Treatment of biliary tract infections caused by susceptible Escherichia coli, Klebsiella, Proteus mirabilis, Staphylococcus aureus, or various streptococci.
Bone and Joint Infections
Treatment of bone and joint infections caused by susceptible S. aureus.
Endocarditis
Treatment of endocarditis caused by susceptible Streptococcus pyogenes. AHA recommends cefazolin as an alternative for treatment of staphylococcal endocarditis or endocarditis caused by viridans streptococci†, S. bovis†, S. pneumoniae†, S. pyogenes, or groups B, C, and G streptococci† in penicillin-allergic individuals; should not be used in those with immediate-type penicillinhypersensitivity (see Cross-hypersensitivity under Cautions).
Alternative for prevention of α-hemolytic (viridans group) streptococcal endocarditis† in individuals undergoing certain dental or upper respiratory tract procedures who have cardiac conditions that put them at highest risk. Oral amoxicillin is usual drug of choice for such prophylaxis; cefazolin (or ceftriaxone) is an alternative in penicillin-allergic individuals or when an oral anti-infective cannot be used. Should not be used in those with immediate-type penicillin hypersensitivity (see Cross-hypersensitivity under Cautions). Consult most recent AHA recommendations for specific information on which cardiac conditions are associated with highest risk of endocarditis and which procedures require prophylaxis.
Respiratory Tract Infections
Treatment of respiratory infections caused by susceptible S. pneumoniae, S. pyogenes (group A β-hemolytic streptococci), S. aureus (including penicillin-resistant strains), Klebsiella, or Haemophilus influenzae.
Septicemia
Treatment of septicemia caused by susceptible S. pneumoniae, S. aureus (including penicillinase-producing strains), E. coli, Klebsiella, or P. mirabilis.
Skin and Skin Structure Infections
Treatment of skin and skin structure infections caused by susceptible S. aureus (including penicillinase-producing strains), S. pyogenes, or other streptococci.
Urinary Tract Infections (UTIs) and Urogenital Infections
Treatment of UTIs caused by susceptible E. coli, P. mirabilis, Klebsiella, some strains of Enterobacter, or some strains of enterococci.
Treatment of prostatitis or epididymitis caused by susceptible E. coli, Klebsiella, P. mirabilis, or some strains of enterococci.
Prevention of Perinatal Group B Streptococcal Disease
Alternative to penicillin G or ampicillin for prevention of perinatal group B streptococcal (GBS) disease† (early-onset neonatal GBS disease) in penicillin-allergic pregnant women who do not have immediate-type penicillin hypersensitivity (see Cross Hypersensitivity under Cautions).
Intrapartum anti-infective prophylaxis to prevent early-onset neonatal GBS disease is administered to women identified as GBS carriers during routine prenatal GBS screening performed at 35–37 weeks during the current pregnancy and to women who have GBS bacteriuria during the current pregnancy, a previous infant with invasive GBS disease, unknown GBS status with delivery at <37 weeks gestation, amniotic membrane rupture for ≥18 hours, or intrapartum temperature of ≥38°C.
Perioperative Prophylaxis
Perioperative prophylaxis in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, high-risk cesarean section, cholecystectomy in high-risk patients) and in those undergoing surgical procedures in which the development of infection at the surgical site would represent a serious risk (e.g., cardiac surgery, prosthetic arthroplasty).
Drug of choice for perioperative prophylaxis for a variety of procedures, including cardiac, noncardiac thoracic, esophageal, gastroduodenal, biliary tract, gynecologic and obstetric, head and neck, neurologic, orthopedic, and vascular surgery.
A drug or regimen with activity against anaerobic bacteria is recommended for procedures that might involve exposure to Bacteroides fragilis or other anaerobic bowel bacteria (e.g., colorectal surgery, appendectomy). Cefoxitin and cefotetan are more active than cefazolin against these bacteria; alternatively, metronidazole can be used in conjunction with cefazolin to provide anaerobic coverage.
Dosage and Administration
Administration
Administer by IV injection or infusion or by deep IM injection.
IV Injection
Reconstitution and Dilution
Reconstitute vials containing 500 mg or 1 g of cefazolin with 2 or 2.5 mL, respectively, of sterile water for injection to provide solutions containing approximately 225 or 330 mg/mL, respectively. Then further dilute reconstituted solution in approximately 5 mL of sterile water for injection.
Rate of Administration
Inject directly into a vein over a period of 3–5 minutes or slowly into the tubing of a freely flowing compatible IV solution.
