Cefoxitin

Cefoxitin Manufacturers

• Wg Critical Care, Llc
  

  ×

  Cefoxitin | Wg Critical Care, Llc

  

  ---

  The intent of this pharmacy bulk package is for the preparation of solutions for intravenous infusion only.

  TREATMENT

  Adults

  The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 3 for dosage guidelines).

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

  Cefoxitin for Injection may be used in patients with reduced renal function with the following dosage adjustments:

  In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 4) may be used as a guide.

  When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

  Males:

  Weight (kg) x (140-age)

  72 x serum creatinine (mg/100 mL)

  Females: 0.85 x above value
  
  In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 4.

  Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients

  The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.

  At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

  In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be

  modified consistent with the recommendations for adults (see Table 4).

  PREVENTION

  Effective prophylactic use depends on the time of administration. Cefoxitin for Injection usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.

  For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

  Adults:

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients (3 months and older):

  30 to 40 mg/kg doses may be given at the times designated above.

  Cesarean section patients:

  For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3-dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES.)

  Table 3 - Guidelines for Dosage of Cefoxitin for Injection

  Type of Infection

  Daily Dosage

  Frequency and Route

  Uncomplicated forms* of infections such as pneumonia, urinary tract infection, cutaneous infection

  3 to 4 grams

  1 gram every

  6 to 8 hours IV

  Moderately severe or severe infections

  6 to 8 grams

  1 gram every 4 hours

  or

  2 grams every 6 to 8 hours IV

  Infections commonly needing antibiotics in higher dosage (e.g., gas gangrene)

  12 grams

  2 grams every 4 hours

  or

  3 grams every 6 hours IV

  *Including patients in whom bacteremia is absent or unlikely.

  Table 4 - Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function

  Renal Function

  Creatinine

  Clearance (mL/min)

  Dose (grams)

  Frequency

  Mild impairment

  50 to 30

  1 to 2

  Every 8 to 12 hours

  Moderate impairment

  29 to 10

  1 to 2

  Every 12 to 24 hours

  Severe impairment

  9 to 5

  0.5 to 1

  Every 12 to 24 hours

  Essentially no function

  < 5

  0.5 to 1

  Every 24 to 48 hours

  Table 5 - Preparation of Solution for Intravenous Administration

  Strength

  Amount of Diluent to be Added (mL)**

  Approximate Withdrawable Volume (mL)

  Approximate

  Average

  Concentration (mg/mL)

  Pharmacy Bulk Package - 10 grams

  43 or 93

  49 or 98.5

  200 or 100

  **Shake to dissolve and let stand until clear.

  PREPARATION OF SOLUTION

  Table 5 is provided for convenience in constituting Cefoxitin for Injection for intravenous administration.

  The 10 gram pharmacy bulk package bottle should be constituted with 43 or 93 mL of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. CAUTION: THE 10 GRAM BULK STOCK SOLUTION IS NOT FOR DIRECT INFUSION. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION. RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the Bulk Packages portion of the COMPATIBILITY AND STABILITY section.

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of Cefoxitin for Injection may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when Cefoxitin for Injection is constituted for administration to pediatric patients in this age range.

  ADMINISTRATION

  Cefoxitin for Injection may be administered intravenously after constitution.

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

  Intravenous Administration

  The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

  For intermittent intravenous administration: Using an infusion system, a solution containing 1 gram or 2 grams may be given over a period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing Cefoxitin for Injection, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of Cefoxitin for Injection may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®†† or scalp vein-type needles are preferred for this type of infusion.

  Solutions of Cefoxitin for Injection, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, Cefoxitin for Injection and aminoglycosides may be administered separately to the same patient.

  Directions for Proper Use of Pharmacy Bulk Package bottle:

  Pharmacy Bulk Package

  Not for Direct Infusion

  RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION

  The Pharmacy Bulk Package bottle is for use in a pharmacy admixture service under a laminar flow hood. Penetration into the Pharmacy Bulk Package bottle should be made only one time after reconstitution with a sterile transfer set or other sterile dispensing device, which allows measured distribution of the contents. Dispense the contents in aliquots using aseptic technique. The use of a syringe with a needle is not recommended as it may cause leakage. AFTER INITIAL ENTRY USE ENTIRE CONTENTS OF THE PHARMACY BULK PACKAGE PROMPTLY. A maximum time of 4 HOURS from initial entry is permitted to complete fluid transfer operations. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS. This time limit should begin with the introducing of solvent or diluent into the Pharmacy Bulk Package bottle. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION. RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION.

  COMPATIBILITY AND STABILITY

  Pharmacy Bulk Package

  Cefoxitin for Injection, as supplied in pharmacy bulk package bottles and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, should be DISCARDED 4 HOURS AFTER INITIAL ENTRY. FURTHER DILUTION IS REQUIRED BEFORE USE. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION. RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION.

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

    0.9 percent Sodium Chloride Injection   5 percent or 10 percent Dextrose Injection   5 percent Dextrose and 0.9 percent Sodium Chloride Injection   5 percent Dextrose Injection with 0.2 percent or 0.45 percent saline solution   Lactated Ringer’s Injection   5 percent Dextrose in Lactated Ringer’s Injection   5 percent Sodium Bicarbonate Injection   M/6 sodium lactate solution   Mannitol 5% and 10%

  After the periods mentioned above, any unused solutions should be discarded.

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  More Info
• Wg Critical Care, Llc
  

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  Cefoxitin | Wg Critical Care, Llc

  

  ---

  TREATMENT

  Adults

  The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 3 for dosage guidelines).

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

  Cefoxitin for Injection may be used in patients with reduced renal function with the following dosage adjustments:

  In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 4) may be used as a guide.

  When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

  Males:

  Weight (kg) x (140-age)

  72 x serum creatinine (mg/100 mL)

  Females: 0.85 x above value

  In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 4.

  Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients

  The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.

  At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

  In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be

  modified consistent with the recommendations for adults (see Table 4).

  PREVENTION

  Effective prophylactic use depends on the time of administration. Cefoxitin for Injection usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.

  For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

  Adults:

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients (3 months and older):

  30 to 40 mg/kg doses may be given at the times designated above.

  Cesarean section patients:

  For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3-dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES.)

  Table 3. Guidelines for Dosage of Cefoxitin for Injection

  Type of Infection

  Daily Dosage

  Frequency and Route

  Uncomplicated forms* of infections such as pneumonia, urinary tract infection, cutaneous infection

  3 to 4 grams

  1 gram every

  6 to 8 hours IV

  Moderately severe or severe infections

  6 to 8 grams

  1 gram every 4 hours

  or

  2 grams every 6 to 8 hours IV

  Infections commonly needing antibiotics in higher dosage (e.g., gas gangrene)

  12 grams

  2 grams every 4 hours

  or

  3 grams every 6 hours IV

  *Including patients in whom bacteremia is absent or unlikely.

  Table 4. Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function

  Renal Function

  Creatinine

  Clearance (mL/min)

  Dose (Grams)

  Frequency

  Mild impairment

  50 to 30

  1 to 2

  Every 8 to 12 hours

  Moderate impairment

  29 to 10

  1 to 2

  Every 12 to 24 hours

  Severe impairment

  9 to 5

  0.5 to 1

  Every 12 to 24 hours

  Essentially no function

  < 5

  0.5 to 1

  Every 24 to 48 hours

  Table 5. Preparation of Solution for Intravenous Administration

  Strength

  Amount of Diluent to be Added (mL)**

  Approximate Withdrawable Volume (mL)

  Approximate

  Average

  Concentration (mg/mL)

  1 gram Vial

  10

  10.5

  95

  2 gram Vial

  10 or 20

  11.1 or 21

  180 or 95

  **Shake to dissolve and let stand until clear.

  PREPARATION OF SOLUTION

  Table 5 is provided for convenience in constituting Cefoxitin for Injection for intravenous administration.

  For Vials

  One gram should be constituted with at least 10 mL, and 2 grams with 10 or 20 mL, of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the Vials portion of the COMPATIBILITY AND STABILITY section.

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of Cefoxitin for Injection may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when Cefoxitin for Injection is constituted for administration to pediatric patients in this age range.

  ADMINISTRATION

  Cefoxitin for Injection may be administered intravenously after constitution.

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

  Intravenous Administration

  The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

  For intermittent intravenous administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Using an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing Cefoxitin for Injection, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of Cefoxitin for Injection may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®†† or scalp vein-type needles are preferred for this type of infusion.

  Solutions of Cefoxitin for Injection, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, Cefoxitin for Injection and aminoglycosides may be administered separately to the same patient.

  COMPATIBILITY AND STABILITY

  Vials

  Cefoxitin for Injection, as supplied in vials and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, maintains satisfactory potency for 6 hours at room temperature or for one week under refrigeration (below 5ºC).

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

    0.9 percent Sodium Chloride Injection   5 percent or 10 percent Dextrose Injection   5 percent Dextrose and 0.9 percent Sodium Chloride Injection   5 percent Dextrose Injection with 0.2 percent or 0.45 percent saline solution   Lactated Ringer’s Injection   5 percent Dextrose in Lactated Ringer’s Injection   5 percent Sodium Bicarbonate Injection   M/6 sodium lactate solution   Mannitol 5% and 10%

  After the periods mentioned above, any unused solutions should be discarded.

