FDA Label for Cefazolin

View Indications, Usage & Precautions

Cefazolin Product Label

The following document was submitted to the FDA by the labeler of this product Fresenius Kabi Usa, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

1 Indications And Usage



To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection, USP for Injection and other antibacterial drugs, Cefazolin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.


Cefazolin for Injection, USP is indicated for the treatment of the following infections when caused by susceptible bacteria.


1.1 Respiratory Tract Infections



Respiratory tract infections due to Streptococcus pneumoniae, Staphylococcus aureus and Streptococcus pyogenes.

Injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.

Cefazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available.


1.2 Urinary Tract Infctions



Urinary tract infections due to Escherichia coli, and Proteus mirabilis.


1.3 Skin And Skin Structure Infections



Skin and skin structure infections due to S. aureus, S. pyogenes, and Streptococcus agalactiae.


1.4 Biliary Tract Infections



Skin and skin structure infections due to S. aureus, S. pyogenes, and Streptococcus agalactiae.


1.5 Bone And Joint Infections



Bone and joint infections due to S. aureus.


1.6 Genital Infections



Genital infections due to E. coli, and P. mirabilis.


1.7 Septicemia



Septicemia due to S. pneumoniae, S. aureus, P. mirabilis, and E. coli.


1.8 Endocarditis



Endocarditis due to S. aureus and S. pyogenes.


1.9 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).

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.


2.1 Adult Population



The recommended adult dosages are outlined in Table 1. Cefazolin for Injection should be administered intramuscularly (IM) or intravenously (IV) over approximately 30 minutes.



Table 1: Recommended Dosing Schedule in Adult Patients with CrCl
Greater Than or Equal To 55 mL/min.
Site and Type of Infection
Dose
Frequency
Moderate to severe infections
500 mg to 1 gram
every 6 to 8 hours
Mild infections caused by susceptible gram-positive cocci
250 mg to 500 mg
every 8 hours
Acute, uncomplicated urinary tract infections
1 gram
every 12 hours
Pneumococcal pneumonia
500 mg
every 12 hours
Severe, life-threatening infections (e.g., endocarditis, septicemia)*
1 gram to 1.5 grams
every 6 hours

 * In rare instances, doses of up to 12 grams of cefazolin per day have been used.


2.2 Perioperative Prophylactic Use



To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:


  • 1 gram IV or IM administered ½ hour to 1 hour prior to the start of surgery.
  • For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).
  • 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.
  • It is important that (i) the preoperative dose be given just prior (1/2 hour to 1 hour) to the start of surgery so that adequate antibacterial concentrations are present in the serum and tissues at the time of initial surgical incision; and (ii) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibacterial drug at the anticipated moments of greatest exposure to infective organisms.


    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.


2.3 Patients With Renal Impairment



Cefazolin may be used in patients with renal impairment with the dosage adjustments outlined in Table 2. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.



Table 2: Dosage Adjustment for Patients with Renal Impairment
Creatinine Clearance
Dose
Frequency
55 mL/min. or greater
full dose
normal frequency
35 to 54 mL/min.
full dose
every 8 hours or longer
11 to 34 mL/min.
1/2 usual dose
every 12 hours
10 mL/min. or less
1/2 usual dose
every 18 to 24 hours

2.4 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.



Table 3: Pediatric Dosage Guide
Weight
25 mg/kg/day
Divided into 3 Doses
25 mg/kg/day
Divided into 4 Doses
 
 
 
Lbs
 
 
 
Kg
 
Approximate Single Dose mg/q 8 h
Vol. (mL) needed with dilution of
125 mg/mL
 
Approximate Single Dose mg/q 6 h
Vol. (mL) needed with dilution of
125 mg/mL
10
20
30
40
50
4.5
9
13.6
18.1
22.7
40 mg
75 mg
115 mg
150 mg
190 mg
0.35 mL
0.6 mL
0.9 mL
1.2 mL
1.5 mL
30 mg
55 mg
85 mg
115 mg
140 mg
0.25 mL
0.45 mL
0.7 mL
0.9 mL
1.1 mL
Weight
50 mg/kg/day
Divided into 3 Doses
50 mg/kg/day
Divided into 4 Doses
 
 
 
Lbs
 
 
 
Kg
 
Approximate Single Dose mg/q 8 h
Vol. (mL) needed with dilution of
225 mg/mL
 
Approximate Single Dose mg/q 6 h
Vol. (mL) needed with dilution of
225 mg/mL
10
20
30
40
50
4.5
9
13.6
18.1
22.7
75 mg
150 mg
225 mg
300 mg
375 mg
0.35 mL
0.7 mL
1 mL
1.35 mL
1.7 mL
55 mg
110 mg
170 mg
225 mg
285 mg
0.25 mL
0.5 mL
0.75 mL
1 mL
1.25 mL

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 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.


