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Colistimethate (Colistimethate Sodium) - Summary

 
 



COLISTIMETHATE SUMMARY

Colistimethate for Injection USP is a sterile parenteral antibiotic product which, when reconstituted (see Reconstitution), is suitable for intramuscular or intravenous administration. Each vial contains colistimethate sodium or pentasodium colistinmethanesulfonate (150 mg colistin base activity).

Colistimethate for Injection is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to Proteus or Neisseria. Colistimethate for Injection has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

Colistimethate for Injection may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli.

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


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NEWS HIGHLIGHTS

Media Articles Related to Colistimethate

Central line infections and ventilator pneumonias decline nationwide
Source: Respiratory / Asthma News From Medical News Today [2014.09.11]
Hospitals across the country have seen sharp declines in rates of central line-associated blood stream infections (CLABSIs) and ventilator-associated pneumonias (VAPs) among critically ill neonates...

Antibiotic Lowers Death Risk for Elderly Patients With Pneumonia: Study
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Title: Antibiotic Lowers Death Risk for Elderly Patients With Pneumonia: Study
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Created: 6/3/2014 4:36:00 PM
Last Editorial Review: 6/4/2014 12:00:00 AM

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Source: MedicineNet Hemolytic Uremic Syndrome Specialty [2014.01.13]
Title: Pneumonia
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
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Source: MedicineNet temazepam Specialty [2012.12.06]
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Pneumonia Quiz: Test Your Medical IQ
Source: MedicineNet sulfamethoxazole Specialty [2010.12.27]
Title: Pneumonia Quiz: Test Your Medical IQ
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Published Studies Related to Colistimethate

Randomized controlled trial of nebulized colistimethate sodium as adjunctive therapy of ventilator-associated pneumonia caused by Gram-negative bacteria. [2010.12]
BACKGROUND: Cases of ventilator-associated pneumonia (VAP) due to multidrug-resistant (MDR) Acinetobacter baumannii and Pseudomonas aeruginosa are common in hospitalized patients at Siriraj Hospital, Bangkok, Thailand. Parenteral colistimethate sodium (CMS) has been used for therapy of VAP caused by MDR A. baumannii and P. aeruginosa at Siriraj Hospital over the past few years, with modest favourable outcomes. Objectives To determine whether nebulized CMS as adjunctive therapy of Gram-negative VAP was safe and beneficial... CONCLUSIONS: Nebulized CMS as adjunctive therapy of Gram-negative VAP seems to be safe. However, a beneficial effect on clinical outcomes of adjunctive nebulized CMS for therapy of Gram-negative VAP was not ascertained.

Randomized controlled trial of nebulized colistimethate sodium as adjunctive therapy of ventilator-associated pneumonia caused by Gram-negative bacteria. [2010.09.28]
Background Cases of ventilator-associated pneumonia (VAP) due to multidrug-resistant (MDR) Acinetobacter baumannii and Pseudomonas aeruginosa are common in hospitalized patients at Siriraj Hospital, Bangkok, Thailand... However, a beneficial effect on clinical outcomes of adjunctive nebulized CMS for therapy of Gram-negative VAP was not ascertained.

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Clinical Trials Related to Colistimethate

Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli [Recruiting]
Approximately 444 subjects who are greater than or equal to 18 to 95 years of age, are non-pregnant, and are in the inpatient setting of one of the six study sites will be evaluated to treatment efficacy. Analysis will include subjects with bloodstream infection (BSI) or pneumonia due to at least one of the following gram-negative bacilli organisms: Acinetobacter baumannii, Klebsiella spp, Escherichia coli, Enterbactor spp. and/or Pseudomonas aeruginosa that demonstrates in vitro non-susceptibility defined as extensively drug-resistant Gram-negative bacilli (XDR-GNB) which includes XDR-AB, XDR-PA and CRE. If a subject has both BSI and pneumonia at the time of study enrollment, they will be included as a subject with pneumonia.

Objectives:

Primary:

•Determine whether the treatment regimen of Colistimethate sodium (colistin) combined with Imipenem-cilistatin (imipenem) is associated with a decreased risk for mortality compared to colistin alone for patients with bloodstream infection (BSI) and/or pneumonia due to XDR-GNB.

Secondary:

•Determine what treatment regimen (colistin monotherapy or colistin combined with imipenem) is more likely to reduce the emergence of colistin resistance among XDR-GNB isolates during therapy.

Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity [Not yet recruiting]

Colistin Versus Colistin Plus Fosfomycin for Infections Caused by MDR Acinetobacter Baumannii [Recruiting]
In Siriraj Hospital, colistin alone for treatment of MDR A. baumannii contributed to mortality 45% Fosfomycin is an antimicrobial which has activity against gram-negative bacterial including MDR A. baumannii In this study, we compare the clinical and microbiologicalresponse of colistin alone versus colistin plus fosfomycin in treatment of A. baumannii infected patients

Population Pharmacokinetic Study of Colistin in Patients Infected With Multiresistant Gram-negative Bacteria [Recruiting]
Nosocomial infections have become a major health problem. They induced important use of antibiotics which is a preponderant factor for the development of bacterial resistance. The multi-resistance to antibiotics affects primarily Gram-negative bacteria. Some strains (as Acinetobacter or Pseudomonas) have become resistant to almost all antibiotics currently available, and the use of old molecules as Colistin may be the only alternative. However, there are few reliable data about Colistin and its PK characteristics. These data are essential to optimize its administration. The aim of the present study is to evaluate the pharmacokinetics of Colistin and its prodrug, colistimethate (CMS) after intravenous administration of Colistimethate alone or combined with inhaled Colistin in severely ill patients infected with multiresistant gram-negative bacteria

Multicenter Open-label Randomized Controlled Trial (RCT) to Compare Colistin Alone Versus Colistin Plus Meropenem [Not yet recruiting]
The purpose of this study is to determine whether the addition of meropenem to colistin is better than colistin alone in the treatment of clinically significant infections caused by multi-drug resistant bacteria

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Page last updated: 2014-09-11

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