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• Fresenius Kabi Usa, Llc
  

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  Cefoxitin | Fresenius Kabi Usa, Llc

  

  ---

  Treatment Adults

  The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 3 for dosage guidelines).

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

  CEFOXITIN FOR INJECTION may be used in patients with reduced renal function with the following dosage adjustments:
  
  

  In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 4) may be used as a guide.
  
  

  When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

  
  

  Males:                 Weight (kg) x (140-age)          

                    72 x serum creatinine (mg/100 mL)
  
   

  Females: 0.85 x above value
  
  

  In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 4.
  
  

  Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis.
  
  In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients

  The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams. At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

  In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults (see Table 4).

  Prevention

  Effective prophylactic use depends on the time of administration. CEFOXITIN FOR INJECTION usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.
  
  

  For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

  Adults:

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients (3 months and older):

  30 to 40 mg/kg doses may be given at the times designated above.

  Cesarean section patients:

  For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3-dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (SeeCLINICAL STUDIES)

  Table 3 - Guidelines for Dosage of CEFOXITIN FOR INJECTION

  Type of Infection
  Daily Dosage
  Frequency and Route
  Uncomplicated forms* of infections such as pneumonia, urinary tract infection, cutaneous infection
  3 to 4 grams
  1 gram every
  6-8 hours IV
  Moderately severe or severe infections
  6 to 8 grams
  1 gram
  every
  4 hours
  or
  2 grams every
  6-8 hours IV
  Infections commonly needing antibiotics in higher dosage (e.g., gas gangrene)
  12 grams
  2 grams
  every
  4 hours
  or
  3 grams every
  6 hours IV
  

  * Including patients in whom bacteremia is absent or unlikely.
  

  Table 4 - Maintenance Dosage of CEFOXITIN FOR INJECTION in Adults with Reduced Renal Function

  
  
  Renal Function
   
  Creatinine
   
  Clearance
  (mL/min)
   
  Dose
   
  (grams)
  
  
  Frequency
   
  Mild impairment
  Moderate impairment
  Severe impairment
  Essentially no function
   
  50 to 30
  29 to 10
  9 to 5
  < 5
   
  1 to 2
  1 to 2
  0.5 to 1
  0.5 to 1
   
  every 8-12 hours
  every 12-24 hours
  every 12-24 hours
  every 24-48 hours
  
  

    

  Table 5 - Preparation of Solution for Intravenous Administration

  
  
  
  Strength
  
  Amount of Diluent to be Added (mL)**
  Approximate
  Withdrawable
  Volume (mL)
   
  Approximate Average
  Concentration
  (mg/mL)
   
  1 gram Vial
   
  2 gram Vial
   
  10
   
  10 or 20
   
  10.5
   
  11.1 or 21
   
  95
   
  180 or 95
  

  ** Shake to dissolve and let stand until clear.

  
  Preparation of Solution

  Table 5 is provided for convenience in constituting CEFOXITIN FOR INJECTION for intravenous administration.

  For Vials

  One gram should be constituted with at least 10 mL, and 2 grams with 10 or 20 mL, of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the Vials  portion of the COMPATIBILITY AND STABILITYsection.
  
  

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of CEFOXITIN FOR INJECTION may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when CEFOXITIN FOR INJECTION is constituted for administration to pediatric patients in this age range.

  Administration

  CEFOXITIN FOR INJECTION may be administered intravenously after constitution.
  
  

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

  Intravenous Administration

  The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.
  
  For intermittent intravenous administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Using an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing CEFOXITIN FOR INJECTION, it is advisable to temporarily discontinue administration of any other solutions at the same site.
  
  

  For the administration of higher doses by continuous intravenous infusion, a solution of CEFOXITIN FOR INJECTION may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®†† or scalp vein-type needles are preferred for this type of infusion.
  
  

  Solutions of CEFOXITIN FOR INJECTION, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, CEFOXITIN FOR INJECTION and aminoglycosides may be administered separately to the same patient.

  Close
  No Recall

  More Info
• West-ward Pharmaceutical Corp
  

  ×

  Cefoxitin | West-ward Pharmaceutical Corp

  

  ---

  The intent of this Pharmacy Bulk Package is for the preparation of solutions for intravenous infusion only.

  TREATMENT Adults

  The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 1 for dosage guidelines).

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

  Cefoxitin for injection may be used in patients with reduced renal function with the following dosage adjustments:

  In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 2) may be used as a guide.

  When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

  Males             =              Weight (kg) x (140-age)
                              72 x serum creatinine (mg/100 mL)

  Females         =             0.85 x male value

  In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 2.

  Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients

  The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.

  At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

  In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults (see Table 2).

  PREVENTION

  Effective prophylactic use depends on the time of administration. Cefoxitin for injection usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.

  For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

  Adults:

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients (3 months and older):

  30 to 40 mg/kg doses may be given at the times designated above.

  Cesarean section patients:

  For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3-dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES.)

  Table 1: Guidelines for Dosage of Cefoxitin for Injection   Type of Infection   Daily Dosage   Frequency and Route * Including patients in whom bacteremia is absent or unlikely.   Uncomplicated forms* of infections such as pneumonia, urinary tract infection, cutaneous infection   3-4 grams   1 gram every 6-8 hours IV   Moderately severe or severe infections   6-8 grams   1 gram every 4 hours
  or
  2 grams every 6-8 hours IV   Infections commonly needing antibiotics in higher dosage (e.g., gas gangrene)   12 grams   2 grams every 4 hours
  or
  3 grams every 6 hours IV Table 2: Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function   Renal Function
    Creatinine Clearance
  (mL/min)   Dose
  (grams)   Frequency
    Mild impairment   50-30   1-2   every 8-12 hours   Moderate impairment   29-10   1-2   every 12-24 hours   Severe impairment   9-5   0.5-1   every 12-24 hours   Essentially no function   <5   0.5-1   every 24-48 hours Table 3: Preparation of Solution for Intravenous Administration   Strength   Amount of Diluent to be Added (mL)*   Approximate Withdrawable Volume (mL)   Approximate Average Concentration (mg/mL) * Shake to dissolve and let stand until clear.  10 grams Pharmacy Bulk Package  43 or 93  49 or 98.5   200 or 100                                         DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE BOTTLE - NOT FOR DIRECT INFUSION For Bulk Packages

  The Pharmacy Bulk Package bottle is for use in a pharmacy admixture service under a laminar flow hood. Penetration into the Pharmacy Bulk Package bottle should be made only one time after reconstitution with a sterile transfer set or other sterile dispensing device, which allows measured distribution of the contents. Dispense the contents in aliquots using aseptic technique. The use of a syringe with a needle is not recommended as it may cause leakage.

  AFTER INITIAL ENTRY USE ENTIRE CONTENTS OF THE PHARMACY BULK PACKAGE PROMPTLY. A maximum time of 4 HOURS from initial entry is permitted to complete fluid transfer operations. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS. This time limit should begin with the introducing of solvent or diluent into the Pharmacy Bulk Package bottle. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION.

  Preparation of Solution

  The directions for preparing cefoxitin for injection Pharmacy Bulk Package are summarized in Table 3.

  For Intravenous Use

  The 10 grams bulk packages should be constituted with 43 or 93 mL of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection.

  RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION.

  These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the Bulk Packages portion of the COMPATIBILITY AND STABILITY section.

  ADMINISTRATION

  Cefoxitin for injection may be administered intravenously after constitution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The intent of this pharmacy bulk package is for the preparation of solutions for intravenous infusion only. 

  Intravenous Administration

  The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

  For intermittent intravenous administration. Using an infusion system, a solution containing 1 gram or 2 grams may be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusions of the solution containing cefoxitin for injection, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of cefoxitin for injection may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®3 or scalp vein-type needles are preferred for this type of infusion.

  Solutions of cefoxitin for injection, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, cefoxitin for injection and aminoglycosides may be administered separately to the same patient.

  3 Registered trademark of Abbott Laboratories, Inc. COMPATIBILITY AND STABILITY Pharmacy Bulk Packages

  Cefoxitin for injection supplied in pharmacy bulk package bottles and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, should be DISCARDED 4 HOURS AFTER INITIAL ENTRY, FURTHER DILUTION IS REQUIRED BEFORE USE. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION.

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

     0.9 percent Sodium Chloride Injection
     5 percent or 10 percent Dextrose Injection
     5 percent Dextrose and 0.9 percent Sodium Chloride Injection
     5 percent Dextrose Injection with 0.2 percent or 0.45 percent saline solution
     Lactated Ringer's Injection
     5 percent Dextrose in Lactated Ringer's Injection
     5 percent Sodium Bicarbonate Injection
     M/6 sodium lactate solution
     Mannitol 5% and 10%

  After the periods mentioned above, any unused solutions should be discarded.

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  TREATMENT Adults

  The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 1 for dosage guidelines).

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

  Cefoxitin for injection may be used in patients with reduced renal function with the following dosage adjustments:

  In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 2) may be used as a guide.

  When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

  Males             =              Weight (kg) x (140-age)
                              72 x serum creatinine (mg/100 mL)

  Females         =             0.85 x male value

  In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 2.

  Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients

  The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.

  At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

  In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults (see Table 2).

  PREVENTION

  Effective prophylactic use depends on the time of administration. Cefoxitin for injection usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.

