Cefazolin

Cefazolin Manufacturers

• Cardinal Health
  

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  Cefazolin | Cardinal Health

  

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  Usual Adult Dosage Type of Infection  
    Dose   Frequency * ln rare instances, doses of up to 12 grams of cefazolin for injection per day have been used

  Moderate to severe infections

   

  500 mg to 1 gram

   

  every 6 to 8 hrs.

  Mild infections caused by susceptible gram–positive cocci

   

  250 mg to 500 mg

   

  every 8 hours

  Acute, uncomplicated urinary tract infections

   

  1 gram

   

  every 12 hours

  Pneumococcal pneumonia

   

  500 mg

   

  every 12 hours

  Severe, life-threatening infections (e.g., endocarditis, septicemia)*

   

  1 gram to 1.5 grams

   

  every 6 hours

  Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  a. 1 gram IV or IM administered 1/2 hour to 1 hour prior to the start of  surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours  postoperatively.

  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) Cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin for injection may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin may be used in patients with reduced renal function with the following dosage adjustments:  Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses.  Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals.  Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for injection in these patients is not recommended.

  Pediatric Dosage Guide Weight
     25 mg/kg/Day
  Divided into 3 Doses  25 mg/kg/Day
  Divided into 4 Doses

  Lbs
   
   

  Kg
   

  Approximate
  Single Dose
  mg/q8h

  Vol. (mL)
  needed with
  dilution of
  125 mg/mL

  Approximate
  Single Dose
  mg/q6h
   

  Vol. (mL)
  needed with
  dilution of
  125 mg/mL

  10

  4.5

  40 mg

  0.35 mL

  30 mg

  0.25 mL

  20

  9

  75 mg

  0.6 mL

  55 mg

  0.45 mL

  30

  13.6

  115 mg

  0.9 mL

  85 mg

  0.7 mL

  40

  18.1

  150 mg

  1.2 mL

  115 mg

  0.9 mL

  50

  22.7

  190 mg

  1.5 mL

  140 mg

  1.1 mL

  Weight 50 mg/kg/Day
  Divided into 3 Doses 50 mg/kg/Day
  Divided into 4 Doses

  Lbs

  Kg

  Approximate
  Single Dose
  mg/q8h

  Vol. (mL)
  needed with
  dilution of
  225 mg/mL

  Approximate
  Single Dose
  mg/q6h

  Vol. (mL)
  needed with
  dilution of
  225 mg/mL

  10

  4.5

  75 mg

  0.35 mL

  55 mg

  0.25 mL

  20

  9

  150 mg

  0.7 mL

  110 mg

  0.5 mL

  30

  13.6

  225 mg

  1 mL

  170 mg

  0.75 mL

  40

  18.1

  300 mg

  1.35 mL

  225 mg

  1 mL

  50

  22.7

  375 mg

  1.7 mL

  285 mg

  1.25 mL

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient.  In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate.  Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  RECONSTITUTION Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration.  If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  When reconstituted or diluted according to the instructions below, cefazolin for injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41 °F).  Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Single-Dose Vials

  For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.

  Vial size Amount of Diluent Approximate Concentration Approximate Available Volume

  1 gram

  2.5 mL

  330 mg/mL

  3 mL

  ADMINISTRATION Intramuscular Administration

  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin should be injected into a large muscle mass. Pain on injection is infrequent with cefazolin.

  Intravenous Administration

  Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion: Dilute reconstituted cefazolin in 50 to 100 mL of 1 of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer's Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer's Injection, USP

  5% Sodium Bicarbonate Injection, USP

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  More Info
• Cardinal Health
  

  ×

  Cefazolin | Cardinal Health

  

  ---

  Usual Adult Dosage:

  Type of Infection

  Dose

  Frequency

  Moderate to severe infections

  500 mg to 1 gram

  every 6 to 8 hours

  Mild infections caused by susceptible gram-positive cocci

  250 mg to 500 mg

  every 8 hours

  Acute, uncomplicated urinary tract infections

  1 gram

  every 12 hours

  Pneumococcal pneumonia

  500 mg

  every 12 hours

  Severe, life threatening infections (e.g., endocarditis, septicemia)*

  1 gram to 1.5 grams

  every 6 hours

   *In rare instances, doses of up to 12 grams of cefazolin per day have been used.

  Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended doses are:

  a. 1 gram IV or IM administered one half to 1 hour prior to the start of surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just prior (one half to 1 hour) to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin may be used in patients with reduced renal function with the following dosage adjustments. Patients with a creatinine clearance of 55 mL/min or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min or serum creatinine of 3.1 to 4.5 mg % should be given one half the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min or less or serum creatinine of 4.6 mg % or greater should be given one half the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis, see CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg/kg (approximately 10 to 20 mg/lb) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg/kg (45 mg/lb) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of cefazolin in these patients is not recommended.

  Pediatric Dosage Guide

  Weight

  25 mg/kg/day Divided into 3 Doses

  lbs

  kg

  Approximate Single Dose

  mg/q8h

  Vol (mL) needed with dilution of 125 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  40 mg

  75 mg

  115 mg

  150 mg

  190 mg

  0.35 mL

  0.6 mL

  0.9 mL

  1.2 mL

  1.5 mL

  Weight

  25 mg/kg/day Divided into 4 Doses

  lbs

  kg

  Approximate Single Dose

  mg/q6h

  Vol (mL) needed with dilution of 125 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  30 mg

  55 mg

  85 mg

  115 mg

  140 mg

  0.25 mL

  0.45 mL

  0.7 mL

  0.9 mL

  1.1 mL

  Weight

  50 mg/kg/day Divided into 3 Doses

  lbs

  kg

  Approximate Single Dose

  mg/q8h

  Vol (mL) needed with dilution of 225 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  75 mg

  150 mg

  225 mg

  300 mg

  375 mg

  0.35 mL

  0.7 mL

  1 mL

  1.35 mL

  1.7 mL

  Weight

  50 mg/kg/day Divided into 4 Doses

  lbs

  kg

  Approximate Single Dose

  mg/q6h

  Vol (mL) needed with dilution of 225 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  55 mg

  110 mg

  170 mg

  225 mg

  285 mg

  0.25 mL

  0.5 mL

  0.75 mL

  1 mL

  1.25 mL

   

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min), 60% of the normal daily dosage given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min), 25% of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min) may be given 10% of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended doses are:

  a. 1 gram IV or IM administered one half to 1 hour prior to the start of surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just prior (one half to 1 hour) to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin may be used in patients with reduced renal function with the following dosage adjustments. Patients with a creatinine clearance of 55 mL/min or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min or serum creatinine of 3.1 to 4.5 mg % should be given one half the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min or less or serum creatinine of 4.6 mg % or greater should be given one half the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis, see CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg/kg (approximately 10 to 20 mg/lb) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg/kg (45 mg/lb) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of cefazolin in these patients is not recommended.

  Pediatric Dosage Guide

  Weight

  25 mg/kg/day Divided into 3 Doses

  lbs

  kg

  Approximate Single Dose

  mg/q8h

  Vol (mL) needed with dilution of 125 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  40 mg

  75 mg

  115 mg

  150 mg

  190 mg

  0.35 mL

  0.6 mL

  0.9 mL

  1.2 mL

  1.5 mL

  Weight

  25 mg/kg/day Divided into 4 Doses

  lbs

  kg

  Approximate Single Dose

  mg/q6h

  Vol (mL) needed with dilution of 125 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  30 mg

  55 mg

  85 mg

  115 mg

  140 mg

  0.25 mL

  0.45 mL

  0.7 mL

  0.9 mL

  1.1 mL

  Weight

  50 mg/kg/day Divided into 3 Doses

  lbs

  kg

  Approximate Single Dose

  mg/q8h

  Vol (mL) needed with dilution of 225 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  75 mg

  150 mg

  225 mg

  300 mg

  375 mg

  0.35 mL

  0.7 mL

  1 mL

  1.35 mL

  1.7 mL

  Weight

  50 mg/kg/day Divided into 4 Doses

  lbs

  kg

  Approximate Single Dose

  mg/q6h

  Vol (mL) needed with dilution of 225 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  55 mg

  110 mg

  170 mg

  225 mg

  285 mg

  0.25 mL

  0.5 mL

  0.75 mL

  1 mL

  1.25 mL

   

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min), 60% of the normal daily dosage given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min), 25% of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min) may be given 10% of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  Intramuscular Administration

  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin for Injection, USP should be injected into a large muscle mass. Pain on injection is infrequent with Cefazolin for Injection, USP.

  Intravenous Administration

  Direct (bolus) injection–Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion–Dilute reconstituted Cefazolin for Injection, USP in 50 to 100 mL of one of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer’s Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer’s Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer’s Injection, USP

  5% Sodium Bicarbonate Injection, USP

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

  Intramuscular Administration

  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin for Injection, USP should be injected into a large muscle mass. Pain on injection is infrequent with Cefazolin for Injection, USP.

  Intravenous Administration

  Direct (bolus) injection–Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion–Dilute reconstituted Cefazolin for Injection, USP in 50 to 100 mL of one of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer’s Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer’s Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer’s Injection, USP

  5% Sodium Bicarbonate Injection, USP

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

  Close
  No Recall

  More Info
• Orchid Healthcare (A Division Of Orchid Chemicals And Pharmaceuticals Ltd.)
  

  ×

  Cefazolin | Orchid Healthcare (a Division Of Orchid Chemicals And Pharmaceuticals Ltd.)

  

  ---

  Usual Adult Dosage Type of Infection Dose Frequency * ln rare instances, doses of up to 12 grams of Cefazolin for injection per day have been used. Moderate to severe infections 500mg to 1gram every 6 to 8 hrs. Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections
   (e.g., endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  1 gram IV administered 1/2 hour to 1 hour prior to the start of surgery. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure). 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) Cefazolin for injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for injection may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin for injection may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2  the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for injection in these patients is not recommended.

  Pediatric Dosage Guide Weight 25 mg/kg/day
  Divided into 3 Doses 25 mg/kg/day
  Divided into 4 Doses Lbs Kg Approximate Single Dose mg/q8h Vol.(mL)
  needed with
  dilution of 125 mg/mL Approximate Single Dose mg/q6h Vol.(mL)
  needed with dilution of 125 mg/mL 10 4.5 40 mg 0.35 mL 30 mg 0.25 mL 20 9 75 mg 0.6 mL 55 mg 0.45 mL 30 13.6 115 mg 0.9 mL 85 mg 0.7 mL 40 18.1 150 mg 1.2 mL 115 mg 0.9 mL 50 22.7 190 mg 1.5 mL 140 mg 1.1 mL Weight
    50 mg/kg/day
  Divided into 3 Doses 50 mg/kg/day
  Divided into 4 Doses Lbs Kg Approximate Single Dose mg/q8h Vol.(mL)
  needed with dilution of 225 mg/mL Approximate Single Dose mg/q6h Vol.(mL)
  needed with dilution of 225 mg/mL 10 4.5 75 mg 0.35 mL 55 mg 0.25 mL 20 9 150 mg 0.7 mL 110 mg 0.5 mL 30 13.6 225 mg 1 mL 170 mg 0.75 mL 40 18.1 300 mg 1.35 mL 225 mg 1 mL 50 22.7 375 mg 1.7 mL 285 mg 1.25 mL

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  RECONSTITUTION Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  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 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.

  THIS PHARMACY BULK PACKAGE IS NOT INTENDED TO BE DISPENSED AS A UNIT

  Pharmacy Bulk Package

  Add Sterile Water for Injection, Bacteriostatic Water for Injection, or Sodium Chloride Injection according to the table below. SHAKE WELL. Use promptly. (Discard vial within 4 hours after initial entry.)

  Vial
   Size Amount of
  Diluent Approximate
  Concentration Approximate
  Available
  Volume 10 grams 45 mL 1 gram/5 mL 51 mL   96 mL 1 gram/10 mL 102  mL   ADMINISTRATION Intravenous Administration

  Intermittent or continuous infusion: Dilute reconstituted Cefazolin for injection in 50 to 100 mL of 1 of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer's Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer's Injection, USP

  5% Sodium Bicarbonate Injection, USP

  When reconstituted or diluted according to the instructions above, Cefazolin for injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41 °F). 

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

  Close
  No Recall

  More Info
• Orchid Healthcare (A Division Of Orchid Chemicals And Pharmaceuticals Ltd.)
  

  ×

  Cefazolin | Orchid Healthcare (a Division Of Orchid Chemicals And Pharmaceuticals Ltd.)

  

  ---

  Usual Adult Dosage Type of Infection Dose Frequency * ln rare instances, doses of up to 12 grams of Cefazolin for injection per day have been used. Moderate to severe infections 500mg to 1gram every 6 to 8 hrs. Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections
   (e.g., endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  1 gram IV administered 1/2 hour to 1 hour prior to the start of surgery. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure). 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) Cefazolin for injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for injection may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin for injection may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for injection in these patients is not recommended.

  Pediatric Dosage Guide Weight 25 mg/kg/day
  Divided into 3 Doses 25 mg/kg/day
  Divided into 4 Doses Lbs Kg Approximate Single Dose mg/q8h Vol.(mL)
  needed with
  dilution of 125 mg/mL Approximate Single Dose mg/q6h Vol.(mL)
  needed with dilution of 125 mg/mL 10 4.5 40 mg 0.35 mL 30 mg 0.25 mL 20 9 75 mg 0.6 mL 55 mg 0.45 mL 30 13.6 115 mg 0.9 mL 85 mg 0.7 mL 40 18.1 150 mg 1.2 mL 115 mg 0.9 mL 50 22.7 190 mg 1.5 mL 140 mg 1.1 mL Weight
    50 mg/kg/day
  Divided into 3 Doses 50 mg/kg/day
  Divided into 4 Doses Lbs Kg Approximate Single Dose mg/q8h Vol.(mL)
  needed with dilution of 225 mg/mL Approximate Single Dose mg/q6h Vol.(mL)
  needed with dilution of 225 mg/mL 10 4.5 75 mg 0.35 mL 55 mg 0.25 mL 20 9 150 mg 0.7 mL 110 mg 0.5 mL 30 13.6 225 mg 1 mL 170 mg 0.75 mL 40 18.1 300 mg 1.35 mL 225 mg 1 mL 50 22.7 375 mg 1.7 mL 285 mg 1.25 mL

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  RECONSTITUTION Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  When reconstituted or diluted according to the instructions below, Cefazolin for injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41 °F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  “Piggyback” Bottles

  Reconstitute with 50 to 100 mL of Sodium Chloride Injection or other IV solution listed under ADMINISTRATION. When adding diluent to vial, allow air to escape by using a small vent needle or by pumping the syringe. SHAKE WELL. Administer with primary IV fluids, as a single dose.

  ADMINISTRATION Intravenous Administration

  Intermittent or continuous infusion: Dilute reconstituted Cefazolin for injection in 50 to 100 mL of 1 of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer's Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer's Injection, USP

  5% Sodium Bicarbonate Injection, USP

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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  Cefazolin | Interchem Corporation

  

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  Usual Adult Dosage:

  *In rare instances, doses of up to 12 grams of CEFAZOLIN FOR INJECTION per day have been used.

  Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hours Mild infections caused by susceptible
  gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life threatening infections (e.g., endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours

  Perioperative Prophylactic Use: To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  1 gram IV or IM administered ½ hour to 1 hour prior to the start of surgery. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure). 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just (½ to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) CEFAZOLIN FOR INJECTION be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of CEFAZOLIN FOR INJECTION may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients With Reduced Renal Function: CEFAZOLIN FOR INJECTION may be used in patients with reduced renal function with the following dosage adjustments:

  Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given ½ the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given ½ the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

  Pediatric Dosage: In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of CEFAZOLIN FOR INJECTION in these patients is not recommended.

  Pediatric Dosage Guide Weight 25 mg/kg/day
  Divided into 3 Doses 25 mg/kg/day
  Divided into 4 Doses Lbs Kg Approximate Single Dose mg/q8h Vol. (mL) needed with dilution of
  125 mg/mL Approximate Single Dose mg/q6h Vol. (mL) needed with dilution of
  125 mg/mL 10 4.5 40 mg 0.35 ml 30 mg 0.25 ml 20 9 75 mg 0.6 ml 55 mg 0.45 ml 30 13.6 115 mg 0.9 ml 85 mg 0.7 ml 40 18.1 150 mg 1.2 ml 115 mg 0.9 ml 50 22.7 190 mg 1.5 ml 140 mg 1.1 ml Weight 50 mg/kg/day
  Divided into 3 Doses 50 mg/kg/day
  Divided into 4 Doses Lbs Kg Approximate Single Dose mg/q8h Vol. (mL) needed with dilution of
  225 mg/mL Approximate Single Dose mg/q6h Vol. (mL) needed with dilution of
  225 mg/mL 10 4.5 75 mg 0.35 ml 55 mg 0.25 ml 20 9 150 mg 0.7 ml 110 mg 0.5 ml 30 13.6 225 mg 1 ml 170 mg 0.75 ml 40 18.1 300 mg 1.35 ml 225 mg 1 ml 50 22.7 375 mg 1.7 ml 285 mg 1.25 ml

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

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  ---

  Intramuscular Administration - Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin should be injected into a large muscle mass. Pain on injection is infrequent with cefazolin.

  Intravenous Administration - Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion: Dilute reconstituted cefazolin in 50 to 100 mL of one of the following solutions:

  Sodium Chloride Injection, USP 5% or 10% Dextrose Injection, USP 5% Dextrose in Lactated Ringer's Injection, USP 5% Dextrose and 0.9% Sodium Chloride Injection, USP 5% Dextrose and 0.45% Sodium Chloride Injection, USP 5% Dextrose and 0.2% Sodium Chloride Injection, USP Lactated Ringer's Injection, USP Invert Sugar 5% or 10% in Sterile Water for Injection Ringer's Injection, USP 5% Sodium Bicarbonate Injection, USP

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• General Injectables & Vaccines, Inc.
  

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  Cefazolin | General Injectables & Vaccines, Inc.

  

  ---

  Usual Adult Dosage:

  Type of Infection
  Dose
  Frequency
  Moderate to severe infections
  500 mg to 1 gram
  every 6 to 8 hrs.
  Mild infections caused by susceptible gram + cocci
  250 mg to 500 mg
  every 8 hrs.
  Acute, uncomplicated urinary tract infections
  1 gram
  every 12 hrs.
  Pneumococcal pneumonia
  500 mg
  every 12 hrs
  Sever, life-threatening infections (e.g., endocarditis, septicemia)*
  1 gram to 1.5 grams
  every 6 hrs
  *In rare instances, doses of up to 12 grams of Cefazolin Injection, USP per day have been used
  
  Perioperative Prophylactic Use
  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:
  
  1. 1 gram IV administered 1/2 hour to 1 hour prior to start of surgery.
  2. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).
  3. 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.
  
  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.
  
  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.
  
  Dosage Adjustment for Patients With Reduced Renal Function
  Cefazolin Injection, USP may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3.0 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given ½ the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given ½ the usual dose every 18 to 24 hours.
  
  All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.
  
  Pediatric Dosage
  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin Injection, USP in these patients is not recommended.
  Pediatric Dosage Guide Weight
  
  25 mg/kg/day divided
  into 3 doses
  25 mg/kg/day divided
  into 4 doses
  
  Lbs
  Kg
  Approximate
  single dose
  mg/q8h
  Vol. (mL)
  needed
  with
  dilution of
  125 mg/mL
  Approximate
  single dose
  mg/q6h
  Vol. (mL)
  needed
  with
  dilution of
  125 mg/mL
  10 4.5 40 mg 0.35 mL
  30 mg
  0.25 mL
  20
  9.0
  75 mg
  0.60 mL
  55 mg
  0.45 mL
  30
  13.6
  115 mg
  0.90 mL
  85 mg
  0.70 mL
  40
  18.1
  150 mg
  1.20 mL
  115 mg
  0.90 mL
  50
  22.7
  190 mg
  1.50 mL
  140 mg
  1.10 mL
  
  Weight
  
  50 mg/kg/day
  divided into 3 doses
  
  50 mg/kg/day divided
  into 4 doses
  
  Lbs
  Kg
  Approximate
  single dose
  mg/q8h
  Vol. (mL)
  needed
  with
  dilution of 25 mg/mL
  Approximate
  single dose
  mg/q6h
  Vol. (mL)
  needed
  with
  dilution of
  225 mg/mL
  10
  4.5
  75 mg
  0.35 mL
  55 mg
  0.25 mL
  20
  9.0
  150 mg
  0.70 mL
  110 mg
  0.50 mL
  30
  13.6
  225 mg
  1.00 mL
  170 mg
  0.75 mL
  40
  18.1 300 mg
  1.35 mL
  225 mg
  1.00 mL
  50
  22.7
  375 mg
  1.70 mL
  285 mg
  1.25 mL
  
  
  
  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.
  
  RECONSTITUTION
  Preparation of Parenteral Solution
  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration.  If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.
  
  When reconstituted or diluted according to the instructions below, Cefazolin is stable for 24 hours at room temperature of for 10 days if stored under refrigeration (5 oC or 41 o F).  Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.
  
  Single dose Vial
  Form IM injection direct (bolus) injection of IV infusion, reconstitute with Sterile Water for Injection according to the following table.  SHAKE WELL. 
  Vial Size
  Amount of diluent
  Approximate
  concentration
  Appriximate
  Available volume
  500 mg
  2 mL
  225 mg/mL
  2.2 mL
  1 gram
  2.5 mL 330 mg/mL
  3 mL
  Infusion bottles
  Reconstitute with 50 to 100 mL of Sodium chloride Injection or other IV solution listed under ADMINISTRATION.  When adding diluent to vial, allow air to escape by using a small vent needle or by pumping the syringe.  SHAKE WELL.  Administer with primary IV fluids, as a single dose. 
  
  ADMINISTRATION
  Intramuscular Administration - Reconstitute vials with Sterile Water for Injection according to the dilution table above.  Shake well until dissolved.  Cefazolin should be injected into a large muscle mass.  Pain on injection is infrequent with cefazolin.
  
  Intravenous Administration - Direct (bolus) injection: following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection.  Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below). 
  
  Intermittent or continuous infusion: Dilute reconstituted cefazolin in 50 to 100 mL of one of the following solutions:
  Sodium Chloride Injection, USP 5% or 10% Dextrose Injection, USP 5% Dextrose in Lactated Ringer's Injection, USP 5% Dextrose and 0.9% Sodium Chloride Injection, USP 5% Dextrose and 0.45% Sodium Chloride Injection, USP 5% Dextrose and 0.2% Sodium Chloride Injection, USP Lactate Ringer's Injection, USP Invert Sugar 5% or 10% in Sterile Water for Injection Ringer's Injection, USP 5% Sodium Bicarbonate Injection, USP
  

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  Usual Adult Dosage Type of Infection Dose Frequency Moderate to severe infections
  500 mg to 1 gram
  every 6 to 8 hours
  Mild infections caused by susceptible gram-positive cocci
  250 mg to 500 mg
  every 8 hours
  Acute, uncomplicated urinary tract infections
  1 gram
  every 12 hours
  Pneumococcal pneumonia
  500 mg
  every 12 hours
  Severe, life-threatening infections (e.g., endocarditis,
  septicemia)*
  1 gram to 1.5 grams
  every 6 hours
  *In rare instances, doses of up to 12 grams of cefazolin per day have been used.
  
  Perioperative Prophylactic Use
  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:
  1. 1 gram IV or IM administered 1/2 hour to 1 hour prior to the start of surgery.
  
  2. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified     depending on the duration of the operative procedure).
  
  3. 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.
  
  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms. In surgery where the occurrence of infection may be particularly devastating (e.g., openheart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.
  
  Dosage Adjustment for Patients with Reduced Renal Function
  Cefazolin may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.
  
  Pediatric Dosage
  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of cefazolin in these patients is not recommended.
  
  Pediatric Dosage Guide Weight
  25 mg/kg/day
  Divided into 3 Doses
  
  25 mg/kg/day
  Divided into 4 Doses
  
  Lbs
  Kg
  Approximate Single Dose
  mg/q8h
  Vol. (mL) needed with dilution of 125
  mg/mL
  Approximate Single Dose
  mg/q6h
  Fol. (mL) needed with dilution of
  125 mg/mL
  10
  4.5
  40 mg
  0.35 mL
  30 mg
  0.25 mL
  20
  9
  75 mg
  0.6 mL
  55 mg
  0.45 mL
  30
  13.6
  115 mg
  0.9 mL
  85 mg
  0.7 mL
  40
  18.1
  150 mg
  1.2 mL
  115 mg
  0.9 mL
  50
  22.7
  190 mg
  1.5 mL
  140 mg
  1.1 mL
  
  Pediatric Dosage Guide Weight
  
  50 mg/kg/day
  Divided into 3 Doses
  
  50 mg/kg/day
  Divided into 4 Doses
  
  Lbs
  Kg
  Approximate Single
  Dose mg/q8h
  Vol. (mL) needed with
  dilution of 225 mg/mL
  Approximate single
  Dose mg/q6h
  Vol. (mL) needed with
  dilution of 225 mg/mL
  10
  4.5
  75 mb
  0.35 mL
  55 mg
  0.25 mL
  20
  9
  150 mg
  0.7 mL
  110 mg
  0.5 mL
  30
  13.6
  225 mg
  1 mL
  170 mg
  0.75 mL
  40
  18.1
  300 mg
  1.35 mL
  225 mg
  1 mL
  50
  22.7
  375 mg
  1.7 mL
  285 mg
  1.25 mL
  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.
  
  RECONSTITUTION
  
  Preparation of Parenteral Solution
  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded. When reconstituted or diluted according to the instructions below, cefazolin for injection USP is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.
  
  Single-Dose Vials
  For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.
  
  Vial Size Amount of Diluent Approximate
  Concentration Approximate
  Available Volume 500 mg
  2 mL
  225 mg/mL
  2.2 mL
  1 gram
  2.5 mL
  330 mg/mL
  3 mL
  
  ADMINISTRATION
  
  Intramuscular Administration
  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin for injection USP should be injected into a large muscle mass. Pain on injection is infrequent with cefazolin for injection USP.
  
  Intravenous Administration
  
  Direct (bolus) injection
  Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).
  
  Intermittent or continuous infusion
  Dilute reconstituted cefazolin for injection USP in 50 to 100 mL of one of the following solutions:
  Sodium Chloride Injection, USP
  5% or 10% Dextrose Injection, USP
  5% Dextrose in Lactated Ringer's Injection, USP
  5% Dextrose and 0.9% Sodium Chloride Injection, USP
  5% Dextrose and 0.45% Sodium Chloride Injection, USP
  5% Dextrose and 0.2% Sodium Chloride Injection, USP
  Lactated Ringer's Injection, USP
  Invert Sugar 5% or 10% in Sterile Water for Injection
  Ringer's Injection, USP
  5% Sodium Bicarbonate Injection, USP
  

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• Cardinal Health
  

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  Note: Cefazolin for Injection in the ADD-Vantage® Vial is not intended for direct intravenous injection.

  Usual Adult Dosage * In rare instances, doses of up to 12 grams of Cefazolin for Injection per day have been used. Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hrs. Mild infections caused by susceptible 250 mg to 500 mg every 8 hours gram-positive cocci Acute, uncomplicated urinary 1 gram every 12 hours tract infections Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections 1 gram to 1.5 grams every 6 hours (e.g., endocarditis, septicemia)* Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  a. 1 gram I.V. administered 1/2 hour to 1 hour prior to the start of surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram I.V. during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram I.V. every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) Cefazolin for Injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for Injection may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin for Injection may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg% or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg% can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg% should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg% or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for Injection in these patients is not recommended.

  Pediatric Dosage Guide Weight

  25 mg/kg/day

  Divided into 3 Doses

  25 mg/kg/day

  Divided into 4 Doses

  Lbs Kg Approximate Single Dose mg/q8h Vol. (mL) needed with dilution of 125 mg/mL Approximate Single Dose mg/q6h Vol. (mL) needed with dilution of 125 mg/mL 10 4.5 40 mg 0.35 mL 30 mg 0.25 mL 20 9 75 mg 0.6 mL 55 mg 0.45 mL 30 13.6 115 mg 0.9 mL 85 mg 0.7 mL 40 18.1 150 mg 1.2 mL 115 mg 0.9 mL 50 22.7 190 mg 1.5 mL 140 mg 1.1 mL Weight

  50 mg/kg/day

  Divided into 3 Doses

  50 mg/kg/day

  Divided into 4 Doses

  Lbs Kg Approximate Single Dose mg/q8h Vol. (mL) needed with dilution of 225 mg/mL Approximate Single Dose mg/q6h Vol. (mL) needed with dilution of 225 mg/mL 10 4.5 75 mg 0.35 mL 55 mg 0.25 mL 20 9 150 mg 0.7 mL 110 mg 0.5 mL 30 13.6 225 mg 1 mL 170 mg 0.75 mL 40 18.1 300 mg 1.35 mL 225 mg 1 mL 50 22.7 375 mg 1.7 mL 285 mg 1.25 mL

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

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  Cefazolin | Cardinal Health

  

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  Usual Adult Dosage * In rare instances, doses of up to 12 grams of Cefazolin for Injection per day have been used. Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hrs. Mild infections caused by susceptible gram-positive cocci

  250 mg to 500 mg

  every 8 hours

  Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia)*

  1 gram to 1.5 grams

  every 6 hours

  Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended doses are:

  a. 1 gram IV or IM administered 1/2 hour to 1 hour prior to the start of surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) Cefazolin for Injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for Injection may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin for Injection may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg% or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg% can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg% should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg% or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: see CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for Injection in these patients is not recommended.

