Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/274
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Cefazolin (Injection, 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: a. 1 gram IV administered��hour to 1 hour prior to start of surgery. b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified
depending on the duration of the operative procedure). c. 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively. It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to 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 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 may be continued for 3 to 5 days following the completion of surgery.<br/>Dosage Adjustment for Patients With Reduced Renal Function:: Cefazolin Injection, USP 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 3.0 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 safetyfor use in premature infants and in neonates has not been established, the use of Cefazolin Injection, USP 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 20to 5 mL/min.) may
be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.
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Cefazolin Injection, USP 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: The sodium content is 46 mg per gram of cefazolin. Cefazolin Injection, USP is a frozen, premixed, iso-osmotic, sterile, nonpyrogenic 50 mL solution containing cefazolin sodium
equivalent to 1 g of Cefazolin, USP. Dextrose, USP has been added to adjust osmolality (approximately 2 g as dextrose hydrous). The pH has been adjusted with sodium bicarbonate. The
solution is intended for intravenous use after thawing to room temperature. This GALAXY container (PL 2040) is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with
the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. However, the suitability of the
plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.
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Human Pharmacology:: Studies have shown that following intravenous administration of cefazolin 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 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 produced a steady serum level at the third hour of approximately 28 mcg/mL. Studies in patients hospitalized with infections indicate that cefazolin 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 are considerably lower than serum levels (<1.0 mcg/mL). In synovial fluid, the cefazolin level becomes comparable to that reached in serum at about 4 hours after drug administration. Studies of cord blood show prompt transfer of cefazolin across the placenta. Cefazolin is present in very low concentrations in
the milk of nursing mothers. Cefazolin 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 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 13-44 mcg/mL) with 50 mg/L (three patients),
and 72 mcg/mL (range 26 to 142 mcg/mL) with 150 mg/L (6 patients). Intraperitoneal administration of cefazolin 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.<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 INDICATIONS AND USAGE.<br/>Gram-Positive Aerobes:: Staphylococcus aureus (including��-lactamase-producing strains) Staphylococcus epidermidis Streptococcus pyogenes, Streptococcus agalactiae, and other strains of streptococci Streptococcus pneumoniae Methicillin-resistant staphylococci are uniformly resistant to cefazolin, and many strains of enterococci are
resistant.<br/>Gram-Negative Aerobes:: Escherichia coli Proteus mirabilis Most strains of indole positive Proteus (Proteus vulgaris), Enterobacter spp., Morganella morganii, Providencia rettgeri, Serratia spp. and Pseudomonas spp. are resistant to cefazolin.
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CEFAZOLIN INJECTION, USP IS CONTRAINDICATED IN PATIENTS WITH KNOWN ALLERGY TO THE CEPHALOSPORIN GROUP OF ANTIBIOTICS. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.
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Cefazolin Injection, USP is supplied as a premixed frozen iso-osmotic solution in 50 mL single dose GALAXY plastic containers as
follows: Store at or below -20��C/-4��F. [See Directions for use of GALAXY Container (PL 2040).] Rx Only
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General:: Prolonged use of cefazolin may result in the overgrowth of non susceptible organisms. Careful clinical observation of the
patient is essential. When cefazolin 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 Injection, USP, 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 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.<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 should only be used to treat bacterial infections.
They do not treat viral infections (e.g., the common cold). When Cefazolin Injection, USP 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 be treatable by cefazolin 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 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 is present in very low concentrations in the milk of nursing mothers. Caution should be exercised when cefazolin 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 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 Sodium
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Cefazolin (Injection, 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.<br/>Other Reactions:: Genital and anal pruritus (including vulvar pruritus, genital moniliasis, and vaginitis).
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BEFORE THERAPY WITH CEFAZOLIN INJECTION, USP IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD
PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFAZOLIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED
BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY. IF AN ALLERGIC
REACTION TO CEFAZOLIN INJECTION, USP OCCURS, DISCONTINUE TREATMENT WITH THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH
EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefazolin, and may range in severity from mild to life-threatening.
Therefore, it 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.
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Cefazolin Injection, USP is indicated in the treatment of the following infections due to susceptible organisms:<br/>Respiratory Tract Infections:: Due to S. pneumoniae, S. aureus (including��-lactamase-producing strains), and S. pyogenes. 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 is effective in eradication of streptococci from the nasopharynx; however, data establishing the efficacy of
cefazolin in the subsequent prevention of rheumatic fever are not available.<br/>Urinary Tract Infections:: Due to E. coli, P. mirabilis.<br/>Skin and Skin Structure Infections:: Due to S. aureus (including��-lactamase-producing strains), S. pyogenes, and other strains of streptococci.<br/>Biliary Tract Infections:: Due to E. coli, various strains of streptococci, P.
mirabilis, and S. aureus.<br/>Bone and Joint Infections:: Due to S. aureus.<br/>Genital Infections:: (i.e., prostatitis, epididymitis) due to E. coli, P.
mirabilis.<br/>Septicemia:: Due to S. pneumoniae, S. aureus (including��-lactamase-producing strains) P. mirabilis, E. coli.<br/>Endocarditis:: Due to S. aureus (including��-lactamase-producing strains), and S. pyogenes. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to
cefazolin.<br/>Perioperative Prophylaxis:: The prophylactic administration of cefazolin 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 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 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 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 and other antibacterial drugs,
cefazolin 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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