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Cleocin

Clinical Pharmacology
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Clinical Pharmacology

Cleocin

Standardized susceptibility test procedures require the use of quality control microorganisms to control the technical aspects of the test procedures. Standard clindamycin powder should provide the following range of values noted in Table 2. NOTE: Quality control microorganisms are specific strains of organisms with intrinsic biological properties relating to resistance mechanisms and their genetic expression within bacteria; the specific strains used for microbiological quality control are not clinically significant.

Table 2. Acceptable Quality Control Ranges for Clindamycin to be Used in Validation of Susceptibility Test Results


QC Strain Acceptable Quality Control Ranges
Minimum Inhibitory Concentration
(MIC in mcg/mL)		 Disk Diffusion
(Zone Diameters in mm)
When Testing Aerobic Pathogens    
Staphylococcus aureus ATCC 29213 0.06—0.25 NA
Staphylococcus aureus ATCC 25923 NA 24—30
Streptococcus pneumoniae ATCC 49619d 0.03—0.12e 19—25f
When Testing Strict Anaerobes    
Bacteroides fragilis ATCC 25285 0.5—2 NA
Bacteroides thetaiotaomicron ATCC 29741 2—8 NA
Eubacterium lentum ATCC 43055 0.06—0.25 NA
NA=Not applicable
d This organism may be used for validation of susceptibility test results when testing Streptococcus spp. other than S. pneumoniae.
e This quality control range for S. pneumoniae is applicable only to tests performed by broth microdilution using cation-adjusted Mueller-Hinton broth with 2 to 5% lysed horse blood inoculated with a direct colony suspension and incubated in ambient air at 35°C for 20 to 24 hours.
f This quality control zone diameter range is applicable only to tests performed using Mueller-Hinton agar supplemented with 5% sheep blood inoculated with a direct colony suspension and incubated in 5% CO2 at 35°C for 20 to 24 hours. ATCC® is a registered trademark of the American Type Culture Collection

Animal Toxicology

One year oral toxicity studies in Spartan Sprague-Dawley rats and beagle dogs at dose levels up to 300 mg/kg/day (approximately 1.6 and 5.4 times the highest recommended adult human dose based on mg/m2, respectively) have shown clindamycin to be well tolerated. No appreciable difference in pathological findings has been observed between groups of animals treated with clindamycin and comparable control groups. Rats receiving clindamycin hydrochloride at 600 mg/kg/day (approximately 3.2 times the highest recommended adult human dose based on mg/m2) for 6 months tolerated the drug well; however, dogs dosed at this level (approximately 10.8 times the highest recommended adult human dose based on mg/m2) vomited, would not eat, and lost weight.

REFERENCES

1.   NCCLS. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard-5th ed. NCCLS document M7-A5, 2000. NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898.

2.   NCCLS. Performance Standards for Antimicrobial Susceptibility Testing: 13th Informational Supplement. NCCLS document M100-S13 (M2 & M7), 2003. NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898.

3.   NCCLS. Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria 5th ed. Approved Standard. NCCLS document M11-A5, 2001. NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898.

4.   NCCLS. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-8th ed. NCCLS document M2-A8 (ISBN 1-56238-393-0), 2003. NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898.

Brand Name: Cleocin
Generic Name: Clindamycin

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