Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 20 February 2017
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)
(6) To report SUSPECTED
6.1 Clinical Trials Experience Because clinical trials are conducted under widely
Hypersensitivity reactions including pruritus, rash, fever and immediate reactions, generally manifested by rash and/or pruritus.
Angioedema and anaphylaxis (bronchospasm and/or hypotension) have been reported.
Gastrointestinal reactions including diarrhea,
The onset of pseudomembranous colitis symptoms may occur during or after treatment.
[see Warnings and Precautions (5.3)] Central
Seizures have been reported with several cephalosporins, including ceftazidime.
In addition, encephalopathy,
[see Warnings and Precautions (5.4)] Hematologic reactions including cases of hemolytic anemia have been reported.
[see Warnings and Precautions (5.2)] Other
6.2 Postmarketing Experience The following
Because these reactions are reported voluntarily from
Nephropathy, which may be
Altered Laboratory Tests: Prolonged prothrombin time, false-positive test for urinary glucose.
[see Warnings and Precautions (5.7)]
2 DOSAGE AND ADMINISTRATION For intravenous use only over approximately 30
(2.1) 2.1 Adult and Pediatric Patients (Who
Ceftazidime for Injection USP and Dextrose Injection USP should be administered intravenously (IV) over approximately 30
The guidelines for dosage of Ceftazidime for Injection USP and Dextrose Injection USP are listed in Table 1.
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.
An estimate of creatinine clearance should be made to determine the
The serum creatinine should represent a
serum creatinine (mg/dL) Females: 0.85?
Further dosing should be determined by therapeutic monitoring,
In patients undergoing hemodialysis,
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.
Such use would result in air embolism due to residual air being drawn from the primary container before
If administration is controlled by a pumping device,
Parenteral drug products should be inspected visually for particulate matter and
Use only if
DUPLEX® Container Storage To avoid
Patient Labeling and Drug Powder/Diluent Inspection Apply patient-specific label on foil side of container.
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
To inspect the drug powder for foreign matter or
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
Unfold the DUPLEX® Container and point the set port in a
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.
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
If leaks are found,
Using aseptic technique, peel foil cover from the set port and attach
Refer to directions for use accompanying the administration set.
Do not introduce additives into the DUPLEX® Container.
Administer Ceftazidime for Injection USP and Dextrose Injection USP intravenously over approximately 30
However, during infusion of Ceftazidime for Injection USP and Dextrose Injection USP, it is advisable to
Vancomycin solution exhibits a physical
The likelihood of precipitation with ceftazidime is dependent on the concentrations of vancomycin and ceftazidime present.
Parenteral drug products should be inspected visually for particulate matter before administration whenever solution and container permit.
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.
8 USE IN SPECIFIC POPULATIONS Pediatric Use: To prevent
(2.2, 8.4) 8.1 Pregnancy Pregnancy Category B Reproduction studies have been performed in mice and
There are, however,
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.
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.
[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.
Because elderly patients are more likely to have
|Date Last Revised||29-05-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|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.].
Freezing solutions of Ceftazidime for Injection USP and
As with other cephalosporins, Ceftazidime for Injection USP and Dextrose Injection USP powder, as well as solutions, tend to
Use only if
|Marketing authorisation holder||B. Braun Medical Inc.|