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 Tazicef (ceftazidime for injection, USP) are listed in Table 3. The following dosage schedule is recommended.
| 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 – 4 weeks) | 30 mg/kg intravenous | every 12 hours |
| Infants and children (1 month – 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.
| 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 Tazicef | 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) = 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 Tazicef 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.
Tazicef (ceftazidime for injection, USP) can also be used in patients undergoing intraperitoneal dialysis and continuous ambulatory peritoneal dialysis. In such patients, a loading dose of 1 gram of Tazicef may be given, followed by 500 mg every 24 hours. In addition to IV use, Tazicef can be incorporated in the dialysis fluid at a concentration of 250 mg for 2 L of dialysis fluid.
Note: Generally, Tazicef should be continued for 2 days after the signs and symptoms of infection have disappeared, but in complicated infections longer therapy may be required.
Administration
Tazicef may be given intravenously or by deep IM injection into a large muscle mass such as the upper outer quadrant of the gluteus maximus or lateral part of the thigh. Intra-arterial administration should be avoided (see PRECAUTIONS).
Intramuscular Administration
For IM administration, Tazicef should be constituted with one of the following diluents: Sterile Water for Injection, Bacteriostatic Water for Injection, or 0.5% or 1% Lidocaine Hydrochloride Injection. Refer to Table 5.
Intravenous Administration
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.
For direct intermittent IV administration, constitute Tazicef 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.
Freezing solutions of ceftazidime for injection is not recommended.
| 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 | 10.6 | 95 |
| 2 gram vial | 10 | 11.2 | 180 |
All vials of Tazicef as supplied are under reduced pressure. When Tazicef 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 Tazicef, like those of most beta-lactam antibacterial drugs, should not be added to solutions of aminoglycoside antibacterial drugs because of potential interaction.
However, if concurrent therapy with Tazicef and an aminoglycoside is indicated, each of these antibacterial drugs can be administered separately to the same patient.
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 Tazicef (ceftazidime for injection, USP) are listed in Table 3. The following dosage schedule is recommended.
| 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 – 4 weeks) | 30 mg/kg intravenous | every 12 hours |
| Infants and children (1 month – 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.
| 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 Tazicef | 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) = 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 Tazicef 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.
Tazicef (ceftazidime for injection, USP) can also be used in patients undergoing intraperitoneal dialysis and continuous ambulatory peritoneal dialysis. In such patients, a loading dose of 1 gram of Tazicef may be given, followed by 500 mg every 24 hours. In addition to IV use, Tazicef can be incorporated in the dialysis fluid at a concentration of 250 mg for 2 L of dialysis fluid.
Note: Generally, Tazicef should be continued for 2 days after the signs and symptoms of infection have disappeared, but in complicated infections longer therapy may be required.
Administration
Tazicef may be given intravenously or by deep IM injection into a large muscle mass such as the upper outer quadrant of the gluteus maximus or lateral part of the thigh. Intra-arterial administration should be avoided (see PRECAUTIONS).
Intramuscular Administration
For IM administration, Tazicef should be constituted with one of the following diluents: Sterile Water for Injection, Bacteriostatic Water for Injection, or 0.5% or 1% Lidocaine Hydrochloride Injection. Refer to Table 5.
Intravenous Administration
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.
For direct intermittent IV administration, constitute Tazicef 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.
Freezing solutions of ceftazidime for injection is not recommended.
| 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 | 10.6 | 95 |
| 2 gram vial | 10 | 11.2 | 180 |
All vials of Tazicef as supplied are under reduced pressure. When Tazicef 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 Tazicef, like those of most beta-lactam antibacterial drugs, should not be added to solutions of aminoglycoside antibacterial drugs because of potential interaction.
However, if concurrent therapy with Tazicef and an aminoglycoside is indicated, each of these antibacterial drugs can be administered separately to the same patient.
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