Cefazolin Sodium

1 INDICATIONS AND USAGE Cefazolin in Dextrose Injection is a cephalosporin antibacterial indicated for: • Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved : ( 1 ) ο Respiratory tract infections ( 1.1 ); ο Urinary tract infections ( 1.2 ); ο Skin and skin structure infections ( 1.3 ); ο Biliary tract infections ( 1.4 ); ο Bone and joint infections ( 1.5 ); ο Genital infections ( 1.6 ); ο Septicemia ( 1.7 ); ο Endocarditis ( 1.8 ) • Perioperative prophylaxis in adults and pediatric patients aged 10 to 17 years old for whom appropriate dosing with this formulation can be achieved ( 1.9 ) To reduce the development of drug-resistant bacteria and...

6 ADVERSE REACTIONS The following serious adverse reactions to Cefazolin in Dextrose Injection are described below and elsewhere in the labeling: • Hypersensitivity Reactions to Cefazolin, Cephalosporins, Penicillins, or Other Beta-lactams [see Warnings and Precautions (5.1) ] • Seizures in Patients with Renal Impairment [see Warnings and Precautions (5.2) ] • Clostridioides difficile -associated Diarrhea [see Warnings and Precautions (5.3) ] • Adult and Pediatric Patients : Most common adverse reactions: gastrointestinal (nausea, vomiting, diarrhea), and allergic reactions (anaphylaxis, urticaria, skin rash). ( 6 ) • Pediatric Patients with Perioperative Prophylaxis : The most frequently reported adverse reactions (incidence ≥ 5%) were nausea, infusion site pain, and headache.

8.1 Pregnancy Risk Summary Available data from published prospective cohort studies, case series and case reports over several decades with cephalosporin use, including cefazolin, in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Cefazolin crosses the placenta. Animal reproduction studies with rats, mice and rabbits administered cefazolin during organogenesis at doses 1 to 3 times the maximum recommended human dose (MRHD) did not demonstrate adverse developmental outcomes.

5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions : Cross-hypersensitivity may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue the drug. ( 5.1 ) • Clostridioides difficile -associated Diarrhea (CDAD) : May range from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. ( 5.3 ) • Prothrombin Activity : May be associated with a fall in prothrombin activity. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated ( 5.5 ) 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. 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 in Dextrose Injection is contraindicated in patients who have a history of immediate hypersensitivity reactions (e.g., anaphyla...