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Cefazolin sodium
MEDICATION
PROTOCOL NO.:
6.2.08
Drafted By:
K. Andrusko, Pharm.D.
Reviewed/
Revised By:
Roger S. Klotz, R.Ph., BCNSP, FASCP,
FACA, FCPhA, CDM
Date Drafted:
Date Reviewed/
Revised:
02/28/89
Approved By: Roger S. Klotz, R.Ph., BCNSP, FASCP,
FACA, FCPhA
Date Effective:
09/30/06
Supersedes Date:
Page:
1 of 21
01/11/06
09/09/06
MEDICATION PROTOCOL
GENERIC NAME:
cefazolin sodium
BRAND NAME:
ANCEF
KEFZOL
(SKB)
(Lilly)
CLINICAL INDICATIONS
Cefazolin is recommended for the treatment of respiratory tract infections, skin and soft tissue infections,
urinary tract infections, bone and joint infections such as septic arthritis, and osteomyelitis.
It is considered an excellent choice for empiric, single agent therapy for community-acquired infections
(especially from strep or staph). It is a first-line agent for most skin and soft tissue infections (except for sacral
decubitus and diabetic lower extremity infections which require anaerobic coverage). 23
It is effective against community-acquired UTI's. It is also the agent of choice for most types of surgical
prophylaxis, including gastroduodenal, biliary, urologic, cesarean section delivery, hysterectomy, cardiac,
orthopedic, vascular, and neurological.23, 43, 49
- Oropharyngeal and Respiratory Infections
Common oropharyngeal infections include: periodontitis, chronic sinusitis, and mastoiditis. Species of
Fusobacterium, Peptostreptococcus, and Bacteroides are the principal microorganisms encountered in
these infections. Cefazolin is sensitive only against Peptostreptococcus.
In general, cefazolin is indicated for respiratory tract infections due to Streptococcus pneumoniae,
Klebsiella spp., susceptible Haemophilus influenzae, Staphylococcus aureus (penicillinase and
nonpenicillinase producing), and group A beta-hemolytic streptococci.
A randomized study involving 286 patients reported by Murabito et al 8 concluded that a twice daily
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CEFAZOLIN SODIUM
MEDICATION
PROTOCOL NO.:
6.2.08
Page:
Page 2 of 20
Date Effective:
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regimen of cefazolin in treatment of pneumococcal pneumonia was both effective and economical.
Cefazolin in average doses of 0.44 gm given QID (IV or IM) for an average of 7 to 9 days produced
100% clinical cure versus 98% for patients receiving an average of 0.54 gm (IV or IM) BID for
approximately the same duration.
Dall et al2 compared treatment of community acquired pneumonia with cefamandole or cefazolin in
patients 35 years of age and older. The results indicated relatively equal effectiveness of cefazolin (94%
cured) and cefamandole (98% cured).
- Skin And Soft Tissue Infections
Skin and soft tissue infections due to S. aureus (penicillinase and nonpenicillinase producing) and group
A beta-hemolytic streptococci and other strains of streptococci are indications for cefazolin 11. The most
common infections are those affecting the skin and associated structures: pimples, boils, carbuncles, and
furuncles. More extensive and deeper infections may develop from cutaneous infections, from
endogenous infections, or from exposure to exogenous sources: hospitalized infants in the nursery - fatal
pneumonia or septicemia; elderly subjects - staphylococcal pneumonia; diabetics - osteomyelitis. Soft
tissue infections are often due to injury of tissue by surgery, trauma, or ischemia. The majority of
infections show no tissue inflammation and are associated with aerobic and anaerobic organisms.12
In a study by Gold et al4, cefazolin was proven to be effective in 116 patients with skin and soft tissue
infections. A favorable clinical response of 88.8% was achieved.
- Genitourinary Tract Infections
Because it achieves high urinary concentrations, cefazolin is indicated in infections due to Escherichia
coli, Proteus mirabilis, Klebsiella spp, and some strains of Enterobacter (the most-common causes of
community-acquired urinary tract infections).11
- Bone And Joint Infections
Cefazolin is indicated in infections due to S. aureus.11
-- Septic arthritis
This arthritis differs from rheumatoid arthritis in that usually one joint is involved and chills are
frequently reported.
The most common pathogens are staphylococci, pneumococci, gonococci, and gram-negative
organisms.13
--- A 1 gm dose of cefazolin IM produced synovial fluid levels of 16 to 29.4 mcg/mL over 8 hr with
the peak concentration at 2 hr.
--- A 500 mg dose IM produced a synovial fluid level of 12 mcg/mL at 2 hr.
