le 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 hcl and other antibacterial drugs, clindamycin hcl 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.

to be discontinued. appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of c. difficile, and surgical evaluation should be instituted as clinically indicated. anaphylactic and severe hypersensitivity reactions anaphylactic shock and anaphylactic reactions have been reported (see adverse reactions). severe hypersensitivity reactions, including severe skin reactions such as toxic epidermal necrolysis (ten), drug reaction with eosinophilia and systemic symptoms (dress), and stevens-johnson syndrome (sjs), some with fatal outcome, have been reported (see adverse reactions). in case of such an anaphylactic or severe hypersensitivity reaction, discontinue treatment permanently and institute appropriate therapy. 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.

ircumstances, the physician may elect to initiate treatment or continue treatment with clindamycin hcl capsules, usp. in cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.

, anaphylactic reaction and hypersensitivity have also been reported. skin and mucous membranes: pruritus, vaginitis, angioedema and rare instances of exfoliative dermatitis have been reported (see hypersensitivity reactions). liver: jaundice and abnormalities in liver function tests have been observed during clindamycin therapy. renal: although no direct relationship of clindamycin to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed. 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. immune system: drug reaction with eosinophilia and systemic symptoms (dress) cases have been reported. musculoskeletal: cases of polyarthritis have been reported.

ution concentrations of clindamycin in the serum increased linearly with increased dose. serum concentrations 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 concentrations of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges. metabolism in vitro studies in human liver and intestinal microsomes indicated that clindamycin is predominantly metabolized by cytochrome p450 3a4 (cyp3a4), with minor contribution from cyp3a5, to form clindamycin sulfoxide and a minor metabolite, n-­desmethylclindamycin. 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. specific populations patients with 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. elderly patients pharmacokinetic studies in elderly volunteers (61-79 years) and younger adults (18-39 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, the average elimination half-life is increased to approximately 4.0 hours (range 3.4-5.1 h) in the elderly compared to 3.2 hours (range 2.1-4.2 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 function1. microbiology mechanism of action clindamycin inhibits bacterial protein synthesis by binding to the 23s rna of the 50s subunit of the ribosome. clindamycin is bacteriostatic. resistance resistance to clindamycin is most often caused by modification of specific bases of the 23s ribosomal rna. cross-resistance between clindamycin and lincomycin is complete. because the binding sites for these antibacterial drugs overlap, cross-resistance is sometimes observed among lincosamides, macrolides and streptogramin b. macrolide-inducible resistance to clindamycin occurs in some isolates of macrolide-resistant bacteria. macrolide-resistant isolates of staphylococci and beta-hemolytic streptococci should be screened for induction of clindamycin resistance using the d-zone test. antimicrobial activity clindamycin has been shown to be active against most of the isolates of the following microorganisms, both in vitro and in clinical infections (see indications and usage): gram-positive bacteria staphylococcus aureus (methicillin-susceptible strains) streptococcus pneumoniae (penicillin-susceptible strains) streptococcus pyogenes anaerobic bacteria clostridium perfringens fusobacterium necrophorum fusobacterium nucleatum peptostreptococcus anaerobius prevotella melaninogenica the following in vitro data are available, but their clinical significance is unknown. at least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (mic) less than or equal to the susceptible breakpoint for clindamycin against isolates of a similar genus or organism group. however, the efficacy of clindamycin in treating clinical infections due to these bacteria has not been established in adequate and well-controlled clinical trials. gram-positive bacteria staphylococcus epidermidis (methicillin-susceptible strains) streptococcus agalactiae streptococcus anginosus streptococcus mitis streptococcus oralis anaerobic bacteria actinomyces israelii clostridium clostridioforme eggerthella lenta finegoldia (peptostreptococcus) magna micromonas (peptostreptococcus) micros prevotella bivia prevotella intermedia propionibacterium acnes susceptibility test 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 in the selection of an appropriate antibacterial drug for treatment. 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 test method2,3 (broth and/or agar). 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 can also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. the zone size should be determined using a standardized method2,5. this procedure uses paper disks impregnated with 2 mcg of clindamycin to test the susceptibility of bacteria to clindamycin. the disk diffusion breakpoints are provided in table 1. anaerobic techniques for anaerobic bacteria, the susceptibility to clindamycin can be determined by a standardized test method2,4. the mic values obtained should be interpreted according to the criteria provided in table 1. table 1. susceptibility test interpretive criteria for clindamycin susceptibility interpretive criteria pathogen minimal inhibitory concentrations (mic in mcg/ml) disk diffusion (zone diameters in mm) s i r s i r staphylococcusspp. ≤0.5 1–2 ≥4 ≥21 15–20 ≤14 streptococcus pneumoniae and other streptococcus spp. ≤0.25 0.5 ≥1 ≥19 16–18 ≤15 anaerobic bacteria ≤2 4 ≥8 na na na na=not applicable a report of susceptible (s) indicates that the antimicrobial drug is likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentration usually achievable at the site of infection. a report of intermediate (i) 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 (r) indicates that the antimicrobial drug is not likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentration usually achievable at the infection site; 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.2,3,4,5 standard clindamycin powder should provide the following range of mic values noted 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 acceptable quality control ranges qc strain minimum inhibitory concentrations (mcg/ml) disk diffusion (zone diameters in mm) 1. enterococcus faecalis has been included in this table for quality control purposes only. 2. quality control for c. difficile is performed using the agar dilution method only, all other obligate anaerobes may be tested by either broth microdilution or agar dilution methods. na=not applicable atcc® is a registered trademark of the american type culture collection