CEFAZOLIN SODIUM solution

Cefazolin Sodium by

Drug Labeling and Warnings

Cefazolin Sodium by is a Prescription medication manufactured, distributed, or labeled by B. Braun Medical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection USP and Dextrose Injection USP and other antibacterial drugs, Cefazolin for Injection USP and Dextrose 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 and Dextrose 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 Infections

    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

    Biliary infections due to E. coli, various isolates of streptococci, P. mirabilis, and S. aureus.

    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 DOSAGE AND ADMINISTRATION

    2.1 Dosage for Treatment of Indicated Infections in Adults

    Cefazolin for Injection USP and Dextrose Injection USP in the DUPLEX® Container should be used only in patients who require the entire 1 or 2 gram dose and not any fraction thereof. The recommended adult dosages are outlined in Table 1. Cefazolin for Injection USP and Dextrose Injection USP should be administered intravenously (IV) over approximately 30 minutes.

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

    2.2 Dosage for Perioperative Prophylactic Use in Adults

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

    • 1 to 2 gram IV administered 1/2 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 during surgery (administration modified depending on the duration of the operative procedure).
    • 500 mg to 1 gram IV 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 Dosage in Pediatric Patients

    The 2 grams dose of Cefazolin for Injection USP and Dextrose Injection USP is not recommended for use in pediatric patients.

    Only administer 1 gram Cefazolin for Injection USP and Dextrose Injection USP to pediatric patients where the individual dose is the entire contents of the 1g DUPLEX® container and not any fraction of it.

    Recommended doses for pediatric patients are as follows:

    • For most mild to moderately severe infections: a total daily dosage of 25 to 50 mg per kg of body weight, divided into 3 or 4 equal doses. 
    • For severe infections, the total daily dosage may be increased to 100 mg per kg of body weight.

    There are no dosage recommendations for pediatric patients for perioperative prophylaxis or for pediatric patients with renal impairment.

    2.4 Dosage in Adult 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

    2.5 Preparation for Use of Cefazolin for Injection USP and Dextrose Injection USP in DUPLEX® Container

    This reconstituted solution is for intravenous use only.

    Do not use plastic containers in series connections. Such use would 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. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Use only if solution is clear and container and seals are intact.

    DUPLEX® Container Storage

    • To avoid inadvertent activation, the DUPLEX® Container should remain in the folded position until activation is intended.

    Patient Labeling and Drug Powder/Diluent Inspection

    • Apply patient-specific label on foil side of container. Use care to avoid activation. Do not cover any portion of foil strip with patient label.
    • Unlatch side tab and unfold DUPLEX® Container (see Diagram 1).
    Diagram 1
    • Visually inspect diluent chamber for particulate matter.
    • Use only if container and seals are intact.
    • To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber (see Diagram 2).
    Diagram 2
    • Protect from light after removal of foil strip.

    Note: If foil strip is removed, the container should be re-folded and the side tab latched until ready to activate. The product must then be used within 7 days, but not beyond the labeled expiration date.

    Reconstitution (Activation)

    • Do not use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use.
    • Unfold the DUPLEX® container and point the set port in a downward direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the diluent meniscus trapping all air above the fold. To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber (see Diagram 3).
    Diagram 3
    • Agitate the liquid-powder mixture until the drug powder is completely dissolved.

    Note: Following reconstitution (activation), product must be used within 24 hours if stored at room temperature or within 7 days if stored under refrigeration.

    Administration

    • Visually inspect the reconstituted solution for particulate matter.
    • Point the set port in a downwards direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the solution meniscus trapping all air above the fold. Squeeze the folded DUPLEX® Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port (see Diagram 4).
    Diagram 4
    • Prior to attaching the IV set, check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be compromised.
    • Using aseptic technique, peel foil cover from the set port and attach sterile administration set (see Diagram 5).
    Diagram 5
    • Refer to directions for use accompanying the administration set.

