Tazicef

Tazicef Manufacturers

• Hospira, Inc.
  

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  Tazicef | Hospira, Inc.

  

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  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 5. The following dosage schedule is recommended.

  Table 5. Recommended Dosage Schedule * 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

  Adults

  Usual recommended dosage

  1 gram IV or IM

  q8 - 12hr

  Uncomplicated urinary tract infections

  250 mg IV or IM

  q12hr

  Bone and joint infections

  2 grams IV

  q12hr

  Complicated urinary tract infections

  500 mg IV or IM

  q8 - 12hr

  Uncomplicated pneumonia; mild skin and
  skin-structure infections

  500 mg to 1 gram

  IV or IM

  q8hr
                       

  Serious gynecologic and intra-abdominal
  infections

  2 grams IV
                         

  q8hr
                             

  Meningitis

  2 grams IV

  q8hr

  Very severe life-threatening infections,
  especially in immunocompromised patients

  2 grams IV
    

  q8hr
                         

  Lung infections caused by Pseudomonas spp.
  in patients with cystic fibrosis with normal
  renal function*

  30 to 50 mg/kg IV

  to a maximum

  of 6 grams/day

  q8hr
                          
                            

  Neonates (0 to 4 weeks)

  30 mg/kg IV

  q12hr

  Infants and children
  (1 month to 12 years)
                                                                 

  30 to 50 mg/kg IV

  to a maximum

  of 6 grams per day†

  q8hr
                      
                        

  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 6.

  Table 6. Recommended Maintenance Dosages of Tazicef (ceftazidime for injection, USP) in Renal Insufficiency

  NOTE: IF THE DOSE RECOMMENDED IN TABLE 5 ABOVE IS LOWER THAN THAT RECOMMENDED FOR PATIENTS WITH RENAL INSUFFICIENCY AS OUTLINED IN TABLE 6, THE LOWER DOSE SHOULD BE USED.

  Creatinine Clearance
  (mL/min)

  Recommended Unit Dose
  of Tazicef

  Frequency of
  Dosing

  50 to 31

  1 gram

  q12h

  30 to 16

  1 gram

  q24h

  15 to 6

  500 mg

  q24h

  <5

  500 mg

  q48h

  When only serum creatinine is available, the following formula (Cockcroft’s equation)5 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 liters 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.

  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 Constitution). 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.

  Intermittent intravenous 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.

  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 antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.

  However, if concurrent therapy with Tazicef and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.

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• Hospira, Inc.
  

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  Tazicef | Hospira, Inc.

  

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  PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION

  NOTE: The Pharmacy Bulk Package is intended for preparing IV admixtures only. Dosage recommendations for intramuscular or intravenous injection and intraperitoneal use are for informational purposes only.

  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 5. The following dosage schedule is recommended. 

  Table 5. Recommended Dosage Schedule * 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

  Adults

  Usual recommended dosage

  1 gram IV or IM

  q8-12hr

  Uncomplicated urinary tract infections

  250 mg IV or IM

  q12hr

  Bone and joint infections

  2 grams IV

  q12hr

  Complicated urinary tract infections

  500 mg IV or IM

  q8-12hr

  Uncomplicated pneumonia; mild skin and

  skin-structure infections

  500 mg to 1 gram

  IV or IM

  q8hr
    

  Serious gynecologic and

  intra-abdominal infections

  2 grams IV
    

  q8hr
    

  Meningitis

  2 grams IV

  q8hr

  Very severe life-threatening infections,

  especially in immunocompromised patients

  2 grams IV
    

  q8hr
    

  Lung infections caused by Pseudomonas

  spp. in patients with cystic fibrosis with

  normal renal function*

  30 to 50 mg/kg IV

  to a maximum

  of 6 grams per day

  q8hr
    
    

  Neonates (0 – 4 weeks)

  30 mg/kg IV

  q12hr

  Infants and children

  (1 month – 12 years)
     

  30 to 50 mg/kg IV

  to a maximum

  of 6 grams per day†

  q8hr
     
    

  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 6. 

  Table 6. Recommended Maintenance Dosages of Tazicef (ceftazidime for injection, USP) in Renal Insufficiency

  NOTE: IF THE DOSE RECOMMENDED IN TABLE 5 ABOVE IS LOWER THAN THAT RECOMMENDED FOR PATIENTS WITH RENAL INSUFFICIENCY AS OUTLINED IN TABLE 6, THE LOWER DOSE SHOULD BE USED.

  Creatinine

  Clearance

  (mL/min)

  Recommended

  Unit Dose of

  Tazicef

  Frequency

  of Dosing

  50 to 31

  30 to 16

  15 to 6

  <5

  1 gram

  1 gram

  500 mg

  500 mg

  q12hr

  q24hr

  q24hr

  q48hr

  When only serum creatinine is available, the following formula (Cockcroft’s equation)4 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 intra-peritoneal 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.

