Ceftazidime Prescribing Information
Ceftazidime for injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:
Ceftazidime for injection, USP may be used alone in cases of confirmed or suspected sepsis. Ceftazidime has been used successfully in clinical trials as empiric therapy in cases where various concomitant therapies with other antibacterial drugs have been used.
Ceftazidime for injection, USP may also be used concomitantly with other antibacterial drugs, such as aminoglycosides, vancomycin, and clindamycin; in severe and life-threatening infections; and in the immunocompromised patient. When such concomitant treatment is appropriate, prescribing information in the labeling for the other antibacterial drugs should be followed. The dose depends on the severity of the infection and the patient’s condition.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftazidime for injection, USP and other antibacterial drugs, ceftazidime for 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.
The usual adult dosage is 1 gram administered intravenously or intramuscularly every 8 to 12 hours. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection, and the condition and renal function of the patient.
The guidelines for dosage of ceftazidime for injection are listed in
Dose | Frequency | |
Adult | ||
Usual recommended dosage | 1 gram intravenous or intramuscular | every 8 to 12 hours |
Uncomplicated urinary tract infection | 250 mg intravenous or intramuscular | every 12 hours |
Bone and joint infections | 2 grams intravenous | every 12 hours |
Complicated urinary tract infections | 500 mg intravenous or intramuscular | every 8 to 12 hours |
Uncomplicated pneumonia; mild skin and skin-structure infections | 500 mg to 1 gram intravenous or intramuscular | every 8 hours |
Serious gynecological and intra-abdominal infections | 2 grams intravenous | every 8 hours |
Meningitis | 2 grams intravenous | every 8 hours |
Very severe life-threatening infections, especially in immunocompromised patients | 2 grams intravenous | every 8 hours |
Lung infections caused by Pseudomonas spp. in patients with cystic fibrosis withnormal renal functionAlthough clinical improvement has been shown, bacteriologic cures cannot be expected in patients with chronic respiratory disease and cystic fibrosis. | 30 to 50 mg/kg intravenous to a maximum of 6 grams per day | every 8 hours |
Neonates (0 to 4 weeks) | 30 mg/kg intravenous | every 12 hours |
Infants and children (1 month to 12 years) | 30 to 50 mg/kg intravenous to a maximum of 6 grams per dayThe higher dose should be reserved for immunocompromised pediatric patients or pediatric patients with cystic fibrosis or meningitis. | every 8 hours |
Dose | Frequency | |
Adult | ||
Usual recommended dosage | 1 gram intravenous or intramuscular | every 8 to 12 hours |
Uncomplicated urinary tract infection | 250 mg intravenous or intramuscular | every 12 hours |
Bone and joint infections | 2 grams intravenous | every 12 hours |
Complicated urinary tract infections | 500 mg intravenous or intramuscular | every 8 to 12 hours |
Uncomplicated pneumonia; mild skin and skin-structure infections | 500 mg to 1 gram intravenous or intramuscular | every 8 hours |
Serious gynecological and intra-abdominal infections | 2 grams intravenous | every 8 hours |
Meningitis | 2 grams intravenous | every 8 hours |
Very severe life-threatening infections, especially in immunocompromised patients | 2 grams intravenous | every 8 hours |
Lung infections caused by Pseudomonas spp. in patients with cystic fibrosis with normal renal functionAlthough clinical improvement has been shown, bacteriologic cures cannot be expected in patients with chronic respiratory disease and cystic fibrosis. | 30 to 50 mg/kg intravenous to a maximum of 6 grams per day | every 8 hours |
Neonates (0 to 4 weeks) | 30 mg/kg intravenous | every 12 hours |
Infants and children (1 month to 12 years) | 30 to 50 mg/kg intravenous to a maximum of 6 grams per dayThe higher dose should be reserved for immunocompromised pediatric patients or pediatric patients with cystic fibrosis or meningitis. | every 8 hours |
No adjustment in dosage is required for patients with hepatic dysfunction.
Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (glomerular filtration rate [GFR] <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 may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage. The recommended dosage is presented in
Note: if the dose recommended in Table 3 above is lower than that recommended for patients with renal insufficiency as outlined inTable 4 , the lower dose should be used. | ||
Creatinine Clearance (mL/min) | Recommended Unit Dose of Ceftazidime for Injection | Frequency of Dosing |
50 to 31 | 1 gram | every 12 hours |
30 to 16 | 1 gram | every 24 hours |
15 to 6 | 500 mg | every 24 hours |
less than 5 | 500 mg | every 48 hours |
Note: if the dose recommended in Table 3 above is lower than that recommended for patients with renal insufficiency as outlined in Table 4 , the lower dose should be used. | ||
Creatinine Clearance (mL/min) | Recommended Unit Dose of Ceftazidime for Injection | Frequency of Dosing |
50 to 31 | 1 gram | every 12 hours |
30 to 16 | 1 gram | every 24 hours |
15 to 6 | 500 mg | every 24 hours |
less than 5 | 500 mg | every 48 hours |
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) =
Females: 0.85 x male value
In patients with severe infections who would normally receive 6 grams of ceftazidime for injection daily 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.
In pediatric patients as for adults, 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.
Ceftazidime for injection can also be used in patients undergoing intraperitoneal dialysis and continuous ambulatory peritoneal dialysis. In such patients, a loading dose of 1 gram of ceftazidime for injection may be given, followed by 500 mg every 24 hours. In addition to IV use, ceftazidime for injection can be incorporated in the dialysis fluid at a concentration of 250 mg for 2 L of dialysis fluid.
Ceftazidime for injection is contraindicated in patients who have shown hypersensitivity to ceftazidime or the cephalosporin group of antibacterial drugs.
Ceftazidime is generally well tolerated. The incidence of adverse reactions associated with the administration of ceftazidime was low in clinical trials. The most common were local reactions following IV injection and allergic and gastrointestinal reactions. Other adverse reactions were encountered infrequently. No disulfiram-like reactions were reported.
The following adverse effects from clinical trials were considered to be either related to ceftazidime therapy or were of uncertain etiology:
BEFORE THERAPY WITH CEFTAZIDIME FOR INJECTION IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFTAZIDIME, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBACTERIAL DRUGS 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 OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against
Elevated levels of ceftazidime in patients with renal insufficiency can lead to seizures, nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia (see
High and prolonged serum ceftazidime concentrations can occur from usual dosages in patients with transient or persistent reduction of urinary output because of renal insufficiency. The total daily dosage should be reduced when ceftazidime is administered to patients with renal insufficiency (see
As with other antibacterial drugs, prolonged use of ceftazidime may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient’s condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Inducible type I beta-lactamase resistance has been noted with some organisms (e.g.,
Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal and 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.
Ceftazidime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Distal necrosis can occur after inadvertent intra-arterial administration of ceftazidime.
Prescribing ceftazidime for injection in the absence of a 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.
Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibacterial drugs or potent diuretics such as furosemide. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs. Nephrotoxicity and ototoxicity were not noted when ceftazidime was given alone in clinical trials.
Chloramphenicol has been shown to be antagonistic to beta-lactam antibacterial drugs, 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.