You are here: Home > Prescription(RX) Drugs > C > Cefazolin (Baxter Healthcare Corporation)

Name:Cefazolin
Manufacturer:Baxter Healthcare Corporation
Category:Prescription Marketed Drugs


Cefazolin Injection, USP in GALAXY Container(PL 2040 Plastic)

CEFAZOLIN - cefazolin sodium injection, solution 
Baxter Healthcare Corporation

----------

Cefazolin Injection, USP
in GALAXY Container
(PL 2040 Plastic)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin Injection, USP and other antibacterial drugs, Cefazolin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DESCRIPTION

Cefazolin Injection, USP is a semi-synthetic cephalosporin for parenteral administration. It is the sodium salt of 3-{[(5-methyl-1,-3,-4-thiadiazol-2-yl)thio]-methyl}-8-oxo-7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid.

Structural Formula:

Image of Structural Formula for Cefazolin Injection, USP

The sodium content is 46 mg per gram of cefazolin.

Cefazolin Injection, USP is a frozen, premixed, iso-osmotic, sterile, nonpyrogenic 50 mL solution containing cefazolin sodium equivalent to 1 g of Cefazolin, USP. Dextrose, USP has been added to adjust osmolality (approximately 2 g as dextrose hydrous). The pH has been adjusted with sodium bicarbonate. The solution is intended for intravenous use after thawing to room temperature.

This GALAXY container (PL 2040) is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. However, the suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.

CLINICAL PHARMACOLOGY

Studies have shown that following intravenous administration of cefazolin to normal volunteers, mean serum concentrations peaked at approximately 185 mcg/mL and were approximately 4 mcg/mL at 8 hours for a 1-gram dose.

The serum half-life for cefazolin is approximately 1.8 hours following IV administration.

In a study (using normal volunteers) of constant intravenous infusion with dosages of 3.5 mg/kg for 1 hour (approximately 250 mg) and 1.5 mg/kg the next 2 hours (approximately 100 mg), cefazolin produced a steady serum level at the third hour of approximately 28 mcg/mL.

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

Bile levels in patients without obstructive biliary disease can reach or exceed serum levels by up to 5 times; however, in patients with obstructive biliary disease, bile levels of cefazolin are considerably lower than serum levels (<1.0 mcg/mL).

In synovial fluid, the level of cefazolin becomes comparable to that reached in serum at about 4 hours after drug administration.

Studies of cord blood show prompt transfer of cefazolin across the placenta. Cefazolin is present in very low concentrations in the milk of nursing mothers.

Cefazolin is excreted unchanged in the urine. In the first 6 hours approximately 60% of the drug is excreted in the urine and this increases to 70% to 80% within 24 hours.

In patients undergoing peritoneal dialysis (2 L/hr.), cefazolin produced mean serum levels of approximately 10 and 30 mcg/mL after 24 hours instillation of a dialyzing solution containing 50 mg/L and 150 mg/L, respectively. Mean peak levels were 29 mcg/mL (range 13 to 44 mcg/mL) with 50 mg/L (3 patients), and 72 mcg/mL (range 26 to 142 mcg/mL) with 150 mg/L (6 patients). Intraperitoneal administration of cefazolin 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.

Microbiology

In vitro tests demonstrate that the bactericidal action of cephalosporins results from inhibition of cell wall synthesis. Cefazolin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in INDICATIONS AND USAGE.

Gram-Positive Aerobes

Staphylococcus aureus (including β-lactamase-producing strains)

Staphylococcus epidermidis

Streptococcus pyogenes, Streptococcus agalactiae, and other strains of streptococci

Streptococcus pneumoniae

Methicillin-resistant staphylococci are uniformly resistant to cefazolin, and many strains of enterococci are resistant.

Gram-Negative Aerobes

Escherichia coli

Proteus mirabilis

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

Susceptibility Tests

Diffusion Techniques

Quantitative methods that require measurement of zone diameters provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure1 that has been recommended for use with disks to test the susceptibility of microorganisms to cefazolin uses the 30-mcg cefazolin disk.

