Tazicef Dosage

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

	Dose	Frequency
* 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.
Adult
Usual recommended dosage	1 gram intravenous	every 8 to 12 hours
Uncomplicated urinary tract infection	250 mg intravenous	every 12 hours
Bone and joint infections	2 grams intravenous	every 12 hours
Complicated urinary tract infections	500 mg intravenous	every 8 to12 hours
Uncomplicated pneumonia; mild skin and skin- structure infections	500 mg to 1 gram intravenous	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.

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 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:

Weight (kg) x (140 - age)
Males: Creatinine clearance (mL/min) = ––––––––––––––––––––––––––
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

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.

Directions for Proper Use of a Pharmacy Bulk Package

Not for direct infusion. This Pharmacy Bulk Package is for use in a hospital pharmacy admixture service, only in a suitable work area, such as a laminar flow hood. Using aseptic technique, the container closure may be penetrated only one time using a suitable sterile dispensing set or transfer device that allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage. The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 4 hours from initial closure entry is permitted to complete fluid transfer operations. This time limit should begin with the introduction of the solvent or diluent into the Pharmacy Bulk Package. DISCARD ANY UNUSED PORTION AFTER 4 HOURS. NOT FOR DIRECT INFUSION. THIS PHARMACY BULK PACKAGE IS NOT INTENDED TO BE DISPENSED AS A UNIT.

Freezing solutions of Tazicef is not recommended.

Table 5. Preparation of Solutions of Tazicef (Pharmacy Bulk Package)

Size	Amount of Diluent to be Added (mL)	Approximate Available Volume (mL)	Approximate Ceftazidime Concentration (mg/mL)
Pharmacy bulk package 6 gram vial	26	30	200

Tazicef (Pharmacy Bulk Package), when constituted as directed with Sterile Water for Injection, should have the contents withdrawn within 4 hours.

After constitution, 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.

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.