRATION.) |
Pregnancy and Fetal Injury
PRECAUTIONS
General
Drug Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Usage in Pregnancy
Nursing Mothers
Pediatric Use
Geriatric Use
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 |
| Conventional TherapyPlus Atenolol(n=244) | Conventional Therapy Alone(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%) |
| 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%) |
OVERDOSAGE
DOSAGE AND ADMINISTRATION
| 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 |