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CEFAZOLIN SODIUM
MEDICATION
PROTOCOL NO.:
6.2.08
Page:
Page 3 of 20
Date Effective:
09/30/06
-- Osteomyelitis
Children
Infections in children usually involve the femur, tibia, and humerus, and are usually spread
hematogenously. The common causative agent is S. aureus although streptococci and gram-negative
bacilli are also known pathogens.
Adults
Conversely, infections in adults are usually caused by the contiguous spread from adjacent tissues. A
large number of cases are the result of infections involving fingers and toes. Less common is
mandibular involvement from infected teeth or bone involvement from chronic sinus
infections. S. aureus is a common pathogen. Unlike childhood osteomyelitis, adult osteomyelitis is
commonly associated with multiple organisms including gram-negative aerobes and anaerobes.
Mixed-flora osteomyelitis is common in diabetics.13
The clinical resolution of osteomyelitis may take 4 to 6 weeks of IV antibiotic therapy following
initial surgical debridement. Underlying diseases in addition to diabetes may predispose to
osteomyelitis: arthritis, malignancy, chronic steroid use, and peripheral vascular disease. Cefazolin is
indicated for bone infections due to S. aureus.
In a study by Ingram et al24, 420 patients with 481 episodes of osteomyelitis were analyzed. The two
main causes were: (a) osteomyelitis associated with contiguous septic focus (surgery or trauma
accounted for 54% of the cases), and (b) osteomyelitis associated with vascular insufficiency (22%
incidence of which diabetes was the leading cause). The most common pathogens were: S. aureus,
Enterobacteriaceae, and P. aeruginosa. Cefazolin was used most frequently (151 courses) and
provided a 90% response rate. Ceftriaxone (138 courses) provided an 87% response rate. Overall,
based on all treatments, the cure rate was 67% for acute episodes and 25% for chronic episodes. S.
aureus was the most common causative agent. The authors also found more favorable outcome from
acute episodes caused by either hematogenous dissemination or a contiguous septic focus if the cases
were not complicated by vascular insufficiency. Less favorable results occurred if the osteomyelitis
was polymicrobial (43% of acute osteomyelitis and 5% of chronic osteomyelitis were cured).
- Orthopedic Surgery
The most likely pathogens in orthopedic surgery include Staphylococci and rarely gram negative
aerobes. Cefazolin is considered by some clinicians to be the antibiotic of choice for surgical
prophylaxis in total hip replacement and internal fixation of fractures 29. However, Liebergall and
colleagues41, in a double-blind, randomized, prospective study, noted that in a total of 102 patients
receiving antibiotic prophylaxis for internal fixation of fractures, there was a postoperative infection rate
of 12.5% in patients receiving cefazolin whereas there were no infections noted in patients receiving
once-daily doses of cefonicid. Other studies have established cefazolin as the drug of choice for
prophylaxis of orthopedic surgeries.43
In a study by Connors et al29 cefazolin was compared to cefuroxime in 29 patients (14 received cefazolin
and 15 received cefuroxime) who underwent total hip replacement or open repair of a hip or femoral
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CEFAZOLIN SODIUM
MEDICATION
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Page 4 of 20
Date Effective:
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fracture. A continuous infusion of cefazolin was initiated 12 hours prior to the start of the surgery to
allow for steady state concentrations. Individualized patient doses were pharmacokinetically calculated
in order to obtain a desired total concentration in the serum of 50 mcg/mL (patients included in the study
also had to be within 15% of their ideal body weight). The mean infusion rate for cefazolin was 178.6 + 46.9
mg/hr. The objectives of the study were to determine the concentrations of free and total drug in serum
and free and total drug in muscle.
This is important for two reasons. First, only unbound drug is thought to exert a pharmacologic effect in
the serum. Secondly, since the target site of infection is the muscle and not the serum, tissue penetration
of free drug is important for drug efficacy. An unexpected finding was that there was no significant
difference in the concentration of total drug in muscle between cefazolin and cefuroxime, although there
was a significant difference between the free serum concentrations. This suggested that the
concentration of free drug in serum alone is not a consistent predictor of the total concentration in tissue.
A study by Tang and colleagues 56 noted that a single 1000 mg dose of cefazolin administered at the
induction of anesthesia offered similar protection to 3 doses of 750 mg cefuroxime in preventing
infection in primary total joint arthroplasty.
Rubinstein et al39 investigated the efficacy of a single dose of 1 gram of cefazolin in reducing
postoperative infections in patients undergoing clean operations on the lumbar spine. In a double blind,
randomized trial, there were 21 wound or urinary infections in the 71 patients who received placebo and in 9
of the 70 patients who received cefazolin. Hospital stay was increased for all infected patients.