    Important Administration Instructions

    • Do not use in series connections.
    • Do not introduce additives into the DUPLEX® Container.
    • Administer Cefazolin for Injection USP and Dextrose Injection USP intravenously over approximately 30 minutes.
  • 3 DOSAGE FORMS AND STRENGTHS

    Dual-chamber, single-use container:

    • 1 g Cefazolin for Injection USP and 50 mL 4% Dextrose Injection USP
    • 2 g Cefazolin for Injection USP and 50 mL 3% Dextrose Injection USP
  • 4 CONTRAINDICATIONS

    4.1 Hypersensitivity to Cefazolin or the Cephalosporin Class of Antibacterial Drugs, Penicillins, or Other Beta-lactams

    Cefazolin for Injection USP and Dextrose Injection USP 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 WARNINGS AND PRECAUTIONS

    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 USP and Dextrose Injection USP 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 USP and Dextrose Injection USP 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 Hypersensitivity to Dextrose-containing Products

    Hypersensitivity reactions, including anaphylaxis, have been reported with administration of dextrose-containing products. These reactions have been reported in patients receiving high concentrations of dextrose (i.e. 50% dextrose)1.  The reactions have also been reported when corn-derived dextrose solutions were administered to patients with or without a history of hypersensitivity to corn products.2

    5.5 Risk of Development of Drug-resistant Bacteria

    Prescribing Cefazolin for Injection USP and Dextrose Injection USP 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 USP and Dextrose Injection USP 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.

    5.6 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.

    5.7 Patients with Overt or Known Subclinical Diabetes Mellitus or Carbohydrate Intolerance

    As with other dextrose-containing solutions, Cefazolin for Injection USP and Dextrose Injection USP should be prescribed with caution in patients with overt or known subclinical diabetes mellitus or carbohydrate intolerance for any reason.

  • 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 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Reproduction studies have been performed in rats, mice and rabbits at doses of 2000, 4000 and 240 mg/kg/day or 1-3 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 USP and Dextrose Injection USP is administered to a nursing woman.

    8.4 Pediatric Use

    The 2 g Cefazolin for Injection USP and Dextrose Injection USP is not recommended for use in pediatric patients.

    To avoid unintentional overdose, 1 gram Cefazolin for Injection USP and Dextrose Injection USP should only be used in pediatric patients who require the entire contents of the 1 gram dose and not any fraction of it [see Dosage and Administration (2.3)].

    There are no dosing recommendations for pediatric patients for perioperative prophylaxis or for pediatric patients with renal impairment.

    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 USP and Dextrose Injection USP 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 and Dextrose Injection USP is a sterile, nonpyrogenic, single use, packaged combination of Cefazolin Sodium USP (lyophilized) and sterile iso-osmotic diluent in the DUPLEX® sterile container. The DUPLEX® Container is a flexible dual chamber container.

    After reconstitution the approximate osmolality for Cefazolin for Injection USP and Dextrose Injection USP is 290 mOsmol/kg.

    The drug chamber is filled with sterile lyophilized Cefazolin Sodium USP, a semi-synthetic cephalosporin and has the following IUPAC nomenclature: Sodium (6R,7R)-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-carboxylate.

    Cefazolin Sodium USP has the following structural formula:

    Diagram of Cefazolin Molecular Structure

    The sodium content is 48 mg/g of cefazolin sodium.

    The diluent chamber contains Dextrose Injection USP, an iso-osmotic diluent using Hydrous Dextrose USP in Water for Injection USP. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents.

    Hydrous Dextrose USP has the following structural (molecular) formula:

    Diagram of Dextrose Molecular Structure

    The molecular weight of Hydrous Dextrose USP is 198.17

    Cefazolin Sodium USP is supplied as a lyophilized form equivalent to either 1 g or 2 g of cefazolin. Dextrose hydrous USP has been added to the diluent to adjust osmolality (approximately 2 g [4.0% w/v] and 1.5 g [3.0% w/v] for the 1 g and 2 g dosages, respectively).

    After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use.

    Reconstituted solutions of Cefazolin for Injection USP and Dextrose Injection USP range in color from pale yellow to amber.

    Not made with natural rubber latex, PVC or DEHP.

    The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.

  • 12 CLINICAL PHARMACOLOGY

    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

    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.

    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.

    Plasma pharmacokinetic parameters of cefazolin in normal volunteers (N=12) following a single 15-minute IV infusion of 2 g of Cefazolin for Injection USP and Dextrose Injection USP are summarized in Table 3.

