Data from FDA - Curated by EPG Health - Last updated 22 December 2016

Indication(s)

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. Cefazolin for Injection USP and Dextrose Injection USP is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: Respiratory tract infections (1.1); urinary tract infections (1.2); skin and skin structure infections (1.3); biliary tract infections (1.4); bone and joint infections (1.5); genital infections (1.6); septicemia (1.7); endocarditis (1.8) and perioperative prophylaxis (1.9). 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.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Fluid Management

Fluid Management

Are you up-to-date with the latest evidence of effective procedures for fluid management?

+ 2 more

Hereditary ATTR amyloidosis

Hereditary ATTR amyloidosis

Explore the pathophysiology, epidemiology and multi-system symptoms associated with hereditary ATTR amyloidosis, as well as how to achieve an early and accurate diagnosis.

ESICM LIVES Highlights

ESICM LIVES Highlights

ESICM LIVES Congress 2018: Bringing you the latest news and insights from the 31st ESICM LIVES Congress, 20–24 October 2018 Paris, France.

Load more

Related Content

Advisory information

contraindications
4 CONTRAINDICATIONS Hypersensitivity to cefazolin or other cephalosporin class antibacterial drugs, penicillins, or other beta-lactams (4.1) 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) ].
Adverse reactions
6 ADVERSE REACTIONS The following serious adverse reactions to cefazolin are described below and elsewhere in the labeling: Hypersensitivity reactions [see Warnings and Precautions (5.1) ] Clostridium difficile-associated diarrhea [see Warnings and Precautions (5.3) ] Most common adverse reactions: gastrointestinal (nausea, vomiting, diarrhea), and allergic reactions (anaphylaxis, urticaria, skin rash). (6) To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-800-227-2862 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION For intravenous use only over approximately 30 minutes. (2) Use this formulation of cefazolin only in patients who require the entire 1 or 2 gram dose and not any fraction thereof. (2.1) Recommended Dosing Schedule in Adult Patients with CrCl Greater Than or Equal To 55 mL/min. (2.1) 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)In rare instances, doses of up to 12 grams of cefazolin per day have been used. 1 gram to 1.5 grams every 6 hours Perioperative prophylaxis 1 gram to 2 grams ½ to 1 hour prior to start of surgery 500 mg to 1 g during surgery for lengthy procedures 500 mg to 1 g every 6 to 8 hours for 24 hours postoperatively 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. 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)In rare instances, doses of up to 12 grams of cefazolin per day have been used. 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). 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). 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). 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). 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). 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. Diagram 1 Diagram 2 Diagram 3 Diagram 4 Diagram 5
Use in special populations
8 USE IN SPECIFIC POPULATIONS Pediatric use: Cefazolin for Injection USP and Dextrose Injection USP should not be used in pediatric patients who require less than the full adult dose of cefazolin. (8.4) Renal impairment: Lower daily dosage of Cefazolin for Injection USP and Dextrose Injection USP is required in patients with impaired renal function (creatinine clearance less than 55 mL/min.) (8.6) 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 1-3 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) ].
Pregnancy and lactation
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.

Interactions

7 DRUG INTERACTIONS Probenecid may decrease renal tubular secretion of cephalosporins when used concurrently, resulting in increased and more prolonged cephalosporin blood levels. Probenecid: may decrease renal tubular secretion of cephalosporins when used concurrently, resulting in increased and more prolonged cephalosporin blood concentrations. (7)

More information

Category Value
Authorisation number NDA050779
Orphan designation No
Product NDC 0264-3103,0264-3105
Date Last Revised 01-08-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 1665050
Marketing authorisation holder B. Braun Medical Inc.