Results of the standardized single-disk susceptibility test1 with a 30-mcg cefazolin disk should be interpreted according to the following criteria:

RECOMMENDED RANGES FOR CEFAZOLIN SUSCEPTIBILITY TESTING

Zone Diameter (mm)      Interpretation
≥18 Susceptible (S)
15 to 17 Intermediate (I)
≤14 Resistant (R)

Standardized single-disk susceptibility test should be performed ONLY with a 30-mcg cefazolin disk. A report of "Susceptible" indicates that the pathogen is likely to be inhibited by usually achievable concentrations of the antimicrobial compound in the blood. A report of "Intermediate" indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that usually achievable concentrations of the antimicrobial compound in the blood are unlikely to be inhibitory and that other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms. The 30-mcg cefazolin disk should provide the following zone diameters in these laboratory test quality control strains:

Microorganism Zone Diameter (mm)
E. coli ATCC 25922      21-27
S. aureus ATCC 25923 29-35

The cefazolin disk should not be used for testing susceptibility to other cephalosporins.

Dilution Techniques

Quantitative methods that are used to determine minimum inhibitory concentrations (MIC) provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure uses a standardized dilution method2 (broth, agar, or microdilution) or equivalent with cefazolin powder. The MIC values obtained should be interpreted according to the following criteria:

MIC (mcg/mL)      Interpretation
≤16 Susceptible (S)
≥64 Resistant (R)

Interpretation should be as stated above for results using diffusion techniques.

As with standard diffusion techniques, dilution methods require the use of laboratory control microorganisms. Standard cefazolin powder should provide the following MIC values:

Microorganism MIC (mcg/mL)
S. aureus ATCC 25923      0.25 to 1.0
E. coli ATCC 25922 1.0 to 4.0

INDICATIONS AND USAGE

Cefazolin Injection, USP is indicated in the treatment of the following infections due to susceptible organisms:

Respiratory Tract Infections:

Due to S. pneumoniae, S. aureus (including β-lactamase-producing strains), and S. pyogenes.

Injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available.

Urinary Tract Infections:

Due to E. coli, P. mirabilis.

Skin and Skin Structure Infections:

Due to S. aureus (including β-lactamase-producing strains), S. pyogenes, and other strains of streptococci.

Biliary Tract Infections:

Due to E. coli, various strains of streptococci, P. mirabilis, and S. aureus.

Bone and Joint Infections:

Due to S. aureus.

Genital Infections:

(i.e., prostatitis, epididymitis) due to E. coli, P. mirabilis.

Septicemia:

Due to S. pneumoniae, S. aureus (including β-lactamase-producing strains) P. mirabilis, E. coli.

Endocarditis:

Due to S. aureus (including β-lactamase-producing strains), and S. pyogenes.

Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefazolin.

Perioperative Prophylaxis:

The prophylactic administration of cefazolin preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones).

The perioperative use of cefazolin may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty).

The prophylactic administration of cefazolin should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted. (See DOSAGE AND ADMINISTRATION.)

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

CONTRAINDICATIONS

Cefazolin Injection, USP is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

WARNINGS

Before therapy with Cefazolin Injection, USP is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefazolin, cephalosporins, penicillins, or other drugs. If this product is given to penicillin-sensitive patients, caution should be exercised because cross-hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Cefazolin Injection, USP occurs, discontinue treatment with the drug. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, IV fluids, IV antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.

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 strains 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 antibiotic 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 antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

PRECAUTIONS

General

Prolonged use of cefazolin may result in the overgrowth of nonsusceptible organisms. Careful clinical observation of the patient is essential.

When cefazolin is administered to patients with low urinary output because of impaired renal function, lower daily dosage is required (see DOSAGE AND ADMINISTRATION).

As with other β-lactam antibiotics, seizures may occur if inappropriately high doses are administered to patients with impaired renal function (see DOSAGE AND ADMINISTRATION).

Cefazolin Injection, USP, as with all cephalosporins, should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.

Prescribing cefazolin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Drug Interactions

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

Drug/Laboratory Test Interactions

A false positive reaction for glucose in the urine may occur with Benedict’s solution, Fehling’s solution or with CLINITEST® tablets, but not with enzyme-based tests such as CLINISTIX®.

Positive direct and indirect antiglobulin (Coombs) tests have occurred; these may also occur in neonates whose mothers received cephalosporins before delivery.

Information for Patients

Patients should be counseled that antibacterial drugs including cefazolin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cefazolin Injection, USP is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cefazolin or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, 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 antibiotic. If this occurs, patients should contact their physician as soon as possible.