2.5 Preparation For Use Of Cefazolin For Injection



Reconstitution

Preparation of Parenteral Solution

Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

When reconstituted or diluted according to the instructions below, Cefazolin for Injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.


Single-Dose Vials

For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.

Table 4: Reconstitution Instructions
Vial Size
Amount of Diluent
Approximate
Concentration
Approximate
Available Volume
500 mg
2 mL
225 mg/mL
2.2 mL
1 gram
2.5 mL
330 mg/mL
3 mL

Administration

Intramuscular Administration

Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved Cefazolin for Injection should be injected into a large muscle mass. Pain on injection is infrequent with Cefazolin for Injection.


Intravenous Administration

Direct (bolus) injection:Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

Intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection in 50 to 100 mL of one of the following solutions:

    Sodium Chloride Injection, USP

    5% or 10% Dextrose Injection, USP

    5% Dextrose in Lactated Ringer’s Injection, USP

    5% Dextrose and 0.9% Sodium Chloride Injection, USP

    5% Dextrose and 0.45% Sodium Chloride Injection, USP

    5% Dextrose and 0.2% Sodium Chloride Injection, USP

    Lactated Ringer’s Injection, USP

    Invert Sugar 5% or 10% in Sterile Water for Injection

    Ringer’s Injection, USP

    5% Sodium Bicarbonate Injection, USP

Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.


3 Dosage Forms And Strengths



Cefazolin for Injection, USP is supplied in 500 mg and 1 gram vials


4.1 Hypersensitivity To Cefazolin Or The Cephalosporin Class Of Antibacterial Drugs, Penicillins, Or Other Beta-Lactams



Cefazolin for Injection is contraindicated in patients who have a history of immediate hypersensitivity reactions (e.g., anaphylaxis, serious skin reactions) to cefazolin or the cephalosporin class of antibacterial drugs, penicillins, or other beta-lactams [see Warnings and Precautions (5.1)].


5.1 Hypersensitivity Reactions To Cefazolin, Cephalosporins, Penicillins, Or Other Beta-Lactams



Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with Cefazolin for Injection is instituted, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to cefazolin, cephalosporins, penicillins, or carbapenems. Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among beta-lactam antibacterial drugs 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 for Injection occurs, discontinue the drug.


5.2 Use In Patients With Renal Impairment



As with other beta-lactam antibacterial drugs, seizures may occur if inappropriately high doses are administered to patients with impaired renal function (creatinine clearance less than 55 mL/min.) [see Dosage and Administration (2.3)].


5.3 Clostridium Difficile-Associated Diarrhea



Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefazolin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.


5.4 Risk Of Development Of Drug-Resistant Bacteria



Prescribing Cefazolin for Injection in the absence of 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.

As with other antimicrobials, prolonged use of Cefazolin for Injection may result in overgrowth of nonsusceptible microorganisms. Repeated evaluation of the patient's condition is essential. Should superinfection occur during therapy, appropriate measures should be taken.


5.5 Drug/Laboratory Test Interactions



Urinary Glucose

The administration of cefazolin may result in a false-positive reaction with glucose in the urine when using CLINITEST® tablets. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (e.g., CLINISTIX®) be used.


Coombs’ Test

Positive direct Coombs' tests have been reported during treatment with cefazolin. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs' testing of newborns whose mothers have received cephalosporin antibacterial drugs before parturition, it should be recognized that a positive Coombs' test may be due to the drug.


6 Adverse Reactions



The following serious adverse reactions to cefazolin are described below and elsewhere in the labeling: 

6.1 Clinical Trials Experience



The following adverse reactions were reported from clinical trials:

Gastrointestinal: Diarrhea, oral candidiasis (oral thrush), mouth ulcers, vomiting, nausea, stomach cramps, epigastric pain, heartburn, flatus, anorexia and pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.3)].

Allergic: Anaphylaxis, eosinophilia, urticaria, itching, drug fever, skin rash, Stevens-Johnson syndrome.

Hematologic: Neutropenia, leukopenia, thrombocytopenia, thrombocythemia.

Hepatic: Transient rise in SGOT, SGPT, and alkaline phosphatase levels has been observed. As with other cephalosporins, reports of hepatitis have been received.

Renal: As with other cephalosporins, reports of increased BUN and creatinine levels, as well as renal failure, have been received.

Local Reactions: Instances of phlebitis have been reported at site of injection. Some induration has occurred.

Other  Reactions: Pruritus (including genital, vulvar and anal pruritus, genital moniliasis, and vaginitis). Dizziness, fainting, lightheadedness, confusion, weakness, tiredness, hypotension, somnolence and headache.


6.2 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 antibacterials: Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal impairment, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, hepatic impairment including cholestasis, and pancytopenia.


