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Coly-Mycin Pharmacology, Pharmacokinetics, Studies, Metabolism - Sterile Colistimethate Sodium

Coly-Mycin Pharmacology, Pharmacokinetics, Studies, Metabolism - Sterile Colistimethate Sodium

CLINICAL PHARMACOLOGY

Typical serum and urine levels following a single 150 mg dose of Coly-Mycin M Parenteral IM or IV in normal adult subjects are shown in Figure 1.

Higher serum levels were obtained at 10 minutes following IV administration. Serum concentration declined with a half-life of 2-3 hours following either intravenous or intramuscular administration in adults and in the pediatric population, including premature infants.

Average urine levels ranged from about 270 mcg/mL at 2 hours to about 15 mcg/mL at 8 hours after intravenous administration and from 200 to about 25 mcg/mL during a similar period following intramuscular administration.

Microbiology:   Colistimethate sodium is a surface active agent which penetrates into and disrupts the bacterial cell membrane. It has been shown to have bactericidal activity against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section:

Aerobic gram-negative microorganisms:

Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae , and Pseudomonas aeruginosa

Susceptibility Tests:   Colistimethate sodium is no longer listed as an antimicrobial for routine testing and reporting by clinical microbiology

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