Ceftazidime

Ceftazidime Manufacturers

• Wg Critical Care, Llc
  

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  Ceftazidime | Crawford Healthcare, Inc.

  

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  ■ Cleanse the affected area and allow to dry.

  ■ Shake bottle well before use.

  ■ Spray 4-6 inches from skin twice daily (morning and night) or as directed by a physician.  No rub-in is required.

  ■ For athlete’s foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks. If condition persists longer, contact a doctor.

  ■ This product is not effective on the scalp or nails.

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• Wg Critical Care, Llc
  

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  Ceftazidime | Lupin Pharmaceuticals, Inc.

  

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  Adults

  Dosage and route of administration should be determined by susceptibility of the causative organisms, severity of the infection, and the condition of the patient (see table for dosage guideline). Cefotaxime for injection may be administered IM or IV after reconstitution. The maximum daily dosage should not exceed 12 grams.

  GUIDELINES FOR DOSAGE OF CEFOTAXIME FOR INJECTION Type of Infection
  Daily Dose
  (grams)
  Frequency and Route
  Gonococcal urethritis/ cervicitis in males and females
  0.5
  0.5 gram IM (single dose)
  Rectal gonorrhea in females
  0.5
  0.5 gram IM (single dose)
  Rectal gonorrhea in males
  1
  1 gram IM (single dose)
  Uncomplicated infections
  2
  1 gram every 12 hours IM or IV
  Moderate to severe infections
  3 to 6
  1 to 2 grams every 8 hours IM or IV
  Infections commonly needing antibiotics in higher dosage (e.g., septicemia)
  6 to 8
  2 grams every 6 to 8 hours IV
  Life-threatening infections
  Up to 12
  2 grams every 4 hours IV
  

  If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefotaxime sodium has no activity against this organism.

  To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended dose is a single 1 gram IM or IV administered 30 to 90 minutes prior to start of surgery.

  Cesarean Section Patients

  The first dose of 1 gram is administered intravenously as soon as the umbilical cord is clamped. The second and third doses should be given as 1 gram intravenously or intramuscularly at 6 and 12 hours after the first dose.

  Neonates, Infants, and Children

  The following dosage schedule is recommended:

  Neonates (birth to 1 month) 

  0 to 1 week of age                    50 mg/kg per dose every 12 hours IV

  1 to 4 weeks of age                  50 mg/kg per dose every 8 hours IV

  It is not necessary to differentiate between premature and normal-gestational age infants.

  Infants and Children (1 month to 12 years)

  For body weights less than 50 kg, the recommended daily dose is 50 to 180 mg/kg IM or IV body weight divided into four to six equal doses. The higher dosages should be used for more severe or serious infections, including meningitis. For body weights 50 kg or more, the usual adult dosage should be used; the maximum daily dosage should not exceed 12 grams.

  Geriatric Use

  This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See PRECAUTIONS, General and PRECAUTIONS, Geriatric Use.)

  Impaired Renal Function

  see PRECAUTIONS, General.

  NOTE: As with antibiotic therapy in general, administration of cefotaxime for injection should be continued for a minimum of 48 to 72 hours after the patient defervesces or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended for infections caused by Group A beta-hemolytic streptococci in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment of several weeks and doses smaller than those indicated above should not be used.

  Preparation of Cefotaxime for Injection

  Cefotaxime for injection for IM or IV administration should be reconstituted as follows:

  Strength
  Diluent
  (mL)
  Withdrawable
  Volume (mL)
  Approximate
  Concentration
  (mg/mL)
  500 mg vial* (IM)
  2
  2.2
  230
  1g vial* (IM)
  3
  3.4
  300
  2g vial* (IM)
  5
  6.0
  330
  500 mg vial* (IV)
  10
  10.2
  50
  1g vial* (IV)
  10
  10.4
  95
  2g vial* (IV)
  10
  11.0
  180
  

  Shake to dissolve; inspect for particulate matter and discoloration prior to use. Solutions of cefotaxime for injection range from very pale yellow to light amber, depending on concentration, diluent used, and length and condition of storage.

  For intramuscular use

  Reconstitute VIALS with Sterile Water for Injection or Bacteriostatic Water for Injection as described above.

  For intravenous use

  Reconstitute VIALS with at least 10 mL of Sterile Water for Injection. For other diluents, see COMPATIBILITY AND STABILITY section.

  NOTE: Solutions of cefotaxime for injection must not be admixed with aminoglycoside solutions. If cefotaxime for injection and aminoglycosides are to be administered to the same patient, they must be administered separately and not as mixed injection.

  A SOLUTION OF 1 G CEFOTAXIME FOR INJECTION IN 14 ML OF STERILE WATER FOR INJECTION IS ISOTONIC.

  IM Administration

  As with all IM preparations, cefotaxime for injection should be injected well within the body of a relatively large muscle such as the upper outer quadrant of the buttock (i.e., gluteus maximus); aspiration is necessary to avoid inadvertent injection into a blood vessel. Individual IM doses of 2 grams may be given if the dose is divided and is administered in different intramuscular sites.

  IV Administration

  The IV route is preferable for patients with bacteremia, bacterial septicemia, peritonitis, meningitis, 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 impending.

  For intermittent IV administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Cefotaxime should not be administered over a period of less than three minutes. (See WARNINGS). With an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing cefotaxime, it is advisable to discontinue temporarily the administration of other solutions at the same site.

  For the administration of higher doses by continuous IV infusion, a solution of cefotaxime may be added to IV bottles containing the solutions discussed below.

