Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2297
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Cefazolin (Injection, Powder, For Solution)
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Usual Adult Dosage:<br/>Perioperative Prophylactic Use: To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are: It is important that (1) the preoperative dose be given just (/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.<br/>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/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/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.<br/>Pediatric Dosage: In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) 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 per kg (45 mg per pound) 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 percent 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 percent 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 percentof the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.<br/>RECONSTITUTION:<br/>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.<br/>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 may be penetrated only one time 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. THIS PHARMACY BULK PACKAGE IS NOT INTENDED TO BE DISPENSED AS A UNIT<br/>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.)<br/>ADMINISTRATION:<br/>Intravenous Administration: Intermittent or continuous infusion: Dilute reconstituted Cefazolin for injection in 50 to 100 mL of 1 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 reconstituted or diluted according to the instructions above, Cefazolin for injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5��C or 41��F). Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.
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Cefazolin for injection is a semi-synthetic cephalosporin for parenteral administration. It is the sodium salt of 3-{[(5-methyl-1,3,4-thiadiazol-2-yl)thio]-methyl}-8-oxo-7-[2-(1H-tetrazol-1-yl) acetamido]-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid. Structural Formula: Each vial contains 48 mg (2 mEq) of sodium/1 gram of cefazolin sodium. Cefazolin for injection, USP is white to off-white crystalline powder. Cefazolin for injection, USP is supplied in 10 grams Pharmacy Bulk Packages. Each Pharmacy Bulk Package contains, cefazolin sodium equivalent to 10 grams of cefazolin. A Pharmacy Bulk Package is sterile dosage form for parenteral use that contains many single doses. The contents are restricted for use in a pharmacy admixture service and are intended for the preparation of admixtures for intravenous use. NOT FOR DIRECT INJECTION. FURTHER DILUTION IS REQUIRED BEFORE USE.
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Studies have shown that following intravenous administration of Cefazolin for injection to normal volunteers, mean serum concentrations peaked at approximately 185 mcg/mL and were approximately 4 mcg/mL at 8 hours for a 1 gram dose. The serum half-life for Cefazolin for injection is approximately 1.8 hours following IV administration. In a study (using normal volunteers) of constant intravenous infusion with dosages of 3.5 mg/kg for 1 hour (approximately 250 mg) and 1.5 mg/kg the next 2 hours (approximately 100 mg), Cefazolin for injection produced a steady serum level at the third hour of approximately 28 mcg/mL. Studies in patients hospitalized with infections indicate that Cefazolin for injection produces mean peak serum levels approximately equivalent to those seen in normal volunteers. Bile levels in patients without obstructive biliary disease can reach or exceed serum levels by up to 5 times; however, in patients with obstructive biliary disease, 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.<br/>Microbiology: In vitro tests demonstrate that the bactericidal action of cephalosporins results from inhibition of cell wall synthesis. Cefazolin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section:<br/>Aerobic Gram-positive microorganisms: Staphylococcus aureus (including penicillinase-producing strains) Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus pyogenes and other strains of Streptococci NOTE: Methicillin-resistant staphylococci are uniformly resistant to cefazolin. Many Enterococcus strains are resistant to cefazolin.<br/>Aerobic Gram-negative microorganisms: Escherichia coli Haemophilus influenzae Klebsiella species Proteus mirabilis NOTE: Most strains of indole positive Proteus (Proteus vulgaris), Enterobacter cloacae, Morganella morganii and Providencia rettgeri are resistant. Serratia, Pseudomonas, Mima and Herellea species are almost uniformly resistant to cefazolin.<br/>Susceptibility Testing:<br/>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. Standardized procedures are based on a dilution method(broth) or equivalent with standardized inoculum concentrations and standardized concentrations of cefazolin powder. The MIC values should be interpreted according to the following criteria: For Enterobacteriaceae and Staphylococcus spp. 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 which 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. Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard cefazolin powder should provide the following MIC values:<br/>Diffusion Techniques: Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedurerequires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 30 mcg cefazolin to test the susceptibility of microorganisms to cefazolin. Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30 mcg cefazolin disk should be interpreted according to the following criteria: For Enterobacteriaceae using the 30 mcg cefazolin disk For Staphylococcus spp, using the 30 mcg cefazolin or the 30 mcg cephalothin disks Interpretation should be as stated above for results using dilution techniques. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for cefazolin. As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 30 mcg cefazolin disk should provide the following zone diameter in this laboratory test quality control strain:
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CEFAZOLIN FOR INJECTION IS CONTRAINDICATED IN PATIENTS WITH KNOWN ALLERGY TO THE CEPHALOSPORIN GROUP OF ANTIBIOTICS.
