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达托霉素:两种静脉制剂的比较。

Daptomycin: a comparison of two intravenous formulations.

作者信息

Frankenfeld Celeste, Mittal Sachin, Melendez Yanira, Mendez-Vigo Luke, Lamp Kenneth C, Keller Kaitlin N, Bertolami Shellie R

机构信息

Merck & Co., Inc., Kenilworth, NJ, USA,

出版信息

Drug Des Devel Ther. 2018 Jun 29;12:1953-1958. doi: 10.2147/DDDT.S167010. eCollection 2018.

Abstract

Daptomycin is a cyclic lipopeptide antibacterial agent with potent bactericidal activity against a broad range of Gram-positive organisms. In 2003, daptomycin for injection received approval from the US Food and Drug Administration (FDA) for the treatment of patients with complicated skin and skin structure infections (cSSSIs); in 2006, it was approved for the treatment of patients with bacteremia, including those with right-sided infective endocarditis caused by methicillin-susceptible and methicillin-resistant isolates. In 2016, the FDA approved a new formulation of daptomycin for injection (daptomycin RF) for the same indications. The efficacy and safety of daptomycin for injection have been established in pivotal clinical trials, and the findings of nonclinical studies indicate that both formulations of daptomycin for injection are equivalent. Herein we refer to the new daptomycin formulation as daptomycin RF to distinguish it from the original formulation. Daptomycin RF provides clinicians and clinical pharmacists with a product that offers improved stability and more rapid, in-vial reconstitution with either sterile or bacteriostatic water for injection, while maintaining the same antibacterial coverage. Here we discuss the rationale for and the potential value of daptomycin RF, and briefly review the similarities and differences between the original formulation of daptomycin and daptomycin RF.

摘要

达托霉素是一种环脂肽类抗菌药物,对多种革兰氏阳性菌具有强大的杀菌活性。2003年,注射用达托霉素获得美国食品药品监督管理局(FDA)批准,用于治疗复杂性皮肤和皮肤结构感染(cSSSIs)患者;2006年,它被批准用于治疗菌血症患者,包括由甲氧西林敏感和耐药菌株引起的右侧感染性心内膜炎患者。2016年,FDA批准了一种新的注射用达托霉素制剂(达托霉素RF)用于相同适应症。注射用达托霉素的疗效和安全性已在关键临床试验中得到确立,非临床研究结果表明两种注射用达托霉素制剂等效。在此我们将新的达托霉素制剂称为达托霉素RF,以将其与原始制剂区分开来。达托霉素RF为临床医生和临床药剂师提供了一种产品,该产品具有更高的稳定性,并且使用无菌或抑菌注射用水在瓶内复溶更快,同时保持相同的抗菌谱。在此我们讨论达托霉素RF的原理和潜在价值,并简要回顾达托霉素原始制剂与达托霉素RF之间的异同。

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Daptomycin: a comparison of two intravenous formulations.达托霉素:两种静脉制剂的比较。
Drug Des Devel Ther. 2018 Jun 29;12:1953-1958. doi: 10.2147/DDDT.S167010. eCollection 2018.

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