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資料１－３ ビソプロロール 調査結果報告書及び添付文書［2.5MB］ (22 ページ)
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妊婦への
4. Clinical particulars
投与
4.6 Fertility, pregnancy and lactation
Pregnancy
Bisoprolol has pharmacological effects that may cause harmful effects on
pregnancy and/or the fetus/newborn. In general, beta-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 fetus and newborn infant. If
treatment with beta-adrenoceptor blockers is necessary, beta1-selective
adrenoceptor blockers are preferable.
Bisoprolol is not recommended during pregnancy unless clearly necessary. If
treatment with bisoprolol is considered necessary, the uteroplacental blood
flow and the fetal growth should be monitored. In case of harmful effects on
pregnancy or the fetus alternative treatment should be reccomended. The
newborn infant must be closely monitored. Symptoms of hypoglycaemia and
bradycardia are generally to be expected within the first 3 days.
経口剤（加国）
(3) 製品名 APO-BISOPROLOL/ APOTEX INC
効能・効果
INDICATIONS AND CLINICAL USAGE
APO-BISOPROLOL (bisoprolol fumarate) is indicated in the management of
patients with
combination
mild to moderate hypertension. It may be used alone or in
with
other
antihypertensive
agents,
particularly
thiazide
diuretics.
APO-BISOPROLOL is not recommended for the emergency treatment of hypertensive
crisis.
用法・用量
DOSAGE AND ADMINISTRATION
In the treatment of mild to moderate hypertension APO-BISOPROLOL (bisoprolol
fumarate) must be individualized to the needs of the patient. The usual
starting dose is 5 mg once-daily either added to a diuretic or alone. If the
response to 5 mg is inadequate, the dose may be increased to 10 mg and then,
if necessary, to 20 mg once daily. An appropriate interval for dose titration
is 2 weeks. Increasing the dose beyond 20 mg once daily produces only a small
incremental benefit.
妊婦への
PRECAUTIONS
投与
Use in Pregnancy:
Bisoprolol fumarate was not teratogenic in rats at doses up to 150 mg/kg/day,
which is 375 times
the maximum recommended human daily dose. Bisoprolol
fumarate was fetotoxic (increased late resorptions) at 50 mg/kg/day and
maternotoxic (decreased food intake and body-weight gain) at 150 mg/kg/day.
Bisoprolol fumarate was not teratogenic in rabbits at doses up to 12.5
mg/kg/day, which is 31 times the maximum recommended human daily dose, but
was embryolethal (increased early resorptions) at 12.5 mg/kg/day.
10
21
4. Clinical particulars
投与
4.6 Fertility, pregnancy and lactation
Pregnancy
Bisoprolol has pharmacological effects that may cause harmful effects on
pregnancy and/or the fetus/newborn. In general, beta-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 fetus and newborn infant. If
treatment with beta-adrenoceptor blockers is necessary, beta1-selective
adrenoceptor blockers are preferable.
Bisoprolol is not recommended during pregnancy unless clearly necessary. If
treatment with bisoprolol is considered necessary, the uteroplacental blood
flow and the fetal growth should be monitored. In case of harmful effects on
pregnancy or the fetus alternative treatment should be reccomended. The
newborn infant must be closely monitored. Symptoms of hypoglycaemia and
bradycardia are generally to be expected within the first 3 days.
経口剤（加国）
(3) 製品名 APO-BISOPROLOL/ APOTEX INC
効能・効果
INDICATIONS AND CLINICAL USAGE
APO-BISOPROLOL (bisoprolol fumarate) is indicated in the management of
patients with
combination
mild to moderate hypertension. It may be used alone or in
with
other
antihypertensive
agents,
particularly
thiazide
diuretics.
APO-BISOPROLOL is not recommended for the emergency treatment of hypertensive
crisis.
用法・用量
DOSAGE AND ADMINISTRATION
In the treatment of mild to moderate hypertension APO-BISOPROLOL (bisoprolol
fumarate) must be individualized to the needs of the patient. The usual
starting dose is 5 mg once-daily either added to a diuretic or alone. If the
response to 5 mg is inadequate, the dose may be increased to 10 mg and then,
if necessary, to 20 mg once daily. An appropriate interval for dose titration
is 2 weeks. Increasing the dose beyond 20 mg once daily produces only a small
incremental benefit.
妊婦への
PRECAUTIONS
投与
Use in Pregnancy:
Bisoprolol fumarate was not teratogenic in rats at doses up to 150 mg/kg/day,
which is 375 times
the maximum recommended human daily dose. Bisoprolol
fumarate was fetotoxic (increased late resorptions) at 50 mg/kg/day and
maternotoxic (decreased food intake and body-weight gain) at 150 mg/kg/day.
Bisoprolol fumarate was not teratogenic in rabbits at doses up to 12.5
mg/kg/day, which is 31 times the maximum recommended human daily dose, but
was embryolethal (increased early resorptions) at 12.5 mg/kg/day.
10
21