  For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

  Adults:

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients (3 months and older):

  30 to 40 mg/kg doses may be given at the times designated above.

  Adults

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients

  (3 months and older):

  30 to 40 mg/kg doses may be given at the times designated above.

  Cesarean section patients:

  For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3-dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES.)

  Table 1: Guidelines for Dosage of Cefoxitin for Injection    Type of Infection    Daily Dosage    Frequency and Route * Including patients in whom bacteremia is absent or unlikely.    Uncomplicated forms* of infections such as pneumonia, urinary tract infection, cutaneous infection    3-4 grams    1 gram every 6-8 hours IV    Moderately severe or severe infections    6-8 grams    1 gram every 4 hours
  or
  2 grams every 6-8 hours IV    Infections commonly needing antibiotics in higher dosage (e.g., gas gangrene)    12 grams    2 grams every 4 hours
  or
  3 grams every 6 hours IV Table 2: Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function    Renal Function
     Creatinine Clearance
  (mL/min)    Dose
  (grams)    Frequency
     Mild impairment    50-30    1-2    every 8-12 hours    Moderate impairment    29-10    1-2    every 12-24 hours    Severe impairment    9-5    0.5-1    every 12-24 hours    Essentially no function    <5    0.5-1    every 24-48 hours Table 3: Preparation of Solution for Intravenous Administration    Strength    Amount of Diluent to be Added (mL)*    Approximate Withdrawable Volume (mL)    Approximate Average Concentration (mg/mL) * Shake to dissolve and let stand until clear.  1 gram vial  10  10.5     95  2 gram vial    10 or 20   11.1 or 21    180 or 95                                            Preparation of Solution

  Table 3 is provided for convenience in constituting cefoxitin for injection for intravenous administration.

  For Vials

  One gram should be constituted with at least 10 mL, and 2 grams with 10 or 20 mL, of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the vials portion of the COMPATIBILITY AND STABILITYsection.

  Benzyl Alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of cefoxitin for injection may be indicated, small pediatric patients in this range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when cefoxitin for injection is constituted for administration to pediatric patients in this age range.

  ADMINISTRATION

  Cefoxitin for injection may be administered intravenously after constitution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. 

  Intravenous Administration

  The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

  For intermittent intravenous administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Using an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing cefoxitin for injection, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of cefoxitin for injection may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®3 or scalp vein-type needles are preferred for this type of infusion.

  Solutions of cefoxitin for injection, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, cefoxitin for injection and aminoglycosides may be administered separately to the same patient.

  3 Registered trademark of Abbott Laboratories, Inc. COMPATIBILITY AND STABILITY Vials

  Cefoxitin for injection, as supplied in vials package and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, maintains satisfactory potency for 6 hours at room temperatue or for one week under refrigeration (below 5ºC). 

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

     0.9 percent Sodium Chloride Injection
     5 percent or 10 percent Dextrose Injection
     5 percent Dextrose and 0.9 percent Sodium Chloride Injection
     5 percent Dextrose Injection with 0.2 percent or 0.45 percent saline solution
     Lactated Ringer's Injection
     5 percent Dextrose in Lactated Ringer's Injection
     5 percent Sodium Bicarbonate Injection
     M/6 sodium lactate solution
     Mannitol 5% and 10%

  After the periods mentioned above, any unused solutions should be discarded.

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  The intent of this pharmacy bulk package is for the preparation of solutions for intravenous infusion only.

  TREATMENT

  Adults

  The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 1 for dosage guidelines).

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

  Cefoxitin for Injection, USP may be used in patients with reduced renal function with the following dosage adjustments:

  In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 2) may be used as a guide.

  When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

  Males:                     Weight (Kg) x (140 –age)      
                            72 x serum creatinine (mg/100ml)

  Females:       0.85 x above value

  In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 2.

  Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients

  The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.

  At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

  In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults (see Table 2).

  PREVENTION

  Effective prophylactic use depends on the time of administration. Cefoxitin for Injection, USP usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.

  For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

  Adults:

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients (3 months and older):

  30 to 40 mg/kg doses may be given at the times designated above.

  Cesarean section patients:

  For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3-dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES.)

  Table 1 - Guidelines for Dosage of Cefoxitin for Injection, USP

  + Including patients in whom bacteremia is absent or unlikely.

  Type of Infection Daily Dosage Frequency and Route Uncomplicated forms+ of infections such as pneumonia, urinary tract infection, cutaneous infection 3-4 grams 1 gram every 6-8 hours IV Moderately severe or severe infections 6-8 grams 1 gram every 4 hours
  or
  2 grams every 6-8 hours IV Infections commonly needing antibiotics in higher dosage (e.g., gas gangrene) 12 grams 2 grams every 4 hours
  or
  3 grams every 6 hours IV
  Table 2 - Maintenance Dosage of Cefoxitin for Injection, USP in Adults with Reduced Renal Function Renal Function Creatinine
  Clearance
  (mL/min) Dose
  (grams) Frequency Mild impairment 50-30 1-2 every 8-12 hours Moderate impairment 29-10 1-2 every 12-24 hours Severe impairment 9-5 0.5-1 every 12-24 hours Essentially no function <5 0.5-1 every 24-48 hours Table 3 - Preparation of Solution for Intravenous Administration

  ++ Shake to dissolve and let stand until clear.

  Strength Amount of Diluent to be Added
  (mL)++ Approximate
  Withdrawable
  Volume (mL) Approximate Average
  Concentration
  (mg/mL) Pharmacy Bulk Package – 10 grams 43 or 93 49 or 98.5 200 or 100 PREPARATION OF SOLUTION

  Table 3 is provided for convenience in constituting Cefoxitin for Injection, USP for intravenous administration.

  The 10 gram pharmacy bulk package bottle should be constituted with 43 or 93 mL of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. CAUTION: THE 10 GRAM BULK STOCK SOLUTION IS NOT FOR DIRECT INFUSION. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION. RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the Bulk Packages portion of the COMPATIBILITY AND STABILITY section.

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of Cefoxitin for Injection, USP may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when Cefoxitin for Injection, USP is constituted for administration to pediatric patients in this age range.

  ADMINISTRATION

  Cefoxitin for Injection, USP may be administered intravenously after constitution.

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

  Intravenous Administration

  The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

  For intermittent intravenous administration: Using an infusion system, a solution containing 1 gram or 2 grams may be given over a period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing Cefoxitin for Injection, USP, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of Cefoxitin for Injection, USP may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY‡ or scalp vein-type needles are preferred for this type of infusion.

  Solutions of Cefoxitin for Injection, USP, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, Cefoxitin for Injection, USP and aminoglycosides may be administered separately to the same patient.

  Directions for Proper Use of Pharmacy Bulk Package bottle:

  Pharmacy Bulk Package
  Not for Direct Infusion

  RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION

  The Pharmacy Bulk Package bottle is for use in a pharmacy admixture service under a laminar flow hood. Penetration into the Pharmacy Bulk Package bottle should be made only one time after reconstitution with a sterile transfer set or other sterile dispensing device, which allows measured distribution of the contents. Dispense the contents in aliquots using aseptic technique. The use of a syringe with a needle is not recommended as it may cause leakage. AFTER INITIAL ENTRY USE ENTIRE CONTENTS OF THE PHARMACY BULK PACKAGE PROMPTLY. A maximum time of 4 HOURS from initial entry is permitted to complete fluid transfer operations. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS. This time limit should begin with the introducing of solvent or diluent into the Pharmacy Bulk Package bottle. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION. RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION.

  COMPATIBILITY AND STABILITY

  Pharmacy Bulk Package

  Cefoxitin for Injection, USP as supplied in pharmacy bulk package bottles and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection should be DISCARDED 4 HOURS AFTER INITIAL ENTRY. FURTHER DILUTION IS REQUIRED BEFORE USE. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION. RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION.

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

    0.9 percent Sodium Chloride Injection   5 percent or 10 percent Dextrose Injection   5 percent Dextrose and 0.9 percent Sodium Chloride Injection   5 percent Dextrose Injection with 0.2 percent or 0.45 percent saline solution   Lactated Ringer's Injection   5 percent Dextrose in Lactated Ringer's Injection   5 percent Sodium Bicarbonate Injection   M/6 sodium lactate solution   Mannitol 5% and 10%

  After the periods mentioned above, any unused solutions should be discarded.

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  ---

  Treatment Adults

  The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 1 for dosage guidelines).

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

  Cefoxitin for Injection may be used in patients with reduced renal function with the following dosage adjustments:

  In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 2) may be used as a guide.

  When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

  Males:

  Females: 0.85 x above value

  In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 2.

  Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients

  The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.

  At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

  In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults (see Table 2).

  Prevention

  Effective prophylactic use depends on the time of administration. Cefoxitin for Injection usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.

  For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

  Adults:

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients (3 months and older):

  30 to 40 mg/kg doses may be given at the times designated above.

  Cesarean section patients:

  For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3-dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES.)

  Table 1 - Guidelines for Dosage of Cefoxitin for Injection

  Type of Infection Daily Dosage Frequency and Route Uncomplicated forms* of infections such as pneumonia, urinary tract infection, cutaneous infection 3-4 grams 1 gram every 6-8 hours IV Moderately severe or severe infections 6-8 grams

  1 gram every 4 hours

  or

  2 grams every 6-8 hours IV Infections commonly needing antibiotics in higher dosage (e.g., gas gangrene) 12 grams

  2 grams every 4 hours

  or

  3 grams every 6 hours IV

  * Including patients in whom bacteremia is absent or unlikely.

