FDA label d2469739-52ff-4c3d-b97e-87c9d9569a6b

5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Include anaphylaxis and serious skin 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: May range from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. ( 5.3 ) Neurological Adverse Reactions: Seizures and other neurological adverse reactions may occur, especially in patients with renal impairment. Adjust dosage in patients with renal impairment. ( 2.3 , 5.4 ) 5.1 Hypersensitivity Reactions to Ceftazidime, Cephalosporins, Penicillins, or Other Drugs Immediate hypersensitivity reactions to ceftazidime have been reported. Careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions with cephalosporins or penicillins. Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among beta-lactam antibacterials has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Ceftazidime for Injection and Dextrose Injection occurs, discontinue the drug. 5.2 Hemolytic Anemia An immune mediated hemolytic anemia has been observed in patients receiving cephalosporin class antibacterials including ceftazidime. Severe cases of hemolytic anemia, including fatalities, have been reported during treatment with cephalosporin class antibacterials in both adults and children. If a patient develops anemia while on ceftazidime, the diagnosis of a cephalosporin associated anemia should be considered and ceftazidime stopped until the etiology is determined. 5.3 Clostridioides difficile -associated Diarrhea Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ceftazidime products, 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 antibacterial 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 use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. 5.4 Neurological Adverse Reactions Seizures, nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonus have been reported in patients treated with ceftazidime, including Ceftazidime for Injection and Dextrose Injection particularly in the setting of renal impairment. Adjust dosing based on creatinine clearance in patients with renal impairment [ see Dosage and Administration ( 2.3) ] . 5.5 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). 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. 5.6 Risk of Development of Drug-resistant Bacteria Prescribing Ceftazidime for Injection and Dextrose 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 Ceftazidime for Injection and Dextrose 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. 5.7 Drug/Laboratory Test Interactions Prothrombin Time Many cephalosporins, including ceftazidime, have been 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. Prothrombin time should be monitored in patients at risk, and exogenous vitamin K administered as indicated. Urinary Glucose The administration of Ceftazidime for Injection and Dextrose Injection may result in a false-positive reaction with glucose in the urine when using glucose tests based on Benedict’s copper reduction reaction that determine the amount of reducing substances like glucose in the urine. It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used. 5.8 Inadvertent Intra-arterial Administration Distal necrosis can occur after inadvertent intra-arterial administration of ceftazidime.

6 ADVERSE REACTIONS The following serious adverse reactions to ceftazidime are described below and elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Hemolytic Anemia [see Warnings and Precautions (5.2) ] Clostridioides difficile -associated diarrhea [see Warnings and Precautions (5.3) ] Neurological Adverse Reactions [see Warnings and Precautions (5.4) ] The most common adverse reactions occurring in less than 2% of patients include: hypersensitivity reactions, gastrointestinal symptoms, and central nervous system reactions. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-800-854-6851 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reactions were reported in less than or equal to 2% of patients from clinical trials: • Local reactions including phlebitis and inflammation at the site of injection. • Hypersensitivity reactions including pruritus, rash, fever and immediate reactions, generally manifested by rash and/or pruritus. Toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme have also been reported with cephalosporin antibacterial drugs, including ceftazidime. Angioedema and anaphylaxis (bronchospasm and/or hypotension) have been reported. • Gastrointestinal reactions including diarrhea, nausea, vomiting, and abdominal pain. The onset of pseudomembranous colitis symptoms may occur during or after treatment. [see Warnings and Precautions (5.3) ] • Central nervous system adverse reactions included headache, dizziness, and paresthesia. Seizures have been reported with several cephalosporins, including ceftazidime. In addition, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonus have been reported in patients with renal impairment treated with unadjusted dosing regimens of ceftazidime [see Warnings and Precautions (5.4) ] • Hematologic reactions including cases of hemolytic anemia have been reported. [see Warnings and Precautions (5.2) ] • Other adverse reactions include candidiasis (including oral thrush) and vaginitis. 6.2 Postmarketing Experience The following adverse reactions have been reported during postapproval use of ceftazidime. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to readily estimate their frequency or establish a causal relationship to drug exposure. • Anaphylaxis, allergic reactions, which, in rare instances, were severe (e.g., cardiopulmonary arrest), urticaria. • Nephropathy, which may be severe (e.g., renal failure). • Hyperbilirubinemia, jaundice. • Pain at the injection site. 6.3 Cephalosporin-class Adverse Reactions In addition to the adverse reactions listed above that have been observed in patients treated with ceftazidime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibacterials: • Adverse Reactions: hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, and pancytopenia. • Altered Laboratory Tests: Prolonged prothrombin time, false-positive test for urinary glucose. [see Warnings and Precautions (5.7) ]