  Compatibility and Stability

  Solutions of cefotaxime for injection reconstituted as described above (Preparation of cefotaxime for injection) remain chemically stable (potency remains above 90%) as follows when stored in original containers and disposable plastic syringes:

  Strength
  Reconstituted
  Concentration
  mg/mL
  Stability at or
  below 22°C
  Stability under
  Refrigeration
  (at or below 5°C)
  Original Containers
  Plastic
  Syringes
  500 mg vial IM
  230
  12 hours
  7 days
  5 days
  1g vial IM
  300
  12 hours
  7 days
  5 days
  2g vial IM
  330
  12 hours
  7 days
  5 days
  500 mg vial IV
  50
  24 hours
  7 days
  5 days
  1g vial IV
  95
  24 hours
  7 days
  5 days
  2g vial IV
  180
  12 hours
  7 days
  5 days
  

  Reconstituted solutions stored in original containers and plastic syringes remain stable for 13 weeks frozen.

  Reconstituted solutions may be further diluted up to 1000 mL with the following solutions and maintain satisfactory potency for 24 hours at or below 22°C, and at least 5 days under refrigeration (at or below 5°C): 0.9% Sodium Chloride Injection; 5 or 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; Lactated Ringer's Solution; Sodium Lactate Injection (M/6); 10% Invert Sugar Injection, 8.5% Travasol® (Amino Acid) Injection without Electrolytes.

  NOTE: Cefotaxime for injection solutions exhibit maximum stability in the pH 5 to 7 range. Solutions of cefotaxime for injection should not be prepared with diluents having a pH above 7.5, such as Sodium Bicarbonate Injection.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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• Sandoz Inc
  

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  Ceftazidime | Sandoz Inc

  

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  Dosage

  The usual adult dosage is 1 gram administered intravenously every 8 to 12 hours. The dosage 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 5. The following dosage schedule is recommended.

  Table 5. Recommended Dosage Schedule Adults Dose Frequency Usual recommended dosage 1 gram IV q8 to 12hr * 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.

  Uncomplicated urinary tract infections

  250 mg IV

  q12hr

  Bone and joint infections

  2 grams IV

  q12hr

  Complicated urinary tract infections

  500 mg IV

  q8 to 12hr

  Uncomplicated pneumonia; mild skin and skin-
  structure infections

  500 mg to 1 gram IV

  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 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 Ceftazidime for Injection 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 Ceftazidime for Injection 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)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 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.

  Administration

  Ceftazidime for injection may be given intravenously. Intra-arterial administration should be avoided (see PRECAUTIONS).

  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.

  For IV infusion, constitute the 6 g Pharmacy Bulk Package bottle with Sterile Water for Injection 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 solution of ceftazidime for injection is not recommended.

  Table 7. Preparation of Solutions of Ceftazidime for Injection

  
  
  
  Size

  
  Amount of Diluent
  to be Added
  (mL)

  
  Approximate
  Available Volume
  (mL)

  Approximate
  Ceftazidime
  Concentration
  (mg/mL)

  Pharmacy bulk package bottle
  6 grams

  26

  30

  200

  All Pharmacy Bulk Package bottles 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 antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.

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

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• Sandoz Inc
  

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  Ceftazidime | Sandoz 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 ceftazidime for injection are listed in Table 5. The following dosage schedule is recommended.

  Table 5. Recommended Dosage Schedule Adults Dose Frequency Usual recommended dosage 1 gram IV or IM q8 to 12hr * 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.

  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 to 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 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 Ceftazidime for Injection 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 Ceftazidime for Injection 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)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 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.

  Administration

  Ceftazidime for injection 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, ceftazidime for injection 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 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, constitute ceftazidime for injection 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, 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 solution of ceftazidime for injection is not recommended.

  Table 7. Preparation of Solutions of Ceftazidime for Injection * 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

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

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

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• Sagent Pharmaceuticals
  

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  Ceftazidime | Sagent Pharmaceuticals

  

  ---

  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 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 to 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 to 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 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 Ceftazidime for Injection 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 Ceftazidime for Injection 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)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 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.

  Administration

  Ceftazidime for injection 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, ceftazidime for injection 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 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, constitute ceftazidime for injection 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, 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.

  Table 7. Preparation of Solutions of Ceftazidime for Injection

  * 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

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

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

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  Ceftazidime | Sagent Pharmaceuticals

  

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  Dosage

  The usual adult dosage is 1 gram administered intravenously every 8 to 12 hours. The dosage 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 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 q8 to 12hr Uncomplicated urinary tract infections 250 mg IV q12hr Bone and joint infections 2 grams IV q12hr Complicated urinary tract infections 500 mg IV q8 to 12hr Uncomplicated pneumonia; mild skin and skin-structure infections 500 mg to 1 gram IV 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 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 Ceftazidime for Injection 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 Ceftazidime for Injection 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)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 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.

  Administration

  Ceftazidime for injection may be given intravenously. Intra-arterial administration should be avoided (see PRECAUTIONS).

  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.

  For IV infusion, constitute the 6 g Pharmacy Bulk Package bottle with Sterile Water for Injection 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.

  Table 7. Preparation of Solutions of Ceftazidime for Injection Size
  Amount of Diluent
  to be Added
  (mL) Approximate
  Available Volume
  (mL) Approximate
  Ceftazidime
  Concentration
  (mg/mL) Pharmacy bulk package bottle
  6 grams 26 30 200

  All Pharmacy Bulk Package bottles 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 antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.

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

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