  Pediatric Dosage Guide Weight

  25 mg/kg/day

  Divided into 3 Doses

  25 mg/kg/day

  Divided into 4 Doses lbs kg

  Approximate

  Single Dose

  (mg/q8 h)

  Vol. (mL)

  Needed with

  Dilution of

  125 mg/mL

  Approximate

  Single Dose

  (mg/q6 h)

  Vol. (mL)

  Needed with

  Dilution of

  125 mg/mL 10 4.5 40 mg 0.35 mL 30 mg 0.25 mL 20 9 75 mg 0.6 mL 55 mg 0.45 mL 30 13.6 115 mg 0.9 mL 85 mg 0.7 mL 40 18.1 150 mg 1.2 mL 115 mg 0.9 mL 50 22.7 190 mg 1.5 mL 140 mg 1.1 mL Weight

  50 mg/kg/day

  Divided into 3 Doses

  50 mg/kg/day

  Divided into 4 Doses lbs kg

  Approximate

  Single Dose

  (mg/q8 h)

  Vol. (mL)

  Needed with

  Dilution of

  225 mg/mL

  Approximate

  Single Dose

  (mg/q6 h)

  Vol. (mL)

  Needed with

  Dilution of

  225 mg/mL 10 4.5 75 mg 0.35 mL 55 mg 0.25 mL 20 9 150 mg 0.7 mL 110 mg 0.5 mL 30 13.6 225 mg 1 mL 170 mg 0.75 mL 40 18.1 300 mg 1.35 mL 225 mg 1 mL 50 22.7 375 mg 1.7 mL 285 mg 1.25 mL

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

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  Cefazolin | App Pharmaceuticals, Llc

  

  ---

  After constitution, cefazolin can be administered by parenteral administration. However, the intent of this pharmacy bulk package is for the preparation of the solutions for intravenous infusion only.

  Usual Adult Dosage

  Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hours

  Mild infections caused by susceptible

  gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours

   *In rare instances, doses of up to 12 grams of cefazolin per day have been used.

  Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  a. 1 gram IV administered ½ hour to 1 hour prior to the start of surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just prior (one half to 1 hour) to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients With Reduced Renal Function

  Cefazolin may be used in patients with reduced renal function with the following dosage adjustments. Patients with a creatinine clearance of 55 mL/min or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given one half the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min or less or serum creatinine of 4.6 mg % or greater should be given one half the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialisi, see CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg/kg (approximately 10 to 20 mg /lb) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg/kg (45 mg/lb) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of cefazolin in these patients is not recommended.

  Pediatric Dosage Guide Weight

  25 mg/kg/day

  Divided into 3 Doses

  25 mg/kg/day

  Divided into 4 Doses lbs kg Approximate Single Dose mg/q8h

  Vol. (mL) needed with dilution of

  125 mg/mL Approximate Single Dose mg/q6h

  Vol. (mL) needed with dilution of

  125 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  40 mg

  75 mg

  115 mg

  150 mg

  190 mg

  0.35 mL

  0.6 mL

  0.9 mL

  1.2 mL

  1.5 mL

  30 mg

  55 mg

  85 mg

  115 mg

  140 mg

  0.25 mL

  0.45 mL

  0.7 mL

  0.9 mL

  1.1 mL Weight

  50 mg/kg/day

  Divided into 3 Doses

  50 mg/kg/day

  Divided into 4 Doses lbs kg Approximate Single Dose mg/q8h

  Vol. (mL) needed with dilution of

  225 mg/mL Approximate Single Dose mg/q6h

  Vol. (mL) needed with dilution of

  225 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  75 mg

  150 mg

  225 mg

  300 mg

  375 mg

  0.35 mL

  0.7 mL

  1 mL

  1.35 mL

  1.7 mL

  55 mg

  110 mg

  170 mg

  225 mg

  285 mg

  0.25 mL

  0.5 mL

  0.75 mL

  1 mL

  1.25 mL

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min), 60% of the normal daily dosage given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min), 25% of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min) may be given 10% of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  a. 1 gram IV administered ½ hour to 1 hour prior to the start of surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just prior (one half to 1 hour) to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients With Reduced Renal Function

  Cefazolin may be used in patients with reduced renal function with the following dosage adjustments. Patients with a creatinine clearance of 55 mL/min or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given one half the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min or less or serum creatinine of 4.6 mg % or greater should be given one half the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialisi, see CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg/kg (approximately 10 to 20 mg /lb) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg/kg (45 mg/lb) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of cefazolin in these patients is not recommended.

  Pediatric Dosage Guide Weight

  25 mg/kg/day

  Divided into 3 Doses

  25 mg/kg/day

  Divided into 4 Doses lbs kg Approximate Single Dose mg/q8h

  Vol. (mL) needed with dilution of

  125 mg/mL Approximate Single Dose mg/q6h

  Vol. (mL) needed with dilution of

  125 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  40 mg

  75 mg

  115 mg

  150 mg

  190 mg

  0.35 mL

  0.6 mL

  0.9 mL

  1.2 mL

  1.5 mL

  30 mg

  55 mg

  85 mg

  115 mg

  140 mg

  0.25 mL

  0.45 mL

  0.7 mL

  0.9 mL

  1.1 mL Weight

  50 mg/kg/day

  Divided into 3 Doses

  50 mg/kg/day

  Divided into 4 Doses lbs kg Approximate Single Dose mg/q8h

  Vol. (mL) needed with dilution of

  225 mg/mL Approximate Single Dose mg/q6h

  Vol. (mL) needed with dilution of

  225 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  75 mg

  150 mg

  225 mg

  300 mg

  375 mg

  0.35 mL

  0.7 mL

  1 mL

  1.35 mL

  1.7 mL

  55 mg

  110 mg

  170 mg

  225 mg

  285 mg

  0.25 mL

  0.5 mL

  0.75 mL

  1 mL

  1.25 mL

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min), 60% of the normal daily dosage given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min), 25% of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min) may be given 10% of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  Intermittent or continuous infusion

  Intermittent or continuous infusion-Dilute reconstituted Cefazolin for Injection, USP in 50 to 100 mL of one of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer’s Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer’s Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer’s Injection, USP

  5% Sodium Bicarbonate Injection, USP

  When diluted according to the instructions above, cefazolin is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F).

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

  Intermittent or continuous infusion

  Intermittent or continuous infusion-Dilute reconstituted Cefazolin for Injection, USP in 50 to 100 mL of one of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer’s Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer’s Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer’s Injection, USP

  5% Sodium Bicarbonate Injection, USP

  When diluted according to the instructions above, cefazolin is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F).

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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  Cefazolin | App Pharmaceuticals, Llc

  

  ---

  Usual Adult Dosage:

  Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hours Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life threatening infections (e.g., endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours

   *In rare instances, doses of up to 12 grams of cefazolin per day have been used.

  Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended doses are:

  a. 1 gram IV or IM administered one half to 1 hour prior to the start of surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just prior (one half to 1 hour) to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin may be used in patients with reduced renal function with the following dosage adjustments. Patients with a creatinine clearance of 55 mL/min or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min or serum creatinine of 3.1 to 4.5 mg % should be given one half the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min or less or serum creatinine of 4.6 mg % or greater should be given one half the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis, see CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg/kg (approximately 10 to 20 mg/lb) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg/kg (45 mg/lb) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of cefazolin in these patients is not recommended.

  Pediatric Dosage Guide

  Weight 25 mg/kg/day Divided into 3 Doses lbs kg

  Approximate Single Dose

  mg/q8h Vol (mL) needed with dilution of 125 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  40 mg

  75 mg

  115 mg

  150 mg

  190 mg

  0.35 mL

  0.6 mL

  0.9 mL

  1.2 mL

  1.5 mL Weight 25 mg/kg/day Divided into 4 Doses lbs kg

  Approximate Single Dose

  mg/q6h Vol (mL) needed with dilution of 125 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  30 mg

  55 mg

  85 mg

  115 mg

  140 mg

  0.25 mL

  0.45 mL

  0.7 mL

  0.9 mL

  1.1 mL Weight 50 mg/kg/day Divided into 3 Doses lbs kg

  Approximate Single Dose

  mg/q8h Vol (mL) needed with dilution of 225 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  75 mg

  150 mg

  225 mg

  300 mg

  375 mg

  0.35 mL

  0.7 mL

  1 mL

  1.35 mL

  1.7 mL Weight 50 mg/kg/day Divided into 4 Doses lbs kg

  Approximate Single Dose

  mg/q6h Vol (mL) needed with dilution of 225 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  55 mg

  110 mg

  170 mg

  225 mg

  285 mg

  0.25 mL

  0.5 mL

  0.75 mL

  1 mL

  1.25 mL

   

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min), 60% of the normal daily dosage given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min), 25% of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min) may be given 10% of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended doses are:

  a. 1 gram IV or IM administered one half to 1 hour prior to the start of surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just prior (one half to 1 hour) to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin may be used in patients with reduced renal function with the following dosage adjustments. Patients with a creatinine clearance of 55 mL/min or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min or serum creatinine of 3.1 to 4.5 mg % should be given one half the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min or less or serum creatinine of 4.6 mg % or greater should be given one half the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis, see CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg/kg (approximately 10 to 20 mg/lb) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg/kg (45 mg/lb) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of cefazolin in these patients is not recommended.

  Pediatric Dosage Guide

  Weight 25 mg/kg/day Divided into 3 Doses lbs kg

  Approximate Single Dose

  mg/q8h Vol (mL) needed with dilution of 125 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  40 mg

  75 mg

  115 mg

  150 mg

  190 mg

  0.35 mL

  0.6 mL

  0.9 mL

  1.2 mL

  1.5 mL Weight 25 mg/kg/day Divided into 4 Doses lbs kg

  Approximate Single Dose

  mg/q6h Vol (mL) needed with dilution of 125 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  30 mg

  55 mg

  85 mg

  115 mg

  140 mg

  0.25 mL

  0.45 mL

  0.7 mL

  0.9 mL

  1.1 mL Weight 50 mg/kg/day Divided into 3 Doses lbs kg

  Approximate Single Dose

  mg/q8h Vol (mL) needed with dilution of 225 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  75 mg

  150 mg

  225 mg

  300 mg

  375 mg

  0.35 mL

  0.7 mL

  1 mL

  1.35 mL

  1.7 mL Weight 50 mg/kg/day Divided into 4 Doses lbs kg

  Approximate Single Dose

  mg/q6h Vol (mL) needed with dilution of 225 mg/mL

  10

  20

  30

  40

  50

  4.5

  9

  13.6

  18.1

  22.7

  55 mg

  110 mg

  170 mg

  225 mg

  285 mg

  0.25 mL

  0.5 mL

  0.75 mL

  1 mL

  1.25 mL

   

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min), 60% of the normal daily dosage given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min), 25% of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min) may be given 10% of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  Intramuscular Administration

  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin for Injection, USP should be injected into a large muscle mass. Pain on injection is infrequent with Cefazolin for Injection, USP.

  Intravenous Administration

  Direct (bolus) injection–Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion–Dilute reconstituted Cefazolin for Injection, USP in 50 to 100 mL of one of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer’s Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer’s Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer’s Injection, USP

  5% Sodium Bicarbonate Injection, USP

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

  Intramuscular Administration

  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin for Injection, USP should be injected into a large muscle mass. Pain on injection is infrequent with Cefazolin for Injection, USP.

  Intravenous Administration

  Direct (bolus) injection–Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion–Dilute reconstituted Cefazolin for Injection, USP in 50 to 100 mL of one of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer’s Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer’s Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer’s Injection, USP

  5% Sodium Bicarbonate Injection, USP

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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• Dispensing Solutions, Inc.
  

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  Cefazolin | Dispensing Solutions, Inc.

  

  ---

  Usual Adult Dosage

  *In rare instances, doses of up to 12 grams of cefazolin per day have been used.

  Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hours Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  1 gram IV or IM administered 1/2 hour to 1 hour prior to the start of surgery. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure). 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) cefazolin for injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin for injection may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients With Reduced Renal Function

  Cefazolin may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg/kg (approximately 10 to 20 mg/lb) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg/kg (45 mg/lb) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of cefazolin in these patients is not recommended.

  Pediatric Dosage Guide
  Weight 25 mg/kg/day
  Divided into 3 Doses 25 mg/kg/day
  Divided into 4 Doses Lbs Kg Approximate Single Dose mg/q8h Vol. (mL) needed with dilution of 125 mg/mL Approximate Single Dose mg/q6h Vol. (mL) needed with dilution of
  125 mg/mL 10 4.5 40 mg 0.35 mL 30 mg 0.25 mL 20 9 75 mg 0.6 mL 55 mg 0.45 mL 30 13.6 115 mg 0.9 mL 85 mg 0.7 mL 40 18.1 150 mg 1.2 mL 115 mg 0.9 mL 50 22.7 190 mg 1.5 mL 140 mg 1.1 mL
  Weight 50 mg/kg/day
  Divided into 3 Doses 50 mg/kg/day
  Divided into 4 Doses Lbs Kg Approximate Single Dose mg/q8h Vol. (mL) needed with dilution of 225 mg/mL Approximate Single Dose mg/q6h Vol. (mL) needed with dilution of 225 mg/mL 10 4.5 75 mg 0.35 mL 55 mg 0.25 mL 20 9 150 mg 0.7 mL 110 mg 0.5 mL 30 13.6 225 mg 1 mL 170 mg 0.75 mL 40 18.1 300 mg 1.35 mL 225 mg 1 mL 50 22.7 375 mg 1.7 mL 285 mg 1.25 mL

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  Reconstitution Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  When reconstituted or diluted according to the instructions below, Cefazolin for Injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F).

  Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Single-Dose Vials

  For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.

  
  Vial Size Amount of Diluent Approximate
  Concentration Approximate
  Available Volume 500 mg 2 mL 225 mg/mL 2.2 mL 1 g 2.5 mL 330 mg/mL 3 mL Administration Intramuscular Administration

  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin for Injection should be injected into a large muscle mass. Pain on injection is infrequent with Cefazolin for Injection.

  Intravenous Administration

  Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection in 50 to 100 mL of 1 of the following solutions:

  Sodium Chloride Injection, USP
  5% or 10% Dextrose Injection, USP
  5% Dextrose in Lactated Ringer's Injection, USP
  5% Dextrose and 0.9% Sodium Chloride Injection, USP
  5% Dextrose and 0.45% Sodium Chloride Injection, USP
  5% Dextrose and 0.2% Sodium Chloride Injection, USP
  Lactated Ringer's Injection, USP
  Invert Sugar 5% or 10% in Sterile Water for Injection
  Ringer's Injection, USP
  5% Sodium Bicarbonate Injection, USP

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• Hospira, Inc.
  

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  Cefazolin | Hospira, Inc.

  

  ---

  Usual Adult Dosage Type of Infection  
    Dose   Frequency * ln rare instances, doses of up to 12 grams of cefazolin for injection per day have been used Moderate to severe infections   500 mg to 1 gram   every 6 to 8 hrs. Mild infections caused by susceptible gram–positive cocci   250 mg to 500 mg   every 8 hours Acute, uncomplicated urinary tract infections   1 gram   every 12 hours Pneumococcal pneumonia   500 mg   every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia)*   1 gram to 1.5 grams   every 6 hours Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  a. 1 gram IV or IM administered 1/2 hour to 1 hour prior to the start of  surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours  postoperatively.

  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) Cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin for injection may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin may be used in patients with reduced renal function with the following dosage adjustments:  Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses.  Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals.  Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for injection in these patients is not recommended.

