Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 22 November 2019

Indication(s)

1 INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftazidime for Injection USP and Dextrose Injection USP and other antibacterial drugs, Ceftazidime for Injection USP and Dextrose Injection USP should be used only to treat 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. Ceftazidime for Injection and Dextrose Injection is indicated for the treatment of the following infections when caused by susceptible bacteria. Ceftazidime 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: Lower respiratory tract infections (1.1); skin and skin-structure infections (1.2); bacterial septicemia (1.3); bone and joint infections (1.4); gynecologic infections (1.5); intra-abdominal infections (1.6); central nervous system infections (1.7). 1.1 Lower Respiratory Tract Infections Lower respiratory tract infections, including pneumonia, caused by Pseudomonas aeruginosa and other Pseudomonas spp.; Haemophilus influenzae, including ampicillin-resistant isolates; Klebsiella spp.; Enterobacter spp.; Proteus mirabilis; Escherichia coli; Serratia spp.; Citrobacter spp.; Streptococcus pneumoniae; and Staphylococcus aureus (methicillin-susceptible isolates). 1.2 Skin and Skin-structure Infections Skin and skin-structure infections caused by Pseudomonas aeruginosa; Klebsiella spp.; Escherichia coli; Proteus spp., including Proteus mirabilis and indole-positive Proteus; Enterobacter spp.; Serratia spp.; Staphylococcus aureus (methicillin-susceptible isolates); and Streptococcus pyogenes (group A beta-hemolytic streptococci). 1.3 Bacterial Septicemia Bacterial septicemia caused by Pseudomonas aeruginosa, Klebsiella spp., Haemophilus influenzae, Escherichia coli, Serratia spp., Streptococcus pneumoniae, and Staphylococcus aureus (methicillin-susceptible isolates). 1.4 Bone and Joint Infections Bone and joint infections caused by Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., and Staphylococcus aureus (methicillin-susceptible isolates). 1.5 Gynecologic Infections Gynecologic infections, including endometritis, pelvic cellulitis, and other infections of the female genital tract caused by Escherichia coli. 1.6 Intra-abdominal Infections Intra-abdominal infections, including peritonitis caused by Escherichia coli, Klebsiella spp., and Staphylococcus aureus (methicillin-susceptible isolates) and polymicrobial infections caused by aerobic and anaerobic organisms and Bacteroides spp. (many isolates of Bacteroides fragilis are resistant). 1.7 Central Nervous System Infections Central nervous system infections, including meningitis, caused by Haemophilus influenzae and Neisseria meningitidis. Ceftazidime has also been used successfully in a limited number of cases of meningitis due to Pseudomonas aeruginosa and Streptococcus pneumoniae.

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Advisory information

contraindications
4 CONTRAINDICATIONS Hypersensitivity Reactions to Ceftazidime or the Cephalosporin Class of Antibiotics, Penicillins, or Other Beta-lactam Antibiotics Ceftazidime 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 ceftazidime or the cephalosporin class of antibiotics, penicillins, or other beta-lactam antibiotics. [see Warnings and Precautions (5.1) ] Hypersensitivity to ceftazidime or other cephalosporin class antibiotics, penicillins, or other beta-lactam antibiotics (4)
Adverse reactions
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) ] Clostridium difficile-associated diarrhea [see Warnings and Precautions (5.3) ] Neurologic Adverse Reactions in Patients with Renal Impairment [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 1-800-227-2862 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 antibiotics, 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 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) ]

