简介:
部份中文盐酸地尔硫卓处方资料(仅供参考)
商品名:HERBESSER for Injection
英文名:Diltiazem Hydrochloride
中文名:盐酸地尔硫卓
生产商:田边三菱制药
药品简介
Herbesser(Diltiazem Hydrochloride)是一种钙通道阻滞剂和血管舒张剂,用于治疗心绞痛和高血压。它具有降压药、血管舒张剂和钙通道阻滞剂的作用。
ヘルベッサー注射用10/ヘルベッサー注射用50
藥用類別名稱
ca 拮抗劑
批准日期:2009年11月
商標名
HERBESSER 5mg for Injection
HERBESSER 10mg for Injection
○一般名
ジルチアゼム塩酸塩(Diltiazem Hydrochloride)(JAN)
○化学名
(2S , 3S)-5-[2-(Dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2, 3, 4, 5-tetrahydro-1, 5-benzothiazepin-3-ylacetate monohydrochloride
○構造式
○分子式
C22H26N2O4S・HCl
○分子量
450.98
○性状
白色晶體或結晶性粉末, 無異味。
很容易溶于甲酸、水, 易溶于甲醇或氯仿, 幾乎不溶于乙腈, 幾乎不溶于乙酸酐或乙醇 (99.5), 幾乎不溶于乙醚。
·旋轉強度 [α]20d: +115 ~ +120° (乾燥後0.2克, 水, 20d, 100mm)
·熔點: 210 ~ 215°c (分解)
藥用藥理學
外周血管, 在血管平滑肌和房室結節, 如冠狀動脈, 通過抑制ca2+流入細胞, 顯示血管舒張作用和房室室淋巴結傳導時間的延長, 高血壓, 心律失常, 心絞痛它顯示的效果。
(1) 對血壓的影響
1) 降低麻醉和麻醉下的高血壓, 但麻醉下的高血壓強于無麻醉下的高血壓, 對血壓高於正常血壓 (大鼠) 也有較強的降壓作用。
2) 降低血壓, 降低外周血管阻力和心肌耗氧量, 增加心臟輸出量 (狗)。
3) 在不減少大腦、冠冠和腎臟血液的情況下降低血壓。 此外, 它還顯示了利尿劑的鈉 (狗, 猴子)。
(2) 對心律失常的影響
1) 房室結節的傳導時間、有效的非相性和功能非反應期延長, 以表示對房室內性心動過速 (犬) 的影響。
抑制心房 (兔) 電刺激引起的室上心律失常。
(3) 對心肌缺血的影響
1) 心肌氧供需平衡改善
1. 通過延長厚冠狀動脈和二次迴圈 (狗) 來增加心肌缺血的血液流動。
2. 抑制冠狀動脈 (豬, 人)。
2) 心肌保護作用
在心肌缺血期間, 通過抑制 ca2+過量流入細胞, 以減少梗死巢的擴散, 以保持心功能和心肌能量代謝 (狗, 貓)。
适应症
0 心動過速心律失常 (上心室性)
0 術中異常高血壓的急診治療
0 高血壓急症
0 不穩定的心絞痛
用法与用量
該製劑(10毫克或50mg為鹽酸齊爾沙津)溶解時, 用於鹽水或葡萄糖注射溶液5ml或更多, 給藥如下。
0心動過速心律失常 (上心室性)
通常情況下, 成人輕輕靜脈注射一次10毫克約3分鐘作為鹽酸齊爾噻嗪。應該注意的是, 年齡, 根據症狀增加或減少。
術中異常高血壓的急診治療
對於一次性靜態便箋
通常情況下, 成人輕輕靜脈注射一次10毫克約1分鐘作為鹽酸齊爾噻嗪。應該注意的是, 年齡, 根據症狀增加或減少。
靜脈輸液
通常情況下, 成人以5 ~15μg滴注靜脈注射, 作為鹽酸鋯, 每磅體重每分鐘公斤。血壓降低到目標值, 滴注率調整, 隨後監測血壓。
0高血壓急症
通常情況下, 成人以5 ~15μg滴注靜脈注射, 作為鹽酸鋯, 每磅體重每分鐘公斤。血壓降低到目標值, 滴注率調整, 隨後監測血壓。
0不穩定的心絞痛
通常情況下, 成人以1 ~5μg滴注靜脈注射, 作為鹽酸鋯, 每磅體重每分鐘公斤。劑量從低劑量開始, 但根據患者的病情適當增加或減少, 最大劑量為每磅體重每公斤5微克。
臨床結果
1. 心動過速心律失常 (上室)
臨床試驗結果, 包括雙盲比較試驗與安慰劑作為控制藥物, 癲癇發作室外性心動過速, 心動過速心房顫動, 觀察劑對心動過速房顫的作用。癲癇發作的上室性心動過速的有效率(有效或更高) 為86.4% (184/213), 心動過速房顫動和粗糙運動的有效率為 86.4(130/149)。
2. 手術中異常高血壓的緊急治療
通過臨床試驗, 包括對硝酸甘油 (注射溶液) 作為對照藥物進行簡單的盲目比較試驗, 觀察了這種藥物在手術中對異常高血壓的急救的有用性。 有效率(超過有效率) 為 94.0%(~ 335)。
3. 高血壓急診
惡性高血壓、高血壓性腦病、離解性主動脈瘤、急性左心衰竭 (超過有效) 高血壓急症的有效率為1000%(28/28)。
4. 不穩定的心絞痛
通過隨機簡單盲比較試驗, 觀察了該藥物對不穩定型心絞痛的有效性。 有效率 (高於適度改善)為80.0%(32 40)。
包装
用於注射
10:10毫克x10瓶,
50:50毫克x10 瓶
制造厂商
田边三菱制药株式会社
注:以上中文不够完整,使用者以原处方资料为准。
完整说明附件:
http://www.info.pmda.go.jp/go/pack/2171405D4050_1_05/2171405D4050_1_05?view=body
HERBESSER for Injection(Diltiazem hydrochloride)
HERBESSER 250 mg for Injection(ヘルベッサー注射用250)