  Pediatric Dosage Guide Weight
     25 mg/kg/Day
  Divided into 3 Doses  25 mg/kg/Day
  Divided into 4 Doses Lbs
   
    Kg
    Approximate
  Single Dose
  mg/q8h Vol. (mL)
  needed with
  dilution of
  125 mg/mL Approximate
  Single Dose
  mg/q6h
    Vol. (mL)
  needed with
  dilution of
  125 mg/mL 10 4.5 40 mg 0.35 mL 30 mg 0.25 mL 20 9 75 mg 0.6 mL 55 mg 0.45 mL 30 13.6 115 mg 0.9 mL 85 mg 0.7 mL 40 18.1 150 mg 1.2 mL 115 mg 0.9 mL 50 22.7 190 mg 1.5 mL 140 mg 1.1 mL Weight 50 mg/kg/Day
  Divided into 3 Doses 50 mg/kg/Day
  Divided into 4 Doses Lbs Kg Approximate
  Single Dose
  mg/q8h Vol. (mL)
  needed with
  dilution of
  225 mg/mL Approximate
  Single Dose
  mg/q6h Vol. (mL)
  needed with
  dilution of
  225 mg/mL 10 4.5 75 mg 0.35 mL 55 mg 0.25 mL 20 9 150 mg 0.7 mL 110 mg 0.5 mL 30 13.6 225 mg 1 mL 170 mg 0.75 mL 40 18.1 300 mg 1.35 mL 225 mg 1 mL 50 22.7 375 mg 1.7 mL 285 mg 1.25 mL

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient.  In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate.  Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  RECONSTITUTION Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration.  If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  When reconstituted or diluted according to the instructions below, cefazolin for injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41 °F).  Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Single-Dose Vials

  For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.

  Vial size Amount of Diluent Approximate Concentration Approximate Available Volume 1 gram 2.5 mL 330 mg/mL 3 mL ADMINISTRATION Intramuscular Administration

  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin should be injected into a large muscle mass. Pain on injection is infrequent with cefazolin.

  Intravenous Administration

  Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion: Dilute reconstituted cefazolin in 50 to 100 mL of 1 of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer's Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer's Injection, USP

  5% Sodium Bicarbonate Injection, USP

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• General Injectables & Vaccines, Inc
  

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  Cefazolin | General Injectables & Vaccines, Inc

  

  ---

  Usual Adult Dosage
  Type of Infection
  Dose
  Frequency
  Moderate to severe infections
  500 mg to 1 gram
  every 6 to 8 hrs
  Mild infections caused by susceptible gram-positive cocci
  250 mg to 500 mg
  every 8 hours
  Acute, uncomplicated urinary tract infections
  1 gram
  every 12 hours
  Pneumococcal pneumonia
  500 mg
  every 12 hours
  Severe, life-threatening infection (e.g., endocarditis, septicemia)*
  1 gram to 1.5 grams
  every 6 hours
  * In rare instances, doses of up to 12 grams of Cefazonlin for Injection per day have been used.
  
  
  Perioperative Prophylactic Use
  
  To prevent postoperative infection in contaminated or potentially contaminated surgery, the recommended doses are:
  
  a. 1 gram IV or IM administered 1/2 hour to 1 hour prior to the start of surgery.
  
  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).
  
  c. 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.
  
  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) Cefazolin for Injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.
  
  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for Injection may be continued for 3 to 5 days following the completion of surgery.
   
  Dosage Adjustment for Patients with Reduced Renal Function
  Cefazolin for Injection may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg% or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg% can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg% should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg% or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: see   CLINICAL PHARMACOLOGY.
    
  Pediatric Dosage
  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for Injection in these patients is not recommended.
  
  Pediatric Dosage Guide
  
  25 mg/kg/day
  
  25 mg/kg/day
  
  
  Weight
  Divided into 3 Doses
  
  Divided into 4 Doses
  
  
  
  Approximate
  Vol (mL)
  Approximate
  Vol. (mL)
  
  
  Single Dose
  Needed with
  Single Dose
   Needed with
  
  lbs kg
  
  125 mg/mL
  
  125 mg/mL
  
  10 4.5
  40 mg
  0.35 mL
  30 mg
  0.25 mL
  
  20 9
  75 mg
  0.6 mL
  55 mg
  0.45 mL
  
  30 13.6
  115 mg
  0.9 mL
  85 mg
  0.7 mL
  
  40 18.1
  150 mg
  1.2 mL
  115 mg
  0.9 mL
  
  50 22.7
  190 mg
  1.5 mL
  140 mg
  1.1 mL
  
  
  50 mg/kg/day
  
  50 mg/kg/day
  
  
  Weight
  Divided Into 3 Doses
  
  Divided into 4 Doses
  
  
  
  Approximate
  Vol. (mL)
  Approximate
  Vol. (mL)
  
  
  Single Dose
  Needed with
  Single Dose
  Needed with
  
  
  (mg/q8 h)
  Dilution of
  (mg/q6 h)
  Dilution of
  
  lbs kg
  
  225 mg/mL
  
  225 mg/mL
  
  10 4.5
  75 mg
  0.35 mL
  55 mg
  0.25 mL
  
  20 9
  150 mg
  0.7 mL
  110 mg
  0.5 mL
  
  30 13.6
  225 mg
  1 mL
  170 mg
  0.75 mL
  
  40 18.1
  300 mg
  1.35 mL
  225 mg
  1 mL
  
  50 22.7
  375 mg
  1.7 mL
  285 mg
  1.25 mL
  
  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.
  
  RECONSTITUTION   Preparation of Parenteral Solution
  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.
  
  When reconstituted or diluted according to the instructions below, cefazolin is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.
  
  Single-Dose Vials
  For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.
  
  Vial Size
  Amount of Diluent
  Approximate Concentration
  Approximate Available Volume
  500 mg
  2 mL
  225 mg/mL
  2.2 mL
  1 gram
  2.5 mL
  330 mg/mL
  3 mL
  ADMINISTRATION   Intramuscular Administration
  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin for Injection should be injected into a large muscle mass. Pain on injection is infrequent with Cefazolin for Injection.
  
  Intravenous Administration
  Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).
  
  Intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection in 50 to 100 mL of 1 of the following solutions:
  
  Sodium Chloride Injection, USP
  
  5% or 10% Dextrose Injection, USP
  
  5% Dextrose in Lactated Ringer’s Injection, USP
  
  5% Dextrose and 0.9% Sodium Chloride Injection, USP
  
  5% Dextrose and 0.45% Sodium Chloride Injection, USP
  
  5% Dextrose and 0.2% Sodium Chloride Injection, USP
  
  Lactated Ringer’s Injection, USP
  
  
  Ringer’s Injection, USP
  
  5% Sodium Bicarbonate Injection, USP
  
  

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• Apotex Corp
  

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  Cefazolin | Apotex Corp

  

  ---

  Usual Adult Dosage

  Type of Infection Dose Frequency * In rare instances, doses of up to 12 grams of Cefazolin for injection per day have been used. Moderate to severe infections 500 mg to 1 gram every 6 to 8 hrs Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours

  Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  a. 1 gram IV administered 1/2 hour to 1 hour prior to the start of surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) Cefazolin for injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for injection may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin for injection may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for injection in these patients is not recommended.

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient.  In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  RECONSTITUTION

  Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  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 after reconstitution 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 4HOURS 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.

  THIS PHARMACY BULK PACKAGE IS NOT INTENDED TO BE DISPENSED AS A UNIT

  Pharmacy Bulk Package

  Add Sterile Water for Injection, Bacteriostatic Water for Injection, or Sodium Chloride Injection according to the table below. SHAKE WELL. Use promptly. (Discard vial within 4 hours after initial entry.)

  Vial Size Amount of
  Diluent Approximate Concentration Approximate
      Available
     Volume 10 grams 45 mL
  96 mL 1 gram/5 mL
  1 gram/10 mL 51 mL
  102 mL 

  ADMINISTRATION

  Intravenous Administration

  Intermittent or continuous infusion: Dilute reconstituted Cefazolin for injection in 50 to 100 mL of 1 of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer's Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer's Injection, USP

  5% Sodium Bicarbonate Injection, USP

  When diluted according to the instructions above, Cefazolin is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). 

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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• Apotex Corp
  

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  Cefazolin | Apotex Corp

  

  ---

  Usual Adult Dosage Type of Infection  
    Dose   Frequency * ln rare instances, doses of up to 12 grams of cefazolin for injection per day have been used Moderate to severe infections   500 mg to 1 gram   every 6 to 8 hrs. Mild infections caused by susceptible gram–positive cocci   250 mg to 500 mg   every 8 hours Acute, uncomplicated urinary tract infections   1 gram   every 12 hours Pneumococcal pneumonia   500 mg   every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia)*   1 gram to 1.5 grams   every 6 hours

  Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  a. 1 gram IV or IM administered 1/2 hour to 1 hour prior to the start of surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours  postoperatively.

  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) Cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin for injection may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses.  Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for injection in these patients is not recommended.

  Pediatric Dosage Guide Weight 25 mg/kg/day
  Divided into 3 Doses 25 mg/kg/day
  Divided into 4 Doses Lbs Kg Approximate
  Single Dose
  mg/q8h Vol. (mL)
  needed with
  dilution of
  125 mg/mL Approximate
  Single Dose
  mg/q6h Vol. (mL)
  needed with
  dilution of
  125 mg/mL 10 4.5 40 mg 0.35 mL 30 mg 0.25 mL 20 9 75 mg 0.6 mL 55 mg 0.45 mL 30 13.6 115 mg 0.9 mL 85 mg 0.7 mL 40 18.1 150 mg 1.2 mL 115 mg 0.9 mL 50 22.7 190 mg 1.5 mL 140 mg 1.1 mL Weight 50 mg/kg/day
  Divided into 3 Doses 50 mg/kg/day
  Divided into 4 Doses Lbs Kg Approximate
  Single Dose
  mg/q8h Vol. (mL)
  needed with
  dilution of
  225 mg/mL Approximate
  Single Dose
  mg/q6h Vol. (mL)
  needed with
  dilution of
  225 mg/mL 10 4.5 75 mg 0.35 mL 55 mg 0.25 mL 20 9 150 mg 0.7 mL 110 mg 0.5 mL 30 13.6 225 mg 1 mL 170 mg 0.75 mL 40 18.1 300 mg 1.35 mL 225 mg 1 mL 50 22.7 375 mg 1.7 mL 285 mg 1.25 mL

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of  70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient.  In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate.  Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  RECONSTITUTION

  Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration.  If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  When reconstituted or diluted according to the instructions below, cefazolin for injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F).  Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Single-Dose Vials

  For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.

  Vial size Amount of Diluent Approximate Concentration Approximate Available Volume 500 mg 2 mL 225 mg/mL 2.2 mL 1 g 2.5 mL 330 mg/mL 3 mL

  ADMINISTRATION

  Intramuscular Administration:

  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin should be injected into a large muscle mass. Pain on injection is infrequent with cefazolin.

  Intravenous Administration:

  Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion: Dilute reconstituted cefazolin in 50 to 100 mL of 1 of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer's Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer's Injection, USP

  5% Sodium Bicarbonate Injection, USP

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• General Injectables & Vaccines, Inc
  

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  Cefazolin | General Injectables & Vaccines, Inc

  

  ---

  Usual Adult Dosage
  
  
  Type of Infection
  Dose
  Frequency
  Moderate to severe infections
  500 mg to 1 gram
  every 6 to 8 hours
  Mild infections caused by susceptivle gram-positive cocci
  250 mg to 500 mg
  every 8 hours
  Acute, uncomplicated urinary tract infections
  1 gram
  every 12 hours
  Pneumocaocal pneumonia
  500 mg
  every 12 hours
  Severe, life-threatening infections (e.g., endocarditis, septicemia) (1)
  1 gram to 1.5 grams
  every 6 hours
  (1) In rare instances, doses of up to 12 grams of cefazolin for injection per day have been used
  
  
  
  Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  a. 1 gram IV or IM administered 1/2 hour to 1 hour prior to the start of surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) Cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin for injection may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for injection in these patients is not recommended.

  Pediatric Dosage Guide Weight
  25 mg/kg/Day
  Divided into 3 Doses 25 mg/kg/Day
  Divided into 4 Doses Lbs
  
  Kg
  Approximate
  Single Dose
  mg/q8h Vol. (mL)
  needed with
  dilution of
  125 mg/mL Approximate
  Single Dose
  mg/q6h
  Vol. (mL)
  needed with
  dilution of
  125 mg/mL 10 4.5 40 mg 0.35 mL 30 mg 0.25 mL 20 9 75 mg 0.6 mL 55 mg 0.45 mL 30 13.6 115 mg 0.9 mL 85 mg 0.7 mL 40 18.1 150 mg 1.2 mL 115 mg 0.9 mL 50 22.7 190 mg 1.5 mL 140 mg 1.1 mL Weight 50 mg/kg/Day
  Divided into 3 Doses 50 mg/kg/Day
  Divided into 4 Doses Lbs Kg Approximate
  Single Dose
  mg/q8h Vol. (mL)
  needed with
  dilution of
  225 mg/mL Approximate
  Single Dose
  mg/q6h Vol. (mL)
  needed with
  dilution of
  225 mg/mL 10 4.5 75 mg 0.35 mL 55 mg 0.25 mL 20 9 150 mg 0.7 mL 110 mg 0.5 mL 30 13.6 225 mg 1 mL 170 mg 0.75 mL 40 18.1 300 mg 1.35 mL 225 mg 1 mL 50 22.7 375 mg 1.7 mL 285 mg 1.25 mL

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  RECONSTITUTION Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  When reconstituted or diluted according to the instructions below, cefazolin for injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41 °F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Single-Dose Vials

  For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.

  Vial size Amount of Diluent Approximate Concentration Approximate Available Volume 1 gram 2.5 mL 330 mg/mL 3 mL ADMINISTRATION Intramuscular Administration

  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin should be injected into a large muscle mass. Pain on injection is infrequent with cefazolin.

  Intravenous Administration

  Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion: Dilute reconstituted cefazolin in 50 to 100 mL of 1 of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer's Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer's Injection, USP

  5% Sodium Bicarbonate Injection, USP

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• Hospira, Inc.
  

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  Cefazolin | Hospira, Inc.

  

  ---

  Usual Adult Dosage

  Type of Infection Dose Frequency * In rare instances, doses of up to 12 grams of Cefazolin for injection per day have been used. Moderate to severe infections 500 mg to 1 gram every 6 to 8 hrs Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia*) 1 gram to 1.5 grams every 6 hours

  Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  a. 1 gram IV administered 1/2 hour to 1 hour prior to the start of surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) Cefazolin for injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for injection may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin for injection may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for injection in these patients is not recommended.

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient.  In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  RECONSTITUTION

  Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  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 after reconstitution 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 4HOURS 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.

  THIS PHARMACY BULK PACKAGE IS NOT INTENDED TO BE DISPENSED AS A UNIT.

  Pharmacy Bulk Package

  Add Sterile Water for Injection, Bacteriostatic Water for Injection, or Sodium Chloride Injection according to the table below. SHAKE WELL. Use promptly. (Discard vial within 4 hours after initial entry.)

  Vial Size Amount of
  Diluent Approximate Concentration Approximate
      Available
     Volume 10 grams 45 mL
  96 mL 1 gram/5 mL
  1 gram/10 mL 51 mL
  102 mL 

  ADMINISTRATION

  Intravenous Administration

  Intermittent or continuous infusion: Dilute reconstituted Cefazolin for injection in 50 to 100 mL of 1 of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer's Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer's Injection, USP

  5% Sodium Bicarbonate Injection, USP

  When diluted according to the instructions above, Cefazolin is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). 

