TAZICEF - ADD-VANTAGE Dosage and Administration

(ceftazidime for injection, USP - ADD-VANTAGE)

DOSAGE AND ADMINISTRATION

Dosage

The usual adult dosage is 1 gram administered intravenously 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.

Table 3. Recommended Dosage Schedule
DoseFrequency
Adult
*
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.
Usual recommended dosage1 gram intravenousevery 8 to 12 hours
Uncomplicated urinary tract infection250 mg intravenousevery 12 hours
Bone and joint infections2 grams intravenousevery 12 hours
Complicated urinary tract infections500 mg intravenousevery 8 to 12 hours
Uncomplicated pneumonia; mild skin and skin-structure infections500 mg to 1 gram intravenousevery 8 hours
Serious gynecological and intra-abdominal infections2 grams intravenousevery 8 hours
Meningitis2 grams intravenousevery 8 hours
Very severe life-threatening infections, especially in immunocompromised patients2 grams intravenousevery 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 dayevery 8 hours
Neonates (0 - 4 weeks)30 mg/kg intravenousevery 12 hours
Infants and children
(1 month to 12 years)
30 to 50 mg/kg intravenous to a maximum of 6 grams per dayevery 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 Tazicef may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage. The recommended dosage is presented in Table 4.

Table 4. Recommended Maintenance Dosages of Tazicef (ceftazidime for injection, USP) in Renal Insufficiency
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 TazicefFrequency of Dosing
50 to 311 gramevery 12 hours
30 to 161 gramevery 24 hours
15 to 6500 mgevery 24 hours
less than 5500 mgevery 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) × (140 - age)
72 × serum creatinine (mg/dL)
Females: 0.85 × 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. Intra-arterial administration should be avoided (see PRECAUTIONS).

Note: Tazicef in ADD-Vantage vials is not intended for direct IV or IM injection.

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.

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.

ADD-Vantage vials are to be constituted only with 50 or 100 mL of 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or 50 mL of 0.45% Sodium Chloride Injection in ADD-Vantage diluent (see Instructions for Use). ADD-Vantage vials should be reconstituted only when it is certain that the patient is ready to receive the drug. Tazicef in ADD-Vantage vials is stable for 24 hours at room temperature.

Note: Tazicef (ceftazidime for injection, USP) in the ADD-Vantage vial is intended to be administered as a single-dose intravenous infusion with the ADD-Vantage flexible diluent container.

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 instructions for use 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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Dosage and Administration

DOSAGE AND ADMINISTRATION

Dosage

The usual adult dosage is 1 gram administered intravenously 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.

Table 3. Recommended Dosage Schedule
DoseFrequency
Adult
*
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.
Usual recommended dosage1 gram intravenousevery 8 to 12 hours
Uncomplicated urinary tract infection250 mg intravenousevery 12 hours
Bone and joint infections2 grams intravenousevery 12 hours
Complicated urinary tract infections500 mg intravenousevery 8 to 12 hours
Uncomplicated pneumonia; mild skin and skin-structure infections500 mg to 1 gram intravenousevery 8 hours
Serious gynecological and intra-abdominal infections2 grams intravenousevery 8 hours
Meningitis2 grams intravenousevery 8 hours
Very severe life-threatening infections, especially in immunocompromised patients2 grams intravenousevery 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 dayevery 8 hours
Neonates (0 - 4 weeks)30 mg/kg intravenousevery 12 hours
Infants and children
(1 month to 12 years)
30 to 50 mg/kg intravenous to a maximum of 6 grams per dayevery 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 Tazicef may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage. The recommended dosage is presented in Table 4.

Table 4. Recommended Maintenance Dosages of Tazicef (ceftazidime for injection, USP) in Renal Insufficiency
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 TazicefFrequency of Dosing
50 to 311 gramevery 12 hours
30 to 161 gramevery 24 hours
15 to 6500 mgevery 24 hours
less than 5500 mgevery 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) × (140 - age)
72 × serum creatinine (mg/dL)
Females: 0.85 × 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. Intra-arterial administration should be avoided (see PRECAUTIONS).

Note: Tazicef in ADD-Vantage vials is not intended for direct IV or IM injection.

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.

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.

ADD-Vantage vials are to be constituted only with 50 or 100 mL of 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or 50 mL of 0.45% Sodium Chloride Injection in ADD-Vantage diluent (see Instructions for Use). ADD-Vantage vials should be reconstituted only when it is certain that the patient is ready to receive the drug. Tazicef in ADD-Vantage vials is stable for 24 hours at room temperature.

Note: Tazicef (ceftazidime for injection, USP) in the ADD-Vantage vial is intended to be administered as a single-dose intravenous infusion with the ADD-Vantage flexible diluent container.

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 instructions for use 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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