IV Infusion
Reconstitution and Dilution
Reconstitute vials containing 500 mg or 1 g of cefazolin with 2 or 2.5 mL, respectively, of sterile water for injection to provide solutions containing approximately 225 or 330 mg/mL, respectively. Then further dilute reconstituted solution in 50–100 mL of a compatible IV solution.
Reconstitute 10- or 20-g pharmacy bulk packages according to the manufacturers' directions and then further dilute in a compatible IV solution prior to IV infusion.
Reconstitute (activate) commercially available Duplex® drug delivery system containing 1 or 2 g of lyophilized cefazolin and 50 mL of dextrose injection in separate chambers according to the manufacturer's directions.
Thaw the commercially available premixed injection (frozen) at room temperature (25°C) or under refrigeration (5°C); do not thaw by immersion in a water bath or by exposure to microwave radiation. A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature. Discard thawed injection if solution is cloudy or contains an insoluble precipitate or if container seals or outlet ports are not intact or leaks are found. Do not use in series connections with other plastic containers, since such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from the secondary container is complete.
IM Injection
Inject IM deeply into a large muscle mass.
Reconstitution
Reconstitute vials containing 500 mg or 1 g of cefazolin with 2 or 2.5 mL, respectively, of sterile water for injection to provide solutions containing approximately 225 or 330 mg/mL, respectively. Shake well until dissolved.
Dosage
Available as cefazolin sodium; dosage expressed in terms of cefazolin.
Pediatric Patients
Mild to Moderately Severe Infections
IV or IM
Children >1 month of age: 25–50 mg/kg daily in 3 or 4 equally divided doses.
Severe Infections
IV
Children >1 month of age: 50–100 mg/kg daily in 3 or 4 equally divided doses.
Endocarditis
Treatment of Staphylococcal Endocarditis
IV
100 mg/kg daily (up to 6 g daily) in 3 or 4 equally divided doses.
For native valve endocarditis, duration of treatment is 6 weeks (with or without gentamicin given during the first 3–5 days).
For endocarditis involving prosthetic valves or other prosthetic materials, duration of treatment is ≥6 weeks (with or without rifampin given for ≥6 weeks).
Prevention of Endocarditis in Patients Undergoing Certain Dental or Respiratory Tract Procedures
IV or IM
A single dose of 50 mg/kg given 0.5–1 hour prior to the procedure.†
Perioperative Prophylaxis
Cardiac or Cardiothoracic Surgery
IV
20–30 mg/kg given at induction of anesthesia (within 0.5–1 hour prior to incision). Some clinicians suggest additional doses of 20–30 mg/kg every 8 hours for up to 72 hours; most clinicians state postoperative doses usually unnecessary and may increase risk of bacterial resistance.
Neurosurgery
IV
20–30 mg/kg given at induction of anesthesia (within 0.5–1 hour prior to incision).
Head and Neck Surgery
IV
20–30 mg/kg given at induction of anesthesia (within 0.5–1 hour prior to incision) for clean head and neck surgery with placement of prosthesis. For clean-contaminated head and neck surgery involving incision through oral or pharyngeal mucosa, 30–40 mg/kg at induction of anesthesia.
GI, Pancreatic, or Biliary Tract Surgery
IV
20–30 mg/kg given at induction of anesthesia (within 0.5–1 hour prior to incision).
Vascular or Orthopedic Surgery
IV
20–30 mg/kg given at induction of anesthesia (within 0.5–1 hour prior to incision). Some clinicians suggest additional doses of 20–30 mg/kg every 8 hours for up to 24 hours; most clinicians state postoperative doses usually unnecessary and may increase risk of bacterial resistance.
Adults
Mild Infections Caused by Gram-positive Bacteria
IV or IM
250–500 mg every 8 hours.
Moderate to Severe Infections
IV or IM
500 mg–1 g every 6–8 hours.
Severe, Life-threatening Infections
IV or IM
1–1.5 g every 6 hours. Dosage up to 12 g daily has been used.
Endocarditis
Treatment of Endocarditis
IV or IM
1–1.5 g every 6 hours. Dosage up to 12 g daily has been used.
AHA recommends 2 g IV every 8 hours for 4–6 weeks for native valve staphylococcal endocarditis (with or without gentamicin during the first 3–5 days).
Prevention of Endocarditis in Patients Undergoing Certain Dental or Upper Respiratory Tract Procedures
IV or IM
A single 1-g dose given 0.5–1 hour prior to the procedure.†
Respiratory Tract Infections
Pneumococcal Pneumonia
IV or IM
500 mg every 12 hours.
Septicemia
IV or IM
1–1.5 g every 6 hours. Doses up to 12 g daily have been used.
Urinary Tract Infections (UTIs)
Acute Uncomplicated Infections
IV or IM
1 g every 12 hours.