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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• App Pharmaceuticals, Llc
  

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  Cefazolin | App Pharmaceuticals, Llc

  

  ---

  After reconstitution, the intent of this Cefazolin for Injection, USP pharmacy bulk package is for the preparation of the solutions for intravenous infusion only.

  Usual Adult Dosage Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hours Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours

  *In rare instances, doses of up to 12 grams of cefazolin per day have been used.

  Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  a. 1 gram IV administered ½  hour to 1 hour prior to the start of surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just (½  to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) cefazolin for injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin for injection may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients With Reduced Renal Function

  Cefazolin may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given ½ the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given ½  the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg/kg (approximately 10 to 20 mg/lb) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg/kg (45 mg/lb) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of cefazolin in these patients is not recommended.

   

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  Reconstitution Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Directions for Proper Use of Pharmacy Bulk Package – NOT FOR DIRECT INFUSION

  The 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 closure may be penetrated only one time after reconstitution using a suitable sterile dispensing set that allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage. After entry, use entire contents of bottle promptly. The entire contents of the bottle should be dispensed within 4 hours of initial entry. Discard Pharmacy Bulk Package bottle within 4 hours after initial entry.

  Pharmacy Bulk Bottles

  Add Sterile Water for Injection, Bacteriostatic Water for Injection, or Sodium Chloride Injection according to the table below. SHAKE WELL. Use promptly. (Discard bottle within 4 hours after initial entry.)

  Bottle Size Amount of Diluent Approximate Concentration Approximate Available Volume 10 grams 45 mL 1 gram/5 mL 51 mL 10 grams 96 mL 1 gram/10 mL 102 mL 20 grams 90 mL 1 gram/5 mL 102 mL

  For ease of dispensing, invert reconstituted bottle and hang by bail band in a laminar flow hood. Dispense aliquots from the bottle into the infusion fluids using a suitable sterile dispensing device. See Intermittent Intravenous Infusion for suitable infusion fluids.

  Administration Intravenous Administration

  Intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection in 50 to 100 mL of 1 of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer’s Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer’s Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer’s Injection, USP

  5% Sodium Bicarbonate Injection, USP

  When diluted according to the instructions above, cefazolin is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

  Close
  No Recall

  More Info
• Cardinal Health
  

  ×

  Cefazolin | Cardinal Health

  

  ---

  Usual Adult Dosage Type of Infection  
    Dose   Frequency * ln rare instances, doses of up to 12 grams of cefazolin for injection per day have been used Moderate to severe infections   500 mg to 1 gram   every 6 to 8 hrs. Mild infections caused by susceptible gram–positive cocci   250 mg to 500 mg   every 8 hours Acute, uncomplicated urinary tract infections   1 gram   every 12 hours Pneumococcal pneumonia   500 mg   every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia)*   1 gram to 1.5 grams   every 6 hours

  Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  a. 1 gram IV or IM administered 1/2 hour to 1 hour prior to the start of surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours  postoperatively.

  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) Cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin for injection may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses.  Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for injection in these patients is not recommended.

  Pediatric Dosage Guide Weight 25 mg/kg/day
  Divided into 3 Doses 25 mg/kg/day
  Divided into 4 Doses Lbs Kg Approximate
  Single Dose
  mg/q8h Vol. (mL)
  needed with
  dilution of
  125 mg/mL Approximate
  Single Dose
  mg/q6h Vol. (mL)
  needed with
  dilution of
  125 mg/mL 10 4.5 40 mg 0.35 mL 30 mg 0.25 mL 20 9 75 mg 0.6 mL 55 mg 0.45 mL 30 13.6 115 mg 0.9 mL 85 mg 0.7 mL 40 18.1 150 mg 1.2 mL 115 mg 0.9 mL 50 22.7 190 mg 1.5 mL 140 mg 1.1 mL Weight 50 mg/kg/day
  Divided into 3 Doses 50 mg/kg/day
  Divided into 4 Doses Lbs Kg Approximate
  Single Dose
  mg/q8h Vol. (mL)
  needed with
  dilution of
  225 mg/mL Approximate
  Single Dose
  mg/q6h Vol. (mL)
  needed with
  dilution of
  225 mg/mL 10 4.5 75 mg 0.35 mL 55 mg 0.25 mL 20 9 150 mg 0.7 mL 110 mg 0.5 mL 30 13.6 225 mg 1 mL 170 mg 0.75 mL 40 18.1 300 mg 1.35 mL 225 mg 1 mL 50 22.7 375 mg 1.7 mL 285 mg 1.25 mL

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of  70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient.  In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate.  Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  RECONSTITUTION

  Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration.  If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  When reconstituted or diluted according to the instructions below, cefazolin for injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F).  Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Single-Dose Vials

  For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.

  Vial size Amount of Diluent Approximate Concentration Approximate Available Volume 500 mg 2 mL 225 mg/mL 2.2 mL 1 g 2.5 mL 330 mg/mL 3 mL

  ADMINISTRATION

  Intramuscular Administration:

  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin should be injected into a large muscle mass. Pain on injection is infrequent with cefazolin.

  Intravenous Administration:

  Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion: Dilute reconstituted cefazolin in 50 to 100 mL of 1 of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer's Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer's Injection, USP

  5% Sodium Bicarbonate Injection, USP

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  Usual Adult Dosage

  Type of infection

  Dose

  Frequency

  Moderate to severe infections

  500 mg to 1 gram

  every 6 to 8 hours

  Mild infections caused by susceptible gram-positive cocci

  250 mg to 500 mg

  every 8 hours

  Acute, uncomplicated urinary tract infections

  1 gram

  every 12 hours

  Pneumococcal pneumonia

  500 mg

  every 12 hours

  Severe, life-threatening infections (e.g., endocarditis, septicemia)*

  1 gram to 1.5 grams

  every 6 hours

  * In rare instances, doses of up to 12 grams of cefazolin for injection per day have been used.

  Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are: 
      a. 1 gram IV administered ½ hour to 1 hour prior to the start of surgery. 
      b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure). 
      c. 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision and (2) cefazolin for injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin for injection may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin for injection may be used in patients with reduced renal function with the following dosage adjustments. Patients with a creatinine clearance of 55 mL/min or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis, see CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg/kg (approximately 10 to 20 mg/lb) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg/kg (45 mg/lb) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of cefazolin for injection in these patients is not recommended.

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min), 60% of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min), 25% of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min) may be given 10% of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  RECONSTITUTION Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Directions for Proper Use of 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 after reconstitution 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.

  Pharmacy Bulk Package
  Add Sterile Water for Injection, Bacteriostatic Water for Injection or Sodium Chloride Injection according to the table below. SHAKE WELL. Use promptly. (Discard vial within 4 hours after initial entry.)

   Pharmacy Bulk Package Size

  Amount of Diluent 

  Appropriate Concentration 

   Approximate Available Volume

  10 grams 

   45 mL

   1 gram/5 mL

  51 mL 

  96 mL 

  1 gram/10 mL 

   102 mL

  20 grams 

   87 mL

  1 gram/5 mL 

  99 mL 

  ADMINISTRATION Intravenous Administration

  Intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection, USP in 50 to 100 mL of one of the following solutions:

  Sodium Chloride Injection, USP
  5% or 10% Dextrose Injection, USP
  5% Dextrose in Lactated Ringer’s Injection, USP
  5% Dextrose and 0.9% Sodium Chloride Injection, USP
  5% Dextrose and 0.45% Sodium Chloride Injection, USP
  5% Dextrose and 0.2% Sodium Chloride Injection, USP
  Lactated Ringer’s Injection, USP
  Invert Sugar 5% or 10% in Sterile Water for Injection
  Ringer’s Injection, USP
  5% Sodium Bicarbonate Injection, USP

  When diluted according to the instructions above, cefazolin is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5ºC or 41ºF).

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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  2.1 Adult Population

  The recommended adult dosages are outlined in Table 1. The intent of this pharmacy bulk package is for the preparation of solutions for IV infusion only.

  * In rare instances, doses of up to 12 grams of cefazolin per day have been used.

  Table 1: Recommended Dosing Schedule in Adult Patients with CrCl Greater Than or Equal To 55 mL/min.

  Site and Type of Infection

  Dose

  Frequency

  Moderate to severe infections

  500 mg to 1 gram

  every 6 to 8 hours

  Mild infections caused by
  susceptible gram-positive cocci

  250 mg to 500 mg

  every 8 hours

  Acute, uncomplicated urinary
  tract infections

  1 gram

  every 12 hours

  Pneumococcal pneumonia

  500 mg

  every 12 hours

  Severe, life-threatening infections
  (e.g., endocarditis, septicemia)*

  1 gram to 1.5 grams

  every 6 hours

  2.2 Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  • 1 to 2 grams IV administered 1/2 hour to 1 hour prior to the start of surgery. • For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure). • 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

  It is important that (i) the preoperative dose be given just prior (1/2 hour to 1 hour) to the start of surgery so that adequate antibacterial concentrations are present in the serum and tissues at the time of initial surgical incision; and (ii) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibacterial drug at the anticipated moments of greatest exposure to infective organisms.

  The prophylactic administration of cefazolin should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  2.3 Patients with Renal Impairment

  Cefazolin may be used in patients with renal impairment with the dosage adjustments outlined in Table 2. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.

  Table 2: Dosage Adjustment for Patients with Renal Impairment

  Creatinine Clearance

  Dose

  Frequency

  55 mL/min. or greater

  full dose

  normal frequency

  35 to 54 mL/min.

  full dose

  every 8 hours or longer

  11 to 34 mL/min.

  1/2 usual dose

  every 12 hours

  10 mL/min. or less

  1/2 usual dose

  every 18 to 24 hours

  2.4 Pediatric Population

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for Injection in these patients is not recommended.

  Cefazolin may be used in pediatric patients with renal impairment with the dosage adjustments outlined in Table 3. All dosage recommendations apply after an initial loading dose.

  Table 3: Dosage Adjustment for Pediatric Patients with Renal Impairment

  Creatinine Clearance

  Dose

  Frequency

  71 mL/min. or greater

  full dose given in
  equally divided doses

  normal frequency

  70 to 41 mL/min.

  60% of usual dose given in
  equally divided doses

  every 12 hours

  40 to 21 mL/min.

  25% of usual dose given in
  equally divided doses

  every 12 hours

  20 to 5 mL/min. or less

  10% of usual dose given in
  equally divided doses

  every 24 hours

  All dosage recommendations apply after an initial loading dose.

  2.5 Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  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. THIS PHARMACY BULK PACKAGE IS NOT INTENDED TO BE DISPENSED AS A UNIT.

  RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION.

  Pharmacy Bulk Package

  Reconstitute the pharmacy bulk package with Sterile Water for Injection or 0.9% Sodium Chloride Injection according to the table below. SHAKE WELL. Use promptly. (Discard vial within 4 hours after initial entry.)

  
  Vial Size

  
  Amount of Diluent

  Approximate
  Concentration

  Approximate
  Available Volume

  10 grams

  45 mL

  96 mL

  1 gram/5 mL

  1 gram/10 mL

  51 mL

  102 mL

  2.7 Intravenous Administration

  Intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection in 50 to 100 mL of one of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer’s Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer’s Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer’s Injection, USP

  5% Sodium Bicarbonate Injection, USP

  When reconstituted and further diluted according to the instructions above, cefazolin is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). Reconstituted or diluted solutions may range in color from pale yellow to yellow without change in potency.

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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  ---

  2.1 Adult Population

  The recommended adult dosages are outlined in Table 1. Cefazolin for Injection USP should be administered intravenously (IV) or intramuscularly (IM).

  * In rare instances, doses of up to 12 grams of cefazolin per day have been used.

  Table 1: Recommended Dosing Schedule in Adult Patients with CrCl Greater Than or Equal To 55 mL/min.

  Site and Type of Infection

  Dose

  Frequency

  Moderate to severe infections

  500 mg to 1 gram

  every 6 to 8 hours

  Mild infections caused by
  susceptible gram-positive cocci

  250 mg to 500 mg

  every 8 hours

  Acute, uncomplicated urinary
  tract infections

  1 gram

  every 12 hours

  Pneumococcal pneumonia

  500 mg

  every 12 hours

  Severe, life-threatening infections
  (e.g., endocarditis, septicemia)*

  1 gram to 1.5 grams

  every 6 hours

  2.2 Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  • 1 gram (IV or IM) or 2 grams IV administered 1/2 hour to 1 hour prior to the start of surgery. • For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure). • 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.

  It is important that (i) the preoperative dose be given just prior (1/2 hour to 1 hour) to the start of surgery so that adequate antibacterial concentrations are present in the serum and tissues at the time of initial surgical incision; and (ii) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibacterial drug at the anticipated moments of greatest exposure to infective organisms.

  The prophylactic administration of cefazolin should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  2.3 Patients with Renal Impairment

  Cefazolin may be used in patients with renal impairment with the dosage adjustments outlined in Table 2. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.

  Table 2: Dosage Adjustment for Patients with Renal Impairment

  Creatinine Clearance

  Dose

  Frequency

  55 mL/min. or greater

  full dose

  normal frequency

  35 to 54 mL/min.

  full dose

  every 8 hours or longer

  11 to 34 mL/min.

  1/2 usual dose

  every 12 hours

  10 mL/min. or less

  1/2 usual dose

  every 18 to 24 hours

  2.4 Pediatric Population

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for Injection in these patients is not recommended.

  Pediatric Dosage Guide

  
  Weight

  25 mg/kg/day
  Divided into 3 Doses

  25 mg/kg/day
  Divided into 4 Doses

  
  
  
  lbs

  
  
  
  kg

  
  Approximate
  Single Dose
  (mg/q8 h)

  Vol. (mL)
  Needed with
  Dilution of
  125 mg/mL

  
  Approximate
  Single Dose
  (mg/q6 h)

  Vol. (mL)
  Needed with
  Dilution of
  125 mg/mL

  10

  4.5

  40 mg

  0.35 mL

  30 mg

  0.25 mL

  20

  9

  75 mg

  0.6 mL

  55 mg

  0.45 mL

  30

  13.6

  115 mg

  0.9 mL

  85 mg

  0.7 mL

  40

  18.1

  150 mg

  1.2 mL

  115 mg

  0.9 mL

  50

  22.7

  190 mg

  1.5 mL

  140 mg

  1.1 mL

  
  Weight

  50 mg/kg/day
  Divided into 3 Doses

  50 mg/kg/day
  Divided into 4 Doses

  
  
  
  lbs

  
  
  
  kg

  
  Approximate
  Single Dose
  (mg/q8 h)

  Vol. (mL)
  Needed with
  Dilution of
  225 mg/mL

  
  Approximate
  Single Dose
  (mg/q6 h)

  Vol. (mL)
  Needed with
  Dilution of
  225 mg/mL

  10

  4.5

  75 mg

  0.35 mL

  55 mg

  0.25 mL

  20

  9

  150 mg

  0.7 mL

  110 mg

  0.5 mL

  30

  13.6

  225 mg

  1 mL

  170 mg

  0.75 mL

  40

  18.1

  300 mg

  1.35 mL

  225 mg

  1 mL

  50

  22.7

  375 mg

  1.7 mL

  285 mg

  1.25 mL

  Cefazolin may be used in pediatric patients with renal impairment with the dosage adjustments outlined in Table 3. All dosage recommendations apply after an initial loading dose.

