• 10 mg once daily for the maintenance therapy.
The maximum recommended dose is 10 mg once daily.
妊婦への

4.6 Fertility, Pregnancy and Lactation

投与

Use in pregnancy(Category C)
Bisoprolol has pharmacological effects that may cause harmful effects on
pregnancy and/or the foetus/newborn. In general, β-adrenoceptor blockers
reduce placental perfusion, which has been associated with growth retardation,
intrauterine

death,

abortion

or

early

labour.

Adverse

effects

(e.g.

hypoglycaemia and bradycardia) may occur in the foetus and newborn infant. If
treatment

with

β-adrenoceptor

blockers

is

necessary,

β1-selective

adrenoceptor blockers are preferable.
Bisoprolol should not be used during pregnancy unless clearly necessary. If
treatment with bisoprolol is considered necessary, the uteroplacental blood
flow and the foetal growth should be monitored. In case of harmful effects on
pregnancy or the foetus alternative treatment should be considered. The
newborn infant must be closely monitored. Symptoms of hypoglycaemia and
bradycardia are generally to be expected within the first 3 days.
Studies in rats have shown that bisoprolol and/or its metabolites cross the
placenta and distribute to the foetus.
Administration of bisoprolol at oral doses of ≥ 50 mg/kg/day to pregnant rats
or ≥ 12.5 mg/kg/day to pregnant rabbits caused embryofoetal toxicity,
resorptions and abortions. The no-effect dose for embryofoetal toxicity and
mortality was 40 mg/kg/day (associated with plasma drug concentrations (AUC)
11 times that expected in humans after 10 mg/kg/day bisoprolol) for rats and
10 mg/kg/day for rabbits (associated with AUC lower than that expected in
humans after 10 mg/kg/day doses). No evidence for teratogenic effects of
bisoprolol was observed at any dose in rats or rabbits.

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