  Table 2 - Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function

  Renal Function

  Creatinine

  Clearance

  (mL/min)

  Dose

  (grams) Frequency

  Mild impairment

  Moderate impairment

  Severe impairment

  Essentially no function

  50-30

  29-10

  9-5

  <5

  1-2

  1-2

  0.5-1

  0.5-1

  every 8-12 hours

  every 12-24 hours

  every 12-24 hours

  every 24-48 hours

  Table 3 - Preparation of Solution for Intravenous Administration

  Strength Amount of Diluent to be Added (mL)**

  Approximate

  Withdrawable

  Volume (mL)

  Approximate Average

  Concentration

  (mg/mL)

  1 gram Vial

  2 gram Vial

  10

  10 or 20

  10.5

  11.1 or 21

  95

  180 or 95

  ** Shake to dissolve and let stand until clear.

  Preparation of Solution

  Table 3 is provided for convenience in constituting Cefoxitin for Injection for intravenous administration.

  For Vials

  One gram should be constituted with at least 10 mL, and 2 grams with 10 or 20 mL, of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the Vials  portion of the COMPATIBILITY AND STABILITY section.

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of Cefoxitin for Injection may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when Cefoxitin for Injection is constituted for administration to pediatric patients in this age range.

  Administration

  Cefoxitin for Injection may be administered intravenously after constitution.

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

  Intravenous Administration

  The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending. For intermittent intravenous administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Using an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing Cefoxitin for Injection, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of Cefoxitin for Injection may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY†† or scalp vein-type needles are preferred for this type of infusion.

  Solutions of Cefoxitin for Injection, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, Cefoxitin for Injection and aminoglycosides may be administered separately to the same patient.

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  Cefoxitin | Fresenius Kabi Usa, Llc

  

  ---

  The intent of this pharmacy bulk package is for the preparation of solutions for intravenous infusion only.

  Treatment
  

  Adults

  The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 3 for dosage guidelines).

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

  CEFOXITIN FOR INJECTION may be used in patients with reduced renal function with the following dosage adjustments:

  In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 4) may be used as a guide.

  When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

  Males:                 Weight (kg) x (140-age)          

                       72 x serum creatinine (mg/100 mL)

  
  

  Females:         0.85 x above value

  In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 4.

  Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis.

  
  
  
  

  In staphylococcal and other infections involving a collection of pus, surgical drainage should be

  carried out where indicated.

  Pediatric Patients

  The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.

  At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

  In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults (see Table 4).

  PREVENTION

  Effective prophylactic use depends on the time of administration. CEFOXITIN FOR INJECTION usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.

  For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

  Adults:

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients (3 months and older):

  30 to 40 mg/kg doses may be given at the times designated above.

  Cesarean section patients:

  For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3-dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES)

  
  
  

  Table 3 - Guidelines for Dosage of CEFOXITIN FOR INJECTION

  Type of Infection
  Daily Dosage
  Frequency and
  Route
  Uncomplicated forms* of infections such as pneumonia, urinary tract infection, cutaneous infection
  3 to 4 grams
  1 gram every 6-8 hours IV
  Moderately severe or severe infections
  6 to 8 grams
  1 gram every 4 hours
  or
  2 grams every 6-8 hours IV
  Infections commonly needing antibiotics in higher dosage (e.g., gas gangrene)
  12 grams
  2 grams every 4 hours
  or
  3 grams every 6 hours IV
  

  * Including patients in whom bacteremia is absent or unlikely.

  
  

  Table 4 - Maintenance Dosage of CEFOXITIN FOR INJECTION in Adults with Reduced Renal Function

  Renal Function
  Creatinine
  Clearance
  (mL/min)
   
  Dose
  (Grams)
  Frequency
  Mild
  impairment
  50 to 30
   
  1 to 2
   
  every 8-12 hours
   
  Moderate
  impairment
  29 to 10
   
  1 to 2
   
  every 12-24 hours
   
  Severe
  impairment
  9 to 5
   
  0.5 to 1
   
  every 12-24 hours
   
  Essentially no
  function
  < 5
  0.5 to 1
  every 24-48 hours
  

  Table 5 - Preparation of Solution for Intravenous Administration

  Strength
  Amount of Diluent to be Added (mL)**
  Approximate
  Withdrawable
  Volume (mL)
  Approximate
  Average
  Concentration
  (mg/mL)
  Pharmacy Bulk
  Package – 10 grams
  43 or 93
  49 or 98.5
  200 or 100
  

  ** Shake to dissolve and let stand until clear.

  
  

  PREPARATION OF SOLUTION

  Table 5 is provided for convenience in constituting CEFOXITIN FOR INJECTION for intravenous administration.

  The 10 gram pharmacy bulk package bottle should be constituted with 43 or 93 mL of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. CAUTION: THE 10 GRAM BULK STOCK SOLUTION IS NOT FOR DIRECT INFUSION. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION. RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the Bulk Packages portion of the COMPATIBILITY AND STABILITY section.

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of CEFOXITIN FOR INJECTION may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when CEFOXITIN FOR INJECTION is constituted for administration to pediatric patients in this age range.

  
  

  ADMINISTRATION

  CEFOXITIN FOR INJECTION may be administered intravenously after constitution.

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

  Intravenous Administration

  The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

  For intermittent intravenous administration: using an infusion system, a solution containing 1 gram or 2 grams may be given over a period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing CEFOXITIN FOR INJECTION, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of CEFOXITIN FOR INJECTION may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®†† or scalp vein-type needles are preferred for this type of infusion.

  Solutions of CEFOXITIN FOR INJECTION, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, CEFOXITIN FOR INJECTION and aminoglycosides may be administered separately to the same patient.

  
  
  

  Directions for Proper Use of Pharmacy Bulk Package bottle:

  
  Pharmacy Bulk Package
  Not for Direct Infusion
  

  RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION

  The Pharmacy Bulk Package bottle is for use in a pharmacy admixture service under a laminar flow hood. Penetration into the Pharmacy Bulk Package bottle should be made only one time after reconstitution with a sterile transfer set or other sterile dispensing device, which allows measured distribution of the contents. Dispense the contents in aliquots using aseptic technique. The use of a syringe with a needle is not recommended as it may cause leakage. AFTER INITIAL ENTRY USE ENTIRE CONTENTS OF THE PHARMACY BULK PACKAGE PROMPTLY. A maximum time of 4 HOURS from initial entry is permitted to complete fluid transfer operations. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS. This time limit should begin with the introducing of solvent or diluent into the Pharmacy Bulk Package bottle. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION. RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION.

  COMPATIBILITY AND STABILITY

  Pharmacy Bulk Package

  CEFOXITIN FOR INJECTION as supplied in pharmacy bulk package bottles and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection should be DISCARDED 4 HOURS AFTER INITIAL ENTRY. FURTHER DILUTION IS REQUIRED BEFORE USE. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION. RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION.

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

  0.9 percent Sodium Chloride Injection

  5 percent or 10 percent Dextrose Injection

  5 percent Dextrose and 0.9 percent Sodium Chloride Injection

  5 percent Dextrose Injection with 0.2 percent or 0.45 percent saline solution

  Lactated Ringer's Injection

  5 percent Dextrose in Lactated Ringer's Injection

  5 percent Sodium Bicarbonate Injection

  M/6 sodium lactate solution

  Mannitol 5% and 10%

  
  

  After the periods mentioned above, any unused solutions should be discarded.

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  Cefoxitin | Citron Pharma Llc

  

  ---

  Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets
  

  Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, remove the tablet from the bottle or PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet.  IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

  Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy
  

  The recommended adult oral dosage of ondansetron orally disintegrating tablets is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatric Use
  

  There is no experience with the use of a 24 mg dosage in pediatric patients.

  Geriatric Use
  

  The dosage recommendation is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy
  

  The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg  ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

  Pediatric Use
  

  For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

  Geriatric Use
  

  The dosage is the same as for the general population.

  Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen
  

  The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day.
  
  For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
  
  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
  
  For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatric Use
  

  There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.

  Geriatric Use
  

  The dosage recommendation is the same as for the general population.

  Postoperative Nausea and Vomiting
  

  The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

  Pediatric Use
  

  There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

  Geriatric Use
  

  The dosage is the same as for the general population.

  Dosage Adjustment for Patients With Impaired Renal Function
  

  The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

  Dosage Adjustment for Patients With Impaired Hepatic Function
  

  In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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• Apotex Corporation
  

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  Cefoxitin | Apotex Corporation

  

  ---

  The intent of this pharmacy bulk package is for the preparation of solution for intravenous infusion only.

  TREATMENT

  Adults

  The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 1 for dosage guidelines).

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

  Cefoxitin for injection may be used in patients with reduced renal function with the following dosage adjustments:

  In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 2) may be used as a guide.

  When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

  Males: Weight (kg) x (140–age)  72 x serum creatinine (mg/100 mL) Females: 0.85 x above value

  In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 2.

  Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated. 

  Pediatric Patients

  The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.

  At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

  In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults (see Table 2).

  PREVENTION

  Effective prophylactic use depends on the time of administration. Cefoxitin for injection usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.