  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

  Pharmacy Bulk Package is for use in a pharmacy admixture service only. Refer to Table 7. See above NOTE concerning the proper use of Pharmacy Bulk Packages.

  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.

  Reconstitute with Sterile Water for Injection according to the following table. 

  Table 7. Preparation of Solutions of Tazicef

  Diluent to Be Added

  Approx. Avail. Volume

  Approx. Avg. Concentration

  26 mL

  56 mL

  30 mL

  60 mL

  1 gram/5 mL

  1 gram/10 mL

  All vials of Tazicef as supplied are under reduced pressure. When Tazicef is dissolved, carbon dioxide is released and a positive pressure develops.

  Solutions of Tazicef, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.

  However, if concurrent therapy with Tazicef and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.

  Directions for Use of Pharmacy Bulk Packages:

  Note: The Pharmacy Bulk Package is for use in a pharmacy admixture service only. Using aseptic technique, the closure should be penetrated only 1 time after reconstitution using a sterile dispensing set which 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. THE ENTIRE CONTENTS OF THE VIAL SHOULD BE DISPENSED WITHIN 4 HOURS OF INITIAL ENTRY.

  A plastic bail attached to the Pharmacy Bulk Package provides a suitable hanging device while dispensing in the pharmacy.

  Reconstitute with Sterile Water for Injection according to Table 7.

  The vacuum may assist entry of the diluent. SHAKE WELL.

  Insert a gas relief needle through the vial closure to relieve the internal pressure. Remove the gas relief needle before extracting any solution.

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• Hospira, Inc.
  

  ×

  Tazicef | Hospira, Inc.

  

  ---

  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 5. The following dosage schedule is recommended. 

  Table 5. Recommended Dosage Schedule * 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

  Adults

  Usual recommended dosage

  1 gram IV or IM

  q8-12hr

  Uncomplicated urinary tract infections

  250 mg IV or IM

  q12hr

  Bone and joint infections

  2 grams IV

  q12hr

  Complicated urinary tract infections

  500 mg IV or IM

  q8-12hr

  Uncomplicated pneumonia; mild skin and

  skin-structure infections

  500 mg to 1 gram

  IV or IM

  q8hr
    

  Serious gynecologic and
  intra-abdominal infections

  2 grams IV
    

  q8hr
                                 

  Meningitis

  2 grams IV

  q8hr

  Very severe life-threatening infections,
  especially in immunocompromised patients

  2 grams IV
                              

  q8hr
    

  Lung infections caused by

  Pseudomonas spp. in patients with cystic

  fibrosis with normal renal function*

  30 to 50 mg/kg IV

  to a maximum

  of 6 grams per day

  q8hr
    
    

  Neonates (0 – 4 weeks)

  30 mg/kg IV

  q12hr

  Infants and children

  (1 month – 12 years)
     

  30 to 50 mg/kg IV

  to a maximum

  of 6 grams per day†

  q8hr
     
    

  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 6.

  Table 6. Recommended Maintenance Dosages of Tazicef (ceftazidime for injection, USP) in Renal Insufficiency

  NOTE: IF THE DOSE RECOMMENDED IN TABLE 5 ABOVE IS LOWER THAN THAT RECOMMENDED FOR PATIENTS WITH RENAL INSUFFICIENCY AS OUTLINED IN TABLE 6, THE LOWER DOSE SHOULD BE USED.

  Creatinine Clearance

  (mL/min)

  Recommended Unit Dose of

  Tazicef

  Frequency of Dosing

  50 to 31

  1 gram

  q12hr

  30 to 16

  1 gram

  q24hr

  15 to 6

  500 mg

  q24hr

  <5

  500 mg

  q48hr

  When only serum creatinine is available, the following formula (Cockcroft’s equation)4 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 reconstituted 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 7.

  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, reconstitute Tazicef as directed in Table 7 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, reconstitute 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 intravenous 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.

  Table 7. Preparation of Solutions of Tazicef

  
  Vial

  Size

  Amount of

  Diluent to

  Be Added

  
  Approximate

  Available Volume

  Approximate

  Ceftazidime

  Concentration

  Intramuscular

  1 gram

  3.0 mL

  3.6 mL

  280 mg/mL

  Intravenous Infusion

  1 gram

  10 mL

  10.6 mL

  95 mg/mL

  2 gram

  10 mL

  11.2 mL

  180 mg/mL

  All vials of Tazicef as supplied are under reduced pressure. When Tazicef is dissolved, carbon dioxide is released and a positive pressure develops.

  Solutions of Tazicef, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.

  However, if concurrent therapy with Tazicef and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.

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  No Recall

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