7 Drug Interactions



Probenecid may decrease renal tubular secretion of cephalosporins when used concurrently, resulting in increased and more prolonged cephalosporin blood levels.


8.1 Pregnancy



Pregnancy Category B

Reproduction studies have been performed in rats, mice and rabbits at doses of 2000, 4000 and 240 mg/kg/day or 1 to 3 times the maximum recommended human dose on a body surface area basis.  There was no evidence of impaired fertility or harm to the fetus due to cefazolin.


8.2 Labor And Delivery



When cefazolin has been administered prior to caesarean section, drug concentrations 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.


8.3 Nursing Mothers



Cefazolin 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.


8.4 Pediatric Use



Safety and effectiveness for use in premature infants and neonates have not been established. See  Dosage and Administration (2.4) for recommended dosage in pediatric patients older than 1 month.


8.5 Geriatric Use



Of the 920 subjects who received cefazolin 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 [see Dosage and Administration (2.3) and Warnings and Precautions (5.2)].


8.6 Patients With Renal Impairment



When Cefazolin for Injection is administered to patients with low urinary output because of impaired renal function (creatinine clearance less than 55 mL/min.), lower daily dosage is required [see Dosage and Administration (2.3) and Warnings and Precautions (5.2)].


11 Description



Cefazolin for 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 pH of the reconstituted solution is between 4 and 6.

Cefazolin for Injection, USP is a sterile white to cream powder supplied in vials. Each vial contains, cefazolin sodium equivalent to 500 mg or 1 gram of cefazolin.

The sodium content is approximately 24 mg (1 mEq)/500 mg of cefazolin sodium or approximately 48 mg (2.1 mEq)/1 gram of cefazolin sodium.

The color of Cefazolin for Injection, USP solutions may range from pale yellow to yellow without a change in potency.

Cefazolin for Injection, USP is to be administered by intramuscular or intravenous routes.


12.1 Mechanism Of Action



Cefazolin is an antibacterial drug [see Microbiology (12.4)].


12.2 Pharmacodynamics



The pharmacokinetic/pharmacodynamic relationship for cefazolin has not been evaluated in patients.


12.3 Pharmacokinetics



After intramuscular administration of cefazolin to normal volunteers, the mean serum concentrations were 37 mcg/mL at 1 hour and 3 mcg/mL at 8 hours following a 500 mg dose, and 64 mcg/mL at 1 hour and 7 mcg/mL at 8 hours following a 1 gram dose.

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 g dose.

The serum half-life for cefazolin is approximately 1.8 hours following IV administration and approximately 2 hours following IM 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 concentration at the third hour of approximately 28 mcg/mL.

Studies in patients hospitalized with infections indicate that cefazolin produces mean peak serum concentrations approximately equivalent to those seen in normal volunteers.

Bile concentrations in patients without obstructive biliary disease can reach or exceed serum concentrations by up to five times; however, in patients with obstructive biliary disease, bile concentrations of cefazolin are considerably lower than serum concentrations (less than 1 mcg/mL).

In synovial fluid, the cefazolin concentration 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. Cefazolin achieves peak urine concentrations of approximately 2,400 mcg/mL and 4,000 mcg/mL respectively following 500 mg and 1 gram intramuscular doses.

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 to 44 mcg/mL) with 50 mg/L (3 patients), and 72 mcg/mL (range 26 to142 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.


12.4 Microbiology



Mechanism of Action

Cefazolin is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis.


Mechanism of Resistance

Predominant mechanisms of bacterial resistance to cephalosporins include the presence of extended-spectrum beta-lactamases and enzymatic hydrolysis.


Lists of Microorganisms

Cefazolin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE (1) section.


Gram-Positive Bacteria

      Staphylococcus aureus

      Staphylococcus epidermidis

      Streptococcus pyogenes, and Streptococcus agalactiae

      Streptococcus pneumoniae


Methicillin-resistant staphylococci are uniformly resistant to cefazolin.


• Gram-Negative Bacteria

      Escherichia coli

      Proteus mirabilis

Most isolates of indole positive Proteus (Proteus vulgaris), Enterobacter spp., Morganella morganii, Providencia rettgeri, Serratia spp., and Pseudomonas spp. are resistant to cefazolin.

Susceptibility Test Methods

When available, the clinical microbiology laboratory should provide the results of in vitro susceptibility test results for antimicrobial drug products used in resident hospitals to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug product for treatment.


Dilution Techniques

Quantitative methods are used to determine minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standard test1, 2 (broth and/or agar). The MIC values obtained should be interpreted according to criteria as provided in Table 5.

Diffusion Techniques

Quantitative methods that require measurement of zone diameters provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be interpreted using a standard test method2, 3. This procedure uses paper disks impregnated with 30 mcg cefazolin to test the susceptibility of microorganisms to cefazolin. The disk diffusion interpretive criteria are provided in Table 5.