- Cardiovascular Indications
- Bacterial Endocarditis (BE)
Organisms that commonly cause BE are gram-positive cocci: streptococci viridans, streptococci
enterococci, Streptococcus bovis, and staphylococci. Cefazolin is effective in bacterial endocarditis
caused by methicillin-susceptible organisms of staph., and penicillin-susceptible organisms of strep.
viridans and Streptococcus bovis14. However, cefazolin is usually reserved for the penicillin-allergic
patient in both cases, and is not usually used as the drug of choice in non-penicillin-allergic patients.
The most common pathogen causing subacute bacterial endocarditis (BE) is streptococcus viridans,
which is considered normal upper respiratory tract flora. Bacterial endocarditis occurs most frequently in
persons with pre-existing cardiac disease.13
The 1997 American Heart Association recommendations for the prevention of bacterial endocarditis list
cefazolin, 1000 mg (25 mg/kg for children) IV within 30 minutes of a dental, respiratory tract, or
esophageal procedure, as an alternative to penicillin or penicillin derivatives in penicillin-allergic
patients at risk for endocarditis who are unable to take oral medications.44
- Cardiovascular Surgery
Since Staphylococcus aureus and Staphylococcus epidermidis are currently the most common pathogens
recovered from clean wound infections, first-generation cephalosporins are widely used for prophylaxis.
Second and third-generation cephalosporins, like cefamandole and ceftriaxone respectively, have been
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CEFAZOLIN SODIUM
MEDICATION
PROTOCOL NO.:
6.2.08
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Page 5 of 20
Date Effective:
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used in an attempt to provide broader coverage for gram-negative rods. However, even though various
dosages and schedules have been used, significant differences among the agents has not been
demonstrated.33
Doebbeling et al33 prospectively compared cefazolin and cefuroxime in a randomly assigned double-blind
study of 213 patients undergoing cardiovascular surgery. Cefazolin (104 patients) was given as a 1 gm
preoperative dose followed by 1 gm every 8 hours x 6 doses. Cefuroxime (109 patients) was given as 1.5 gm
preoperative dose followed by 1.5 gm every 12 hours x 4 doses. Cefazolin was given for a mean duration of
2.35 days versus 2.9 days for cefuroxime.
A total of 15 patients in the cefazolin group had infections versus 18 patients in the cefuroxime group
(not statistically significant). However, 10 sternal wound infections occurred in the cefuroxime-treated
patients versus one in the cefazolin group (p = 0.010). The increased ICU stay post-operatively was
approximately 4 times longer for patients with sternal wound infection. This also increased the total
postoperative stay from 4.4 to 29.6 days.
They also found that staphylococcal wound infections occurred in 7 cefuroxime-treated patients versus
one on cefazolin (p = 0.066). Conversely, there was a tendency for streptococcal wound infections
(especially Groups B and D) to occur more frequently in the cefazolin group (4 vs zero, p = 0.110). In
addition, the mean total length of stay, postoperative stay in the ICU, and total postoperative length of
stay were slightly lower for the patients receiving cefazolin (although the difference was not
statistically-significant).
Despite the widespread use of modern aseptic techniques and perioperative antimicrobial prophylaxis,
Staphylococcus aureus wound infections continue to complicate "clean" surgical procedures. Cefazolin
is the most commonly used antibiotic. Although some Staphylococcus aureus infections are caused by
resistant strains, the majority of wound isolates is susceptible to methicillin and accordingly, is
considered to be cephalosporin-susceptible by conventional microbiological methods.
- Vascular Surgery
Edwards and colleagues36 compared cefamandole with cefazolin in the prophylaxis of wound infections
in clean vascular surgery. Eight hundred and ninety-three patients with aortic or infrainguinal arterial
procedures were randomized to receive either cefamandole or cefazolin. The difference in infection rates
associated with cefamandole versus cefazolin prophylaxis was not significant although there was a
significant cost savings if cefazolin was chosen for prophylaxis. Based on this, many institutions
continue to recommend the use of cefazolin in the prophylaxis of wound infections in vascular surgery.
- OB/GYN Indications
-- Cesarean Section Prophylaxis
Postpartum endometritis and wound infections are not uncommon complications following cesarean
section delivery. The incidence of postpartum endometritis ranges from 5% in a typical private
practice setting to as high as 85% in indigent patients 22. The incidence increases in women who labor
with ruptured amniotic membranes for greater than 6 hours. The incidence of wound infections can
depend on endogenous factors (obesity, chronic disease, vaginitis) and exogenous factors (poor
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CEFAZOLIN SODIUM
MEDICATION
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6.2.08
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Page 6 of 20
Date Effective:
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surgical technique, improper preparation of the surgical site, preoperative hospitalization greater than
one day). There is significant correlation between rate of infection and whether or not the C-section
was elective or emergency (3.8% versus 7.5%).