Prevention of Perinatal Group B Streptococcal (GBS) Disease
IV
An initial 2-g dose (at time of labor or rupture of membranes) followed by 1 g every 8 hours until delivery.†
Perioperative Prophylaxis
General Adult Dosage
IV or IM
Manufacturers recommend 1 g given 0.5–1 hour prior to surgery; 0.5–1 g during surgery for lengthy procedures (e.g., ≥2 hours); and 0.5–1 g every 6–8 hours for 24 hours postoperatively. Manufacturers also recommend that prophylaxis be continued for 3–5 days following surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery, prosthetic arthroplasty).
Most clinicians recommend 1–2 g given within 60 minutes of initial incision and, if surgery is >4 hours or major blood loss occurs, additional intraoperative doses given every 4–8 hours. Postoperative doses usually unnecessary and may increase risk of bacterial resistance.
Cardiac, Cardiothoracic, or Noncardiac Thoracic Surgery.
IV
1–2 g given at induction of anesthesia (within 0.5–1 hour prior to incision).
In patients undergoing open-heart surgery, some experts recommend an additional dose when the patient is removed from bypass.
For cardiothoracic surgery and heart and/or lung transplantation, some experts suggest additional 1-g doses every 8 hours for up to 48–72 hours; others state that prophylaxis for ≤24 hours is appropriate. There is no evidence to support continuing prophylaxis until chest and mediastinal drainage tubes are removed.
Neurosurgery or Head and Neck Surgery
IV
1–2 g given at induction of anesthesia (within 0.5–1 hour prior to incision).
For clean, contaminated head and neck surgery, some experts suggest 2 g given at induction of anesthesia and every 8 hours for 24 hours.
GI, Gastroduodenal, Colorectal, Pancreatic, or Biliary Tract Surgery
IV
1–2 g given at induction of anesthesia (within 0.5–1 hour prior to incision).
For colorectal surgery, use in conjunction with IV metronidazole.
Vascular or Orthopedic Surgery
IV
1–2 g given at induction of anesthesia (within 0.5–1 hour prior to incision).
Some experts suggest additional 1-g doses every 8 hours for up to 24 hours.
Gynecologic and Obstetric Surgery
IV
1–2 g given at induction of anesthesia (within 0.5–1 hour prior to incision) for hysterectomy or as soon as umbilical cord is clamped for cesarean section.
Special Populations
Hepatic Impairment
No dosage recommendations.
Renal Impairment
Dosage adjustments recommended in patients with Clcr <55 mL/minute.
Administer an initial loading dose appropriate for the severity of the infection, followed by dosage based on the degree of renal impairment.
Dosage for Adults with Renal Impairment
Clcr (mL/minute)
Dose
Frequency
35–54
Full dose
≥8-hour intervals
11–34
50% of usual dose
Every 12 hours
≤10
50% of usual dose
Every 18–24 hours
Dosage for Children >1 Month of Age with Renal Impairment
Hypersensitivity to corn or corn products: Duplex® delivery system containing lyophilized cefazolin and dextrose injection and premixed injection (frozen) containing cefazolin in dextrose injection.
Warnings/Precautions
Warnings
Superinfection/Clostridium difficile-associated Diarrhea and Colitis
Possible emergence and overgrowth of nonsusceptible organisms, especially Enterobacter, Pseudomonas, enterococci, or Candida. Careful observation of the patient is essential. Institute appropriate therapy if superinfection occurs.
Treatment with anti-infectives may permit overgrowth of Clostridium difficile. C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including cefazolin, and may range in severity from mild diarrhea to fatal colitis.
Consider CDAD if diarrhea develops during or after therapy and manage accordingly. Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.
If CDAD is suspected or confirmed, anti-infective therapy not directed against C. difficile may need to be discontinued. Some mild cases may respond to discontinuance alone. Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.
Sensitivity Reactions
Hypersensitivity Reactions
Possible hypersensitivity reactions such as urticaria, pruritus, rash (maculopapular, erythematous, morbilliform), fever and chills, eosinophilia, joint pain or inflammation, edema, erythema, genital and anal pruritus, angioedema, shock, hypotension, vasodilatation, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, exfoliative dermatitis, and anaphylaxis.
If an allergic reaction occurs, discontinue cefazolin and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).
Cross-hypersensitivity
Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.
Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. Cautious use recommended in individuals hypersensitive to penicillins: avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.
General Precautions
History of GI Disease
Use with caution in those with a history of GI disease, particularly colitis. (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)
Prolonged PT
Prolonged PT reported with some cephalosporins.
