2010年12月,美国FDA批准Cubist制药的达托霉素(daptomycin)注射剂Cubicin以一日1次2min静脉内推注用新给药方案 达托霉素 (Daptomycin) 是由Lilly（礼来）公司最初研究，Cubist制药公司开发的一环脂肽类抗生素。因应病人对新型耐药抗生素的迫切需求，2003年底，美国食品与药物管理局（FDA）经过快速审理程序批准注射用 达托霉素(Daptomycin 商品名cubicin)用于治疗由一些革兰氏阳性敏感菌株引起的并发性皮肤及皮肤结构感染，如脓肿、手术切口感染和皮肤溃疡。达托霉素 的作用机制与其他抗生素不同，它通过扰乱细胞膜对氨基酸的转运，从而阻碍细菌细胞壁肽聚糖的生物合成，改变细胞质膜的性质；另外，它还能通过破坏细菌的细胞膜，使其内容物外泄而达到杀菌的目的，因此细菌对达托霉素产生耐药性可能会比较困难。 CUBICIN Rx Generic Name and Formulations: Daptomycin 500mg/vial; lyophilized pwd for IV inj after reconstitution or IV infusion after reconstitution and dilution; preservative-free. Company: Cubist Pharmaceuticals, Inc. Indications for CUBICIN: Susceptible complicated skin and skin structure infections, and S. aureus bacteremia including MRSA and MSSA right-sided endocarditis. Limitations of use: not for treatment of pneumonia or left-sided endocarditis due to S. aureus. Not studied in prosthetic valve endocarditis. Adult: Give by IV inj over 2 mins or IV infusion over 30 mins. Skin and skin structure: 4mg/kg once every 24hrs for 7–14 days. S. aureus bacteremia: 6mg/kg once every 24hrs for at least 2–6 weeks. Renal impairment (CrCl <30mL/min): increase dosing interval to once every 48hrs; coincide dose for after dialysis. Children: <18yrs: not established. Avoid use in children <12 months; risk of CNS or muscular effects. Warnings/Precautions: Monitor renal function and CPK weekly (or more frequently if renal impaired); discontinue if CPK (≥5xULN) and myopathy occur, or if CPK (≥10xULN) without myopathy occurs. Monitor for neuropathy, eosinophilic pneumonia. Persisting or relapsing S. aureus bacteremia/endocarditis: repeat blood cultures and evaluate. Decreased efficacy observed in patients with moderate baseline renal impairment. Severe hepatic impairment. Elderly. Pregnancy (Cat.B). Nursing mothers. Interactions: Consider suspending statins. May cause false elevation of PT/INR results when certain recombinant thromboplastin reagents are utilized for the assay. Pharmacological Class: Cyclic lipopeptide. Adverse Reactions: Abnormal liver function tests, elevated CPK, dyspnea; hypersensitivity reactions, eosinophilic pneumonia (discontinue if develops), peripheral neuropathy, myopathy, rhabdomyolysis, C. difficile-associated diarrhea. How Supplied: Single-use vial (10mL)—1 美国上市包装 CUBICIN 500MG SDV LYO PWD DPSH 10/PAC  DAPTOMYCIN     67919-0011-01     CUBICIN SDV 500MG D/S 10  DAPTOMYCIN     67919-0011-01      CUBICIN 500MG SDV LYO PWD 1/EA  DAPTOMYCIN     67919-0011-01    CUBICIN SDV 500MG 1  DAPTOMYCIN     67919-0011-01 生产厂商：MERCK SHARP & DOHME 日本上市包装 350mg: 10vials 生产厂商：MSD有限公司 日本的原处方资料附件：http://www.info.pmda.go.jp/go/pack/6119402D1021_1_06/