Ceftazidime
Dosing in kidney impairment
DOSAGE AND ADMINISTRATION Dosage 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 Table 3 .
The following dosage schedule is recommended. [See table below.] 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 function* 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 day** every 8 hours Impaired Hepatic Function No adjustment in dosage is required for patients with hepatic dysfunction.
Impaired Renal Function 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 Table 4 . [See table below.] 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) x (140 - age) 72 x serum creatinine (mg/dL) 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. Note: Generally, ceftazidime for injection should be continued for 2 days after the signs and symptoms of infection have disappeared, but in complicated infections longer therapy may be required.
| *Although clinical improvement has been shown, bacteriologic cures cannot be expected in patients with chronic respiratory disease and cystic fibrosis. | ||
| **The higher dose should be reserved for immunocompromised pediatric patients or pediatric patients with cystic fibrosis or meningitis. | ||
| 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 function* | 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 day** | every 8 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 |
Preparation and administration
For direct intermittent IV administration, constitute ceftazidime for injection as directed in Table 5 with Sterile Water for Injection. Slowly inject directly into the vein over a period of 3 to 5 minutes or give through the tubing of an administration set while the patient is also receiving one of the compatible IV fluids (see COMPATIBILITY AND STABILITY ).
For IV infusion, constitute the 1 gram, or 2 gram vial and add an appropriate quantity of the resulting solution to an IV container with one of the compatible IV fluids listed under the COMPATIBILITY AND STABILITY section. Intermittent IV infusion with a Y-type administration set can be accomplished with compatible solutions.
However, during infusion of a solution containing ceftazidime, it is desirable to discontinue the other solution. [See table below.] Discard unused portion. All vials of ceftazidime for injection as supplied are under reduced pressure. When ceftazidime for injection is dissolved, carbon dioxide is released and a positive pressure develops.
For ease of use please follow the recommended techniques of constitution described on the detachable Instructions for Constitution section of this insert. Solutions of ceftazidime for injection, like those of most beta-lactam antibacterial drugs, should not be added to solutions of aminoglycoside antibacterial drugs because of potential interaction.
| * To obtain a dose of 1 g, withdraw 10 mL from the vial following reconstitution. | |||
| ** To obtain a dose of 2 g, withdraw 11.5 mL from the vial following reconstitution. | |||
| Size | Amount of Diluent to be Added (mL) | Approximate Available Volume (mL) | Approximate Ceftazidime Concentration (mg/mL) |
| Intramuscular | |||
| 1 gram vial | 3 | 3.6 | 280 |
| Intravenous | |||
| 1 gram vial | 10 | 10.8* | 100 |
| 2 gram vial | 10 | 11.5** | 170 |