Bisoprolol Fumarate and Hydrochlorothiazide (Page 5 of 8)

Nonteratogenic Effects

Thiazides cross the placental barrier and appear in the cord blood. The use of thiazides in pregnant women requires that the anticipated benefit be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, pancreatitis, thrombocytopenia, and possibly other adverse reactions that have occurred in the adult.

Nursing Mothers

Bisoprolol fumarate alone or in combination with HCTZ has not been studied in nursing mothers. Thiazides are excreted in human breast milk. Small amounts of bisoprolol fumarate (<2% of the dose) have been detected in the milk of lactating rats. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of bisoprolol fumarate and hydrochlorothiazide in pediatric patients have not been established.

Geriatric Use

In clinical trials, at least 270 patients treated with bisoprolol fumarate plus HCTZ were 60 years of age or older. HCTZ added significantly to the antihypertensive effect of bisoprolol in elderly hypertensive patients. No overall differences in effectiveness or safety were observed between these patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

ADVERSE REACTIONS

Bisoprolol fumarate and hydrochlorothiazide

Bisoprolol fumarate/HCTZ 6.25 mg is well tolerated in most patients. Most adverse effects (AEs) have been mild and transient. In more than 65,000 patients treated worldwide with bisoprolol fumarate, occurrences of bronchospasm have been rare. Discontinuation rates for AEs were similar for bisoprolol fumarate/HCTZ 6.25 mg and placebo-treated patients.

In the United States, 252 patients received bisoprolol fumarate (2.5, 5, 10, or 40 mg)/ HCTZ 6.25 mg and 144 patients received placebo in two controlled trials. In Study 1, bisoprolol fumarate 5/HCTZ 6.25 mg was administered for 4 weeks. In Study 2, bisoprolol fumarate 2.5, 10, or 40/HCTZ 6.25 mg was administered for 12 weeks. All adverse experiences, whether drug related or not, and drug related adverse experiences in patients treated with bisoprolol fumarate 2.5-10/ HCTZ 6.25 mg, reported during comparable, 4 week treatment periods by at least 2% of bisoprolol fumarate/ HCTZ 6.25 mg-treated patients (plus additional selected adverse experiences) are presented in the following table:

a) Averages adjusted to combine across studies.

b) Combined across studies.

% of Patients with Adverse Experiences a
Body System / Adverse Experience All Adverse Experiences Drug Related Adverse Experiences
Placebo b B 2 . 5 - 40 / H 6 . 25 b Placebo b B 2 . 5 - 10 / H 6 . 25 b
( n = 144 ) ( n = 252 ) ( n = 144 ) ( n = 221 )
% % % %
Cardiovascular
bradycardia 0.7 1.1 0.7 0.9
arrhythmia 1.4 0.4 0.0 0.0
peripheral ischemia 0.9 0.7 0.9 0.4
chest pain 0.7 1.8 0.7 0.9
Respiratory
bronchospasm 0.0 0.0 0.0 0.0
cough 1.0 2.2 0.7 1.5
rhinitis 2.0 0.7 0.7 0.9
URI 2.3 2.1 0.0 0.0
Body as a Whole
asthenia 0.0 0.0 0.0 0.0
fatigue 2.7 4.6 1.7 3.0
peripheral edema 0.7 1.1 0.7 0.9
Central Nervous System
dizziness 1.8 5.1 1.8 3.2
headache 4.7 4.5 2.7 0.4
Musculoskeletal
muscle cramps 0.7 1.2 0.7 1.1
myalgia 1.4 2.4 0.0 0.0
Psychiatric
insomnia 2.4 1.1 2.0 1.2
somnolence 0.7 1.1 0.7 0.9
loss of libido 1.2 0.4 1.2 0.4
impotence 0.7 1.1 0.7 1.1
Gastrointestinal
diarrhea 1.4 4.3 1.2 1.1
nausea 0.9 1.1 0.9 0.9
dyspepsia 0.7 1.2 0.7 0.9

Other adverse experiences that have been reported with the individual components are listed below.

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