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cancidas (caspofungin acetate) injection, powder(二十)
2016-07-05 09:52:43 来源: 作者: 【 】 浏览:9909次 评论:0
o-administration of dexamethasone with CANCIDAS may result in clinically meaningful reductions in caspofungin trough concentrations. This finding may indicate that pediatric patients will have similar reductions with inducers as seen in adults. When CANCIDAS is co-administered to pediatric patients with inducers of drug clearance, such as rifampin, efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, a CANCIDAS dose of 70 mg/m2 daily (not to exceed an actual daily dose of 70 mg) should be considered.
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Registered trademark of Astellas Pharma, Inc.


12.4 Microbiology
Mechanism of Action

Caspofungin acetate, the active ingredient of CANCIDAS, inhibits the synthesis of β (1,3)-D-glucan, an essential component of the cell wall of susceptible Aspergillus species and Candida species. β (1,3)-D-glucan is not present in mammalian cells. Caspofungin has shown activity against Candida species and in regions of active cell growth of the hyphae of Aspergillus fumigatus.

Activity in vitro

Caspofungin has been shown to be active both in vitro and in clinical infections against most strains of the following microorganisms:

Aspergillus fumigatus

Aspergillus flavus

Aspergillus terreus

Candida albicans

Candida glabrata

Candida guilliermondii

Candida krusei

Candida parapsilosis

Candida tropicalis

Susceptibility Testing Methods [see References (15)]

Aspergillus Species and Other Filamentous fungi

No interpretive criteria have been established for Aspergillus species and other filamentous fungi.

Candida Species

The interpretive standards for caspofungin against Candida species are applicable only to tests performed using Clinical Laboratory and Standards Institute (CLSI) microbroth dilution reference method M27A for MIC (partial inhibition endpoint) read at 24 hours.

Broth Microdilution Techniques: Quantitative methods are used to determine antifungal minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of Candida spp. to antifungal agents. MICs should be determined using a standardized procedure at 24 hours [see References (15)]. Standardized procedures are based on a microdilution method (broth) with standardized inoculum concentrations and standardized concentrations of caspofungin powder. The MIC values should be interpreted according to the criteria provided in Table 8.

TABLE 8: Susceptibility Interpretive Criteria for Caspofungin 
Pathogen Broth Microdilution MIC* (μg/mL) at 24 hours
  S   I   R
*
A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable.

The current absence of data on caspofungin-resistant isolates precludes defining any categories other than “Susceptible.” Isolates yielding test results suggestive of a “Non-Susceptible” category should be retested, and if the result is confirmed, the isolate should be submitted to a reference laboratory for further testing. 
Candida species   ≤2    (†)   (†)

Quality Control

Standardized susc

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