Pindolol (Page 3 of 4)

Nursing Mothers

Since pindolol is secreted in human milk, nursing should not be undertaken by mothers receiving the drug.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

CLINICAL LABORATORY

Minor persistent elevations in serum transaminases (SGOT, SGPT) have been noted in 7% of patients during pindolol tablets administration, but progressive elevations were not observed. These elevations were not associated with any other abnormalities that would suggest hepatic impairment, such as decreased serum albumin and total proteins. During more than a decade of worldwide marketing, there have been no reports in the medical literature of overt hepatic injury. Alkaline phosphatase, lactic acid dehydrogenase (LDH), and uric acid are also elevated on rare occasions. The significance of these findings is unknown.

ADVERSE REACTIONS

Most adverse reactions have been mild. The incidences listed in the following table are derived from 12-week comparative double-blind, parallel design trials in hypertensive patients given pindolol tablets as monotherapy, given various active control drugs as monotherapy, or given placebo. Data for pindolol tablets and the positive controls were pooled from several trials because no striking differences were seen in the individual studies, with one exception. When considering all adverse reactions reported, the frequency of edema was noticeably higher in positive control trials (16% pindolol tablets vs. 9% positive control) than in placebo controlled trials (6% pindolol tablets vs. 3% placebo). The table includes adverse reactions either volunteered or elicited, and at least possibly drug-related, which were reported in greater than 2% of pindolol tablets patients and other selected important reactions.

ADVERSE REACTIONS WHICH WERE VOLUNTEERED OR ELICITED
*
Active Controls: Patients received either propranolol, α-methyldopa or a diuretic (hydrochlorothiazide or chlorthalidone).

(and at least possibly drug-related)

Body System/ Adverse Reactions

Pindolol Tablets (N = 322) %

Active Controls * (N = 188) %

Placebo (N = 78) %

Central Nervous System

Bizarre or Many Dreams

5

0

6

Dizziness

9

11

1

Fatigue

8

4

4

Hallucinations

< 1

0

0

Insomnia

10

3

10

Nervousness

7

3

5

Weakness

4

2

1

Autonomic Nervous System

Paresthesia

3

1

6

Cardiovascular

Dyspnea

5

4

6

Edema

6

3

1

Heart Failure

< 1

< 1

0

Palpitations

< 1

1

0

Musculoskeletal

Chest Pain

3

1

3

Joint Pain

7

4

4

Muscle Cramps

3

1

0

Muscle Pain

10

9

8

Gastrointestinal

Abdominal Discomfort

4

4

5

Nausea

5

2

1

Skin

Pruritus

1

< 1

0

Rash

< 1

< 1

1

The following selected (potentially important) adverse reactions were seen in 2% or fewer patients and their relationship to pindolol tablets is uncertain. CENTRAL NERVOUS SYSTEM: anxiety, lethargy; AUTONOMIC NERVOUS SYSTEM: visual disturbances, hyperhidrosis; CARDIOVASCULAR: bradycardia, claudication, cold extremities, heart block, hypotension, syncope, tachycardia, weight gain; GASTROINTESTINAL: diarrhea, vomiting; RESPIRATORY: wheezing; UROGENITAL: impotence, pollakiuria; MISCELLANEOUS: eye discomfort or burning eyes.

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