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION For intravenous use only over approximately 30 minutes. (2) Recommended Dosage Schedule for Creatinine Clearance greater than 50 mL/min Adults Dose Frequency Bone and joint infections 2 grams IV every 12hr Uncomplicated pneumonia; mild skin and skin-structure infections 500 mg*–1 gram IV every 8hr Serious gynecologic and intra-abdominal infections 2 grams IV every 8hr Meningitis 2 grams IV every 8hr Very severe life-threatening infections, especially in immunocompromised patients 2 grams IV every 8hr * Use this formulation of ceftazidime only in patients who require the entire 1 or 2 gram dose and not any fraction thereof. (2.1) 2.1 Adult and Pediatric Patients (Who Require the Full Adult Dose) Ceftazidime 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. Ceftazidime for Injection USP and Dextrose Injection USP should be administered intravenously (IV) over approximately 30 minutes. The guidelines for dosage of Ceftazidime for Injection USP and Dextrose Injection USP are listed in Table 1. The following dosage schedule is recommended. Table 1: Recommended Dosage Schedule for Creatinine Clearance greater than 50 mL/min Adults Dose Frequency Bone and joint infections 2 grams IV every 12hr Uncomplicated pneumonia; mild skin and skin-structure infections 500 mg*–1 gram IV every 8hr Serious gynecologic and intra-abdominal infections 2 grams IV every 8hr Meningitis 2 grams IV every 8hr Very severe life-threatening infections, especially in immunocompromised patients 2 grams IV every 8hr * Use this formulation of ceftazidime only in patients who require the entire 1 or 2 gram dose and not any fraction thereof. 2.2 Pediatric Population Ceftazidime for Injection and Dextrose Injection in the DUPLEX® Container is designed to deliver a 1 g or 2 g dose of ceftazidime. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of ceftazidime [see Use in Specific Populations (8.4) ] 2.3 Patients with Renal Impairment Ceftazidime for Injection and Dextrose Injection in the DUPLEX® Container is designed to deliver a 1 g or 2 g dose of ceftazidime. To prevent unintentional overdose, this product should not be used in patients with creatinine clearance less than or equal to 15 mL/min who require less than a 1 g dose of ceftazidime. In patients with impaired renal function (creatinine clearance less than or equal to 50 mL/min), it is recommended that the dosage of ceftazidime be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1 gram of Ceftazidime for Injection USP and Dextrose Injection USP may be given. An estimate of creatinine clearance should be made to determine the appropriate maintenance dosage. The recommended dosage is presented in Table 2. Table 2: Recommended Maintenance Dosages of Ceftazidime for Injection USP and Dextrose Injection USP in Renal Insufficiency Creatinine Clearance (mL/min) Recommended Unit Dose of Ceftazidime for Injection USP and Dextrose Injection USP Frequency of Dosing 50–31 1 gram every 12hr 30–16 1 gram every 24hr NOTE: IF THE DOSE RECOMMENDED IN TABLE 1 ABOVE IS LOWER THAN THAT RECOMMENDED FOR PATIENTS WITH RENAL INSUFFICIENCY AS OUTLINED IN TABLE 2, THE LOWER DOSE SHOULD BE USED. When only serum creatinine is available, the following formula (Cockcroft's equation)1 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function: Males: Creatinine Clearance (mL/min) = Weight (kg) × (140-age) 72 × serum creatinine (mg/dL) Females: 0.85 × above value In patients with severe infections who would normally receive 2 grams IV every 8hr of Ceftazidime for Injection USP and Dextrose Injection USP were it not for renal insufficiency, the unit dose given in the table above may be increased by 50% or the dosing frequency may be increased appropriately. Further dosing should be determined by therapeutic monitoring, severity of the infection, and susceptibility of the causative organism. The creatinine clearance should be adjusted for body surface area or lean body mass, and the dosing frequency should be reduced in cases of renal insufficiency. In patients undergoing hemodialysis, a loading dose of 1 gram is recommended, followed by 1 gram after each hemodialysis period. 2.4 Preparation for Use of Ceftazidime 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. Diagram 1 Diagram 2 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 12 hours if stored at room temperature or within 3 days if stored under refrigeration. Diagram 3 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. Diagram 4 Diagram 5 Important Administration Instructions Do not use in series connections. Do not introduce additives into the DUPLEX® Container. Administer Ceftazidime for Injection USP and Dextrose Injection USP intravenously over approximately 30 minutes. Intermittent intravenous infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of Ceftazidime for Injection USP and Dextrose Injection USP, it is advisable to discontinue the other solution. Vancomycin solution exhibits a physical incompatibility when mixed with a number of drugs, including ceftazidime. The likelihood of precipitation with ceftazidime is dependent on the concentrations of vancomycin and ceftazidime present. It is therefore recommended, when both drugs are to be administered by intermittent IV infusion, that they be given separately, flushing the IV lines (with 1 of the compatible IV fluids) between the administration of these 2 agents. Note: Parenteral drug products should be inspected visually for particulate matter before administration whenever solution and container permit. Solutions of Ceftazidime for Injection USP and Dextrose Injection USP should not be added to solutions of aminoglycoside antibacterials because of potential inactivation. If concurrent therapy with Ceftazidime for Injection USP and Dextrose Injection USP and an aminoglycoside is indicated, each of these antibacterials should be administered separately to the same patient. The IV route is preferable for patients with bacterial septicemia, bacterial meningitis, peritonitis, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or pending.
Use in special populations
8 USE IN SPECIFIC POPULATIONS Pediatric Use: To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of ceftazidime. (2.2, 8.4) 8.1 Pregnancy Pregnancy Category B Reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to ceftazidime. 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. 8.2 Labor and Delivery Ceftazidime has not been studied for use during labor and delivery. Treatment should only be given if clearly indicated. 8.3 Nursing Mothers Ceftazidime is excreted in human milk in low concentrations. Caution should be exercised when Ceftazidime for Injection USP and Dextrose Injection USP is administered to a nursing woman. 8.4 Pediatric Use Ceftazidime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is designed to deliver a 1 g or 2 g dose of ceftazidime. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of ceftazidime. [see Dosage and Administration (2.2) ] 8.5 Geriatric Use Of the 2,221 subjects who received ceftazidime in 11 clinical studies, 824 (37%) were 65 and older while 391 (18%) were 75 and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater susceptibility of some older individuals to drug effects cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of adverse 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) ] 8.6 Patients with Renal Impairment Ceftazidime is substantially eliminated by the kidneys, and the risk of adverse reactions to Ceftazidime may be greater in patients with renal impairment due to slower elimination by the kidneys. Consequently, dosage adjustment is required in patients with moderate (CrCl 30 to 50 mL/min) and severe (CrCl 16 to 29 mL/min) renal impairment [see Dosage and Administration (2.3) Warnings and Precautions (5.4) and Clinical Pharmacology (12.3) ]
Pregnancy and lactation
8.3 Nursing Mothers Ceftazidime is excreted in human milk in low concentrations. Caution should be exercised when Ceftazidime for Injection USP and Dextrose Injection USP is administered to a nursing woman.