Carcinogenesis/Mutagenesis

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

Pregnancy

Teratogenic Effects

Pregnancy Category B

Reproduction studies have been performed in rats, mice, and rabbits at doses up to 25 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefazolin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

When cefazolin has been administered prior to caesarean section, drug levels in cord blood have been approximately one quarter to one third of maternal drug levels. The drug appears to have no adverse effect on the fetus.

Nursing Mothers

Cefazolin is present in very low concentrations in the milk of nursing mothers. Caution should be exercised when cefazolin is administered to a nursing woman.

Pediatric Use

Safety and effectiveness for use in premature infants and neonates have not been established. See DOSAGE AND ADMINISTRATION for recommended dosage in pediatric patients older than 1 month.

Geriatric Use

Of the 920 subjects who received cefazolin injection in clinical studies, 313 (34%) were 65 years and over, while 138 (15%) were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see PRECAUTIONS, General and DOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS

The following reactions have been reported:

Gastrointestinal

Diarrhea, oral candidiasis (oral thrush), vomiting, nausea, stomach cramps, anorexia, and pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS). Nausea and vomiting have been reported rarely.

Allergic

Anaphylaxis, eosinophilia, 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

Rare instances of phlebitis have been reported at site of injection.

Other Reactions

Genital and anal pruritus (including vulvar pruritus, genital moniliasis, and vaginitis).

DOSAGE AND ADMINISTRATION

Usual Adult Dosage:

*
In rare instances, doses of up to 12 grams of Cefazolin Injection, USP per day have been used
Type of Infection Dose Frequency
Moderate to severe infections 500 mg to 1 gram every 6 to 8 hrs.
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

Perioperative Prophylactic Use

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

  1. 1 gram IV administered ½ hour to 1 hour prior to start of surgery.
  2. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure).
  3. 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

Dosage Adjustment for Patients With Reduced Renal Function

Cefazolin Injection, USP may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3.0 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given ½ the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given ½ the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

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 Injection, USP in these patients is not recommended.

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/q8h
Vol. (mL)
needed with
dilution of
125 mg/mL
Approximate
Single Dose
mg/q6h
Vol. (mL)
needed with
dilution of
125 mg/mL
10 4.5 40 mg 0.35 mL 30 mg 0.25 mL
20 9.0 75 mg 0.60 mL 55 mg 0.45 mL
30 13.6 115 mg 0.90 mL 85 mg 0.70 mL
40 18.1 150 mg 1.20 mL 115 mg 0.90 mL
50 22.7 190 mg 1.50 mL 140 mg 1.10 mL
Weight 50 mg/kg/day
Divided into 3 Doses
50 mg/kg/day
Divided into 4 Doses
Lbs Kg Approximate
Single Dose
mg/q8h
Vol. (mL)
needed with
dilution of
225 mg/mL
Approximate
Single Dose
mg/q6h
Vol. (mL)
needed with
dilution of
225 mg/mL
10 4.5 75 mg 0.35 mL 55 mg 0.25 mL
20 9.0 150 mg 0.70 mL 110 mg 0.50 mL
30 13.6 225 mg 1.00 mL 170 mg 0.75 mL
40 18.1 300 mg 1.35 mL 225 mg 1.00 mL
50 22.7 375 mg 1.70 mL 285 mg 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.

DIRECTIONS FOR USE OF CEFAZOLIN INJECTION, USP IN GALAXY CONTAINER (PL 2040 PLASTIC)

Cefazolin Injection, USP in GALAXY Container (PL 2040 Plastic) is to be administered either as a continuous or intermittent infusion using sterile equipment.

Storage

Store in a freezer capable of maintaining a temperature of -20°C (-4°F).

Thawing of Plastic Container

Thaw frozen container at room temperature (25°C/ 77°F) or under refrigeration (5°C/41°F). (DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.)

Check for minute leaks by squeezing container firmly. If leaks are detected, discard solution as sterility may be impaired.

Do not add supplementary medication.

The container should be visually inspected. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded.

The thawed solution is stable for 30 days under refrigeration (5°C/41°F) and 48 hours at 25°C/77°F. Do not refreeze thawed antibiotics.

CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

Preparation for administration:

  1. Suspend container from eyelet support.
  2. Remove protector from outlet port at bottom of container.
  3. Attach administration set. Refer to complete directions accompanying set.