  For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

  Adults:

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients (3 months and older):

  30 to 40 mg/kg doses may be given at the times designated above.

  Cesarean section patients:

  For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3 dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES.) 

  Table 1 - Guidelines for Dosage of Cefoxitin for Injection

  Type of Infection

  Daily Dosage

  Frequency and Route

  Uncomplicated forms+ of
     infections such as pneumonia,
     urinary tract infection,
     cutaneous infection

  3-4 grams

  1 gram every 6-8 hours IV

  Moderately severe or severe
     infections

  6-8 grams

  1 gram every 4 hours
  or
  2 grams every 6-8 hours IV 

  Infections commonly needing
     antibiotics in higher dosage
     (e.g., gas gangrene)

  12 grams

  2 grams every 4 hours
  or
  3 grams every 6 hours IV

  + Including patients in whom bacteremia is absent or unlikely.

  Table 2 - Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function

  Renal Function

  Creatinine
  Clearance
  (mL/min)

   

  Dose
  (grams)

  Frequency

  Mild impairment

  Moderate impairment

  Severe impairment

     Essentially no function

  50-30

  29-10

  9-5

  <5

  1-2

  1-2

  0.5-1

  0.5-1 

  every 8-12 hours

  every 12-24 hours

  every 12-24 hours

  every 24-48 hours

  Table 3 - Preparation of Solution for Intravenous Administration

  Strength

   Amount of Diluent to be
  Added (mL)++

   Approximate
  Withdrawable
  Volume (mL)

  Approximate
  Average
  Concentration
  (mg/mL)

  1 gram Vial

  2 gram Vial

  10 gram Bulk

  10

  10 or 20

  43 or 93 

  10.5

  11.1 or 21

  49 or 98.5

  95

  180 or 95

  200 or 100

  ++ Shake to dissolve and let stand until clear.

  PREPARATION OF SOLUTION

  Table 3 is provided for convenience in constituting cefoxitin for injection for intravenous administration.

  For Pharmacy Bulk Packages

  The 10 gram bulk packages should be constituted with 43 or 93 mL of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. CAUTION: THE 10 GRAM BULK STOCK SOLUTION IS NOT FOR DIRECT INFUSION. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the Pharmacy Bulk Packages portion of the COMPATIBILITY AND STABILITY section.

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of cefoxitin for injection may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when cefoxitin for injection is constituted for administration to pediatric patients in this age range.

  ADMINISTRATION

  Cefoxitin for injection may be administered intravenously after constitution.

  The intent of this pharmacy bulk package is for the preparation of solution for intravenous infusion only.

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

  Intravenous Administration

  The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

  During infusion of the solution containing cefoxitin, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of cefoxitin may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®†† or scalp vein-type needles are preferred for this type of infusion.

  _________________________________________________________________

  †† Registered trademark of Abbott Laboratories, Inc.

  Solutions of cefoxitin, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, cefoxitin and aminoglycosides may be administered separately to the same patient.

  COMPATIBILITY AND STABILITY 

  Pharmacy Bulk Package

  Cefoxitin for injection, as supplied in the bulk package and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, maintains satisfactory potency for 4 hours at room temperature.

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

  0.9 percent Sodium Chloride Injection
  5 percent or 10 percent Dextrose Injection
  5 percent Dextrose and 0.9 percent Sodium Chloride Injection
  5 percent Dextrose Injection with 0.2 percent or 0.45 percent Sodium Chloride Injection.
  Lactated Ringer's Injection
  5 percent Dextrose in Lactated Ringer's Injection
  5 percent Sodium Bicarbonate Injection
  M/6 sodium lactate solution
  Mannitol 5% and 10%

  After the periods mentioned above, any unused solutions should be discarded.

  Directions for Dispensing: Pharmacy Bulk Package-Not for Direct Infusion

  The Pharmacy Bulk Package is for use in a pharmacy admixture service only under a laminar flow hood. Entry into the vial must be made only one time with a sterile transfer set or other sterile dispensing device, and the contents dispensed in aliquots using aseptic technique. The use of syringe and needle is not recommended as it may cause leakage (see DOSAGE AND ADMINISTRATION). AFTER INITIAL ENTRY, USE ENTIRE CONTENTS OF VIAL PROMPTLY. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS.

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• Wg Critical Care, Llc
  

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  Cefoxitin | Wg Critical Care, Llc

  

  ---

  TREATMENT

  Adults

  The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 3 for dosage guidelines).

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

  Cefoxitin for Injection may be used in patients with reduced renal function with the following dosage adjustments:

  In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 4) may be used as a guide.

  When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

  Males:

  Weight (kg) x (140-age)

  72 x serum creatinine (mg/100 mL)

  In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 4.

  Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients

  The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.

  At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

  In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be

  modified consistent with the recommendations for adults (see Table 4).

  PREVENTION

  Effective prophylactic use depends on the time of administration. Cefoxitin for Injection usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.

  For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

  Adults:

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients (3 months and older):

  30 to 40 mg/kg doses may be given at the times designated above.

  Cesarean section patients:

  For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3-dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES.)

  Table 3. Guidelines for Dosage of Cefoxitin for Injection

  Type of Infection

  Daily Dosage

  Frequency and Route

  Uncomplicated forms* of infections such as pneumonia, urinary tract infection, cutaneous infection

  3 to 4 grams

  1 gram every

  6 to 8 hours IV

  Moderately severe or severe infections

  6 to 8 grams

  1 gram every 4 hours

  or

  2 grams every 6 to 8 hours IV

  Infections commonly needing antibiotics in higher dosage (e.g., gas gangrene)

  12 grams

  2 grams every 4 hours

  or

  3 grams every 6 hours IV

  *Including patients in whom bacteremia is absent or unlikely.

  Table 4. Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function

  Renal Function

  Creatinine

  Clearance (mL/min)

  Dose (Grams)

  Frequency

  Mild impairment

  50 to 30

  1 to 2

  Every 8 to 12 hours

  Moderate impairment

  29 to 10

  1 to 2

  Every 12 to 24 hours

  Severe impairment

  9 to 5

  0.5 to 1

  Every 12 to 24 hours

  Essentially no function

  < 5

  0.5 to 1

  Every 24 to 48 hours

  Table 5. Preparation of Solution for Intravenous Administration

  Strength

  Amount of Diluent to be Added (mL)**

  Approximate Withdrawable Volume (mL)

  Approximate

  Average

  Concentration (mg/mL)

  1 gram Vial

  10

  10.5

  95

  2 gram Vial

  10 or 20

  11.1 or 21

  180 or 95

  **Shake to dissolve and let stand until clear.

  PREPARATION OF SOLUTION

  Table 5 is provided for convenience in constituting Cefoxitin for Injection for intravenous administration.

  One gram should be constituted with at least 10 mL, and 2 grams with 10 or 20 mL, of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the COMPATIBILITY AND STABILITY section.

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of Cefoxitin for Injection may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when Cefoxitin for Injection is constituted for administration to pediatric patients in this age range.

  ADMINISTRATION

  Cefoxitin for Injection may be administered intravenously after constitution.

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

  Intravenous Administration

  The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

  For intermittent intravenous administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Using an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing Cefoxitin for Injection, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of Cefoxitin for Injection may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®†† or scalp vein-type needles are preferred for this type of infusion.

  Solutions of Cefoxitin for Injection, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, Cefoxitin for Injection and aminoglycosides may be administered separately to the same patient.

  COMPATIBILITY AND STABILITY

  Cefoxitin for Injection, as supplied in vials and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, maintains satisfactory potency for 6 hours at room temperature or for one week under refrigeration (below 5ºC).

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

    0.9 percent Sodium Chloride Injection   5 percent or 10 percent Dextrose Injection   5 percent Dextrose and 0.9 percent Sodium Chloride Injection   5 percent Dextrose Injection with 0.2 percent or 0.45 percent saline solution   Lactated Ringer’s Injection   5 percent Dextrose in Lactated Ringer’s Injection   5 percent Sodium Bicarbonate Injection   M/6 sodium lactate solution   Mannitol 5% and 10%

  After the periods mentioned above, any unused solutions should be discarded.

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• Wg Critical Care, Llc
  

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  Cefoxitin | Wg Critical Care, Llc

  

  ---

   The intent of this pharmacy bulk package is for the preparation of solutions for intravenous infusion only.

  TREATMENT

  Adults

  The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 3 for dosage guidelines).

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

  Cefoxitin for Injection may be used in patients with reduced renal function with the following dosage adjustments:

  In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 4) may be used as a guide.

  When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

  Males: Weight (kg) x (140-age) 72 x serum creatinine (mg/100 mL)

  Females: 0.85 x above value
  
  In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 4.

  Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients

  The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.

  At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

  In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be

  modified consistent with the recommendations for adults (see Table 4).

  PREVENTION

  Effective prophylactic use depends on the time of administration. Cefoxitin for Injection usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.

  For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

  Adults:

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients (3 months and older):

  30 to 40 mg/kg doses may be given at the times designated above.

  Cesarean section patients:

  For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3-dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES.)

  Table 3. Guidelines for Dosage of Cefoxitin for Injection

  Type of Infection Daily Dosage Frequency and Route Uncomplicated forms* of infections such as pneumonia, urinary tract infection, cutaneous infection 3 to 4 grams

  1 gram every

  6 to 8 hours IV Moderately severe or severe infections 6 to 8 grams

  1 gram every 4 hours

  or

  2 grams every 6 to 8 hours IV Infections commonly needing antibiotics in higher dosage (e.g., gas gangrene) 12 grams

  2 grams every 4 hours

  or

  3 grams every 6 hours IV

  *Including patients in whom bacteremia is absent or unlikely.