These infections are frequently polymicrobial and involve the microflora of the lower genital tract.
Cefazolin is the standard prophylactic agent. Faro et al22 studied 10 different antibiotic regimens for
prophylaxis in 1580 patients. In summary, they found cefazolin 2 gm x 1 dose; ampicillin 2 gm x 1 dose;
piperacillin 4 gm x 1 dose; and cefotetan 1 gm x 1 dose to be more effective than the other antibiotics
tested. However, patients treated with cefotetan and piperacillin had the lowest infection rates (6.1%
and 8.4% respectively).
However, in another study conducted by Probst et al27 in 646 women who delivered by C-section, a
single intraoperative dose of cefazolin 2 gm was found to be as effective as cefotetan 2 gm in
preventing endometritis. Infections developed in 8.91% of the cefotetan group (which is comparable
to the previous study) versus 11.6% in the cefazolin group. No statistically significant difference
between the two groups was observed (p = 0.269); therefore, the authors concluded that since the two
drugs are equal in efficacy, cefazolin is more cost effective, and therefore should be used whenever
possible.
A prospective investigation done by Duff et al3 indicated that a 1 gm single IV dose of cefazolin was
as effective as 1 gm single IV dose of cefonicid used prophylactically in women having unscheduled
cesarean delivery.
Currier et al37 compared cefazolin with cefoxitin for cesarean section infection prophylaxis. Using a
two-stage design, patients received either cefazolin (n = 481) or cefoxitin (n = 1799). Of the 2280 women
studied in both groups, 4.3% developed postpartum endometritis. There was no statistically
significant difference in the incidence of endometritis between the groups. However the cost of
prophylaxis was significantly higher (5X) for women who received cefoxitin rather than cefazolin.
Based on this fact, the authors concluded that cefazolin prophylaxis should be favored over cefoxitin.
Also, moxalactam was proven not to be any more beneficial than cefazolin in decreasing the
incidence of febrile morbidity associated with cesarean section after labor 9.
According to a study by Meyer et al 55, The combination of cefazolin and metronidazole is more
effective, and results in fewer postoperative infections, decreased duration of hospitalization, and
lower medication cost than cefazolin alone.
-- Hysterectomy
In the study done on patients undergoing vaginal hysterectomy, one single preoperative dose of
cefazolin was shown to be as effective as 3 preoperative doses of cefazolin or a single dose of
cefonicid in preventing postoperative infectious morbidity10. However, in a study done on patients
undergoing total abdominal hysterectomy, Hemsell40 noted that patients receiving cefazolin as a
single preoperative dose had a significantly higher postoperative infection rate than patients receiving
a single dose of cefotetan.
- Central-line Catheter Infections in Home TPN Patients
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CEFAZOLIN SODIUM
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Miller et al26 studied 58 episodes of catheter-related sepsis in 21 patients retrospectively. Organisms
isolated from blood were gram-positive cocci 59%; gram-negative bacilli 25%; and yeast 16%. Attempts
were made to treat the catheter infections at home with antibiotic therapy (except if it was fungal, which
resulted in immediate hospitalization). The gram-negative infections more often resulted in
hospitalization (92% with less than 50% catheter removal) versus gram-positive infections (57%
hospitalized and 23% catheter removal). Empiric therapy consisted of cefazolin 1 gm IV every 12 hours.
This was found to be effective in only 33% of the episodes whereas vancomycin was effective in 62% of
the episodes.
- Head and Neck Surgery
Most head and neck operations are associated with bacterial contamination of the operative field by flora
of the upper aerodigestive tract and the risk of subsequent wound infection is substantial. 31 Antibiotic
prophylaxis in head and neck surgical oncology is the standard of practice. The efficacy of cefazolin
alone was compared to cefazolin plus metronidazole in 400 patients with head and neck cancer. Twentythree patient variables i.e. nutritional status, concomitant diseases, type of surgery, and treatment factors
were evaluated to study their impact on the rate of infection. Sixty-three wounds were recorded for an
overall infection rate of 19.75%. Poor nutritional status and alcohol consumption were the only two
patient-related factors, which significantly correlated with wound infection. In addition, the highest
infection rates were found in patients with advanced disease. The infection rate for surgical procedures
greater than 6 hours in duration was 32.9% versus 8% for procedures less than 2 hours in duration. In
addition, cefazolin plus metronidazole was found to be superior to cefazolin alone (9.5% versus 18.6%
respective rates of wound infection).