  Table 3: Dosage Adjustment for Pediatric Patients with Renal Impairment

  Creatinine Clearance

  Dose

  Frequency

  71 mL/min. or greater

  full dose given in
  equally divided doses

  normal frequency

  70 to 41 mL/min.

  60% of usual dose given in
  equally divided doses

  every 12 hours

  40 to 21 mL/min.

  25% of usual dose given in
  equally divided doses

  every 12 hours

  20 to 5 mL/min. or less

  10% of usual dose given in
  equally divided doses

  every 24 hours

  All dosage recommendations apply after an initial loading dose.

  2.5 Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  When reconstituted or diluted according to the instructions below, cefazolin is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Single-Dose Vials

  For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.

  
  Vial Size

  
  Amount of Diluent

  Approximate
  Concentration

  Approximate
  Available Volume

  500 mg

  2 mL

  225 mg/mL

  2.2 mL

  2.6 Intramuscular Administration

  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin for Injection should be injected into a large muscle mass. Pain on injection is infrequent with Cefazolin for Injection.

  2.7 Intravenous Administration

  Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection in 50 to 100 mL of one of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer’s Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer’s Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer’s Injection, USP

  5% Sodium Bicarbonate Injection, USP

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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  No Recall

  More Info
• Sandoz Inc
  

  ×

  Cefazolin | Sandoz Inc

  

  ---

  2.1 Adult Population

  The recommended adult dosages are outlined in Table 1. Cefazolin for Injection USP should be administered intravenously (IV) or intramuscularly (IM).

  * In rare instances, doses of up to 12 grams of cefazolin per day have been used.

  Table 1: Recommended Dosing Schedule in Adult Patients with CrCl Greater Than or Equal To 55 mL/min.

  Site and Type of Infection

  Dose

  Frequency

  Moderate to severe infections

  500 mg to 1 gram

  every 6 to 8 hours

  Mild infections caused by
  susceptible gram-positive cocci

  250 mg to 500 mg

  every 8 hours

  Acute, uncomplicated urinary
  tract infections

  1 gram

  every 12 hours

  Pneumococcal pneumonia

  500 mg

  every 12 hours

  Severe, life-threatening infections
  (e.g., endocarditis, septicemia)*

  1 gram to 1.5 grams

  every 6 hours

  2.2 Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  • 1 gram (IV or IM) or 2 grams IV administered 1/2 hour to 1 hour prior to the start of surgery. • For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure). • 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.

  It is important that (i) the preoperative dose be given just prior (1/2 hour to 1 hour) to the start of surgery so that adequate antibacterial concentrations are present in the serum and tissues at the time of initial surgical incision; and (ii) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibacterial drug at the anticipated moments of greatest exposure to infective organisms.

  The prophylactic administration of cefazolin should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  2.3 Patients with Renal Impairment

  Cefazolin may be used in patients with renal impairment with the dosage adjustments outlined in Table 2. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.

  Table 2: Dosage Adjustment for Patients with Renal Impairment

  Creatinine Clearance

  Dose

  Frequency

  55 mL/min. or greater

  full dose

  normal frequency

  35 to 54 mL/min.

  full dose

  every 8 hours or longer

  11 to 34 mL/min.

  1/2 usual dose

  every 12 hours

  10 mL/min. or less

  1/2 usual dose

  every 18 to 24 hours

  2.4 Pediatric Population

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for Injection in these patients is not recommended.

  Pediatric Dosage Guide

  
  Weight

  25 mg/kg/day
  Divided into 3 Doses

  25 mg/kg/day
  Divided into 4 Doses

  
  
  
  lbs

  
  
  
  kg

  
  Approximate
  Single Dose
  (mg/q8 h)

  Vol. (mL)
  Needed with
  Dilution of
  125 mg/mL

  
  Approximate
  Single Dose
  (mg/q6 h)

  Vol. (mL)
  Needed with
  Dilution of
  125 mg/mL

  10

  4.5

  40 mg

  0.35 mL

  30 mg

  0.25 mL

  20

  9

  75 mg

  0.6 mL

  55 mg

  0.45 mL

  30

  13.6

  115 mg

  0.9 mL

  85 mg

  0.7 mL

  40

  18.1

  150 mg

  1.2 mL

  115 mg

  0.9 mL

  50

  22.7

  190 mg

  1.5 mL

  140 mg

  1.1 mL

  
  Weight

  50 mg/kg/day
  Divided into 3 Doses

  50 mg/kg/day
  Divided into 4 Doses

  
  
  
  lbs

  
  
  
  kg

  
  Approximate
  Single Dose
  (mg/q8 h)

  Vol. (mL)
  Needed with
  Dilution of
  225 mg/mL

  
  Approximate
  Single Dose
  (mg/q6 h)

  Vol. (mL)
  Needed with
  Dilution of
  225 mg/mL

  10

  4.5

  75 mg

  0.35 mL

  55 mg

  0.25 mL

  20

  9

  150 mg

  0.7 mL

  110 mg

  0.5 mL

  30

  13.6

  225 mg

  1 mL

  170 mg

  0.75 mL

  40

  18.1

  300 mg

  1.35 mL

  225 mg

  1 mL

  50

  22.7

  375 mg

  1.7 mL

  285 mg

  1.25 mL

  Cefazolin may be used in pediatric patients with renal impairment with the dosage adjustments outlined in Table 3. All dosage recommendations apply after an initial loading dose.

  Table 3: Dosage Adjustment for Pediatric Patients with Renal Impairment

  Creatinine Clearance

  Dose

  Frequency

  71 mL/min. or greater

  full dose given in
  equally divided doses

  normal frequency

  70 to 41 mL/min.

  60% of usual dose given in
  equally divided doses

  every 12 hours

  40 to 21 mL/min.

  25% of usual dose given in
  equally divided doses

  every 12 hours

  20 to 5 mL/min. or less

  10% of usual dose given in
  equally divided doses

  every 24 hours

  All dosage recommendations apply after an initial loading dose.

  2.5 Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  When reconstituted or diluted according to the instructions below, cefazolin is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Single-Dose Vials

  For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.

  
  Vial Size

  
  Amount of Diluent

  Approximate
  Concentration

  Approximate
  Available Volume

  500 mg

  2 mL

  225 mg/mL

  2.2 mL

  1 gram

  2.5 mL

  330 mg/mL

  3 mL

  2.6 Intramuscular Administration

  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin for Injection should be injected into a large muscle mass. Pain on injection is infrequent with Cefazolin for Injection.

  2.7 Intravenous Administration

  Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection in 50 to 100 mL of one of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer’s Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer’s Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer’s Injection, USP

  5% Sodium Bicarbonate Injection, USP

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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  Cefazolin for Injection USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof.

  Cefazolin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than the 1 gram dose of Cefazolin.

  THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION WITH STERILE WATER FOR INJECTION, USP TO A CONCENTRATION OF 100 mg per mL AND FURTHER DILUTION IN 50 mL OF A COMPATIBLE SOLUTION.

  THIS IS A PHARMACY BULK PACKAGE - NOT FOR DIRECT INJECTION

  USE THIS FORMULATION OF CEFAZOLIN ONLY IN PATIENTS WHO REQUIRE A 1 GRAM DOSE.

  2.1 Adult Population

  Cefazolin for Injection, USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof. Cefazolin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than the 1 gram dose of Cefazolin.

  Cefazolin for Injection should be reconstituted with Sterile Water for Injection, USP to a concentration of 100 mg per mL and further diluted in 50 mL of a compatible solution. The recommended adult dosages are outlined in Table 1. Cefazolin for Injection, USP, Pharmacy Bulk Package SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof. Cefazolin for Injection should be administered intravenously (IV) over approximately 30 minutes.

  Table 1: Recommended Dosing Schedule in Adult Patients with CrCl Greater Than or Equal to 55 mL/min.

  *In rare instances, doses up to 12 grams of cefazolin per day have been used.

  **This formulation of Cefazolin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than the 1 gram dose of cefazolin.

  Site and Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1gram Every 6 to 8 hours Mild infections caused by susceptible gram-positive cocci 250 mg to
  500 mg Every 8 hours Acute, uncomplicated urinary tract infections 1 gram Every 12 hours Pneumococcal pneumonia 500 mg Every 12 hours Severe, life- threatening infections (e.g., endocarditis, septicemia)* 1 gram to
  1.5 grams Every 6 hours 2.2 Perioperative Prophylactic Use

  Cefazolin for Injection, USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof.

  Cefazolin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than the 1 gram dose of cefazolin.

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  1 gram to 2 grams I.V. administered ½ hour to 1 hour prior to the start of surgery. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram I.V. during surgery (administration modified depending on the duration of the operative procedure). 500 mg to 1 gram I.V. every 6 to 8 hours for 24 hours postoperatively.

  It is important that (i) the preoperative dose be given just (½ to 1 hour) prior to the start of surgery so that adequate antibacterial concentrations are present in the serum and tissues at the time of initial surgical incision; and (ii) cefazolin may be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibacterial drug at the anticipated moments of greatest exposure to infective organisms. The prophylactic administration of cefazolin should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  2.3 Patients with Renal Impairment

  Cefazolin for Injection, USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof.

  Cefazolin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients with renal impairment who require less than the 1 gram dose of cefazolin. Cefazolin may be used in patients with renal impairment with the dosage adjustments outlined in Table 2. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.

  Table 2: Dosage Adjustment for Patients with Renal Impairment Creatinine Clearance Dose Frequency 55 mL/minute or greater Full dose Normal frequency 35 to 54 mL/minute Full dose Every 8 hours or longer 11 to 34 mL/minute ½ usual dose Every 12 hours 10 mL/minute or less ½ usual dose Every 18 to 24 hours 2.4 Preparation for Use of Cefazolin for Injection, USP bag SmartPak® Pharmacy Bulk Package

  Cefazolin for Injection, USP, Pharmacy Bulk Package bag SmartPak® should be used only in patients who require a 1 gram dose and not any fraction thereof.

  Cefazolin for Injection USP, Pharmacy Bulk Package bag SmartPak® should not be used in patients who require less than the 1 gram dose of cefazolin.

  Directions for Proper Use of a Pharmacy Bulk Package

  NOT FOR DIRECT INFUSION. The Pharmacy Bulk Package is for use in the 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 after reconstitution 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 reconstitution port 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. This pharmacy bulk package is not intended to be dispensed as a unit. PRIOR TO RECONSTITUTION: Visually examine outer (natural foil) bag for damage. IF THE SEAL IS BROKEN OR DAMAGE IS OBSERVED, DO NOT OPEN THE OUTER BAG. STERILITY OF THE INNER BAG SURFACE MAY BE COMPROMISED. DISCARD BOTH BAGS IMMEDIATELY. DO NOT USE THE INNER BAG IF PARTICULATE OR FOREIGN MATTER IS PRESENT, IF THE DRY POWDER IS DARK YELLOW OR BROWN, IF THE SEALS ARE NOT INTACT, OR IF THERE IS ANY OTHER DAMAGE TO THE BAG. IN SUCH CASES, DISCARD THE BAG IMMEDIATELY. After initial reconstitution port entry, use entire contents of the Pharmacy Bulk Package promptly. Any unused portion must be discarded after 4 HOURS. Gather the following items prior to the reconstitution of the product: Appropriate number of bags of Sterile Water for Injection and, depending upon the method of filling, appropriate sterile tubing and adapters.

  INSTRUCTION FOR RECONSTITUTION OF THE PHARMACY BULK PACKAGE BAG SmartPak®

  The entire contents of the bag and the preparation process (reconstitution and dilution) should be completed within 4 hours of initial entry.

  Document the date and time reconstitution starts in the designated place on the container label. The entire contents of the bag must be used within 4 hours from the time of initial entry. Remove the translucent unthreaded cap from the reconstitution (smaller) port and discard it. Reconstitute the powder through the reconstitution (smaller) port, using Sterile Water for Injection according to the table below Reconstitution Table SmartPak® Bag Size Amount of Sterile Water Approximate Concentration 100 grams 960 mL 100 mg/mL (1 g/10 mL) 300 grams 2880 mL 100 mg/mL (1 g/10 mL) After reconstitution is complete, remove the transfer needle from the reconstitution port. Place the bag on a flat surface of a laminar flow hood and mix for at least 15 minutes for the 100 gram product or 25 minutes for the 300 gram product by rocking gently from side to side. CAUTION: To avoid possible leakage caused by the heavy weight of the added water, do not shake vigorously or pull strongly on the bag. When foam dissipates, visually inspect the bag to verify the solution is clear, colorless to pale yellow and free of particulate matter. DO NOT USE THE INNER BAG IF PARTICULATE OR FOREIGN MATTER IS PRESENT. Unscrew the clear threaded cap from the transfer (larger) port and discard it. Attach sterile tubing and filling adapter unit to the transfer port. Reconstituted solution can now be transferred using the transfer port and the filling adapter.

  It should be noted that the spike placed into the transfer port of the Pharmacy Bulk Package SmartPak® is NEVER removed during this procedure and that the reconstitution port is self-sealing.

  Dilution

  Hang the bag from two eyelets. Following reconstitution, transfer 10 mL of the reconstituted solution into transfusion bags, each containing 50 mL of one of the compatible solutions below.   Compatible solutions for dilution are the following:   Sodium Chloride Injection, USP   5% Dextrose Injection, USP Dilution should be completed within the 4 hour preparation process. When diluted according to the instructions above, cefazolin is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F).

  Administration

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

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  2.1 Adult Population

  The recommended adult dosages are outlined in Table 1. Cefazolin for Injection should be administered intravenously (IV) over approximately 30 minutes.

  After constitution, cefazolin can be administered by parenteral administration. However, the intent of this pharmacy bulk package is for the preparation of the solutions for intravenous infusion only.

  Table 1: Recommended Dosing Schedule in Adult Patients with CrCl Greater Than or Equal To 55 mL/min.

  * In rare instances, doses of up to 12 grams of cefazolin per day have been used.

  Site and Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hours Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours 2.2 Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  1 gram IV administered ½ hour to 1 hour prior to the start of surgery. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure). 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

  It is important that (i) the preoperative dose be given just prior (1/2 hour to 1 hour) to the start of surgery so that adequate antibacterial concentrations are present in the serum and tissues at the time of initial surgical incision; and (ii) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibacterial drug at the anticipated moments of greatest exposure to infective organisms.

  The prophylactic administration of cefazolin should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  2.3 Patients with Renal Impairment

  Cefazolin may be used in patients with renal impairment with the dosage adjustments outlined in Table 2. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.

  Table 2: Dosage Adjustment for Patients with Renal Impairment Creatinine Clearance Dose Frequency 55 mL/min. or greater full dose normal frequency 35 to 54 mL/min. full dose every 8 hours or longer 11 to 34 mL/min. 1/2 usual dose every 12 hours 10 mL/min. or less 1/2 usual dose every 18 to 24 hours 2.4 Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for Injection in these patients is not recommended.

