erobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection. streptococci: serious respiratory tract infections; serious skin and soft tissue infections. staphylococci: serious respiratory tract infections; serious skin and soft tissue infections. pneumococci: serious respiratory tract infections. bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. to reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules, usp and other antibacterial drugs, clindamycin hydrochloride capsules, usp 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.

anagement, protein supplementation, antibiotic treatment of c. difficile , and surgical evaluation should be instituted as clinically indicated. a careful inquiry should be made concerning previous sensitivities to drugs and other allergens. usage in meningitis- since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.

ver, it was postulated from studies that when given every eight hours, accumulation should rarely occur. therefore, dosage modification in patients with liver disease may not be necessary. however, periodic liver enzyme determinations should be made when treating patients with severe liver disease. prescribing clindamycin hydrochloride capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

elationship of clindamycin to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed in rare instances. hematopoietic : transient neutropenia (leukopenia) and eosinophilia have been reported. reports of agranulocytosis and thrombocytopenia have been made. no direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing. musculoskeletal : rare instances of polyarthritis have been reported.

damycin in the serum increased linearly with increased dose. serum levels exceed the mic (minimum inhibitory concentration) for most indicated organisms for at least six hours following administration of the usually recommended doses. clindamycin is widely distributed in body fluids and tissues (including bones). no significant levels of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges. excretion the average biological half-life is 2.4 hours. approximately 10% of the bioactivity is excreted in the urine and 3.6% in the feces; the remainder is excreted as bioinactive metabolites. special populations renal impairment 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 from the serum. use in elderly pharmacokinetic studies in elderly volunteers (61 to 79 years) and younger adults (18 to 39 years) indicate that age alone does not alter clindamycin pharmacokinetics (clearance, elimination half-life, volume of distribution, and area under the serum concentration-time curve) after iv administration of clindamycin phosphate. after oral administration of clindamycin hydrochloride, elimination half-life is increased to approximately 4 hours (range 3.4 to 5.1 h) in the elderly compared to 3.2 hours (range 2.1 to 4.2 h) in younger adults. the extent of absorption, however, is not different between age groups and no dosage alteration is necessary for the elderly with normal hepatic function and normal (age-adjusted) renal function. microbiology clindamycin inhibits bacterial protein synthesis by binding to the 50s subunit of the ribosome. it has activity against gram-positive aerobes and anaerobes as well as some 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 inducible resistance has been identified in macrolide-resistant staphylococci and beta-hemolytic streptococci. macrolide-resistant isolates of these organisms should be screened for clindamycin inducible resistance using the d-zone test. clindamycin has been shown to be active against most of the isolates of the following microorganisms, both in vitro and in clinical infections, as described in the indications and usage 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 at least 90% of the microorganisms listed below exhibit in vitro minimum inhibitory concentrations (mics) less than or equal to the clindamycin susceptible mic breakpoint for organisms of a similar type to those shown in table 1. however, the efficacy of clindamycin in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials. 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 when available, the clinical microbiology laboratory should provide cumulative in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. these reports should aid the physician in selecting the most effective antimicrobial. dilution techniques quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (mics). these mics provide estimates of the susceptibility of bacteria to antimicrobial compounds. the mics should be determined using a standardized procedure based on dilution method (broth, agar, or microdilution) 1,2 or equivalent using standardized inoculum and concentrations of clindamycin. 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 also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. the standardized procedure 1,3 requires the use of standardized inoculum concentrations. this procedure uses paper disks impregnated with 2 mcg of clindamycin to test the susceptibility of microorganisms to clindamycin. reports from the laboratory providing results of the standard single-disk susceptibility test with a 2 mcg clindamycin disk should be interpreted according to the criteria 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) s i r s i r staphylococcus spp. ≤ 0.5 1 to 2 ≥ 4 ≥ 21 15 to 20 ≤ 14 streptococcus pneumoniae and other streptococcus spp. ≤ 0.25 0.5 ≥ 1 ≥ 19 16 to 18 ≤ 15 anaerobic bacteria ≤ 2 4 ≥ 8 na na na na = not applicable a report of “susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. a report of “intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. this category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. this category also provides a buffer zone that prevents small, uncontrolled technical factors from causing major discrepancies in interpretation. a report of “resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected. quality control standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of the supplies and reagents used in the assay, and the techniques of the individuals performing the test. 1,2,3,4 standard clindamycin powder should provide the mic ranges in table 2. for the disk diffusion technique using the 2 mcg clindamycin disk the criteria provided in table 2 should be achieved. table 2. acceptable quality control ranges for clindamycin to be used in validation of susceptibility test results acceptable quality control ranges qc strain minimum inhibitory concentration range(mcg/ml) disk diffusion range(zone diameters in mm) when testing aerobic pathogens staphylococcus aureus atcc 29213 0.06 to 0.25 na staphylococcus aureus atcc 25923 na 24 to 30 streptococcus pneumoniae atcc 49619 0.03 to 0.12 19 to 25 when testing anaerobes bacteroides fragilis atcc 25285 0.5 to 2 na bacteroides thetaiotaomicron atcc 29741 2 to 8 na eubacterium lentum atcc 43055 0.06 to 0.25 na na = not applicable atcc ® is a registered trademark of the american type culture collection

1-40 bottles of 40 ndc 63187-141-44 bottles of 44 ndc 63187-141-60 bottles of 60 store at 20° - 25° c (68° - 77° f) [see usp controlled room temperature]. to report suspected adverse reactions, contact the fda at 1-800-fda-1088 or www.fda.gov/medwatch .

mach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. if this occurs, patients should contact their physician as soon as possible.