Table 5: Susceptibility Test Interpretive Criteria for Cefazolina

Pathogen

Minimum Inhibitory Concentration
(mcg/mL)

Disk Diffusion Zone Diameter (mm)b

S

I

R

S

I

R
Escherichia coli
Proteus mirabilis

≤ 1

2

≥ 4

-

-

-
Staphylococcus aureus

≤ 8

16

≥ 32

≥ 18

15 to 17

≤ 14

Abbreviations: S= susceptible, I= intermediate, R= resistant

aInterpretive criteria are based on 1 g every 8 hr
bThe cefazolin disk should not be used for determining susceptibility to other cephalosporins



NOTE:

S. pyogenes and S. agalactiae that have a penicillin MIC of ≤ 0.12 mcg/mL, or disk diffusion zone diameters of ≥ 24 mm with a 10 mcg penicillin disk, may be interpreted as susceptible to cefazolin. Non-meningitis isolates of S. pneumoniae that have a penicillin MIC of ≤ 0.06 mcg/ml, may be interpreted as susceptible to cefazolin.


A report of Susceptible indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations at the infection site necessary to inhibit growth of the pathogen. 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 product is physiologically concentrated or in situations where a high dosage of the drug product can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant indicates that the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations usually achievable at the infection site; other therapy should be selected.



Quality Control

Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individual performing the test1, 2, 3. Standard cefazolin powder should provide the following MIC values noted in Table 6. For the diffusion technique using the 30 mcg disk, the criteria in Table 6 should be achieved.



Table 6: Acceptable Quality Control Ranges for Cefazolin
QC Isolate
Minimum Inhibitory Concentration mcg/mL
Disk Diffusion Zone Diameters (mm)
E. coli ATCC® 25922
1 to 4
21 to 27
S. aureus ATCC® 29213
0.25 to 1
------------
S. aureus ATCC® 25923
-------------
29 to 35



13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility



Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of Cefazolin for Injection have not been performed.


15 References



  • Clinical Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard-Ninth Edition. CLSI Document M07-A9. CLSI, 940 West Valley Road, Suite 2500, Wayne, PA, 2012.
  • Clinical Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twentieth Informational Supplement. CLSI document M100-S20. CLSI, Wayne, PA, 2010.
  • Clinical Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-Eleventh Edition. CLSI Document M02-A11. CLSI, Wayne, PA, 2012.

16 How Supplied/Storage And Handling



Cefazolin for Injection, USP 

Product
No.
 NDC
No.    
Cefazolin for Injection, USP 
23610 63323-236-10 500 mg 
23710 63323-237-10 1 gram 

Cefazolin for Injection, USP, is supplied in 500 mg and 1 gram vials. Each vial contains cefazolin sodium equivalent to 500 mg or 1 gram of cefazolin and is packaged 25 per tray.


Preservative Free.


As with other cephalosporins, Cefazolin for Injection, USP tends to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected.


Before reconstitution protect from light and store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].


The container closure is not made with natural rubber latex.


17 Patient Counseling Information



Patients should be advised that allergic reactions, including serious allergic reactions could occur and that serious reactions require immediate treatment and discontinuation of cefazolin. Patients should report to their health care provider any previous allergic reactions to cefazolin, cephalosporins, penicillins, or other similar antibacterials.

Patients should be advised that diarrhea is a common problem caused by antibiotics, which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterials. If this occurs, patients should contact a physician as soon as possible.

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 be treatable by Cefazolin for Injection or other antibacterial drugs in the future.


Rx only


ATCC is a registered trademark of American Type Culture Collection.

CLINITEST is a registered trademark of Siemens Medical Solutions Diagnostics.

CLINISTIX is a registered trademark of Bayer Healthcare LLC.


Manufactured for:




Made in Italy

451180B
Revised: October 2014


Package Label.Principal Display Panel



PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Cefazolin 500 mg Vial Label
NDC
63323-236-10
23610

CEFAZOLIN FOR INJECTION, USP

500 mg per vial
FOR I.V. OR I.M. USE

Rx only





PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Cefazolin 500 mg Vial Carton Panel
NDC
63323-236-10
23610

CEFAZOLIN FOR INJECTION, USP

500 mg per vial
FOR INTRAVENOUS OR INTRAMUSCULAR USE

Rx only
25 Vials






PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Cefazolin 1 gram Vial Label
NDC
63323-237-10
23710

CEFAZOLIN FOR INJECTION, USP

1 gram per vial
FOR I.V. OR I.M. USE

Rx only




PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Cefazolin 1 gram Vial Carton Panel
NDC
63323-237-10
23710

CEFAZOLIN FOR INJECTION, USP

1 gram per vial
FOR INTRAVENOUS OR INTRAMUSCULAR USE

Rx only
25 Vials



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