Bisoprolol Fumarate (Page 3 of 4)

Nursing Mothers

Small amounts of bisoprolol fumarate (< 2% of the dose) have been detected in the milk of lactating rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when bisoprolol fumarate is administered to nursing women.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

BISOPROLOL FUMARATE has been used in elderly patients with hypertension. Response rates and mean decreases in systolic and diastolic blood pressure were similar to the decreases in younger patients in the U.S. clinical studies. Although no dose response study was conducted in elderly patients, there was a tendency for older patients to be maintained on higher doses of bisoprolol fumarate.

Observed reductions in heart rate were slightly greater in the elderly than in the young and tended to increase with increasing dose. In general, no disparity in adverse experience reports or dropouts for safety reasons was observed between older and younger patients. Dose adjustment based on age is not necessary.

ADVERSE REACTIONS

Safety data are available in more than 30,000 patients or volunteers. Frequency estimates and rates of withdrawal of therapy for adverse events were derived from two U.S. placebo-controlled studies.

In Study A, doses of 5, 10, and 20 mg bisoprolol fumarate were administered for 4 weeks. In Study B, doses of 2.5, 10, and 40 mg of bisoprolol fumarate were administered for 12 weeks. A total of 273 patients were treated with 5 to 20 mg of bisoprolol fumarate; 132 received placebo.

Withdrawal of therapy for adverse events was 3.3% for patients receiving bisoprolol fumarate and 6.8% for patients on placebo. Withdrawals were less than 1% for either bradycardia or fatigue/lack of energy.

The following table presents adverse experiences, whether or not considered drug related, reported in at least 1% of patients in these studies, for all patients studied in placebo-controlled clinical trials (2.5 to 40 mg), as well as for a subgroup that was treated with doses within the recommended dosage range (5 to 20 mg). Of the adverse events listed in the table, bradycardia, diarrhea, asthenia, fatigue, and sinusitis appear to be dose related.

Body System / Adverse Experience All AdverseExperiences (% a ) Bisoprolol Fumarate
Placebo 5 to20 mg 2 . 5 to 40 mg
( n = 132 ) ( n = 273 ) ( n = 404 )
% % %

percentage of patients with event a

Skin
increased sweating 1.5 0.7 1.0
Musculoskeletal
arthralgia 2.3 2.2 2.7
Central Nervous System
dizziness 3.8 2.9 3.5
headache 11.4 8.8 10.9
hypoesthesia 0.8 1.1 1.5
Autonomic Nervous System
dry mouth 1.5 0.7 1.3
Heart Rate / Rhythm
bradycardia 0 0.4 0.5
Psychiatric
vivid dreams 0 0 0
insomnia 2.3 1.5 2.5
depression 0.8 0 0.2
Gastrointestinal
diarrhea 1.5 2.6 3.5
nausea 1.5 1.5 2.2
vomiting 0 1.1 1.5
Respiratory
bronchospasm 0 0 0
cough 4.5 2.6 2.5
dyspnea 0.8 1.1 1.5
pharyngitis 2.3 2.2 2.2
rhinitis 3.0 2.9 4.0
sinusitis 1.5 2.2 2.2
URI 3.8 4.8 5.0
Body as a Whole
asthenia 0 0.4 1.5
chest pain 0.8 1.1 1.5
fatigue 1.5 6.6 8.2
edema (peripheral) 3.8 3.7 3.0

The following is a comprehensive list of adverse experiences reported with bisoprolol fumarate in worldwide studies, or in postmarketing experience (in italics):

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