Interactions

7 DRUG INTERACTIONS Aminoglycosides: Increased potential of nephrotoxicity and ototoxicity. (7.1) Chloramphenicol: Has been shown to be antagonistic to beta-lactam antibiotics, including ceftazidime. (7.2) 7.1 Aminoglycosides Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Ceftazidime for Injection USP and Dextrose Injection USP because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibacterials. Nephrotoxicity and ototoxicity were not noted when ceftazidime was given alone in clinical trials. 7.2 Chloramphenicol Chloramphenicol has been shown to be antagonistic to beta-lactam antibacterials, including ceftazidime, based on in vitro studies and time kill curves with enteric gram-negative bacilli. Due to the possibility of antagonism in vivo, particularly when bactericidal activity is desired, this drug combination should be avoided.

More information

Category Value
Authorisation number NDA050823
Agency product number 9M416Z9QNR
Orphan designation No
Product NDC 0264-3145,0264-3143
Date Last Revised 12-08-2019
Type HUMAN PRESCRIPTION DRUG
RXCUI 1659283
Storage and handling Store the unactivated unit at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature.]. Protect from light. Freezing solutions of Ceftazidime for Injection USP and Dextrose Injection USP is not recommended. As with other cephalosporins, Ceftazidime for Injection USP and Dextrose Injection USP powder, as well as solutions, tend 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.
Marketing authorisation holder B. Braun Medical Inc.