---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件（201131020382337.pdf）的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文亚胺培南-西拉司丁钠处方资料（仅供参考）

药物名称：亚胺培南-西拉司丁钠

药物别名：亚胺硫霉素-西拉司丁钠，TIENAM，PRIMAXIN

英文名称：Imipenem／Cilastin Sodium

说明：注射用亚胺培南-西拉司丁：每支0.25g；0.5g；1g（以亚胺培南计量）。其中含有等量的西拉司丁钠。
 
功用作用：亚胺培南对革兰阳性、阴性的需氧和厌氧菌具有抗菌作用。肺炎链球菌、化脓性链球菌、金黄色葡萄球菌（包括产酶株）、大肠杆菌、克雷白杆菌、不动杆菌部分菌株、脆弱拟杆菌及其他拟杆菌、消化球菌和消化链球菌的部分菌株对本品甚敏感。 粪链球菌、表皮链球菌、流感嗜血杆菌、奇异变形杆菌、沙雷杆菌、产气肠杆菌、阴沟肠杆菌、绿脓杆菌、气性坏疽梭菌、难辨梭菌等对本品也相当敏感。本品有较好的耐酶性能，与其他β-内酰胺类药物间较少出现交叉耐药性。 　　
口服不吸收，静注本品250mg、500mg或1000mg（均按亚胺培南计量）后20分钟，血药峰浓度分别为20μg／ml、35μg／ml或66μg／ml，蛋白结合率约为20％。体内分布以细胞间液、肾脏、上额窦、子宫颈、卵巢、盆腔、肺等部位最高，在胆汁、前列腺、扁桃体、痰中也有较多量，并有一定量进入脑脊液中。t1/2约为1小时。 　　
亚胺培南单独应用，受肾肽酶的影响而分解，在尿中只能回收少量的原形药物。西拉司丁是肾肽酶抑制剂，保护亚胺培南在肾脏中不受破坏，因此在尿中回收的原形药物可达70％。西拉司丁并阻抑亚胺培南进入肾小管上皮组织，因而减少亚胺培南的排泄并减轻药物的肾毒性。 　　
临床上应用本品于敏感菌所致的腹膜炎、肝胆感染、腹腔内脓肿、阑尾炎、妇科感染、下呼吸道感染、皮肤和软组织感染、尿路感染、骨和关节感染以及败血症等。
 
用法用量：静滴或肌注。用量以亚胺培南计，根据病情，1次0.25～1g，1日2～4次。对中度感染一般可按1次1g、1日2次给予。 　　
静滴可选用等渗氯化钠注射液、5％～10％葡萄糖液作溶剂。每0.5g药物用100ml溶剂，制成5mg／ml液体，缓缓滴入。肌注用1％利多卡因注射液为溶剂，以减轻疼痛。 　　
对肾功能不足者应按肌酐清除率调整剂量：肌酐清除率为31～70ml／分的患者，每6～8小时用0.5g，每日最高剂量1.5～2g；21～30ml／分者，每8～12小时用0.5g，每日最高剂量1～1.5g；＜20ml／分者每12小时用0.25～0.5g，每日最高剂量0.5～1g。
 
注意事项：
（1）本品可引起注射部位疼痛、血栓性静脉炎等，可对症处理，并注意改换注射部位以防止发生。 　　
（2）本品可引起恶心、呕吐、腹泻等胃肠道症状，也偶引起伪膜性肠炎。血液学方面的副作用有嗜酸细胞增多、白细胞减少、中性细胞减少、粒细胞缺少、血小板减少或增多、血红蛋白减少等，并可致抗人球蛋白（Coombs）试验阳性。 对肝脏的副作用有氨基转移酶、血胆红素或碱性磷酸酶的升高。肾功能方面的副作用有血肌酐和血尿素氮的升高。但儿童用本药时常可发现红色尿，这是由于药物引起变色，并非血尿。也可发现一些神经系统方面的症状，如肌痉挛、精神障碍等。 　　
（3）本品也可致过敏反应，如皮肤瘙痒、皮疹、荨麻疹、药热等，过敏体质者慎用。 　　
（4）本品应在使用前溶解，用盐水溶解的药液只能在室温存放10小时，含葡萄糖的药液只能存放4小时。 　　
（5）本品不可与含乳酸钠的输液或其他碱性药液相配伍。 

Although clinical improvement has been observed in patients with cystic fibrosis, chronic pulmonary disease, and lower respiratory tract infections caused by P aeruginosa, bacterial eradication may not necessarily be achieved.

As with other beta-lactam antibiotics, some strains of P aeruginosa may develop resistance fairly rapidly during treatment with PRIMAXIN I.V. During therapy of P aeruginosa infections, periodic susceptibility testing should be done when clinically appropriate.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of PRIMAXIN I.V. and other antibacterial drugs, PRIMAXIN I.V. should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Selected Important Safety Information
PRIMAXIN I.V. is contraindicated in patients who have shown hypersensitivity to any component of this product.

SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING THERAPY WITH BETA-LACTAMS. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN PERSONS WITH A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS.

BEFORE INITIATING THERAPY WITH PRIMAXIN I.V., CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OTHER BETA-LACTAMS, AND OTHER ALLERGENS. IF AN ALLERGIC REACTION TO PRIMAXIN I.V. OCCURS, DISCONTINUE THE DRUG. SEIZURES AND OTHER CNS ADVERSE EVENTS HAVE BEEN REPORTED DURING TREATMENT WITH PRIMAXIN I.V.

Co-administration of carbapenems, including PRIMAXIN I.V., to patients receiving valproic acid or divalproex sodium results in a reduction of valproic acid concentrations, which may drop below the therapeutic range and increase the risk of breakthrough seizures. Increasing the dose of valproic acid or divalproex sodium may not be sufficient. Concomitant use of PRIMAXIN I.V. and valproic acid/divalproex sodium is generally not recommended. Consider other anti-bacterials in patients whose seizures are well controlled on valproic acid or divalproex sodium. If PRIMAXIN I.V. is necessary, consider supplemental anticonvulsant therapy.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including PRIMAXIN I.V., and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. CDAD has been reported to occur over 2 months after administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C difficile may need to be discontinued.

Central nervous system (CNS) adverse experiences such as confusional states, myoclonic activity, and seizures have been reported during treatment with PRIMAXIN I.V., especially when recommended dosages were exceeded. These experiences have occurred most commonly in patients with CNS disorders (eg, brain lesions or history of seizures) and/or compromised renal function. However, there have been reports of CNS adverse experiences in patients who had no recognized or documented underlying CNS disorder or compromised renal function.

The most frequently reported systemic adverse clinical reactions that were reported as possibly, probably, or definitely related to PRIMAXIN I.V. were nausea (2.0%), diarrhea (1.8%), vomiting (1.5%), rash (0.9%), fever (0.5%), hypotension (0.4%), seizures (0.4%), dizziness (0.3%), pruritus (0.3%), urticaria (0.2%), and somnolence (0.2%).

Prescribing PRIMAXIN I.V. in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件（201131020382337.pdf）的“原文Priscribing Information”为准
---------------------------------------------------------------

2011-3-11更新