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Cleocin (clindamycin) drug information: dosage, uncomfortable side effects, drug interactions and us
Human Pharmacology

Serum level studies using a 150 mg oral dose of clindamycin hydrochloride in 24 normal adult volunteers revealed that clindamycin was rapidly absorbed after oral administration. The average peak serum a higher level 2. 50 mcg/mL was reached in 45 minutes; serum levels averaged 1. 51 mcg/mL at 3 hours and 0. 70 mcg/mL at 6 hours. Absorption connected with an oral dose is virtually complete (90%), and the concomitant administration of food will not appreciably customize the serum concentrations; serum levels are actually uniform and predictable from person to person and dose to dose. Serum level studies following multiple doses of CLEOCIN (clindamycin) HCl for approximately Two weeks show no evidence accumulation or altered metabolism of drug.

Serum half-life of clindamycin is increased slightly in patients with markedly reduced renal function. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin in the serum.

Concentrations of clindamycin from the serum increased linearly to comprehend dose. Serum levels exceed the MIC (minimum inhibitory concentration) for some indicated organisms for around six hours following administration of the usually recommended doses. Clindamycin is widely distributed in body fluids and tissues (including bones). The standard biological half-life is 2. 4 hours. Approximately 10% on the bioactivity is excreted in the urine and three. 6% within the feces; the others is excreted as bioinactive metabolites.

Doses all the way to 2 grams of clindamycin every day for 2 weeks are already well tolerated by healthy volunteers except that the incidence of gastrointestinal unwanted side effects is greater with all the higher doses.

No significant levels of clindamycin are attained inside the cerebrospinal fluid, even a good inflamed meninges.

Pharmacokinetic studies in elderly volunteers (61-79 years) and younger adults (18-39 years) indicate that age alone will not alter clindamycin pharmacokinetics (clearance, elimination half-life, volume of distribution, and area within the serum concentration-time curve) after IV administration of clindamycin phosphate. After oral administration of clindamycin hydrochloride, elimination half every day life is increased to approximately 4. 0 hours (range 3. 4-5. 1 h) inside elderly in comparison with 3. Two hours (range 2. 1 - 4. 2 h) in younger adults. The extent of absorption, however, isn't different between ages with out dosage alteration is important to the elderly with normal hepatic function and normal (age adjusted) renal function.

Microbiology

Clindamycin inhibits bacterial protein synthesis by binding on the 50S subunit
of the ribosome. It has activity against Gram-positive aerobes and anaerobes
as well as the Gram-negative anaerobes. Clindamycin is bacteriostatic. Cross-resistance
between clindamycin and lincomycin is complete. Antagonism in vitro has
been demonstrated between clindamycin and erythromycin.

Clindamycin may be active against a lot of the isolates in the
following microorganisms, at vitro plus in clinical infections, as
described inside INDICATIONS section.

Gram-positive aerobes

Staphylococcus aureus (methicillin-susceptible strains)

Streptococcus pneumoniae (penicillin-susceptible strains)

Streptococcus pyogenes

Anaerobes

Prevotella melaninogenica

Fusobacterium necrophorum

Fusobacterium nucleatum

Peptostreptococcus anaerobius

Clostridium perfringens

The following in vitro data can be obtained, on the other hand clinical significance
is unknown. At the least 90% from the following microorganisms exhibit an in vitro
minimum inhibitory concentration (MIC) under or comparable to the susceptible
breakpoint for clindamycin. However, the protection and effectiveness of clindamycin
for treating clinical infections caused by these microorganisms haven't been established
in adequate and well-controlled clinical studies.

Gram-positive aerobes

Staphylococcus epidermidis (methicillin-susceptible strains)

Streptococcus agalactiae

Streptococcus anginosus

Streptococcus oralis

Streptococcus mitis

Anaerobes

Prevotella intermedia

Prevotella bivia

Propionibacterium acnes

Micromonas ("Peptostreptococcus") micros

Finegoldia ("Peptostreptococcus") magna

Actinomyces israelii

Clostridium clostridioforme

Eubacterium lentum

Susceptibility Testing Methods

NOTE: Susceptibility testing by dilution methods necessitates the use of
clindamycin susceptibility powder.

When available, the results of in vitro susceptibility tests should
be provided on the physician as periodic reports that describe the susceptibility
profile of nosocomial and community-acquired pathogens. These reports should
aid problems when deciding on the most efficient antimicrobial.

Dilution Techniques

Quantitative methods are widely used to determine antimicrobial minimum inhibitory
concentrations (MICs). These MICs provide estimates on the susceptibility of bacteria to antimicrobial compounds. The MICs must be determined utilizing a standardized
procedure. Standardized procedures are based on a dilution method (broth and
agar)1,2,3 or equivalent with standardized inoculum concentrations
and standardized concentrations of clindamycin powder. The MIC values should
be interpreted according to the criteria provided in Table 1.