  • * Tmax reported as median (range)
    		•
      Table 3: Mean (Standard Deviation) Plasma Pharmacokinetic Parameters of Cefazolin in Normal Volunteers
        N 

    Cmax

    (mcg/mL)    		 

    Tmax* 
    (h)

    		  AUC0-inf(mcg*h/mL) 

     t1/2
    (h)

    		 

    CL
    (L/h)

    		 

     Vz
    (L)

      Single 2 g Dose as a 15-Minute IV Infusion  12  280.9 (45.9)  0.25 (0.25-0.33)  509.9 (89.3)  2.01 (0.28)  4.03 (0.68)  11.50 (1.53)

    N= number of subjects observed;  Cmax = maximum plasma concentration;  Tmax = time to maximum plasma concentration;  AUC0-inf = area under the plasma concentration-time curve extrapolated to infinity;   t1/2 = apparent plasma terminal elimination half-life;  CL = total clearance;  Vz = volume of distribution

    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 1.0 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.

    12.4 Microbiology

    Mechanism of Action

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

    Resistance

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

    Antimicrobial Activity

    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 agalactiae
      • Streptococcus pneumoniae
      • Streptococcus pyogenes

    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 Testing

    For specific information regarding susceptibility test interpretive criteria, and associated test methods and quality control standards recognized by FDA for this drug, please see: http://www.fda.gov/STIC.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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

  • 15 REFERENCES

    1. Czarny D, Prichard PJ, Fennessy M, Lewis S. Anaphylactoid reaction to 50% solution of dextrose. Med J Aust 1980;2:255-258.
    2. Guharoy, SR, Barajas M. Probably Anaphylactic Reaction to Corn-Derived Dextrose Solution. Vet Hum Toxicol 1991;33:609-610.
  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Cefazolin for Injection USP and Dextrose Injection USP in the DUPLEX® Container is a flexible dual chamber container supplied in two concentrations. After reconstitution, the concentrations are equivalent to 1 g and 2 g cefazolin. The diluent chamber contains approximately 50 mL of Dextrose Injection USP. Dextrose Injection USP has been adjusted to 4.0% and 3.0% for the 1 g and 2 g doses, respectively, such that the reconstituted solution is iso-osmotic.

    Cefazolin for Injection USP and Dextrose Injection USP is supplied sterile and nonpyrogenic in the DUPLEX® Container packaged 24 units per case.

      NDC REF   Dose  Volume
      0264-3103-11  3103-11  1 g  50 mL
      0264-3105-11  3105-11  2 g  50 mL

    Store the unactivated unit at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). Do not freeze.

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

    Use only if prepared solution is clear and free from particulate matter.

  • 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 USP and Dextrose Injection USP should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cefazolin for Injection USP and Dextrose 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 for Injection USP and Dextrose Injection USP or other antibacterial drugs in the future.

  • SPL UNCLASSIFIED SECTION

    Rx only

    DUPLEX is a registered trademark of B. Braun Medical Inc.
    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.

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524 USA
    1-800-227-2862

    Prepared in USA. API from USA and Italy.

    Y36-002-958    LD-105-8

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 1g Cefazolin

    Cefazolin for Injection USP and Dextrose Injection USP

    1g*

    REF 3103-11
    NDC: 0264-3103-11

    DUPLEX® CONTAINER

    50 mL

    Use only after mixing contents of both chambers.
    For IV Use Only      Iso-osmotic      Single Dose      Sterile/Nonpyrogenic

    * Contains Cefazolin Sodium USP equivalent to 1 g cefazolin.

    Reconstitution: Hold container with set port in a downward direction and fold the diluent chamber just below the solution meniscus. To activate seal, squeeze folded diluent chamber until seal between diluent and drug chamber opens, releasing diluent into drug chamber. Agitate the reconstituted solution until the drug powder is completely dissolved. Fold the container a second time and squeeze until seal between drug chamber and set port opens.