- Cefazolin compared to other first-generation cephalosporins
Cefazolin may be the first-generation cephalosporin of choice due to its ability to achieve higher blood
levels than cephalothin and cephapirin, its apparent lack of comparative nephrotoxic potential and its
pharmacokinetics, which allows q 8 hour dosing. In addition, cefazolin can be administered
intramuscularly (IM) without the severe pain caused by cephalothin and other cephalosporins 15.
- Cefazolin compared to second-generation cephalosporins
Cefamandole is reportedly more resistant to inactivation by beta-lactamases produced by gram-positive
and gram-negative organisms than other cephalosporins, and therefore was found to be relatively as
effective as cefazolin in empiric treatment of community acquired pneumonia 2. Conversely, cefonicid
may be less effective than cefazolin in S. aureus skin infections. Other studies have reported comparable
efficacy. Ceforanide has been found to be equally effective to cefazolin in some studies; however, it
offers no advantage over cefazolin for surgical prophylaxis. In addition, cefoxitin is active against most
gram-negative organisms that have developed resistance to cefazolin and other cephalosporins. 16
Doebbeling et al33 found cefazolin to be better than cefuroxime in preventing sternal wound infections
after cardiovascular surgery.
- Cefazolin compared to third-generation cephalosporins
The third-generation cephalosporins have expanded gram-negative coverage over cefazolin. Miki et al7
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Date Effective:
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studied the therapeutic efficacy and safety of cefotaxime and cefazolin in patients with respiratory tract
infections. A total of 256 patients were treated. They found the bacteriological efficacy of cefotaxime to
be superior to that of cefazolin.
- Cefazolin compared to imipenem/cilastatin
Imipenem/cilastatin has been found to be equally as effective as cefazolin in the treatment of mild to
moderate bacterial infections1.
PHARMACOLOGY
Cefazolin is a first-generation cephalosporin. Cephalosporins inhibit mucopeptide synthesis in the bacterial cell
wall by inhibiting a series of enzymes. The result is a defective, osmotically unstable cell wall. Cefazolin may
be bactericidal or bacteriostatic, depending on the organism susceptibility, dose, tissue concentration and rate at
which the organisms multiply.11 First generation cephalosporins are generally inactivated by beta-lactamase
producing organisms.
First Generation Cephalosporins
-
cefazolin
cefadroxil
cephalexin
cephradine
cephapirin
cephalothin
Bacteria generally susceptible to cefazolin and other
first generation cephalosporins
Gram-positive
- Staphylococci
- Streptococcus pneumoniae
- Beta-hemolytic streptococci
Gram-negative
-
Escherichia coli
Moraxella catarrhalis
Klebsiella spp
Proteus mirabilis
Salmonella spp
Shigella spp
Anaerobes
- Clostridium spp
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- Peptococcus spp
- Peptostreptococcus spp
In vitro data suggest that cefazolin is effective against most gram-positive organisms at serum levels of
0.5 to 1.0 mcg/mL. The MIC 90 of methicillin-susceptible isolates of Staphylococcus epidermidis is 4
mcg/mL for cefazolin (for methicillin-resistant isolates, it is 64 mcg/mL) (30). Enterococcus faecalis is
resistant and requires an MIC of 32 mcg/mL. Susceptible strains of E. coli, K. pneumoniae, or P.
mirabilis are generally inhibited in vitro by concentrations of 0.8 to 12.5 mg/mL. 15
- Resistance
Cefazolin is not active against penicillin-resistant pneumococci, which have recently been expanding. In
addition, cefazolin is ineffective against methicillin-resistant staphylococci even when in vitro tests may
suggest susceptibility42.
Findings by Kernodle et al34 demonstrate that "surgical prophylaxis failures" may occur because some
Staphylococcus aureus isolates are efficient in hydrolyzing the cephalosporin. Cefazolin is particularly
susceptible to degradation. Despite routine susceptibility testing not detecting the resistance, the relative
resistance is expressed in vivo and has been found to contribute to the pathogenesis of Staphylococcus
aureus surgical wound infections. They found cefamandole patients had half the incidence of deep
wound Staphylococcus aureus infections compared to the cefazolin patients (2 gm of cefamandole was
given initially, followed by 1 gm every 2 to 3 hours during surgery and 1 gm every 4 to 6 hours
postoperatively times 72 hours, whereas 2 gm of cefazolin was given initially, followed by 1 gm every 4
hours during surgery, and 1 gm every 6 hours postoperatively times 72 hours).
PHARMACOKINETICS1
- Absorption23
-- peak levels achieved are 50 to 100 mcg/mL after a single 1 gm intravenous dose infused over 30 minutes.
(This is several times the concentration needed to inhibit susceptible organisms.)
