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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］ (21 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 adequate and well-controlled studies in pregnant women.
Bisoprolol fumarate should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
経口剤（英国）
(2) 製品名 Bisoprolol 2.5 mg Film-coated Tablet/Accord Healthcare Limited
効能・効果
4. Clinical particulars
4.1 Therapeutic indications
Treatment of Hypertension
Treatment of stable chronic angina
Treatment of stable chronic heart failure with reduced systolic left
ventricular function in addition to ACE inhibitors, and diuretics, and
optionally cardiac glycosides
用法・用量
4.2 Posology and method of administration
Bisoprolol fumarate tablet should be taken in morning and can be taken with
food in morning. They should be swallowed in liquid and should not be chewed.
Posology
Treatment of hypertension and chronic stable angina pectoris
Adults
The dosage should be individually adjusted. It is recommended to start with
5 mg per day. The usual dose is 10 mg once daily with a maximum recommended
dose of 20 mg per day.
Treatment of stable chronic heart failure
Adults
Standard treatment of CHF consists of an ACE inhibitor (or an angiotensin
receptor blocker in case of intolerance to ACE inhibitors), a beta-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
- 10 mg once daily for the maintenance therapy.
The maximum recommended dose is 10 mg once daily.
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20
Bisoprolol fumarate should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
経口剤（英国）
(2) 製品名 Bisoprolol 2.5 mg Film-coated Tablet/Accord Healthcare Limited
効能・効果
4. Clinical particulars
4.1 Therapeutic indications
Treatment of Hypertension
Treatment of stable chronic angina
Treatment of stable chronic heart failure with reduced systolic left
ventricular function in addition to ACE inhibitors, and diuretics, and
optionally cardiac glycosides
用法・用量
4.2 Posology and method of administration
Bisoprolol fumarate tablet should be taken in morning and can be taken with
food in morning. They should be swallowed in liquid and should not be chewed.
Posology
Treatment of hypertension and chronic stable angina pectoris
Adults
The dosage should be individually adjusted. It is recommended to start with
5 mg per day. The usual dose is 10 mg once daily with a maximum recommended
dose of 20 mg per day.
Treatment of stable chronic heart failure
Adults
Standard treatment of CHF consists of an ACE inhibitor (or an angiotensin
receptor blocker in case of intolerance to ACE inhibitors), a beta-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
- 10 mg once daily for the maintenance therapy.
The maximum recommended dose is 10 mg once daily.
9
20