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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］ (23 ページ)
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| 出典情報 | 薬事・食品衛生審議会 薬事分科会医薬品等安全対策部会安全対策調査会（令和5年度第15回 3／26）《厚生労働省》 |
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There are no studies in pregnant women. APO-BISOPROLOL should be used during
pregnancy only if the potential benefit justifies the potential risk to the
fetus.
【以下 SIVEM PHARMACEUTICALS ULC 社製品のみ記載】
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 Page 7 of 40 BISOPROLOL TABLETS
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.
経口剤（豪州）
(4) 製品名 BICOR /Alphapharm Pty Ltd
効能・効果
4.1 Therapeutic Indications
Treatment of stable chronic moderate to severe heart failure in addition to
ACE inhibitors, and diuretics, and optionally cardiac glycosides.
用法・用量
4.2 DOSE AND METHOD OF ADMINISTRATION
Dosage (dose and interval) Treatment of CHF consists of an ACE inhibitor (or
an angiotensin receptor blocker in case of intolerance to ACE inhibitors), a
β-blocker, diuretics, and when appropriate cardiac glycosides. Patients
should be stable (without acute failure) when bisoprolol treatment is
initiated. It is recommended that the treating physician should be experienced
in the management of chronic heart failure.
Titration phase
The treatment of stable chronic heart failure with bisoprolol requires a
titration phase.
The treatment with bisoprolol is to be started with a gradual uptitration
according to the following steps:
• 1.25 mg once daily for 1 week, if well tolerated increase to
• 2.5 mg once daily for a further week, if well tolerated increase to
• 3.75 mg once daily for a further week, if well tolerated increase to
• 5 mg once daily for the 4 following weeks, if well tolerated increase to
• 7.5 mg once daily for the 4 following weeks, if well tolerated increase to
11
22
pregnancy only if the potential benefit justifies the potential risk to the
fetus.
【以下 SIVEM PHARMACEUTICALS ULC 社製品のみ記載】
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 Page 7 of 40 BISOPROLOL TABLETS
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.
経口剤（豪州）
(4) 製品名 BICOR /Alphapharm Pty Ltd
効能・効果
4.1 Therapeutic Indications
Treatment of stable chronic moderate to severe heart failure in addition to
ACE inhibitors, and diuretics, and optionally cardiac glycosides.
用法・用量
4.2 DOSE AND METHOD OF ADMINISTRATION
Dosage (dose and interval) Treatment of CHF consists of an ACE inhibitor (or
an angiotensin receptor blocker in case of intolerance to ACE inhibitors), a
β-blocker, diuretics, and when appropriate cardiac glycosides. Patients
should be stable (without acute failure) when bisoprolol treatment is
initiated. It is recommended that the treating physician should be experienced
in the management of chronic heart failure.
Titration phase
The treatment of stable chronic heart failure with bisoprolol requires a
titration phase.
The treatment with bisoprolol is to be started with a gradual uptitration
according to the following steps:
• 1.25 mg once daily for 1 week, if well tolerated increase to
• 2.5 mg once daily for a further week, if well tolerated increase to
• 3.75 mg once daily for a further week, if well tolerated increase to
• 5 mg once daily for the 4 following weeks, if well tolerated increase to
• 7.5 mg once daily for the 4 following weeks, if well tolerated increase to
11
22