testinal 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 tissues 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 palmitate hydrochloride for oral solution and other antibacterial drugs, clindamycin palmitate hydrochloride for oral solution 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.

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.

atment or continue treatment with clindamycin palmitate hydrochloride for oral solution. note : in cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days. reconstitution instructions: when reconstituted with water as follows, each 5 ml (teaspoon) of solution contains clindamycin palmitate hcl equivalent to 75 mg clindamycin. reconstitute bottles of 100 ml with 75 ml of water. add a large portion of the water and shake vigorously; add the remainder of the water and shake until the solution is uniform. storage conditions: store at controlled room temperature 20° to 25°c (68° to 77°f) [see usp]. do not refrigerate the reconstituted solution; when chilled, the solution may thicken and be difficult to pour. the solution is stable for 2 weeks at room temperature.

sensitivity 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. to report suspected adverse reactions, contact avet pharmaceuticals inc. at 1-866-901-drug (3784) or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

is excreted rapidly. serum levels exceed the mics for most indicated organisms for at least six hours following administration of the usually recommended doses of clindamycin palmitate hydrochloride for oral solution in adults and pediatric patients. 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. 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 approximately 10% of the bioactivity is excreted in the urine and 3.6% in the feces; the remainder is excreted as bioinactive metabolites. the average serum half-life after doses of clindamycin palmitate hydrochloride for oral solution is approximately two hours in pediatric patients. special 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, 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; administration of clindamycin palmitate hcl resulted in a similar elimination half-life value of about 4.5 hours in elderly subjects. however, the extent of absorption 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 1 . obese pediatric patients aged 2 to less than 18 years and obese adults aged 18 to 20 years an analysis of pharmacokinetic data in obese pediatric patients aged 2 to less than 18 years and obese adults aged 18 to 20 years demonstrated that clindamycin clearance and volume of distribution, normalized by total body weight, are comparable regardless of obesity. 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, as described in the indications and usage section. 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 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. 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 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 susceptibilty testing for specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by fda for this drug, please see: http://www.fda.gov/stic.