Monitor PT in patients at risk, including those with renal or hepatic impairment, poor nutritional state, receiving prolonged therapy, or stabilized on anticoagulant therapy. Administer vitamin K when indicated.
Selection and Use of Anti-infectives
To reduce development of drug-resistant bacteria and maintain effectiveness of cefazolin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.
When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.
Patients with Diabetes
The commercially available Duplex® delivery system containing 1 g of lyophilized cefazolin and 50 mL of dextrose 4% injection should be used with caution in patients with overt or known subclinical diabetes mellitus or in patients with carbohydrate intolerance for any reason.
Sodium Content
Contains approximately 48 mg (2 mEq) of sodium per g of cefazolin.
Specific Populations
Pregnancy
Category B.
Lactation
Distributed into milk; use with caution.
Pediatric Use
Safety and efficacy not established in premature infants or neonates ≤1 month of age.
Geriatric Use
No overall differences in safety and efficacy in those ≥65 years of age compared with younger adults, but the possibility of increased sensitivity in some geriatric individuals cannot be ruled out.
Substantially eliminated by kidneys; risk of toxicity may be greater in those with impaired renal function. Select dosage with caution and consider monitoring renal function because of age-related decreases in renal function. (See Renal Impairment under Dosage and Administration.)
Renal Impairment
Possible increased serum concentrations and serum half-life.
Possibility of seizures if inappropriately high dosage used in patients with impaired renal function.
Use with caution and reduce dosage. (See Renal Impairment under Dosage and Administration.)
Decreased renal clearance and increased concentrations of cefazolin
Tests for glucose
Possible false-positive reactions in urine glucose tests using Clinitest®, Benedict’s solution, or Fehling’s solution
Use glucose tests based on enzymatic glucose oxidase reactions (e.g., Clinistix®)
Pharmacokinetics
Absorption
Bioavailability
Not appreciably absorbed from GI tract; must be administered parenterally.
After IM injection, peak serum concentrations attained within 1–2 hours.
Distribution
Extent
Widely distributed into tissues and fluids, including synovial fluid.
Only low concentrations distribute into CSF.
Crosses the placenta and is distributed into milk.
Plasma Protein Binding
74–86%.
Elimination
Metabolism
Not appreciably metabolized.
Elimination Route
Excreted unchanged in urine. Approximately 60% of a dose excreted within 6 hours and 70–80% excreted within 24 hours in those with normal renal impairment.
Half-life
Serum half-life approximately 1.8 hours after IV administration and 2 hours after IM administration.
Special Populations
Half-life increased in renal impairment.
Stability
Storage
Parenteral
Powder for Injection or IV Infusion
20–25°C; protect from light.
Powder and reconstituted solutions may darken; does not indicate loss of potency.
Reconstituted solutions containing 225 or 330 mg of cefazolin per mL prepared using sterile or bacteriostatic water for injection or sodium chloride injection are stable for 24 hours at room temperature or 10 days at 5°C.
Store commercially available Duplex® drug delivery system containing 1 or 2 g of lyophilized cefazolin and 50 mL of dextrose injection at 20–25°C (may be exposed to 15–30°C). Following reconstitution (activation), use within 24 hours if stored at room temperature or within 7 days if stored in a refrigerator; do not freeze.
Injection (Frozen) for IV Infusion
-20°C or lower. Thawed solutions stable for 48 hours when stored at room temperature (25°C) or 30 days under refrigeration (5°C).
Do not refreeze after thawing.
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Based on spectrum of activity, classified as a first generation cephalosporin. Has a limited spectrum of activity compared with second, third, and fourth generation cephalosporins.
Usually bactericidal.
Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.
Spectrum of activity includes many gram-positive aerobic bacteria and some gram-negative aerobic bacteria; inactive against fungi and viruses.
Gram-positive aerobes: active in vitro and in clinical infections against penicillinase-producing and nonpenicillinase-producing Staphylococcus aureus and S. epidermidis; Streptococcus pyogenes (group A β-hemolytic streptococci); S. agalactiae (group B streptococci); and S. pneumoniae.Enterococci and oxacillin-resistant (methicillin-resistant) staphylococci are resistant.
Gram-negative aerobes: active in vitro and in clinical infections against some strains of Haemophilus influenzae, Escherichia coli, Klebsiella, Proteus mirabilis, and Enterobacter aerogenes. Inactive against most other gram-negative bacteria, including Citrobacter, E. cloacae, Morganella, Providencia, Pseudomonas, and Serratia.
Importance of completing full course of therapy, even if feeling better after a few days.
Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with cefazolin or other antibacterials in the future.
Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.
Importance of discontinuing cefazolin and informing clinician if an allergic reaction occurs.
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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