treptococci, and other strains of streptococci. biliary tract infections: due to e. coli , various strains of streptococci, p. mirabilis, klebsiella species and s. aureus . bone and joint infections: due to s. aureus . genital infections: (i.e., prostatitis, epididymitis) due to e. coli, p. mirabilis, klebsiella species, and some strains of enterococci . septicemia: due to s. pneumoniae , s. aureus (penicillin-sensitive and penicillin-resistant), p. mirabilis , e. coli, and klebsiella species. endocarditis: due to s. aureus (penicillin-sensitive and penicillin-resistant) and group a beta-hemolytic streptococci . perioperative prophylaxis: the prophylactic administration of cefazolin for injection, usp preoperatively, intraoperatively and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high‑risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice or common duct bile stones). the perioperative use of cefazolin for injection, usp may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty). the prophylactic administration of cefazolin for injection, usp should usually be discontinued within a 24 hour period after the surgical procedure. in surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin for injection, usp may be continued for 3 to 5 days following the completion of surgery. if there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted (see dosage and administration ). to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefazolin for injection, usp and other antibacterial drugs, cefazolin for injection, 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.

is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. studies indicate that a toxin produced by clostridium difficile is a primary cause of “antibiotic-associated colitis”. after the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. in moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an oral antibacterial drug clinically effective against c. difficile colitis.

mbin time should be monitored in patients at risk and exogenous vitamin k administered as indicated. prescribing cefazolin for injection 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.

it is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) cefazolin for injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms. in surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin for injection may be continued for 3 to 5 days following the completion of surgery. dosage adjustment for patients with reduced renal function cefazolin for injection may be used in patients with reduced renal function with the following dosage adjustments: patients with a creatinine clearance of 55 ml/min or greater or a serum creatinine of 1.5 mg % or less can be given full doses. patients with creatinine clearance rates of 35 to 54 ml/min or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. patients with creatinine clearance rates of 11 to 34 ml/min or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. patients with creatinine clearance rates of 10 ml/min or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. all reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. patients undergoing peritoneal dialysis: see clinical pharmacology . pediatric dosage in pediatric patients, a total daily dosage of 25 to 50 mg/kg (approximately 10 to 20 mg/lb) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. total daily dosage may be increased to 100 mg/kg (45 mg/lb) of body weight for severe infections. since safety for use in premature infants and in neonates has not been established, the use of cefazolin for injection in these patients is not recommended. in pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 ml/min), 60% of the normal daily dose given in equally divided doses every 12 hours should be sufficient. in patients with moderate impairment (creatinine clearance of 40 to 20 ml/min), 25% of the normal daily dose given in equally divided doses every 12 hours should be adequate. pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 ml/min) may be given 10% of the normal daily dose every 24 hours. all dosage recommendations apply after an initial loading dose. reconstitution preparation of parenteral solution parenteral drug products should be shaken well when reconstituted, and inspected visually for particulate matter prior to administration. if particulate matter is evident in reconstituted fluids, the drug solutions should be discarded. reconstituted solutions may range in color from pale yellow to yellow without a change in potency. directions for proper use of a pharmacy bulk package not for direct infusion. this pharmacy bulk package is for use in a hospital pharmacy admixture service only in a suitable work area, such as a laminar flow hood. using aseptic technique, the container closure may be penetrated only one time after reconstitution using a suitable sterile dispensing set or transfer device that allows measured dispensing of the contents. use of a syringe and needle is not recommended as it may cause leakage. the withdrawal of container contents should be accomplished without delay. however, should this not be possible, a maximum time of 4 hours from initial closure entry is permitted to complete fluid transfer operations. this time limit should begin with the introduction of the solvent or diluent into the pharmacy bulk package. discard any unused portion after 4 hours . pharmacy bulk package add sterile water for injection, bacteriostatic water for injection or sodium chloride injection according to the table below. shake well. use promptly. (discard vial within 4 hours after initial entry.) pharmacy bulk package size amount of diluent appropriate concentration approximate available volume 10 grams 45 ml 1 gram/5 ml 51 ml 96 ml 1 gram/10 ml 102 ml 20 grams 87 ml 1 gram/5 ml 99 ml administration intravenous administration intermittent or continuous infusion: dilute reconstituted cefazolin for injection, usp in 50 to 100 ml of one of the following solutions: sodium chloride injection, usp 5% or 10% dextrose injection, usp 5% dextrose in lactated ringer’s injection, usp 5% dextrose and 0.9% sodium chloride injection, usp 5% dextrose and 0.45% sodium chloride injection, usp 5% dextrose and 0.2% sodium chloride injection, usp lactated ringer’s injection, usp invert sugar 5% or 10% in sterile water for injection ringer’s injection, usp 5% sodium bicarbonate injection, usp when diluted according to the instructions above, cefazolin is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5ºc or 41ºf). prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

ital moniliasis and vaginitis). to report suspected adverse reactions, contact west-ward pharmaceuticals corp. at 1-877-233-2001 or fda at 1-800-fda-1088 or www.fda.gov/medwatch .

bile levels of cefazolin for injection are considerably lower than serum levels (<1 mcg/ml). in synovial fluid, the level of cefazolin for injection becomes comparable to that reached in serum at about 4 hours after drug administration. studies of cord blood show prompt transfer of cefazolin for injection across the placenta. cefazolin for injection is present in very low concentrations in the milk of nursing mothers. cefazolin for injection is excreted unchanged in the urine. in the first 6 hours approximately 60% of the drug is excreted in the urine and this increases to 70% to 80% within 24 hours. in patients undergoing peritoneal dialysis (2 l/hr), cefazolin for injection produced mean serum levels of approximately 10 and 30 mcg/ml after 24 hours’ instillation of a dialyzing solution containing 50 mg/l and 150 mg/l, respectively. mean peak levels were 29 mcg/ml (range 13 to 44 mcg/ml) with 50 mg/l (3 patients), and 72 mcg/ml (range 26 to 142 mcg/ml) with 150 mg/l (6 patients). intraperitoneal administration of cefazolin for injection is usually well tolerated. controlled studies on adult normal volunteers, receiving 1 gram 4 times a day for 10 days, monitoring cbc, sgot, sgpt, bilirubin, alkaline phosphatase, bun, creatinine and urinalysis, indicated no clinically significant changes attributed to cefazolin for injection. microbiology mechanism of action cefazolin is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. resistance predominant mechanisms of bacterial resistance to cephalosporins include the presence of extended-spectrum beta-lactamases and enzymatic hydrolysis. antimicrobial activity cefazolin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the indications and usage (1 ) section: gram-positive bacteria staphylococcus aureus staphylococcus epidermidis streptococcus agalactiae streptococcus pneumoniae streptococcus pyogenes methicillin-resistant staphylococci are uniformly resistant to cefazolin. gram-negative bacteria: escherichia coli proteus mirabilis most isolates of indole positive proteus ( proteus vulgaris ), enterobacter spp., morganella morganii, providencia rettgeri, serratia spp., and pseudomonas spp . are resistant to cefazolin. susceptibility test methods for specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by fda for this drug, please see: https://www.fda.gov/stic.

a registered trademark of bayer corporation. manufactured by: hikma farmacÊutica (portugal) s.a. estrada do rio da mó, nº8, 8a and 8b – fervença 2705-906 terrugem snt portugal distributed by: west-ward a hikma company eatontown, nj 07724 usa revised: september 2018 pin089-wes/6