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Cubicin (Daptomycin) - Summary

 

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CUBICIN SUMMARY

Cubicin®
(daptomycin for injection)
Rx only

CUBICIN contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus.

CUBICIN (daptomycin for injection) is indicated for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms (see also DOSAGE AND ADMINISTRATION): Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only). Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram-negative or anaerobic organisms (see CLINICAL STUDIES).

Daptomycin is not indicated for the treatment of pneumonia.

Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to daptomycin. Empiric therapy may be initiated while awaiting test results. Antimicrobial therapy should be adjusted as needed based upon test results.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN and other antibacterial drugs, CUBICIN 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.

CUBICIN NEWS HIGHLIGHTS

Published Studies Related to Cubicin (Daptomycin)

Daptomycin for endocarditis and/or bacteraemia: a systematic review of the experimental and clinical evidence. [2007.07]

Pharmacokinetics and tolerability of daptomycin at doses up to 12 milligrams per kilogram of body weight once daily in healthy volunteers. [2006.10]

Daptomycin versus standard therapy for bacteremia and endocarditis caused by Staphylococcus aureus. [2006.08.17]

Daptomycin for treating infected diabetic foot ulcers: evidence from a randomized, controlled trial comparing daptomycin with vancomycin or semi-synthetic penicillins for complicated skin and skin-structure infections. [2005.02]

The safety and efficacy of daptomycin for the treatment of complicated skin and skin-structure infections. [2004.06.15]

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Clinical Trials Related to Cubicin (Daptomycin)

Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD) [Suspended]

Study Comparing CUBICINŽ (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas [Completed]

Cubicin(R) for Complicated Post-Surgical Wound Infections [Terminated]

Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections [Terminated]

Daptomycin in the Treatment of Subjects With Infective Endocarditis or Bacteremia Due to S. Aureus [Completed]

more>>

Page last updated: 2007-08-04

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