- Distribution23
-- therapeutic concentrations are achieved in blood, urine, bile, and most body tissues. (However,
cefazolin does not penetrate well into the CSF even in the presence of inflamed meninges.)
protein binding29 – 74% to 86%
volume of distribution - 0.14 L/kg
placenta - cefazolin crosses the placenta. According to a study by Fiore and colleagues 54, a 1000 mg
dose of cefazolin administered as much as 6 hours prior to elective Cesarean delivery achieved fetal
levels equal to, or greater than, the MIC90 for all group B streptococcus.
- Metabolism
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-- is not significantly metabolized.
- Excretion
-- the chief route is renal as unchanged drug.
half-life23 - 2 hours (on the average)
renal clearance (Cl) - 64 ml/min/1.72 m2
renal failure1
CrCl
T1/2
70 to 40 mL/min
3 to 5 hr
40 to 20 mL/min
6 to 12 hr
20 to 5 mL/min
15 to 30 hr
Less than 5 mL/min
30 to 40 hr
Newborn Infants (age 2 to 28 days, weighing 1220 to 3900 grams)
Newborn infants are physiologically different than adults. Newborns have a large extracellular fluid
volume, immature liver and kidney, high levels of bilirubin and nonesterified fatty acids. This makes it
difficult to establish dosage regimens due to changes in tissue distribution, metabolism, and excretion of
drugs.21
Volume of Distribution (Vd) =
0.212 to 0.373 L/Kg (0.4 L/kg)
Changes in extracellular space are thought to be the major factor determining interindividual
differences in Vd; beta-lactam antibiotics like cefazolin are localized in the extracellular water space
and bound to albumin. The change in the unconjugated bilirubin-to-albumin molar ratio is
predominantly responsible for the variation in the unbound fraction of cefazolin in newborns.
- BREAST MILK
Cephalosporins are distributed into milk and these drugs should be used with caution in nursing
women15.
EQUIPMENT REQUIREMENTS
required
X
optional
N/A
volumetric (i.e., pole mount)
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X
ambulatory pump (i.e., CADD-Plus)
X
syringe pump
X
elastomeric infusion device
controller
DOSING/ADMINISTRATION
- Adult
--
Intramuscular
---
total daily dosages are the same for IV and IM11
---
inject into a large muscle mass
---
0.9% sodium chloride is no longer recommended as a diluent for cefazolin for IM use due to the
possibility of crystal formation
---
reconstitute with sterile water for injection or bacteriostatic water for injection.
----
add 2 mL to 250 mg yield concentration of 125 mg/mL
----
add 2 mL to 500 mg yield concentration of 225 mg/mL
----
add 2.5 mL to 1 gm yield concentration of 330 mg/mL
--
Intravenous
---
up to 1.0 gm should be diluted in 50 ml and administered over 30 minutes
---
greater than 1.0 gm should be diluted in 100 ml and administered over 30 minutes usually.
---
When drug administration is via a controlled-release membrane device (MICROS) that uses
gravity flow to deliver drug doses within a predetermined infusion period, it was found that the
primary fluid i.e. D5W, 0.9% NS, D51/2 NS does affect the delivery of cefazolin. For example,
0.9% NS delivered > 95% of the cefazolin dose in 35 to 45 minutes (40  5) versus D51/2 NS in
50 minutes.28
--
Intraperitoneal
--
According to Manley et al51, a dose of 15 mg/kg/day (total body weight) is sufficient to achieve
serum concentrations greater than the minimum inhibitory concentrations for sensitive
organisms for 48 hours and dialysate concentrations for 24 hours.
-- Mild infections
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caused by susceptible gram-positive cocci
250 to 500 mg q 8 hr
-- Moderate to severe infections
i.e. pneumococcal pneumonia caused by susceptible gram-positive cocci
500 to 1 gm Q 6 to 8 hrs
Alternately, some clinicians have combined 2000 mg of cefazolin with probenecid 1000 mg and
administered it once daily in the treatment of skin and soft tissue infections59, 60.
-- Pneumococcal pneumonia
500 mg q 12 hr. (Product Information)
In a randomized study of 286 patients with pneumococcal pneumonia, 500 mg cefazolin given q 12
hrs was found to be as effective as given QID8.
-- Severe, life-threatening infections
i.e. endocarditis, septicemia
1 to 2 gm q 8 hrs or 1 to 1.5 gm q 6 hrs; up to 12 gm/d have been used
-- UTI's
1 gm Q 12 hrs
-- Perioperative Prophylaxis
i.e. vaginal hysterectomy, gastric by-pass, cholecystectomy, gynecologic surgery
1 gm IV or IM 1/2 to 1 hr. prior to surgery, which should be followed by 0.5 to 1 gm IV or IM Q 6 to
8 hours postoperatively (Product Information).
procedures greater than 2 hrs - give an additional 0.5 to 1 gm IV or IM during surgery
---
A single dose of 1 gm cefazolin was proven to be as effective as 3 doses of 1 gm cefazolin
given IV 1/2 hr prior to surgery followed by 2 doses q 6 hrs10.
