よむ、つかう、まなぶ。
資料１－２ カルベジロール 調査結果報告書及び添付文書［1.9MB］ (21 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_38855.html |
| 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》 |
ページ画像
ダウンロードした画像を利用する際は「出典情報」を明記してください。
低解像度画像をダウンロード
プレーンテキスト
資料テキストはコンピュータによる自動処理で生成されており、完全に資料と一致しない場合があります。
テキストをコピーしてご利用いただく際は資料と付け合わせてご確認ください。
premature delivery, and delivery complications (e.g., need for cesarean
section and post-partum hemorrhage). Hypertension increases the fetal risk
for intrauterine growth restriction and intrauterine death. Pregnant women
with hypertension should be carefully monitored and managed accordingly.
Fetal/Neonatal Adverse Reactions: Neonates of women with hypertension who are
treated with betablockers during the third trimester of pregnancy may be at
increased risk for hypotension, bradycardia, hypoglycemia, and respiratory
depression. Observe newborns for symptoms of hypotension, bradycardia,
hypoglycemia, and respiratory depression and manage accordingly.
Data
Animal Data: Studies performed in rats and rabbits given carvedilol during
fetal organogenesis revealed increased postimplantation loss in rats at a
maternally toxic dose of 300 mg per kg per day (50 times the MRHD as mg per
m2 ) and in rabbits (in the absence of maternal toxicity) at doses of 75 mg
per kg per day (25 times the MRHD as mg per m2 ). In the rats, there was also
a decrease in fetal body weight at 300 mg per kg per day (50 times the MRHD
as mg per m2 ) accompanied by an increased incidence of fetuses with delayed
skeletal development. In rats, the no-effect level for embryo-fetal toxicity
was 60 mg per kg per day (10 times the MRHD as mg per m2 ); in rabbits, it was
15 mg per kg per day (5 times the MRHD as mg per m2 ). In a pre- and postnatal development study in rats administered carvedilol from late gestation
through lactation, increased embryo-lethality was observed at a maternally
toxic dose of 200 mg per kg per day (approximately 32 times the MRHD as mg
per m2 ), and pup mortality and delays in physical growth/development were
observed at 60 mg per kg per day (10 times the MRHD as mg per m2 ) in the
absence of maternal toxicity. The no-effect level was 12 mg per kg per day (2
times the MRHD as mg per m2 ). Carvedilol was present in fetal rat tissue.
経口剤（英国）
(2) 製品名 Carvedilol 12.5 mg film-coated tablets / Aurobindo Pharma - Milpharm Ltd.
効能・効果
4. Clinical particulars
4.1 Therapeutic indications
Essential hypertension
Chronic stable angina pectoris
Adjunctive treatment of moderate to severe stable chronic heart failure
用法・用量
4.2 Posology and method of administration
Essential Hypertension:
Carvedilol may be used for the treatment of hypertension alone or in
combination with other antihypertensives, especially thiazide diuretics. Once
daily dosing is recommended, however the recommended maximum single dose is
25 mg and the recommended maximum daily dose is 50 mg.
Adults:
The recommended initial dose is 12.5 mg once a day for the first two days.
10
20
section and post-partum hemorrhage). Hypertension increases the fetal risk
for intrauterine growth restriction and intrauterine death. Pregnant women
with hypertension should be carefully monitored and managed accordingly.
Fetal/Neonatal Adverse Reactions: Neonates of women with hypertension who are
treated with betablockers during the third trimester of pregnancy may be at
increased risk for hypotension, bradycardia, hypoglycemia, and respiratory
depression. Observe newborns for symptoms of hypotension, bradycardia,
hypoglycemia, and respiratory depression and manage accordingly.
Data
Animal Data: Studies performed in rats and rabbits given carvedilol during
fetal organogenesis revealed increased postimplantation loss in rats at a
maternally toxic dose of 300 mg per kg per day (50 times the MRHD as mg per
m2 ) and in rabbits (in the absence of maternal toxicity) at doses of 75 mg
per kg per day (25 times the MRHD as mg per m2 ). In the rats, there was also
a decrease in fetal body weight at 300 mg per kg per day (50 times the MRHD
as mg per m2 ) accompanied by an increased incidence of fetuses with delayed
skeletal development. In rats, the no-effect level for embryo-fetal toxicity
was 60 mg per kg per day (10 times the MRHD as mg per m2 ); in rabbits, it was
15 mg per kg per day (5 times the MRHD as mg per m2 ). In a pre- and postnatal development study in rats administered carvedilol from late gestation
through lactation, increased embryo-lethality was observed at a maternally
toxic dose of 200 mg per kg per day (approximately 32 times the MRHD as mg
per m2 ), and pup mortality and delays in physical growth/development were
observed at 60 mg per kg per day (10 times the MRHD as mg per m2 ) in the
absence of maternal toxicity. The no-effect level was 12 mg per kg per day (2
times the MRHD as mg per m2 ). Carvedilol was present in fetal rat tissue.
経口剤（英国）
(2) 製品名 Carvedilol 12.5 mg film-coated tablets / Aurobindo Pharma - Milpharm Ltd.
効能・効果
4. Clinical particulars
4.1 Therapeutic indications
Essential hypertension
Chronic stable angina pectoris
Adjunctive treatment of moderate to severe stable chronic heart failure
用法・用量
4.2 Posology and method of administration
Essential Hypertension:
Carvedilol may be used for the treatment of hypertension alone or in
combination with other antihypertensives, especially thiazide diuretics. Once
daily dosing is recommended, however the recommended maximum single dose is
25 mg and the recommended maximum daily dose is 50 mg.
Adults:
The recommended initial dose is 12.5 mg once a day for the first two days.
10
20