Atenolol (Page 4 of 7)

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 mmHg 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

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