Prescription Drug Information: Atenolol (Page 3 of 4)

Teratogenic Effects

Pregnancy Category D

See WARNINGS, Pregnancy and Fetal Injury.

Nursing Mothers

Atenolol is excreted in human breast milk at a ratio of 1.5 to 6.8 when compared to the concentration in plasma. Caution should be exercised when atenolol is administered to a nursing woman. Clinically significant bradycardia has been reported in breastfed infants. Premature infants, or infants with impaired renal function, may be more likely to develop adverse effects.

Neonates born to mothers who are receiving atenolol at parturition or breastfeeding may be at risk for hypoglycemia and bradycardia. Caution should be exercised when atenolol is administered during pregnancy or to a woman who is breastfeeding (see WARNINGS , Pregnancy and Fetal Injury).

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Hypertension and Angina Pectoris Due to Coronary Atherosclerosis

Clinical studies of atenolol did not include sufficient number of patients aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Acute Myocardial Infarction

Of the 8,037 patients with suspected acute myocardial infarction randomized to atenolol in the ISIS-1 trial (see CLINICAL PHARMACOLOGY), 33% (2,644) were 65 years of age and older. It was not possible to identify significant differences in efficacy and safety between older and younger patients; however, elderly patients with systolic blood pressure < 120 mm Hg seemed less likely to benefit (see INDICATIONS AND USAGE).

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Evaluation of patients with hypertension or myocardial infarction should always include assessment of renal function.

ADVERSE REACTIONS

Most adverse effects have been mild and transient.

The frequency estimates in the following table were derived from controlled studies in hypertensive patients in which adverse reactions were either volunteered by the patient (U.S. studies) or elicited, e.g., by checklist (foreign studies). The reported frequency of elicited adverse effects was higher for both atenolol and placebo-treated patients than when these reactions were volunteered. Where frequency of adverse effects of atenolol and placebo is similar, causal relationship to atenolol is uncertain.

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

Light-headedness

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

In a series of investigations in the treatment of acute myocardial infarction, bradycardia and hypotension occurred more commonly, as expected for any beta blocker, in atenolol-treated patients than in control patients. However, these usually responded to atropine and/or to withholding further dosage of atenolol. The incidence of heart failure was not increased by atenolol. Inotropic agents were infrequently used. The reported frequency of these and other events occurring during these investigations is given in the following table.

In a study of 477 patients, the following adverse events were reported during either intravenous and/or oral atenolol administration:

Conventional Therapy Plus 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%)

In the subsequent International Study of Infarct Survival (ISIS-1) including over 16,000 patients of whom 8,037 were randomized to receive atenolol treatment, the dosage of intravenous and subsequent oral atenolol was either discontinued or reduced for the following reasons:

Reasons for Reduced Dosage
*
Full dosage was 10 mg and some patients received less than 10 mg but more than 5 mg.

IV Atenolol Reduced Dose (< 5 mg) *

Oral Partial Dose

Hypotension/Bradycardia

105 (1.3%)

1168 (14.5%)

Cardiogenic Shock

4 (0.04%)

35 (0.44%)

Reinfarction

0 (0%)

5 (0.06%)

Cardiac Arrest

5 (0.06%)

28 (0.34%)

Heart Block (> first degree)

5 (0.06%)

143 (1.7%)

Cardiac Failure

1 (0.01%)

233 (2.9%)

Arrhythmias

3 (0.04%)

22 (0.27%)

Bronchospasm

1 (0.01%)

50 (0.62%)

During postmarketing experience with atenolol, the following have been reported in temporal relationship to the use of the drug: elevated liver enzymes and/or bilirubin, hallucinations, headache, impotence, Peyronie’s disease, postural hypotension which may be associated with syncope, psoriasiform rash or exacerbation of psoriasis, psychoses, purpura, reversible alopecia, thrombocytopenia, visual disturbance, sick sinus syndrome, and dry mouth. Atenolol, like other beta blockers, has been associated with the development of antinuclear antibodies (ANA), lupus syndrome, and Raynaud’s phenomenon.

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