-- Morbidly Obese (64.5 + 9.6 kg to 127.3 + 16.8 kg)
---
Using standard doses of 1 gm cefazolin IM for patients who underwent gastroplasty resulted in
a 16% wound infection rate when compared to a 2.5% wound infection rate in non-obese
patients requiring clean-contaminated surgery. Instead, morbidly obese patients require 2 gm
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IV (not IM or SQ). Increasing the dose in this fashion resulted in the above 16% infection rate
being reduced to 5.6%20.
-- C-Section Prophylaxis
2 gm IV as a single dose given immediately following clamping of the neonatal umbilical cord 43.
--- A single dose of 1 gm IV cefazolin was found to be as effective as 1 gm IV cefonicid when used
prophylactically in women undergoing unscheduled c-section deliveries3.
--- Cefazolin 2 gm x 1 dose was found to be superior to cefazolin 1 gm x 3 doses22.
- RENAL FAILURE
-- reduced dosage is indicated in patients with reduced renal function (Product Information)
CrCl
Dose
greater than 55
35 to 54 mL/min
full doses
full doses
(frequency not to exceed q 8 hrs)
11 to 34 mL/min
½ usual dose q 12 hours
less than 10 ml/min
½ usual dose q 18 to q 24 hours
Anephric on high-effeciency/high-flux hemodialyzers 15-20 mg/kg after each dialysis 52
-- Bennett et al1 recommend:
CrCl
Interval
greater than 50 mL/min
50 to 10 mL/min
less than 10 mL/min
Q 8 hrs
Q 12 hrs
Q 24 to 48 hrs
- PEDIATRICS
-- Mild to Moderate Infections
---
total daily dose of 25 to 50 mg/kg/day divided into 3 or 4 equal doses
-- Severe Infections
---
total daily dose may be increased to 100 mg/kg/day divided into 3 or 4 equal doses
- Newborns (2 to 28 days)
-- mild to moderate infections21
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30 mg/kg IV infused over 30 minutes diluted in D5W
STABILITY/COMPATIBILITY
- Cefazolin in D5W 5 gm/L was found to be stable for 14 days when refrigerated at 5C18. Galanti et al46,
found cefazolin in D5W (1 gm/100 mL) to be stable for 30 days when refrigerated at 4C. However, at
14 days in 0.9% NS cefazolin was only 86.7% active19. (By definition, drugs are considered stable if
they retain 90% of their activity over a given time period)
- When reconstituted with water for injection, D5W, or 0.9% NS in concentrations of 1 gm/2.5 ml,
500 mg/100 mL and 10 gm/45 mL, cefazolin retained more than 90% potency for up to 26 weeks
when frozen within one hour after constitution when stored at -10 and -20C.
- Cefazolin 1 gm was diluted with sterile water for injection to a concentration of 73.2 mg/mL and a total
of 25 mL and placed in a CADD-VT portable infusion pump (Pharmacia Deltec). The pump was set to
deliver a dose over 1 hour every 8 hours with a KVO setting of 0.2 ml/hr. The PVC drug-filled
reservoirs were stored at -20C immediately after preparation for a period of 30 days, thawed to
refrigerated temperature (5C) for a 4-day storage period, and then placed in the pump for a 1-day
pumping cycle at 37C. The drug was analyzed by HPLC for drug concentration and DEHP leaching.
Cefazolin was found to be stable (greater than 90% potency retained) and DEHP concentrations were
not observed to be above 1 ppm.35
- According to a study by Allen et al45, cefazolin at a concentration of 20 mg/mL in either 5% dextrose or
0.9% NaCl is stable for 24 hours, 7 days, and 12 weeks, respectively, when stored in the latex reservoir
of elastomeric infusion devices or in glass containers at 25 C, 5 C, and -20C, respectively.
- According to a study by Wu et al 53, cefazolin is stable for at least 20 days at 4o C, 11 days at 25o C, and
24 hours at 37o C in heparanized and nonheparanized peritoneal dialysis solutions.
- Cefazolin in Liquifilm Tears in a concentration of 33 mg/ml was found to be stable for 28 days at
refrigerator temperature, maintaining its osmolality and pH within the ophthalmic tolerated range, as
well as its antimicrobial potency48. Although the authors did not endorse room temperature storage, the
data presented indicated that the above measured indicators remained within tolerated range as well as
maintained antimicrobial potency for 28 days.