Diffusion Techniques

Quantitative methods that require the measurement of zone diameters in addition provide
reproducible estimates with the susceptibility of bacteria to antimicrobial compounds. One standardized procedure2,3 necessitates by using standardized
inoculum concentrations. This action uses paper disks impregnated with 2
mcg of clindamycin to evaluate the susceptibility of microorganisms to clindamycin. The disk diffusion interpretive criteria are provided in Table 1.

Table 1. Susceptibility Interpretive Criteria for Clindamycin

Pathogen
Susceptibility Interpretive Criteria
Minimal Inhibitory Concentrations

(MIC in mcg/mL)
Disk Diffusion

(Zone Diameters in mm)
Staphylococcus spp. S

≤ 0. 5
I

1-2
R

≥ 4
S

≥ 21
I

15-20
R

≤ 14
Streptococcus pneumoniae as well as other Streptococcus spp. ≤ 0. 25*
0. 5
≥ 1
≥ 19
16-18
≤ 15
Anaerobic Bacteria
≤ 2
4
≥ 8
NA
NA
NA
NA=not applicable

* These interpretive standards for S. pneumoniae along with other Streptococcus
spp. can be applied and then tests performed by broth microdilution using
cation-adjusted Mueller-Hinton broth with 2 to 5% lysed horse blood inoculated
that has a direct colony suspension and incubated in ambient air at 35C
for 20 to Twenty four hours.

These zone diameter interpretive standards can be applied and then tests
performed using Mueller-Hinton agar supplemented with 5% sheep blood inoculated
that has a direct colony suspension and incubated in 5% CO2 at 35C
for 25 to Twenty four hours.

These interpretive criteria are for those anaerobic bacterial pathogens; no
organism specific interpretive criteria can be purchased.

A report of "Susceptible" points too the pathogen is likely to
be inhibited if your antimicrobial compound within the blood reaches the concentrations
usually achievable. A study of "Intermediate" indicates that the
result might be of interest equivocal, of course, if the microorganism will not be fully
vulnerable to alternative, clinically feasible drugs, test must be repeated. This category implies possible clinical applicability in body sites the place that the
drug is physiologically concentrated or in situations where high dosage of drug
can be employed. This category also gives a buffer zone that prevents small,
uncontrolled technical factors from causing major discrepancies in interpretation. A written report of "Resistant" signifies that the pathogen is not likely
to be inhibited when the antimicrobial compound inside blood reaches the concentrations
usually achievable; other therapy ought to be selected.

Standardized susceptibility test procedures have to have 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: Qc microorganisms are specific strains of organisms with intrinsic biological properties relating to resistance mechanisms in addition to their genetic expression within bacteria; the particular strains employed for microbiological quality control are certainly not clinically significant.

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

QC Strain
Acceptable Qc Ranges
Minimum Inhibitory Concentration

(MIC in mcg/mL)
Disk Diffusion

(Zone Diameters inmm)
When Testing Aerobic Pathogens
Staphylococcus aureus ATCC 29213
0. 06-0. 25
NA
Staphylococcus aureus ATCC 25923
NA
24-30
Streptococcus pneumoniae ATCC 49619
0. 03-0. 12
19-25
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 ATCC is really a registered
trademark of the American Type Culture Collection

* This organism works extremely well for validation of susceptibility test results
when testing Streptococcus spp. apart from S pneumoniae.

This qc range for S pneumoniae
does apply just to tests done by broth microdilution using cation-adjusted
Mueller-Hinton broth with 2 to 5% lysed horse blood inoculated which has a
direct colony suspension and incubated in ambient air at 35C for
20 to A day.

This quality control zone diameter range is applicable
and then tests performed using Mueller-Hinton agar supplemented with 5%
sheep blood inoculated using a direct colony suspension and incubated in
5% CO2 at 35C for 20 to Twenty four hours.

Animal Toxicology

One year oral toxicity studies in Spartan Sprague-Dawley rats and beagle dogs
at dose levels as much as 300 mg/kg/day (approximately 1. 6 and 5 4 times the greatest
recommended adult human dose determined by mg/m2, respectively) demonstrate
clindamycin to get well tolerated. No appreciable difference in pathological
findings has been observed between teams of animals cured with clindamycin
and comparable control groups. Rats receiving clindamycin hydrochloride at 600
mg/kg/day (approximately 3. Twice the very best recommended adult human dose
depending on mg/m2) for six months tolerated the drug well; however, dogs
dosed as of this level (approximately 10. 8 times the greatest recommended adult
human dose based on mg/m2) vomited, would not eat, and excess lbs lost.

REFERENCES

1. NCCLS. Techniques 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. Techniques for Antimicrobial Susceptibility Testing of Anaerobic
Bacteria 5th ed. Approved Standard. NCCLS document M11-A5, 2001. clarinex online without a prescription 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.

Last reviewed on RxList: 1/13/2010
This monograph may be modified to incorporate the generic and name in many instances.

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