   Table 4. Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function

  Renal Function

  Creatinine

  Clearance (mL/min) Dose (Grams) Frequency Mild impairment 50 to 30 1 to 2 Every 8 to 12 hours Moderate impairment 29 to 10 1 to 2 Every 12 to 24 hours Severe impairment 9 to 5 0.5 to 1 Every 12 to 24 hours Essentially no function < 5 0.5 to 1 Every 24 to 48 hours

   Table 5. Preparation of Solution for Intravenous Administration

  Strength Amount of Diluent to be Added (mL)** Approximate Withdrawable Volume (mL)

  Approximate

  Average

  Concentration (mg/mL) Pharmacy Bulk Package - 10 grams 43 or 93 49 or 98.5 200 or 100

  **Shake to dissolve and let stand until clear.

  Directions for Proper Use of Pharmacy Bulk Package Bottle - Not for Direct Infusion: The Pharmacy Bulk Package Bottle is for use in a pharmacy admixture service only under a laminar flow hood. Penetration into the Pharmacy Bulk Package Bottle should be made only one time after reconstitution with a sterile transfer set or other sterile dispensing device, which allows measured distribution of the contents. Dispense the contents in aliquots using aseptic technique. The use of syringe with a needle is not recommended as it may cause leakage (See DOSAGE AND ADMINISTRATION). AFTER INITIAL ENTRY USE ENTIRE CONTENTS OF THE PHARMACY BULK PACKAGE PROMPTLY. A maximum time of 4 HOURS from initial entry is permitted to complete fluid transfer operations. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS. This time limit should begin with the introducing of solvent or diluent into the Pharmacy Bulk Package bottle. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION.

  PREPARATION OF SOLUTION

  Table 5 is provided for convenience in constituting Cefoxitin for Injection for intravenous administration.

  For Bulk Packages

  The 10 gram bulk packages should be constituted with 43 or 93 mL of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. CAUTION: THE 10 GRAM BULK STOCK SOLUTION IS NOT FOR DIRECT INFUSION. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the COMPATIBILITY AND STABILITY section.

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of Cefoxitin for Injection may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when Cefoxitin for Injection is constituted for administration to pediatric patients in this age range.

  ADMINISTRATION

  Cefoxitin for Injection may be administered intravenously after constitution.

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

  Intravenous Administration

  The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

  For intermittent intravenous administration, using an infusion system, a solution containing 1 gram or 2 grams may be given over a period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing Cefoxitin for Injection, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of Cefoxitin for Injection may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®†† or scalp vein-type needles are preferred for this type of infusion.

  Solutions of Cefoxitin for Injection, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, Cefoxitin for Injection and aminoglycosides may be administered separately to the same patient.

  COMPATIBILITY AND STABILITY

  Pharmacy Bulk Package

  Cefoxitin for Injection, as supplied in pharmacy bulk package bottles and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, should be DISCARDED 4 HOURS AFTER INITIAL ENTRY. FURTHER DILUTION IS REQUIRED BEFORE USE.

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

    0.9 percent Sodium Chloride Injection   5 percent or 10 percent Dextrose Injection   5 percent Dextrose and 0.9 percent Sodium Chloride Injection   5 percent Dextrose Injection with 0.2 percent or 0.45 percent saline solution   Lactated Ringer’s Injection   5 percent Dextrose in Lactated Ringer’s Injection   5 percent Sodium Bicarbonate Injection   M/6 sodium lactate solution   Mannitol 5% and 10%

  After the periods mentioned above, any unused solutions should be discarded.

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• Apotex Corporation
  

  ×

  Cefoxitin | Apotex Corporation

  

  ---

  TREATMENT

  Adults

  The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 3 for dosage guidelines).

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

  Cefoxitin for injection may be used in patients with reduced renal function with the following dosage adjustments:

  In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 4) may be used as a guide.

  When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

  Males:                                            Weight (kg) x (140–age)                
                                                      72 x serum creatinine (mg/100 mL)

  Females:                                    0.85 x above value

  In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 4.

  Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients

  The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.

  At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

  In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults (see Table 4).

  PREVENTION

  Effective prophylactic use depends on the time of administration. Cefoxitin for injection usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.

  For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

  Adults:

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients (3 months and older):

  30 to 40 mg/kg doses may be given at the times designated above.

  Cesarean section patients:

  For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3 dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES.)

  Table 3 - Guidelines for Dosage of Cefoxitin for Injection

  Type of Infection

  Daily Dosage

  Frequency and Route

  Uncomplicated forms+ of 
     infections such as pneumonia,
     urinary tract infection,
     cutaneous infection

  3 to 4 grams

  1 gram every 6 to 8 hours IV

  Moderately severe or severe
     infections

  6 to 8 grams

  1 gram every 4 hours
  or
  2 grams every 6 to 8 hours IV

  Infections commonly needing
     antibiotics in higher dosage
     (e.g., gas gangrene)

  12 grams

  2 grams every 4 hours
  or
  3 grams every 6 hours IV

   + Including patients in whom bacteremia is absent or unlikely.

  Table 4 - Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function

  Renal Function

  Creatinine
  Clearance
  (mL/min)

  Dose
  (grams)

  Frequency

  Mild impairment
  Moderate impairment
  Severe impairment
  Essentially no function

  50 to 30
  29 to 10
  9 to 5
  <5

  1 to 2
  1 to 2
  0.5 to 1
  0.5 to 1

  every 8 to 12 hours
  every 12 to 24 hours
  every 12 to 24 hours
  every 24 to 48 hours

  Table 5 - Preparation of Solution for Intravenous Administration

  Strength

  Amount of Diluent to be
  Added (mL)++

  Approximate
  Withdrawable
  Volume (mL)

  Approximate
  Average
  Concentration
  (mg/mL)

  1 gram Vial 
  2 gram Vial
  10 gram Bulk

  10
  10 or 20
  43 or 93

  10.5
  11.1 or 21
  49 or 98.5

  95
  180 or 95
  200 or 100

   ++ Shake to dissolve and let stand until clear.

  PREPARATION OF SOLUTION

  Table 5 is provided for convenience in constituting cefoxitin for injection for intravenous administration.

  For Vials

  One gram should be constituted with at least 10 mL, and 2 grams with 10 or 20 mL, of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the Vials and Bulk Packages portion of the COMPATIBILITY AND STABILITY section.

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of cefoxitin for injection may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when cefoxitin for injection is constituted for administration to pediatric patients in this age range.

  ADMINISTRATION

  Cefoxitin for injection may be administered intravenously after constitution.

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

  Intravenous Administration

  The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

  For intermittent intravenous administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Using an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing cefoxitin, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of cefoxitin may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®†† or scalp vein-type needles are preferred for this type of infusion.

  Solutions of cefoxitin, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, cefoxitin and aminoglycosides may be administered separately to the same patient.

  COMPATIBILITY AND STABILITY

  Vials

  Cefoxitin for injection, as supplied in vials and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, maintains satisfactory potency for 6 hours at room temperature or for one week under refrigeration (below 5°C).

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

  0.9 percent Sodium Chloride Injection
  5 percent or 10 percent Dextrose Injection
  5 percent Dextrose and 0.9 percent Sodium Chloride Injection
  5 percent Dextrose Injection with 0.2 percent or 0.45 percent Sodium Chloride Injection.

  ________________________________________________________
  †† Registered trademark of Abbott Laboratories, Inc.

  Lactated Ringer's Injection
  5 percent Dextrose in Lactated Ringer's Injection
  5 percent Sodium Bicarbonate Injection
  M/6 sodium lactate solution
  Mannitol 5% and 10%

  After the periods mentioned above, any unused solutions should be discarded.

  TREATMENT

  Adults

  The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 3 for dosage guidelines).

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

  Cefoxitin for injection may be used in patients with reduced renal function with the following dosage adjustments:

  In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 4) may be used as a guide.

  When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

  Males:                                            Weight (kg) x (140–age)                
                                                      72 x serum creatinine (mg/100 mL)

  Females:                                    0.85 x above value

  In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 4.

  Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients

  The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.

  At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

  In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults (see Table 4).

  PREVENTION

  Effective prophylactic use depends on the time of administration. Cefoxitin for injection usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.

  For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

  Adults:

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients (3 months and older):

  30 to 40 mg/kg doses may be given at the times designated above.

  Cesarean section patients:

  For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3 dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES.)

  Table 3 - Guidelines for Dosage of Cefoxitin for Injection

  Type of Infection

  Daily Dosage

  Frequency and Route

  Uncomplicated forms+ of 
     infections such as pneumonia,
     urinary tract infection,
     cutaneous infection

  3 to 4 grams

  1 gram every 6 to 8 hours IV

  Moderately severe or severe
     infections

  6 to 8 grams

  1 gram every 4 hours
  or
  2 grams every 6 to 8 hours IV

  Infections commonly needing
     antibiotics in higher dosage
     (e.g., gas gangrene)

  12 grams

  2 grams every 4 hours
  or
  3 grams every 6 hours IV

   + Including patients in whom bacteremia is absent or unlikely.