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  2.5 Preparation for Use of Cefazolin for Injection

  Reconstitution

  Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Directions for Proper Use of a Pharmacy Bulk Package

  Not for direct infusion. The Pharmacy Bulk Package is for use in the hospital pharmacy admixture service only in a suitable work area, such as a laminar flow hood. Using aseptic technique, the closure may be penetrated only one time using a suitable sterile dispensing set that allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage. After entry, use entire contents of Pharmacy Bulk Package promptly. The entire contents of the Pharmacy Bulk Package should be dispensed within 4 hours of initial entry. This time limit should begin with the introduction of the solvent or diluent into the Pharmacy Bulk Package. Discard Pharmacy Bulk Package within 4 hours after initial entry.

  Pharmacy Bulk Packages

  Add Sterile Water for Injection, Bacteriostatic Water for Injection or Sodium Chloride Injection according to the table below. SHAKE WELL.

  Pharmacy Bulk
  Package Size Amount of Diluent Approximate
  Concentration Approximate
  Available Volume 10 grams 45 mL 1 gram/5 mL 51 mL 10 grams 96 mL 1 gram/10 mL 102 mL

  Administration

  Intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection in 50 to 100 mL of one of the following solutions:

    Sodium Chloride Injection, USP   5% or 10% Dextrose Injection, USP   5% Dextrose in Lactated Ringer's Injection, USP   5% Dextrose and 0.9% Sodium Chloride Injection, USP   5% Dextrose and 0.45% Sodium Chloride Injection, USP   5% Dextrose and 0.2% Sodium Chloride Injection, USP   Lactated Ringer's Injection, USP   Invert Sugar 5% or 10% in Sterile Water for Injection   Ringer's Injection, USP   5% Sodium Bicarbonate Injection, USP

  When diluted according to the instructions above, Cefazolin for Injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F).

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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  Hold container 4-6 inches from the skin & spray to apply. Spread evenly by hand 15 minuted before sun exposure DO NOT spray directly into face. Spray on hands then apply to face. Do not apply in windy conditions. Use in a well-ventilated area

  Reapply:

  After 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours

  Sun Protection Measures

  Spending time in the sun increases your risk of skin cancer & early aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and othre sun protection measures including:

  limit time in the sun, especially from 10am - 2 pm wear long-sleeve shirts, pants, hats, and sunglasses

  Children under 6 months: Ask a doctor

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  2.1 Adult Population

  The recommended adult dosages are outlined in Table 1. Cefazolin for Injection should be administered intravenously (IV) over approximately 30 minutes.

  After constitution, cefazolin can be administered by parenteral administration. However, the intent of this pharmacy bulk package is for the preparation of the solutions for intravenous infusion only.

  Table 1: Recommended Dosing Schedule in Adult Patients with CrCl Greater Than or Equal To 55 mL/min.

  Site and Type of Infection

  Dose

  Frequency

  Moderate to severe infections

  500 mg to

  1 gram

  every 6 to 8 hours

  Mild infections caused by susceptible gram-positive cocci

  250 mg to

  500 mg

  every 8 hours

  Acute, uncomplicated urinary tract infections

  1 gram

  every 12 hours

  Pneumococcal pneumonia

  500 mg

  every 12 hours

  Severe, life-threatening infections (e.g., endocarditis, septicemia)*

  1 gram to

  1.5 grams

  every 6 hours

  * In rare instances, doses of up to 12 grams of cefazolin per day have been used.

  2.2 Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  • 1 gram IV administered ½ hour to 1 hour prior to the start of surgery. • For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure). • 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

  It is important that (i) the preoperative dose be given just prior (1/2 hour to 1 hour) to the start of surgery so that adequate antibacterial concentrations are present in the serum and tissues at the time of initial surgical incision and (ii) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibacterial drug at the anticipated moments of greatest exposure to infective organisms.

  The prophylactic administration of cefazolin should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  2.3 Patients with Renal Impairment

  Cefazolin may be used in patients with renal impairment with the dosage adjustments outlined in Table 2. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.

  Table 2: Dosage Adjustment for Patients with Renal Impairment

  Creatinine Clearance

  Dose

  Frequency

  55 mL/min. or greater

  full dose

  normal frequency

  35 to 54 mL/min.

  full dose

  every 8 hours or longer

  11 to 34 mL/min.

  1/2 usual dose

  every 12 hours

  10 mL/min. or less

  1/2 usual dose

  every 18 to 24 hours

  2.4 Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for Injection in these patients is not recommended.

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  2.5 Preparation for Use of Cefazolin for Injection

  Reconstitution

  Preparation of Parenteral Solution: Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Directions for Proper Use of a Pharmacy Bulk Package

  Not for direct infusion. The Pharmacy Bulk Packageis for use in the hospital pharmacy admixture service only in a suitable work area, such as a laminar flow hood. Using aseptic technique, the closure may be penetrated only one time using a suitable sterile dispensing set that allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage. After entry, use entire contents of Pharmacy Bulk Package promptly. The entire contents of the Pharmacy Bulk Package should be dispensed within 4 hours of initial entry. This time limit should begin with the introduction of the solvent or diluent into the Pharmacy Bulk Package. Discard Pharmacy Bulk Package within 4 hours after initial entry.

  Pharmacy Bulk Packages

  Add Sterile Water for Injection, Bacteriostatic Water for Injection or Sodium Chloride Injection according to the table below. SHAKE WELL.

  Pharmacy Bulk Package Size

  Amount of Diluent

  Approximate

  Concentration

  Approximate

  Available Volume

  10 grams

  45 mL

  1 gram/5 mL

  51 mL

  10 grams

  96 mL

  1 gram/10 mL

  102 mL

  Administration

  Intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection in 50 to 100 mL of one of the following solutions:

    Sodium Chloride Injection, USP   5% or 10% Dextrose Injection, USP   5% Dextrose in Lactated Ringer’s Injection, USP   5% Dextrose and 0.9% Sodium Chloride Injection, USP   5% Dextrose and 0.45% Sodium Chloride Injection, USP   5% Dextrose and 0.2% Sodium Chloride Injection, USP   Lactated Ringer’s Injection, USP   Invert Sugar 5% or 10% in Sterile Water for Injection   Ringer’s Injection, USP   5% Sodium Bicarbonate Injection, USP

  When diluted according to the instructions above, Cefazolin for Injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F).

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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  Usual Adult Dosage Type of Infection  
    Dose   Frequency * ln rare instances, doses of up to 12 grams of cefazolin for injection per day have been used

  Moderate to severe infections

   

  500 mg to 1 gram

   

  every 6 to 8 hrs.

  Mild infections caused by susceptible gram–positive cocci

   

  250 mg to 500 mg

   

  every 8 hours

  Acute, uncomplicated urinary tract infections

   

  1 gram

   

  every 12 hours

  Pneumococcal pneumonia

   

  500 mg

   

  every 12 hours

  Severe, life-threatening infections (e.g., endocarditis, septicemia)*

   

  1 gram to 1.5 grams

   

  every 6 hours

  Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  a. 1 gram IV or IM administered 1/2 hour to 1 hour prior to the start of surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours  postoperatively.

  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) Cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin for injection may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses.  Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for injection in these patients is not recommended.

  Pediatric Dosage Guide Weight 50 mg/kg/day
  Divided into 3 Doses 50 mg/kg/day
  Divided into 4 Doses

  Weight

  25 mg/kg/day
  Divided into 3 Doses

  25 mg/kg/day
  Divided into 4 Doses

  Lbs

  Kg

  Approximate
  Single Dose
  mg/q8h

  Vol. (mL)
  needed with
  dilution of
  125 mg/mL

  Approximate
  Single Dose
  mg/q6h

  Vol. (mL)
  needed with
  dilution of
  125 mg/mL

  10

  4.5

  40 mg

  0.35 mL

  30 mg

  0.25 mL

  20

  9

  75 mg

  0.6 mL

  55 mg

  0.45 mL

  30

  13.6

  115 mg

  0.9 mL

  85 mg

  0.7 mL

  40

  18.1

  150 mg

  1.2 mL

  115 mg

  0.9 mL

  50

  22.7

  190 mg

  1.5 mL

  140 mg

  1.1 mL

  Lbs

  Kg

  Approximate
  Single Dose
  mg/q8h

  Vol. (mL)
  needed with
  dilution of
  225 mg/mL

  Approximate
  Single Dose
  mg/q6h

  Vol. (mL)
  needed with
  dilution of
  225 mg/mL

  10

  4.5

  75 mg

  0.35 mL

  55 mg

  0.25 mL

  20

  9

  150 mg

  0.7 mL

  110 mg

  0.5 mL

  30

  13.6

  225 mg

  1 mL

  170 mg

  0.75 mL

  40

  18.1

  300 mg

  1.35 mL

  225 mg

  1 mL

  50

  22.7

  375 mg

  1.7 mL

  285 mg

  1.25 mL

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of  70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient.  In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate.  Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  RECONSTITUTION

  Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration.  If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  When reconstituted or diluted according to the instructions below, cefazolin for injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F).  Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Single-Dose Vials

  For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.

  Vial size Amount of Diluent Approximate Concentration Approximate Available Volume

  500 mg

  2 mL

  225 mg/mL

  2.2 mL

  1 g

  2.5 mL

  330 mg/mL

  3 mL

  ADMINISTRATION

  Intramuscular Administration:

  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin should be injected into a large muscle mass. Pain on injection is infrequent with cefazolin.

  Intravenous Administration:

  Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion: Dilute reconstituted cefazolin in 50 to 100 mL of 1 of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer's Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer's Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer's Injection, USP

  5% Sodium Bicarbonate Injection, USP

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• Hospira, Inc
  

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  Cefazolin | Hospira, Inc

  

  ---

  2.1 Adult Population

  The recommended adult dosages are outlined in Table 1. Cefazolin for Injection USP should be administered intravenously (IV). Cefazolin for Injection in the ADD-Vantage® Vial is not intended for direct intravenous injection.

  * In rare instances, doses of up to 12 grams of cefazolin per day have been used.

  Table 1: Recommended Dosing Schedule in Adult Patients with CrCl Greater Than or Equal To 55 mL/min.

  Site and Type of Infection

  Dose

  Frequency

  Moderate to severe infections

  500 mg to 1 gram

  every 6 to 8 hours

  Mild infections caused by
  susceptible gram-positive cocci

  250 mg to 500 mg

  every 8 hours

  Acute, uncomplicated urinary
  tract infections

  1 gram

  every 12 hours

  Pneumococcal pneumonia

  500 mg

  every 12 hours

  Severe, life-threatening infections
  (e.g., endocarditis, septicemia)*

  1 gram to 1.5 grams

  every 6 hours

  2.2 Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  • 1 gram or 2 grams IV administered 1/2 hour to 1 hour prior to the start of surgery. • For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure). • 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

  It is important that (i) the preoperative dose be given just prior (1/2 hour to 1 hour) to the start of surgery so that adequate antibacterial concentrations are present in the serum and tissues at the time of initial surgical incision; and (ii) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibacterial drug at the anticipated moments of greatest exposure to infective organisms.

  The prophylactic administration of cefazolin should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  2.3 Patients with Renal Impairment

  Cefazolin may be used in patients with renal impairment with the dosage adjustments outlined in Table 2. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.

  Table 2: Dosage Adjustment for Patients with Renal Impairment

  Creatinine Clearance

  Dose

  Frequency

  55 mL/min. or greater

  full dose

  normal frequency

  35 to 54 mL/min.

  full dose

  every 8 hours or longer

  11 to 34 mL/min.

  1/2 usual dose

  every 12 hours

  10 mL/min. or less

  1/2 usual dose

  every 18 to 24 hours

  2.4 Pediatric Population

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for Injection in these patients is not recommended.

  Cefazolin may be used in pediatric patients with renal impairment with the dosage adjustments outlined in Table 3. All dosage recommendations apply after an initial loading dose.

  Table 3: Dosage Adjustment for Pediatric Patients with Renal Impairment

  Creatinine Clearance

  Dose

  Frequency

  71 mL/min. or greater

  full dose given in
  equally divided doses

  normal frequency

  70 to 41 mL/min.

  60% of usual dose given in
  equally divided doses

  every 12 hours

  40 to 21 mL/min.

  25% of usual dose given in
  equally divided doses

  every 12 hours

  20 to 5 mL/min. or less

  10% of usual dose given in
  equally divided doses

  every 24 hours

  All dosage recommendations apply after an initial loading dose.

  2.5 Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  When reconstituted or diluted according to the instructions below, cefazolin is stable for 24 hours at room temperature. Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  ADD-Vantage® Vials

  ADD-Vantage® Vials of Cefazolin for Injection are to be reconstituted only with 0.9% Sodium Chloride Injection or 5% Dextrose Injection in the 50 mL or 100 mL ADD-Vantage® Flexible Diluent Containers or with 0.45% Sodium Chloride Injection in the 50 mL ADD-Vantage® Flexible Diluent Container. Cefazolin for Injection supplied in single dose ADD-Vantage® Vials should prepared as directed below.

  INSTRUCTIONS FOR USE

  To Open Diluent Container:

  Peel overwrap at corner and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

  To Assemble Vial and Flexible Diluent Container:

  (Use Aseptic Technique)

  1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:
  a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1), then pull straight up to remove the cap (SEE FIGURE 2).
  NOTE: Once the breakaway cap has been removed, do not access vial with syringe.
  
  
  b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover (SEE FIGURE 3). 2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click (SEE FIGURE 4). The clicking sound does not assure a seal; the vial must be turned as far as it will go.
  NOTE: Once vial is seated, do not attempt to remove (SEE FIGURE 4). 3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. 4. Label appropriately.
  

  To Reconstitute the Drug:

  1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. 2. With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container (SEE FIGURE 5). 3. Pull the inner cap from the drug vial (SEE FIGURE 6). Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix. 4. Mix container contents thoroughly and use within the specified time.
  

  Preparation for Administration:

  (Use Aseptic Technique)

  1. Confirm the activation and admixture of vial contents. 2. Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. 3. Close flow control clamp of administration set. 4. Remove cover from outlet port at bottom of container. 5. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
  NOTE: See full directions on administration set carton. 6. Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger. 7. Squeeze and release drip chamber to establish proper fluid level in chamber. 8. Open flow control clamp and clear air from set. Close clamp. 9. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. 10. Regulate rate of administration with flow control clamp.

  WARNING: Do not use flexible container in series connections.

  Compatibility and Stability

  Ordinarily ADD-Vantage® Vials should be reconstituted only when it is certain that the patient is ready to receive the drug. However, Cefazolin for Injection in ADD-Vantage® vials is stable for 24 hours at room temperature when reconstituted as directed (See RECONSTITUTION, ADD-Vantage® Vials and INSTRUCTIONS FOR USE).

  (DO NOT REFRIGERATE OR FREEZE CEFAZOLIN SODIUM IN ADD-VANTAGE® VIALS.)

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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• Sagent Pharmaceuticals
  

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  Cefazolin | Laboratoires Boiron

  

  ---

  Cream:
  Apply a thin layer of Arnicare Cream to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed.
  
  Pellets:
  Adults and children 2 years of age and older: Dissolve 5 pellets in the mouth 3 times a day until relieved or as directed by a doctor.
  