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Cefazolin for injection, USP Each Pharmacy Bulk Package contains cefazolin sodium equivalent to 10 grams of cefazolin. Cefazolin for injection is available as follows: 10 vials 10 grams/100 mL vials per carton (NDC 63304-941-10). As with other cephalosporins, Cefazolin for injection tends to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected. Store dry powder at 20��to 25��C (68��to 77��F) [See USP Controlled Room Temperature]. Before reconstitution PROTECT FROM LIGHT.
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General: Prolonged use of Cefazolin for injection may result in the overgrowth of nonsusceptible organisms. Careful clinical observation of the patient is essential. When Cefazolin for injection is administered to patients with low urinary output because of impaired renal function, lower daily dosage is required . As with other��-lactam antibiotics, seizures may occur if inappropriately high doses are administered to patients with impaired renal function . Cefazolin for injection, as with all cephalosporins, should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin 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 increase the risk of the development of drug-resistant bacteria.<br/>Drug Interactions: Probenecid may decrease renal tubular secretion of cephalosporins when used concurrently, resulting in increased and more prolonged cephalosporin blood levels.<br/>Drug/Laboratory Test Interactions: A false positive reaction for glucose in the urine may occur with Benedict's solution, Fehling's solution or with CLINITEST tablets, but not with enzyme-based tests such as CLINISTIX. Positive direct and indirect antiglobulin (Coombs) tests have occurred; these may also occur in neonates whose mothers received cephalosporins before delivery.<br/>Information for Patients: Patients should be counseled that antibacterial drugs including Cefazolin for injection, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cefazolin for injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not betreatable by Cefazolin for injection or other antibacterial drugs in the future.<br/>Carcinogenesis/Mutagenesis: Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of Cefazolin for injection have not been performed.<br/>Pregnancy:<br/>Teratogenic Effects:<br/>Labor and Delivery: When cefazolin has been administered prior to caesarean section, drug levels in cord blood have been approximately one quarter to one third of maternal drug levels. The drug appears to have no adverse effect on the fetus.<br/>Nursing Mothers: Cefazolin for injection is present in very low concentrations in the milk of nursing mothers. Caution should be exercised when Cefazolin for injection is administered to a nursing woman.<br/>Pediatric Use: Safety and effectiveness for use in premature infants and neonates have not been established. See DOSAGE AND ADMINISTRATION for recommended dosage in pediatric patients older than 1 month.<br/>Geriatric Use: Of the 920 subjects who received Cefazolin for injection in clinical studies, 313 (34%) were 65 years and over, while 138 (15%) were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function .
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Cefazolin
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Cefazolin (Injection, Powder, For Solution)
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The following reactions have been reported:<br/>Gastrointestinal: Diarrhea, oral candidiasis (oral thrush), vomiting, nausea, stomach cramps, anorexia, and pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment . Nausea and vomiting have been reported rarely.<br/>Allergic: Anaphylaxis, eosinophilia, itching, drug fever, skin rash, Stevens-Johnson syndrome.<br/>Hematologic: Neutropenia, leukopenia, thrombocytopenia, thrombocythemia.<br/>Hepatic: Transient rise in SGOT, SGPT and alkaline phosphatase levels has been observed. As with other cephalosporins, reports of hepatitis have been received.<br/>Renal: As with other cephalosporins, reports of increased BUN and creatinine levels, as well as renal failure, have been received.<br/>Local Reactions: Rare instances of phlebitis have been reported at site of injection. Some induration has occurred.<br/>Other Reactions: Genital and anal pruritus (including vulvar pruritus, genital moniliasis, and vaginitis).<br/>Cephalosporin-class Adverse Reactions: In addition to the adverse reactions listed above that have been observed in patients treated with cefazolin, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: Adverse Reactions: Allergic reactions, urticaria, serum sickness-like reaction, erythema multiforme, toxic epidermal necrolysis, colitis, renal dysfunction, toxic nephropathy, abdominal pain, reversible hyperactivity, hypertonia, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, and superinfection. Altered Laboratory Tests: Prolonged prothrombin time, positive direct Coombs' test, false-positive test for urinary glucose, elevated bilirubin, elevated LDH, increased creatinine, pancytopenia, and agranulocytosis. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced . If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
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Cefazolin for injection is indicated in the treatment of the following serious infections due to susceptible organisms: Respiratory Tract Infections due to S. pneumoniae, Klebsiella species, H. influenzae, S. aureus (penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci. Injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin for injection is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin for injection in the subsequent prevention of rheumatic fever are not available at present. Urinary Tract Infections due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterobacter and enterococci. Skin and Skin Structure Infections due to S. aureus (penicillin-sensitive and penicillin-resistant), group A beta-hemolytic streptococci, 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 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 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 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 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. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for injection and other antibacterial drugs, Cefazolin for injection 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.
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Cefazolin
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