BOX WARNING
INTRAVENOUS ADMINISTRATION
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Direct Intermittent Administration— Slowly inject one-half of the total daily dose over a period of 3 to 5 minutes every 12 hours.
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Continuous Infusion—Slowly inject one-half of the total daily dose over 3 to 5 minutes. Add the remaining half of the total daily dose of Coly- Mycin M Parenteral to one of the following:
0.9% NaCI
5% dextrose in 0.9% NaCI
5% dextrose in water
5% dextrose in 0.45% NaCI
5% dextrose in 0.225% NaCI
lactated Ringer’s solution
10% invert sugar solution
There are not sufficient data to recommend usage of Coly-Mycin M Parenteral with other drugs or other than the above listed infusion solutions.
Administer the second half of the total daily dose by slow intravenous infusion, starting 1 to 2 hours after the initial dose, over the next 22 to 23 hours. In the presence of impaired renal function, reduce the infusion rate depending on the degree of renal impairment.
The choice of intravenous solution and the volume to be employed are dictated by the requirements of fluid and electrolyte management.
Any infusion solution containing colistimethate sodium should be freshly prepared and used for no longer than 24 hours.
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COLY-MYCIN SUMMARY
Coly-Mycin® M Parenteral
(Colistimethate for Injection, USP)
Coly-Mycin® M Parenteral (Colistimethate for Injection, USP) is a sterile parenteral antibiotic product which, when reconstituted (see Reconstitution), is suitable for intramuscular or intravenous administration.
Coly-Mycin M Parenteral 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. Coly-Mycin M Parenteral has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
Coly-Mycin M Parenteral 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.
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NEWS HIGHLIGHTS
Published Studies Related to Coly-Mycin (Colistimethate Injection)
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.
Pharmacokinetics of colistin and colistimethate sodium after a single 80-mg intravenous dose of CMS in young healthy volunteers. [2011.06]
Colistin pharmacokinetics (PK) was investigated in young healthy volunteers after a 1-h infusion of 80 mg (1 million international units (MIU)) of the prodrug colistin methanesulfonate (CMS). Concentration levels of CMS and colistin were determined in plasma and urine using a new chromatographic assay and analyzed simultaneously with a population approach after correcting the urine-related data for postexcretion hydrolysis of CMS into colistin...
Colistimethate sodium therapy for multidrug-resistant isolates in pediatric patients. [2010.06]
AIM: The aim of the present study was to assess the efficacy and safety of colistimethate sodium therapy in multidrug-resistant nosocomial infections caused by Pseudomonas aeruginosa or Acinetobacter baumannii in neonates and children... CONCLUSION: Colistimethate sodium appears to be safe and effective for the treatment of severe infections caused by multidrug-resistant P. aeruginosa or A. baumannii in pediatric patients.
Polymyxin B and colistimethate are comparable as to efficacy and renal toxicity. [2009.12]
We compared 41 patients who received colistimethate with 41 who received polymyxin B for the treatment of serious infections caused by carbapenem-resistant Acinetobacter spp.
Clinical Trials Related to Coly-Mycin (Colistimethate Injection)
Intravenous Colistin Versus Intravenous Colistin Plus Nebulized Colistin in VAP Due MDR Acinetobacter Baumannii [Recruiting]
Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus
inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline
solution in patients with VAP due to baumannii carbapenems resistant.
Renal Impairment Associated With Colistin Levels [Not yet recruiting]
Colistin is a relatively old antibiotic drug which its use has been abandoned through the
1970s because it was considered nephrotoxic.
Recently ( the last decade) it has been reappraised because multidrug resistant Gram
negative bacteria have emerged causing life threatening infections with no other good enough
treatment. Moreover, more controlled studies from the recent years show less toxic effect of
the drug.
The investigators' study is a prospective study comparing renal function in a group of
hospitalized patients with sepsis (infection) receiving intravenous treatment with Colistin
(antibiotics) with a control group which its patients receive other non nephrotoxic
antibiotics.
The investigators' study hypothesis is that patients receiving Colistin would have renal
function decline in higher rates than those seen usually in hospitalized patients in the
Internal medicine wards with sepsis.
Another goal of the study is to find correlation between Colistin levels in the plasma
(after Colistin reaches steady state) and nephrotoxicity seen during or after use of this
drug.
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
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
Colistin Plus Rifampicin in MDR P. Aeruginosa and A. Baumanii [Recruiting]
In Siriraj Hospital, Colistin alone for treatment of MDR. A. baumanii or P. aeruginosa
contributed to mortality 45%. In vitro studies revealed synergism of Rifampicin and
Colistin.
In this study, patients with documented MDR. P. aeruginosa or A. baumanii will be allocated to
receive Colistin alone and another group will receive Colistin plus Rifampicin.
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