- Cefazolin 20 mg/ml formed an immediate gray haze, only visible by Tyndall beam, when mixed with
cisatracurium 2 mg and 5 mg/ml in a simulated Y-site administration.50
ADVERSE EFFECTS
- eosinophilia - signs and symptoms of the reaction usually occur a few days after initiation of therapy
and subside within a few days after discontinuance of the drug.15
- non-immunologic positive Coombs’ Test (false-positive) - A false-positive Coombs’ Test is the
detection of an antibiotic on the surface of RBC's. It can be misinterpreted as a diagnosis of hemolytic
anemia. The mechanism of this reaction is usually non-immunologic in nature; it occurs when a
cefazolin-globulin complex coats the erythrocytes and reacts non-specifically with Coombs’ serum. This
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is most likely to occur in patients who receive large doses of cefazolin or have impaired renal function 15.
This reaction is extremely rare.23
- thrombophlebitis - may occur with IV administration of cefazolin, but produces severe reactions much
less frequently than cephalothin15. May be minimized by: increasing the dilution of the antibiotics,
slowing the infusion rate, or using an in-line filter in the IV set.23
- seizures - several cases have been reported, but generally these have been associated in elderly patients
with renal failure.
- hepatotoxicity - elevation of AST (SGOT), ALT (SGPT) and alkaline phosphatase. These are generally
mild and disappear when therapy is discontinued.15
- GI complaints - most frequent adverse effects are nausea, vomiting and diarrhea, which are usually mild
and transient. Other adverse effects are abdominal pain, tenesmus, dyspepsia, glossitis and heartburn 15.
- hypersensitivity reactions - hypersensitivity signs such as erythema, rash (maculopapular,
erythematous, or morbilliform) have been reported to occur in 5% or less of patients. 15 Anaphylactic
reactions occur rarely with cefazolin and appear to occur less frequently than with penicillin42. The
frequency of cross-reactivity between cephalosporins and penicillins has been estimated at between 3 to
7%; other studies have shown even lower frequencies of cross-reactivity.42 Lack of reactivity to one
cephalosporin (i.e. cefazolin) does not necessarily indicate lack of reactivity to all cephalosproins
according to anecdotal reports58.
- pseudomembranous colitis - cefazolin is one of the two most commonly implicated antibiotics
(clindamycin is the other)32. Occurs during or following discontinuance of therapy. Clostridium difficile
is the causative agent. If colitis is moderate to severe or is not relieved by discontinuance of the therapy
then metronidazole should be administered.
- renal effects - renal toxicity, manifested by increases in BUN and serum creatinine have been reported
rarely.15
- hematologic effects - mild neutropenia and thrombocytopenia have been reported rarely.
- fetal effects - safe use has not been established, therefore, this drug should be used during pregnancy
only when clearly needed.
- PREGNANCY
No controlled studies on the use of cefazolin have been published. Cefazolin does cross the placenta.
Cefazolin has been designated a Risk Factor B drug by the manufacturer.
DRUG INTERACTIONS11, 15
- drug - drug
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-- aminoglycosides - additive or synergistic effect.
-- oral contraceptives - decreased effectiveness of the oral contraceptive.
-- probenecid - decreased clearance of cefazolin.
A study by Spina and Dillon 57 noted that probenecid 500 mg QID was as effective in maintaining
therapeutic serum concentrations of cefazolin at steady state when administered with a single 2000
mg cefazolin dose as administering cefazolin 2000 mg q 8 hours without probenecid. A study by
Brown et al59 compared ceftriaxone plus probenecid with cefazolin plus probenecid to treat skin and
soft tissue infections and noted no statisticas difference in efficacy between the two regimens. The
study is significant in that cefazolin is significantly less expensive than ceftriaxone.
-- warfarin - additive hypoprothrombinemic effects have been seen.
- drug - lab
-- false positive Coomb's Test
-- glucose, urine. False positive urine glucose reactions have occurred with Benedict's solution,
Fehling's solution or Clinitest. (NOTE: Use glucose oxidase tests instead.)
-- protein, urine. False positive tests for urinary proteins have been reported when the sulfosalicylic
method is used.
-- false low aminoglycoside levels from improper handling and administration of samples.
DOSAGE FORMS AVAILABLE
- Vials containing 500 mg and 1 g of sterile cefazolin sodium powder for reconstitution and
administration.
- Bulk packages containing 5 gram, 10 gram, and 20 gram powder for institutional compounding.
- Piggyback vials containing 500 mg and 1 gram of sterile cefazolin sodium powder for dilution and
administration.
- Vials containing 500 mg and 1 gram of sterile cefazolin sodium powder for use with the ADDVantage Flexible Diluent Container.
- Premixed frozen solutions containing 500 mg and 1 gram of sterile cefazolin sodium per 50 ml 5%
dextrose in water.
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