  Table 4 - Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function

  Renal Function

  Creatinine
  Clearance
  (mL/min)

  Dose
  (grams)

  Frequency

  Mild impairment
  Moderate impairment
  Severe impairment
  Essentially no function

  50 to 30
  29 to 10
  9 to 5
  <5

  1 to 2
  1 to 2
  0.5 to 1
  0.5 to 1

  every 8 to 12 hours
  every 12 to 24 hours
  every 12 to 24 hours
  every 24 to 48 hours

  Table 5 - Preparation of Solution for Intravenous Administration

  Strength

  Amount of Diluent to be
  Added (mL)++

  Approximate
  Withdrawable
  Volume (mL)

  Approximate
  Average
  Concentration
  (mg/mL)

  1 gram Vial 
  2 gram Vial
  10 gram Bulk

  10
  10 or 20
  43 or 93

  10.5
  11.1 or 21
  49 or 98.5

  95
  180 or 95
  200 or 100

   ++ Shake to dissolve and let stand until clear.

  PREPARATION OF SOLUTION

  Table 5 is provided for convenience in constituting cefoxitin for injection for intravenous administration.

  For Vials

  One gram should be constituted with at least 10 mL, and 2 grams with 10 or 20 mL, of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the Vials and Bulk Packages portion of the COMPATIBILITY AND STABILITY section.

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of cefoxitin for injection may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when cefoxitin for injection is constituted for administration to pediatric patients in this age range.

  ADMINISTRATION

  Cefoxitin for injection may be administered intravenously after constitution.

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

  Intravenous Administration

  The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

  For intermittent intravenous administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Using an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing cefoxitin, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of cefoxitin may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®†† or scalp vein-type needles are preferred for this type of infusion.

  Solutions of cefoxitin, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, cefoxitin and aminoglycosides may be administered separately to the same patient.

  COMPATIBILITY AND STABILITY

  Vials

  Cefoxitin for injection, as supplied in vials and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, maintains satisfactory potency for 6 hours at room temperature or for one week under refrigeration (below 5°C).

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

  0.9 percent Sodium Chloride Injection
  5 percent or 10 percent Dextrose Injection
  5 percent Dextrose and 0.9 percent Sodium Chloride Injection
  5 percent Dextrose Injection with 0.2 percent or 0.45 percent Sodium Chloride Injection.

  ________________________________________________________
  †† Registered trademark of Abbott Laboratories, Inc.

  Lactated Ringer's Injection
  5 percent Dextrose in Lactated Ringer's Injection
  5 percent Sodium Bicarbonate Injection
  M/6 sodium lactate solution
  Mannitol 5% and 10%

  After the periods mentioned above, any unused solutions should be discarded.

  Close
  No Recall

  More Info
• Apotex Corporation
  

  ×

  Cefoxitin | Apotex Corporation

  

  ---

  TREATMENT

  Adults

  The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 3 for dosage guidelines).

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

  Cefoxitin for injection may be used in patients with reduced renal function with the following dosage adjustments:

  In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 4) may be used as a guide.

  When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

  Males:                                               Weight (kg) x (140–age)               
                                                    72 x serum creatinine (mg/100 mL)

  Females:                                    0.85 x above value

  In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 4.

  Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients

  The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.

  At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

  In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults (see Table 4).

  PREVENTION

  Effective prophylactic use depends on the time of administration. Cefoxitin for injection usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.

  For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

  Adults:

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients (3 months and older):

  30 to 40 mg/kg doses may be given at the times designated above.

  Cesarean section patients:

  For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3 dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES.)

  Table 3 - Guidelines for Dosage of Cefoxitin for Injection

  Type of Infection

  Daily Dosage

  Frequency and Route

  Uncomplicated forms+ of 
     infections such as pneumonia,
     urinary tract infection,
     cutaneous infection

  3 to 4 grams

  1 gram every 6 to 8 hours IV

  Moderately severe or severe
     infections

  6 to 8 grams

  1 gram every 4 hours
  or
  2 grams every 6 to 8 hours IV

  Infections commonly needing
     antibiotics in higher dosage
     (e.g., gas gangrene)

  12 grams

  2 grams every 4 hours
  or
  3 grams every 6 hours IV

   + Including patients in whom bacteremia is absent or unlikely.

  Table 4 - Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function

  Renal Function

  Creatinine
  Clearance
  (mL/min)

  Dose
  (grams)

  Frequency

  Mild impairment
  Moderate impairment
  Severe impairment
  Essentially no function

  50 to 30
  29 to 10
  9 to 5
  <5

  1 to 2
  1 to 2
  0.5 to 1
  0.5 to 1

  every 8 to 12 hours
  every 12 to 24 hours
  every 12 to 24 hours
  every 24 to 48 hours

  Table 5 - Preparation of Solution for Intravenous Administration

  Strength

  Amount of Diluent to be
  Added (mL)++

  Approximate
  Withdrawable
  Volume (mL)

  Approximate
  Average
  Concentration
  (mg/mL)

  1 gram Vial 
  2 gram Vial
  10 gram Bulk

  10
  10 or 20
  43 or 93

  10.5
  11.1 or 21
  49 or 98.5 

  95
  180 or 95
  200 or 100

   ++ Shake to dissolve and let stand until clear.

  PREPARATION OF SOLUTION

  Table 5 is provided for convenience in constituting cefoxitin for injection for intravenous administration.

  For Vials

  One gram should be constituted with at least 10 mL, and 2 grams with 10 or 20 mL, of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the Vials and Bulk Packages portion of the COMPATIBILITY AND STABILITY section.

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of cefoxitin for injection may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when cefoxitin for injection is constituted for administration to pediatric patients in this age range.

  ADMINISTRATION

  Cefoxitin for injection may be administered intravenously after constitution.

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

  Intravenous Administration

  The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

  For intermittent intravenous administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Using an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing cefoxitin, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of cefoxitin may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®†† or scalp vein-type needles are preferred for this type of infusion.

  Solutions of cefoxitin, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, cefoxitin and aminoglycosides may be administered separately to the same patient.

  COMPATIBILITY AND STABILITY

  Vials

  Cefoxitin for injection, as supplied in vials and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, maintains satisfactory potency for 6 hours at room temperature or for one week under refrigeration (below 5°C).

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

  0.9 percent Sodium Chloride Injection
  5 percent or 10 percent Dextrose Injection
  5 percent Dextrose and 0.9 percent Sodium Chloride Injection
  5 percent Dextrose Injection with 0.2 percent or 0.45 percent Sodium Chloride Injection.

  ________________________________________________________
  †† Registered trademark of Abbott Laboratories, Inc.

  Lactated Ringer's Injection
  5 percent Dextrose in Lactated Ringer's Injection
  5 percent Sodium Bicarbonate Injection
  M/6 sodium lactate solution
  Mannitol 5% and 10%

  After the periods mentioned above, any unused solutions should be discarded.

  TREATMENT

  Adults

  The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (see Table 3 for dosage guidelines).

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

  Cefoxitin for injection may be used in patients with reduced renal function with the following dosage adjustments:

  In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 4) may be used as a guide.

  When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

  Males:                                               Weight (kg) x (140–age)               
                                                    72 x serum creatinine (mg/100 mL)

  Females:                                    0.85 x above value

  In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 4.

  Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients

  The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.

  At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

  In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults (see Table 4).

  PREVENTION

  Effective prophylactic use depends on the time of administration. Cefoxitin for injection usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.

  For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

  Adults:

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients (3 months and older):

  30 to 40 mg/kg doses may be given at the times designated above.

  Cesarean section patients:

  For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3 dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES.)

  Table 3 - Guidelines for Dosage of Cefoxitin for Injection

  Type of Infection

  Daily Dosage

  Frequency and Route

  Uncomplicated forms+ of 
     infections such as pneumonia,
     urinary tract infection,
     cutaneous infection

  3 to 4 grams

  1 gram every 6 to 8 hours IV

  Moderately severe or severe
     infections

  6 to 8 grams

  1 gram every 4 hours
  or
  2 grams every 6 to 8 hours IV

  Infections commonly needing
     antibiotics in higher dosage
     (e.g., gas gangrene)

  12 grams

  2 grams every 4 hours
  or
  3 grams every 6 hours IV

   + Including patients in whom bacteremia is absent or unlikely.

  Table 4 - Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function

  Renal Function

  Creatinine
  Clearance
  (mL/min)

  Dose
  (grams)

  Frequency

  Mild impairment
  Moderate impairment
  Severe impairment
  Essentially no function

  50 to 30
  29 to 10
  9 to 5
  <5

  1 to 2
  1 to 2
  0.5 to 1
  0.5 to 1

  every 8 to 12 hours
  every 12 to 24 hours
  every 12 to 24 hours
  every 24 to 48 hours

  Table 5 - Preparation of Solution for Intravenous Administration

  Strength

  Amount of Diluent to be
  Added (mL)++

  Approximate
  Withdrawable
  Volume (mL)

  Approximate
  Average
  Concentration
  (mg/mL)

  1 gram Vial 
  2 gram Vial
  10 gram Bulk

  10
  10 or 20
  43 or 93

  10.5
  11.1 or 21
  49 or 98.5 

  95
  180 or 95
  200 or 100

   ++ Shake to dissolve and let stand until clear.

