盐酸罗哌卡因注射液 ROPIVACAINE HCL/PF（商品名：NAROPIN）参比制剂，美国上市，一次性进口中，平价供应。
英文名：ROPIVACAINE HCL/PF
商品名：NAROPIN
中文名：盐酸罗哌卡因注射液
生产商：FRESENIUS KABI USA LLC
上市国家：美国
包装规格及价格
NAROPIN 2 MG-ML VL 25X20 ML ROPIVACAINE HCL/PF FRESENIUS KABI USA LLC 63323028523 $304.95
NAROPIN 2 MG-ML SDV 200 ML ROPIVACAINE HCL/PF FRESENIUS KABI USA LLC 63323028564 $131.08
NAROPIN 2 MG-ML SDV 100 ML ROPIVACAINE HCL/PF FRESENIUS KABI USA LLC 63323028565 $85.54
NAROPIN 7.5 MG-ML AMP 5X20 ML ROPIVACAINE HCL/PF FRESENIUS KABI USA LLC 63323028720 $143.47
NAROPIN 5 MG-ML VL 25X20 ML ROPIVACAINE HCL/PF FRESENIUS KABI USA LLC 63323028623 $455.77
NAROPIN 0.5% 150 MG VL 25X30 ML ROPIVACAINE HCL/PF FRESENIUS KABI USA LLC 63323028635 $1,063.15
NAROPIN 0.2% 2MG/ML BAG 24X100 ML ROPIVACAINE HCL/PF FRESENIUS KABI USA LLC 63323028561 $1,397.14
NAROPIN 0.2% 2MG/ML BAG 24X200 ML ROPIVACAINE HCL/PF FRESENIUS KABI USA LLC 63323028563 $2,793.90
NAROPIN 5 MG-ML SDV 5X30 ML ROPIVACAINE HCL/PF FRESENIUS KABI USA LLC 63323028631 $158.84
NAROPIN 10 MG-ML AMP 5X20 ML ROPIVACAINE HCL/PF FRESENIUS KABI USA LLC 63323028820 $164.26
NAROPIN 0.5% 30ML SDV APP 25/PAC ROPIVACAINE HCL FRESENIUS KABI USA LLC 63323-0286-35 $1,437.84
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部份中文盐酸罗哌卡因处方资料（仅供参考）
商品名：Naropin
英文名：Ropivacainehydro chloride
中文名：盐酸罗哌卡因注射液
生产商：FRESENIUS KABI USA LLC
药理作用
自从发现长效局部麻醉药以来，在使用时常伴发心脏突然停搏了提高此类药物的安全性，必须寻找脂溶性较低的长效局部麻醉药。本品由Astra公司研制，1996年英国首次上市面上的长效局部麻醉新药。
适应症
本品推荐用于外科手术麻醉、助产过程、局部或区域性麻醉，以及急性疼痛或手术后疼痛的治疗。
用法用量
用于外科手术麻醉时，建议本品硬膜外用药的剂量为113-200mg，以改变注射液的浓度或容量达到调整剂量。用于术后镇痛时本品用药剂量：硬膜外静脉推注20-40mg，间隔时间≥30min后方可增加剂量（至多为20-30mg）；或者连续硬膜外输注本品2mg/ml，输注速率为6~14ml/h（腰）或4-8l/h（胸）。
不良反应
本品不良反应与丁哌卡因相似，主要有低血压、恶心、呕吐、心动过缓、暂时性感觉异常、背痛、尿潴留和发热。
注意事项
本品必须在专人监督指导下使用，使用过程中注意观察病人的中枢神经系统和心血管毒性反应。哺乳妇女和12岁以下儿童慎用。本品在肝脏代谢，因此与确知在肝脏代谢的其他药（如茶的功效与作用碱、丙咪嗪）或肝脏GYPIA酶系统的抑制剂（如维拉帕米、氟伏沙明）有相互作用。对已接受其他局麻醉药病人使用本品时应注意它们有毒性相加作用。严重肝功能障碍病人使用本品时产生不良反应的危险性较大，必须密切监护。心血管功能受损者和严重肾功能不良者慎用。本品只宜采用通过腰或胸的硬膜外麻醉给药，不可静脉注射或脊髓麻醉并避免大容量的快速注射。
NAROPIN Injection SDV 0.5% 30mL Preservative Free 25/Pk
NAROPIN- ropivacaine hydrochloride injection, solution
Rx only
DESCRIPTION
Naropin® Injection contains ropivacaine HCl which is a member of the amino amide class of local anesthetics. Naropin Injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. Sodium hydroxide and/or hydrochloric acid may be used for pH adjustment. It is administered parenterally.
Ropivacaine HCl is chemically described as S-(-)-1-propyl-2?,6?-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder.
C17 H26 N2 O�HCl�H2 O M.W. 328.89
At 25°C ropivacaine HCl has a solubility of 53.8 mg/mL in water, a distribution ratio between n-octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine.
Naropin Injection is preservative-free and is available in single dose containers in 2 (0.2%), 5 (0.5%), 7.5 (0.75%) and 10 mg/mL (1%) concentrations. The specific gravity of Naropin Injection solutions range from 1.002 to 1.005 at 25°C.
CLINICAL PHARMACOLOGY
Mechanism of Action
Ropivacaine is a member of the amino amide class of local anesthetics and is supplied as the pure S-(-)-enantiomer. Local anesthetics block the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone. |