    After reconstitution each 50 mL single dose unit contains: Cefazolin for Injection USP (equivalent to 1 g cefazolin) with approx. 2.0 g (4.0% w/v) Hydrous Dextrose USP in Water for Injection USP. Sodium content is 48 mg/g of cefazolin sodium.
    Approximate osmolality: 290 mOsmol/kg

    Prior to Reconstitution: Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Use only if container and seals are intact. Do not peel foil strip until ready for use. After foil strip removal, product must be used within 7 days, but not beyond the labeled expiration date. Protect from light after removal of foil strip.

    After Reconstitution: Use only if prepared solution is clear and free from particulate matter. Use within 24 hours if stored at room temperature or within 7 days if stored under refrigeration. Do not use in a series connection. Do not introduce additives into this container. Prior to administration check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be impaired. Do not freeze.

    Not made with natural rubber latex, PVC or DEHP.

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524

    Rx only

    Prepared in USA. API from USA and Italy.

    LD-201-7
    Y37-002-541

    EXP
    LOT

    PEEL HERE

    Drug Chamber
    Discard unit if foil strip is damaged. Peel foil strip only when ready for use. Visually inspect drug prior to reconstitution.
    See package insert for complete directions for reconstitution and administration.
    LD-336-1  X27-001-485

    3103-11 Container Label
    Drug Chamber Label
  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 2g Cefazolin

    Cefazolin for Injection USP and Dextrose Injection USP

    2g*

    REF 3105-11
    NDC: 0264-3105-11

    DUPLEX® CONTAINER

    50 mL

    Use only after mixing contents of both chambers.
    For IV Use Only      Iso-osmotic      Single Dose      Sterile/Nonpyrogenic

    * Contains Cefazolin Sodium USP equivalent to 2 g cefazolin.

    Reconstitution: Hold container with set port in a downward direction and fold the diluent chamber just below the solution meniscus. To activate seal, squeeze folded diluent chamber until seal between diluent and drug chamber opens, releasing diluent into drug chamber. Agitate the reconstituted solution until the drug powder is completely dissolved. Fold the container a second time and squeeze until seal between drug chamber and set port opens.

    After reconstitution each 50 mL single dose unit contains: Cefazolin for Injection USP (equivalent to 2 g cefazolin) with approx. 1.5 g (3.0% w/v) Hydrous Dextrose USP in Water for Injection USP. Sodium content is 48 mg/g of cefazolin sodium.
    Approximate osmolality: 290 mOsmol/kg

    Prior to Reconstitution: Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Use only if container and seals are intact. Do not peel foil strip until ready for use. After foil strip removal, product must be used within 7 days, but not beyond the labeled expiration date. Protect from light after removal of foil strip.

    After Reconstitution: Use only if prepared solution is clear and free from particulate matter. Use within 24 hours if stored at room temperature or within 7 days if stored under refrigeration. Do not use in a series connection. Do not introduce additives into this container. Prior to administration check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be impaired. Do not freeze.

    Not made with natural rubber latex, PVC or DEHP.

    B. Braun Medical Inc.
    Bethlehem, PA 18018-3524

    Rx only

    Prepared in USA. API from USA and Italy.

    LD-200-4
    Y37-002-542

    EXP
    LOT

    PEEL HERE

    Drug Chamber
    Discard unit if foil strip is damaged. Peel foil strip only when ready for use. Visually inspect drug prior to reconstitution.
    See package insert for complete directions for reconstitution and administration.
    LD-336-1  X27-001-485

    3105-11 Container Label
    Drug Chamber Label
  • INGREDIENTS AND APPEARANCE
    CEFAZOLIN SODIUM 
    cefazolin sodium solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0264-3103
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CEFAZOLIN SODIUM (UNII: P380M0454Z) (CEFAZOLIN - UNII:IHS69L0Y4T) CEFAZOLIN1 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) 2 g  in 50 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0264-3103-1124 in 1 CASE07/27/2000
    150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA05077907/27/2000
    CEFAZOLIN SODIUM 
    cefazolin sodium solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0264-3105
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CEFAZOLIN SODIUM (UNII: P380M0454Z) (CEFAZOLIN - UNII:IHS69L0Y4T) CEFAZOLIN2 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) 1.5 g  in 50 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0264-3105-1124 in 1 CASE01/13/2012
    150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA05077901/13/2012
    Labeler - B. Braun Medical Inc. (002397347)
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