Brand name : HERBESSER 250 mg for Injection
Active ingredient: Diltiazem hydrochloride
Dosage form: injection
Print on wrapping:
Effects of this medicine
This medicine has calcium antagonistic action to inhibit calcium ion influx of extracellular fluid into cells, and thereby dilates coronary artery and peripheral blood vessels, reduces blood pressure, and slows conduction of impulses in the atrioventricular node, a pathway that the electric energy occurred in the sinoatrial node generating normal sinus rhythm is transmitted from the atria to ventricles.
It is usually used to treat tachyarrhythmia, hypertensive emergency and unstable angina, and for emergency treatment of malignant hypertension during operation.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have hypotension, cardiogenic shock, second-degree or higher atrioventricular (AV) block, sick sinus syndrome (with persistent sinus bradycardia at less than 50 beats/minute, sinus arrest, sinoatrial block, etc.), congestive cardiac failure or cardiomyopathy.
•If you are pregnant, possibly pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•Tachyarrhythmia (supraventricular): In general, for adults, this medicine is given by intravenous
injection slowly over approximately 3 minutes.
Emergency treatment of malignant hypertension during operation: In general, for adults, this medicine is given by intravenous injection slowly over approximately 1 minute. If it is given by intravenous drip infusion, your doctor decides the infusion rate and time monitoring the blood pressure.
Hypertensive emergency, unstable angina: In general, for adults, this medicine is given by intravenous drip infusion. The infusion rate and time depend on your symptom.
Precautions while taking this medicine
• Possible adverse reactions to this medicine
The most commonly reported adverse reactions include bradycardia, decreased blood pressure and AV block (skipped pulse beats). If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•slow pulse, general malaise/shortness of breath, dizziness/syncope [complete AV block, severe bradycardia, cardiac arrest]
•respiratory distress, general edema, fatiguability [congestive cardiac failure]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Mitsubishi Tanabe Pharma CorporationInjection
Published: 2/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. |