  PREPARATION OF SOLUTION

  Table 5 is provided for convenience in constituting cefoxitin for injection for intravenous administration.

  For Vials

  One gram should be constituted with at least 10 mL, and 2 grams with 10 or 20 mL, of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the Vials and Bulk Packages portion of the COMPATIBILITY AND STABILITY section.

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of cefoxitin for injection may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when cefoxitin for injection is constituted for administration to pediatric patients in this age range.

  ADMINISTRATION

  Cefoxitin for injection may be administered intravenously after constitution.

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

  Intravenous Administration

  The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

  For intermittent intravenous administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Using an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing cefoxitin, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of cefoxitin may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®†† or scalp vein-type needles are preferred for this type of infusion.

  Solutions of cefoxitin, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, cefoxitin and aminoglycosides may be administered separately to the same patient.

  COMPATIBILITY AND STABILITY

  Vials

  Cefoxitin for injection, as supplied in vials and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, maintains satisfactory potency for 6 hours at room temperature or for one week under refrigeration (below 5°C).

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

  0.9 percent Sodium Chloride Injection
  5 percent or 10 percent Dextrose Injection
  5 percent Dextrose and 0.9 percent Sodium Chloride Injection
  5 percent Dextrose Injection with 0.2 percent or 0.45 percent Sodium Chloride Injection.

  ________________________________________________________
  †† Registered trademark of Abbott Laboratories, Inc.

  Lactated Ringer's Injection
  5 percent Dextrose in Lactated Ringer's Injection
  5 percent Sodium Bicarbonate Injection
  M/6 sodium lactate solution
  Mannitol 5% and 10%

  After the periods mentioned above, any unused solutions should be discarded.

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  ---

  TREATMENT

  Adults

  The usual adult dosage range is 1 gram to 2 grams every six to eight hours. Dosage should be determined by susceptibility of the causative organisms, severity of infection, and the condition of the patient (seeTable 3for dosage guidelines).

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

  Cefoxitin for injection may be used in patients with reduced renal function with the following dosage adjustments:

  In adults with renal insufficiency, an initial loading dose of 1 gram to 2 grams may be given. After a loading dose, the recommendations for maintenance dosage (Table 4) may be used as a guide.

  When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

  Males:                       Weight (kg) x (140–age)              
  72 x serum creatinine (mg/100 mL) Females:                 0.85 x above value

  In patients undergoing hemodialysis, the loading dose of 1 to 2 grams should be given after each hemodialysis, and the maintenance dose should be given as indicated in Table 4.

  Antibiotic therapy for group A beta-hemolytic streptococcal infections should be maintained for at least 10 days to guard against the risk of rheumatic fever or glomerulonephritis. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients

  The recommended dosage in pediatric patients three months of age and older is 80 to 160 mg/kg of body weight per day divided into four to six equal doses. The higher dosages should be used for more severe or serious infections. The total daily dosage should not exceed 12 grams.

  At this time no recommendation is made for pediatric patients from birth to three months of age (see PRECAUTIONS).

  In pediatric patients with renal insufficiency, the dosage and frequency of dosage should be modified consistent with the recommendations for adults (see Table 4).

  PREVENTION

  Effective prophylactic use depends on the time of administration. Cefoxitin for injection usually should be given one-half to one hour before the operation, which is sufficient time to achieve effective levels in the wound during the procedure. Prophylactic administration should usually be stopped within 24 hours since continuing administration of any antibiotic increases the possibility of adverse reactions but, in the majority of surgical procedures, does not reduce the incidence of subsequent infection.

  For prophylactic use in uncontaminated gastrointestinal surgery, vaginal hysterectomy, or abdominal hysterectomy, the following doses are recommended:

  Adults:

  2 grams administered intravenously just prior to surgery (approximately one-half to one hour before the initial incision) followed by 2 grams every 6 hours after the first dose for no more than 24 hours.

  Pediatric Patients (3 months and older):

  30 to 40 mg/kg doses may be given at the times designated above.

  Cesarean section patients:

  For patients undergoing cesarean section, either a single 2 gram dose administered intravenously as soon as the umbilical cord is clamped OR a 3 dose regimen consisting of 2 grams given intravenously as soon as the umbilical cord is clamped followed by 2 grams 4 and 8 hours after the initial dose is recommended. (See CLINICAL STUDIES.)

  Table 3 - Guidelines for Dosage of Cefoxitin for Injection

  Type of Infection

  Daily Dosage

  Frequency and Route

  Uncomplicated forms+ of  infections such as pneumonia, urinary tract infection, cutaneous infection

  3 to 4 grams

  1 gram every 6 to 8 hours IV 

  Moderately severe or severe infections

  6 to 8 grams

  1 gram every 4 hours
  or
  2 grams every 6 to 8 hours IV  

  Infections commonly needing antibiotics in higher dosage (e.g., gas gangrene)

  12 grams

  2 grams every 4 hours
  or
  3 grams every 6 hours IV

  + Including patients in whom bacteremia is absent or unlikely.

   

  Table 4 - Maintenance Dosage of Cefoxitin for Injection in Adults with Reduced Renal Function

  Renal Function

  Creatinine
  Clearance
  (mL/min)

  Dose
  (grams)

  Frequency

  Mild impairment
  Moderate impairment
  Severe impairment
  Essentially no function

  50 to30
  29 to 10
  9 to 5
  <5

  1 to 2
  1 to 2
  0.5 to 1
  0.5 to 1

  every 8 to12 hours
    every 12 to24 hours
    every 12 to 24 hours
    every 24 to 48 hours

   

  Table 5 - Preparation of Solution for Intravenous Administration

  Strength
   

   Amount of Diluent to be
  Added (mL)++ 

  Approximate
  Withdrawable
  Volume (mL) 

  Approximate
  Average
  Concentration
  (mg/mL) 

  1 gram Vial
  2 gram Vial
  10 gram Bulk

  10
  10 or 20
  43 or 93 

  10.5
  11.1 or 21
  49 or 98.5

  95
  180 or 95
  200 or 100

  ++ Shake to dissolve and let stand until clear.

  PREPARATION OF SOLUTION

  Table 5 is provided for convenience in constituting cefoxitin for injection for intravenous administration.

  For Vials

  One gram should be constituted with at least 10 mL, and 2 grams with 10 or 20 mL, of Sterile Water for Injection, Bacteriostatic Water for Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection. These primary solutions may be further diluted in 50 to 1000 mL of the diluents listed under the Vials and Bulk Packages portion of the COMPATIBILITY AND STABILITY section.

  Benzyl alcohol as a preservative has been associated with toxicity in neonates. While toxicity has not been demonstrated in pediatric patients greater than three months of age, in whom use of cefoxitin for injection may be indicated, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Therefore, diluent containing benzyl alcohol should not be used when cefoxitin for injection is constituted for administration to pediatric patients in this age range.

  ADMINISTRATION

  Cefoxitin for injection may be administered intravenously after constitution.

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

  Intravenous Administration

  The intravenous route is preferable for patients with bacteremia, bacterial septicemia, or other severe or life-threatening infections, or for patients who may be poor risks because of lowered resistance resulting from such debilitating conditions as malnutrition, trauma, surgery, diabetes, heart failure, or malignancy, particularly if shock is present or impending.

  For intermittent intravenous administration, a solution containing 1 gram or 2 grams in 10 mL of Sterile Water for Injection can be injected over a period of three to five minutes. Using an infusion system, it may also be given over a longer period of time through the tubing system by which the patient may be receiving other intravenous solutions. However, during infusion of the solution containing cefoxitin, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For the administration of higher doses by continuous intravenous infusion, a solution of cefoxitin may be added to an intravenous bottle containing 5 percent Dextrose Injection, 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose and 0.9 percent Sodium Chloride Injection. BUTTERFLY®†† or scalp vein-type needles are preferred for this type of infusion.

  Solutions of cefoxitin, like those of most beta-lactam antibiotics, should not be added to aminoglycoside solutions (e.g., gentamicin sulfate, tobramycin sulfate, amikacin sulfate) because of potential interaction. However, cefoxitin and aminoglycosides may be administered separately to the same patient.

  COMPATIBILITY AND STABILITY 

  VIALS

  Cefoxitin for injection, as supplied in vials and constituted to 1 gram/10 mL with Sterile Water for Injection, Bacteriostatic Water for Injection, (see PREPARATION OF SOLUTION), 0.9 percent Sodium Chloride Injection, or 5 percent Dextrose Injection, maintains satisfactory potency for 6 hours at room temperature or for one week under refrigeration (below 5°C).

  These primary solutions may be further diluted in 50 to 1000 mL of the following diluents and maintain potency for an additional 18 hours at room temperature or an additional 48 hours under refrigeration:

  0.9 percent Sodium Chloride Injection
  5 percent or 10 percent Dextrose Injection
  5 percent Dextrose and 0.9 percent Sodium Chloride Injection
  5 percent Dextrose Injection with 0.2 percent or 0.45 percent Sodium Chloride Injection.
  Lactated Ringer's Injection
  5 percent Dextrose in Lactated Ringer's Injection
  5 percent Sodium Bicarbonate Injection
  M/6 sodium lactate solution
  Mannitol 5% and 10%

  After the periods mentioned above, any unused solutions should be discarded.

  _____________________________________________
  †† Registered trademark of Abbott Laboratories, Inc.

   

  Close
  No Recall

  More Info