HOW SUPPLIED

Cefazolin Injection, USP is supplied as a premixed frozen iso-osmotic solution in 50 mL single dose GALAXY plastic containers as follows:

  2G3503     NDC 0338-3503-41     1 g cefazolin in 50 mL  

Store at or below -20°C/-4°F. [See Directions for use of GALAXY Container (PL 2040).]

Rx Only

REFERENCES

  1. National Committee for Clinical Laboratory Standards (NCCLS). January 2003. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-Eighth Edition. NCCLS Document M2-A8 and Disk Diffusion Supplemental Tables M100-S13. NCCLS, Wayne, PA, USA.
  2. National Committee for Clinical Laboratory Standards (NCCLS). January 2003. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, Approved Standard-Sixth Edition. NCCLS Document M7-A6 and MIC Testing Supplemental Tables, M100-S13. NCCLS, Wayne, PA, USA.

Baxter and GALAXY are trademarks of Baxter International Inc.

CLINITEST is a registered trademark of Miles Inc.

CLINISTIX is a registered trademark of Bayer Corporation.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA

07-19-58-687

September 2008

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

Container Label

Representative Container Label

Baxter

1 g

Cefazolin Injection, USP

GALAXY
Single Dose Container

50 mL
Iso-osmotic

NDC 0338-3503-41
Code 2G3503
Sterile Nonpyrogenic

Each 50 mL contains: Cefazolin Sodium equivalent to 1 g Cefazolin, UP
with approx. 2 g Dextrose Hydrous, USP added to adjust osmolality.

pH adjusted with sodium bicarbonate.

Usual Dosage: For I.V. use only. See insert.

Cautions: Do not add supplementary medication or additives. Must not be
used in series connections. Check for minute leaks and solution clarity.
See insert.

Rx only

Store at or below -20°C/-4°F. Thaw at room temperature (25°C/77°F) or under
refrigeration (5°C/41°F). DO NOT FORCE THAW BY IMMERSION IN WATER
BATHS OR BY MICROWAVE IRRADIATION.
Thawed solution is stabled for 30
days under refrigeration and 48 hours at room temperature. Do not refreeze.

U.S. Pat. Nos. 4,686,125; 4,779,997
PL 2040 Plastic
Baxter and GALAXY are trademarks of Baxter International Inc.
Manufactured by Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Made in USA

07-34-51-260

Carton Label

Representative Carton Label

Baxter

Cefazolin Injection, USP

1 g

NDC 0338-3503-41
Code 2G3503

12 - 50 mL Single Dose Containers Iso-osmotic

Store at or below -20°C/-4°F. Do not refreeze.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

*FOR BAR CODE POSITION ONLY

(01) 20303383503415

GALAXY Container

Sterile Nonpyrogenic

Each 50 mL contains: Cefazolin Sodium equivalent to 1 g of Cefazolin, USP with approx. 2 g
Dextrose Hydrous, USP added to adjust osmolality. pH adjusted with sodium bicarbonate.

Usual Dosage: For I.V. use only. See insert.

Cautions: Do not add supplementary medications or additives. Must not be used in series
connections. Check for minute leaks by squeezing thawed bag firmly. If leaks are found,
discard bag as sterility may be impaired. Do not use unless solution is clear. Rx only

Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE
THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. Thawed solution
is stable for 30 days under refrigeration (5°C/41°F) and 48 hours at room temperature
(25°C/77°F). Do not refreeze.

Baxter and GALAXY are trademarks of Baxter International Inc.

PL 2040 Plastic

07-04-51-259


CEFAZOLIN 
cefazolin sodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-3503
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFAZOLIN SODIUM (CEFAZOLIN) CEFAZOLIN SODIUM 1 g  in 50 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE 2 g  in 50 mL
SODIUM BICARBONATE  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-3503-41 50 mL in 1 BAG None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA063002 03/28/1991

Labeler - Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 194684502 MANUFACTURE

Revised: 12/2009 Baxter Healthcare Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


Copyright © 2017 Drugsdb.eu by Dionisios Fentas || Terms of Use

Loading

Prescription Marketed Drugs Alphabetically
A| B| C| D| E| F| G| H| I| J| K| L| M| N| O| P| Q| R| S| T| U| V| W| X| Y| Z| 0-9

Categories:
Prescription(RX) Drugs
Over-the-counter (OTC) Drugs
Homeopathic Drugs
Animal Drugs
Feedback