  
  

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• West-ward Pharmaceutical Corp
  

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  Cefazolin | West-ward Pharmaceutical Corp

  

  ---

  Usual Adult Dosage

  *

  ln rare instances, doses of up to 12 grams of cefazolin per day have been used

   Type of Infection Dose  Frequency   Moderate to severe infections  500 mg to 1 gram  every 6 to 8 hours  Mild infections caused by susceptible gram–positive cocci  250 mg to 500 mg  every 8 hours  Acute, uncomplicated urinary tract infections  1 gram  every 12 hours  Pneumococcal pneumonia  500 mg  every 12 hours  Severe, life-threatening infections (e.g., endocarditis, septicemia)*  1 gram to 1.5 grams  every 6 hours Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  a. 1 gram IV or IM administered 1/2 hour to 1 hour prior to the start of surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin for injection may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: see CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of cefazolin in these patients is not recommended.

  Pediatric Dosage Guide  Weight  25 mg/kg/day Divided into 3 Doses  25 mg/kg/day Divided into 4 Doses  Lbs  Kg  Approximate Single Dose mg/q8h Vol. (mL) needed with dilution of 125 mg/mL Approximate Single Dose mg/q6h  Vol. (mL) needed with dilution of 125 mg/mL  10  4.5  40 mg  0.35 mL  30 mg  0.25 mL  20  9  75 mg  0.6 mL  55 mg  0.45 mL  30  13.6  115 mg  0.9 mL  85 mg  0.7 mL  40  18.1  150 mg  1.2 mL  115 mg  0.9 mL  50  22.7  190 mg  1.5 mL  140 mg  1.1 mL  Weight 50 mg/kg/day Divided into 3 Doses  50 mg/kg/day Divided into 4 Doses  Lbs  Kg  Approximate Single Dose mg/q8h Vol. (mL) needed with dilution of 225 mg/mL Approximate Single Dose mg/q6h Vol. (mL) needed with dilution of 225 mg/mL  10  4.5  75 mg  0.35 mL  55 mg  0.25 mL  20  9  150 mg  0.7 mL  110 mg  0.5 mL  30  13.6  225 mg  1 mL  170 mg  0.75 mL  40  18.1  300 mg  1.35 mL  225 mg  1 mL  50  22.7  375 mg  1.7 mL  285 mg  1.25 mL

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  RECONSTITUTION Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  When reconstituted or diluted according to the instructions below, cefazolin for injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Single-Dose Vials

  For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.

   Vial size  Amount of Diluent  ApproximateConcentration Approximate Available Volume  500 mg  2 mL  225 mg/mL  2.2 mL  1 gram  2.5 mL  330 mg/mL  3 mL ADMINISTRATION Intramuscular Administration

  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin should be injected into a large muscle mass. Pain on injection is infrequent with cefazolin.

  Intravenous Administration

  Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion: Dilute reconstituted cefazolin in 50 to 100 mL of 1 of the following solutions:

  Sodium Chloride Injection, USP 5% or 10% Dextrose Injection, USP 5% Dextrose in Lactated Ringer's Injection, USP 5% Dextrose and 0.9% Sodium Chloride Injection, USP 5% Dextrose and 0.45% Sodium Chloride Injection, USP 5% Dextrose and 0.2% Sodium Chloride Injection, USP Lactated Ringer's Injection, USP Invert Sugar 5% or 10% in Sterile Water for Injection Ringer's Injection, USP 5% Sodium Bicarbonate Injection, USP

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• Baxter Healthcare Corporation
  

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  Cefazolin | Baxter Healthcare Corporation

  

  ---

  Usual Adult Dosage:

  * In rare instances, doses of up to 12 grams of Cefazolin Injection per day have been used. Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hrs. Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract
  infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g.,
  endocarditis, septicemia)* 1 gram to 1.5 grams every 6 hours Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  1 gram IV administered ½ hour to 1 hour prior to start of surgery. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV during surgery (administration modified depending on the duration of the operative procedure). 500 mg to 1 gram IV every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients With Reduced Renal Function

  Cefazolin Injection may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3.0 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given ½ the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given ½ the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: See CLINICAL PHARMACOLOGY.

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• Cardinal Health
  

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  Cefazolin | Cardinal Health

  

  ---

  2.1 Adult Population

  The recommended adult dosages are outlined in Table 1. Cefazolin for Injection USP should be administered intravenously (IV) or intramuscularly (IM).

  Table 1: Recommended Dosing Schedule in Adult Patients with CrCl Greater Than or Equal To 55 mL/min.

  Site and Type of Infection

  Dose

  Frequency

  Moderate to severe infections

  500 mg to 1 gram

  every 6 to 8 hours

  Mild infections caused by
  susceptible gram-positive cocci

  250 mg to 500 mg

  every 8 hours

  Acute, uncomplicated urinary
  tract infections

  1 gram

  every 12 hours

  Pneumococcal pneumonia

  500 mg

  every 12 hours

  Severe, life-threatening infections
  (e.g., endocarditis, septicemia)a

  1 gram to 1.5 grams

  every 6 hours

  a) In rare instances, doses of up to 12 grams of cefazolin per day have been used.

  2.2 Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  • •1 gram (IV or IM) or 2 grams IV administered 1/2 hour to 1 hour prior to the start of surgery. • •For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure). • •500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.

  It is important that (i) the preoperative dose be given just prior (1/2 hour to 1 hour) to the start of surgery so that adequate antibacterial concentrations are present in the serum and tissues at the time of initial surgical incision; and (ii) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient concentrations of the antibacterial drug at the anticipated moments of greatest exposure to infective organisms.

  The prophylactic administration of cefazolin should usually be discontinued within a 24-hour period after the surgical procedure. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin may be continued for 3 to 5 days following the completion of surgery.

  2.3 Patients with Renal Impairment

  Cefazolin may be used in patients with renal impairment with the dosage adjustments outlined in Table 2. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection.

  Table 2: Dosage Adjustment for Patients with Renal Impairment

  Creatinine Clearance

  Dose

  Frequency

  55 mL/min. or greater

  full dose

  normal frequency

  35 to 54 mL/min.

  full dose

  every 8 hours or longer

  11 to 34 mL/min.

  1/2 usual dose

  every 12 hours

  10 mL/min. or less

  1/2 usual dose

  every 18 to 24 hours

  2.4 Pediatric Population

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of Cefazolin for Injection in these patients is not recommended.

  Pediatric Dosage Guide

  
  Weight

  25 mg/kg/day
  Divided into 3 Doses

  25 mg/kg/day
  Divided into 4 Doses

  
  
  
  lbs

  
  
  
  kg

  
  Approximate
  Single Dose
  (mg/q8 h)

  Vol. (mL)
  Needed with
  Dilution of
  125 mg/mL

  
  Approximate
  Single Dose
  (mg/q6 h)

  Vol. (mL)
  Needed with
  Dilution of
  125 mg/mL

  10

  4.5

  40 mg

  0.35 mL

  30 mg

  0.25 mL

  20

  9

  75 mg

  0.6 mL

  55 mg

  0.45 mL

  30

  13.6

  115 mg

  0.9 mL

  85 mg

  0.7 mL

  40

  18.1

  150 mg

  1.2 mL

  115 mg

  0.9 mL

  50

  22.7

  190 mg

  1.5 mL

  140 mg

  1.1 mL

  
  Weight

  50 mg/kg/day
  Divided into 3 Doses

  50 mg/kg/day
  Divided into 4 Doses

  
  
  
  lbs

  
  
  
  kg

  
  Approximate
  Single Dose
  (mg/q8 h)

  Vol. (mL)
  Needed with
  Dilution of
  225 mg/mL

  
  Approximate
  Single Dose
  (mg/q6 h)

  Vol. (mL)
  Needed with
  Dilution of
  225 mg/mL

  10

  4.5

  75 mg

  0.35 mL

  55 mg

  0.25 mL

  20

  9

  150 mg

  0.7 mL

  110 mg

  0.5 mL

  30

  13.6

  225 mg

  1 mL

  170 mg

  0.75 mL

  40

  18.1

  300 mg

  1.35 mL

  225 mg

  1 mL

  50

  22.7

  375 mg

  1.7 mL

  285 mg

  1.25 mL

  Cefazolin may be used in pediatric patients with renal impairment with the dosage adjustments outlined in Table 3. All dosage recommendations apply after an initial loading dose.

  Table 3: Dosage Adjustment for Pediatric Patients with Renal Impairment

  Creatinine Clearance

  Dose

  Frequency

  71 mL/min. or greater

  full dose given in
  equally divided doses

  normal frequency

  70 to 41 mL/min.

  60% of usual dose given in
  equally divided doses

  every 12 hours

  40 to 21 mL/min.

  25% of usual dose given in
  equally divided doses

  every 12 hours

  20 to 5 mL/min. or less

  10% of usual dose given in
  equally divided doses

  every 24 hours

  All dosage recommendations apply after an initial loading dose.

  2.5 Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  When reconstituted or diluted according to the instructions below, cefazolin is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Single-Dose Vials

  For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.

  
  Vial Size

  
  Amount of Diluent

  Approximate
  Concentration

  Approximate
  Available Volume

  500 mg

  2 mL

  225 mg/mL

  2.2 mL

  1 gram

  2.5 mL

  330 mg/mL

  3 mL

  2.6 Intramuscular Administration

  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin for Injection should be injected into a large muscle mass. Pain on injection is infrequent with Cefazolin for Injection.

  2.7 Intravenous Administration

  Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion: Dilute reconstituted Cefazolin for Injection in 50 to 100 mL of one of the following solutions:

  Sodium Chloride Injection, USP

  5% or 10% Dextrose Injection, USP

  5% Dextrose in Lactated Ringer’s Injection, USP

  5% Dextrose and 0.9% Sodium Chloride Injection, USP

  5% Dextrose and 0.45% Sodium Chloride Injection, USP

  5% Dextrose and 0.2% Sodium Chloride Injection, USP

  Lactated Ringer’s Injection, USP

  Invert Sugar 5% or 10% in Sterile Water for Injection

  Ringer’s Injection, USP

  5% Sodium Bicarbonate Injection, USP

  Prior to administration parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

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  Cefazolin | Cardinal Health

  

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  Usual Adult Dosage

  * ln rare instances, doses of up to 12 grams of cefazolin per day have been used

   Type of Infection

  Dose 

  Frequency 

   Moderate to severe infections

   500 mg to 1 gram

   every 6 to 8 hours

   Mild infections caused by susceptible gram–positive cocci

   250 mg to 500 mg

   every 8 hours

   Acute, uncomplicated urinary tract infections

   1 gram

   every 12 hours

   Pneumococcal pneumonia

   500 mg

   every 12 hours

   Severe, life-threatening infections (e.g., endocarditis, septicemia)*

   1 gram to 1.5 grams

   every 6 hours

  Perioperative Prophylactic Use

  To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

  a. 1 gram IV or IM administered 1/2 hour to 1 hour prior to the start of surgery.

  b. For lengthy operative procedures (e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery (administration modified depending on the duration of the operative procedure).

  c. 500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours postoperatively.

  It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

  In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of cefazolin for injection may be continued for 3 to 5 days following the completion of surgery.

  Dosage Adjustment for Patients with Reduced Renal Function

  Cefazolin may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less can be given full doses. Patients with creatinine clearance rates of 35 to 54 mL/min. or serum creatinine of 1.6 to 3 mg % can also be given full doses but dosage should be restricted to at least 8 hour intervals. Patients with creatinine clearance rates of 11 to 34 mL/min. or serum creatinine of 3.1 to 4.5 mg % should be given 1/2 the usual dose every 12 hours. Patients with creatinine clearance rates of 10 mL/min. or less or serum creatinine of 4.6 mg % or greater should be given 1/2 the usual dose every 18 to 24 hours. All reduced dosage recommendations apply after an initial loading dose appropriate to the severity of the infection. Patients undergoing peritoneal dialysis: see CLINICAL PHARMACOLOGY.

  Pediatric Dosage

  In pediatric patients, a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg per pound) of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg per kg (45 mg per pound) of body weight for severe infections. Since safety for use in premature infants and in neonates has not been established, the use of cefazolin in these patients is not recommended.

  Pediatric Dosage Guide

   Weight

   25 mg/kg/day Divided into 3 Doses

   25 mg/kg/day Divided into 4 Doses

   Lbs

   Kg

   Approximate Single Dose mg/q8h

  Vol. (mL) needed with dilution of 125 mg/mL

  Approximate Single Dose mg/q6h 

  Vol. (mL) needed with dilution of 125 mg/mL

   10

   4.5

   40 mg

   0.35 mL

   30 mg

   0.25 mL

   20

   9

   75 mg

   0.6 mL

   55 mg

   0.45 mL

   30

   13.6

   115 mg

   0.9 mL

   85 mg

   0.7 mL

   40

   18.1

   150 mg

   1.2 mL

   115 mg

   0.9 mL

   50

   22.7

   190 mg

   1.5 mL

   140 mg

   1.1 mL

   Weight

  50 mg/kg/day Divided into 3 Doses

   50 mg/kg/day Divided into 4 Doses

   Lbs

   Kg

   Approximate Single Dose mg/q8h

  Vol. (mL) needed with dilution of 225 mg/mL

  Approximate Single Dose mg/q6h

  Vol. (mL) needed with dilution of 225 mg/mL

   10

   4.5

   75 mg

   0.35 mL

   55 mg

   0.25 mL

   20

   9

   150 mg

   0.7 mL

   110 mg

   0.5 mL

   30

   13.6

   225 mg

   1 mL

   170 mg

   0.75 mL

   40

   18.1

   300 mg

   1.35 mL

   225 mg

   1 mL

   50

   22.7

   375 mg

   1.7 mL

   285 mg

   1.25 mL

  In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25 percent of the normal daily dose given in equally divided doses every 12 hours should be adequate. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose.

  RECONSTITUTION Preparation of Parenteral Solution

  Parenteral drug products should be SHAKEN WELL when reconstituted, and inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, the drug solutions should be discarded.

  When reconstituted or diluted according to the instructions below, cefazolin for injection is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). Reconstituted solutions may range in color from pale yellow to yellow without a change in potency.

  Single-Dose Vials

  For IM injection, IV direct (bolus) injection or IV infusion, reconstitute with Sterile Water for Injection according to the following table. SHAKE WELL.

   Vial size

   Amount of Diluent

   ApproximateConcentration

  Approximate Available Volume

   500 mg

   2 mL

   225 mg/mL

   2.2 mL

   1 gram

   2.5 mL

   330 mg/mL

   3 mL

  ADMINISTRATION Intramuscular Administration

  Reconstitute vials with Sterile Water for Injection according to the dilution table above. Shake well until dissolved. Cefazolin should be injected into a large muscle mass. Pain on injection is infrequent with cefazolin.

  Intravenous Administration

  Direct (bolus) injection: Following reconstitution according to the above table, further dilute vials with approximately 5 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below).

  Intermittent or continuous infusion: Dilute reconstituted cefazolin in 50 to 100 mL of 1 of the following solutions:

  • Sodium Chloride Injection, USP • 5% or 10% Dextrose Injection, USP • 5% Dextrose in Lactated Ringer's Injection, USP • 5% Dextrose and 0.9% Sodium Chloride Injection, USP • 5% Dextrose and 0.45% Sodium Chloride Injection, USP • 5% Dextrose and 0.2% Sodium Chloride Injection, USP • Lactated Ringer's Injection, USP • Invert Sugar 5% or 10% in Sterile Water for Injection • Ringer's Injection, USP • 5% Sodium Bicarbonate Injection, USP

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