Cefuroxime Sodium

Cefuroxime Sodium Manufacturers

• Samson Medical Technologies, L.l.c.
  

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  Cefuroxime Sodium | Samson Medical Technologies, L.l.c.

  

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  THIS IS A PHARMACY BULK PACKAGE – NOT FOR DIRECT INJECTION.

  BEFORE ADMINISTRATION, THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION TO A CONCENTRATION OF 95 mg/mL OR 100 mg/mL AND TRANSFER INTO STERILE SYRINGES.

  Dosage: Adults: The usual adult dosage range for Cefuroxime for Injection is 750 mg to 1.5 grams every 8 hours, usually for 5 to 10 days. In uncomplicated urinary tract infections, skin and skin-structure infections, disseminated gonococcal infections, and uncomplicated pneumonia, a 750-mg dose every 8 hours is recommended. In severe or complicated infections, a 1.5-gram dose every 8 hours is recommended.

     In bone and joint infections, a 1.5-gram dose every 8 hours is recommended. In clinical trials, surgical intervention was performed when indicated as an adjunct to therapy with cefuroxime.  A course of oral antibiotics was administered when appropriate following the completion of parenteral administration of cefuroxime.

     In life-threatening infections or infections due to less susceptible organisms, 1.5 grams every 6 hours may be required. In bacterial meningitis, the dosage should not exceed 3 grams every 8 hours.  For preventive use for clean-contaminated or potentially contaminated surgical procedures, a 1.5-gram dose administered intravenously just before surgery (approximately one-half to 1 hour before the initial incision) is recommended. Thereafter, give 750 mg intravenously every 8 hours when the procedure is prolonged.

     For preventive use during open-heart surgery, a 1.5-gram dose administered intravenously at the induction of anesthesia and every 12 hours thereafter for a total of 6 grams is recommended.

  Impaired Renal Function: A reduced dosage must be employed when renal function is impaired. Dosage should be determined by the degree of renal impairment and the susceptibility of the causative organism (see Table 2).

  Table 2. Dosage of Cefuroxime For Injection in Adults With Reduced Renal Function

  Creatinine Clearance(mL/min)

  Dose

  Frequency

  >20

  750 mg-1.5 grams

  q8h

  10-20

  750 mg

  q12h

  <10

  750 mg

  q24h*

  ­­­­­­­­­­­­­­­­­­­­­­­­­­­­*Since cefuroxime is dialyzable, patients on hemodialysis should be given a further dose at the end of the dialysis.

     When only serum creatinine is available, the following formula2 (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: Creatinine clearance (mL/min) = Weight (kg) x (140 - age)
                                                                      72 x serum creatinine (mg/dL)

  Females: 0.85 x male value

  Note: As with antibiotic therapy in general, administration of cefuroxime should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended in infection caused by Streptococcus pyogenes in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment for several weeks; and doses smaller than those indicated above should not be used. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

    

  Pediatric Patients Above 3 Months of Age:

  Administration of 50 to 100 mg/kg/day in equally divided doses every 6 to 8 hours has been successful for most infections susceptible to cefuroxime. The higher dosage of 100 mg/kg/day (not to exceed the maximum adult dosage) should be used for the more severe or serious infections.

     In bone and joint infections, 150 mg/kg/day (not to exceed the maximum adult dosage) is recommended in equally divided doses every 8 hours. In clinical trials, a course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration of cefuroxime.

     In cases of bacterial meningitis, a larger dosage of Cefuroxime for Injection is recommended, 200 to 240 mg/kg/day intravenously in divided doses every 6 to 8 hours.

     In pediatric patients with renal insufficiency, the frequency of dosing should be modified consistent with the recommendations for adults.

  Preparation of Solution:

  The directions for preparing cefuroxime for intravenous use are summarized in Table 3. 

  AFTER INITIAL ENTRY USE ENTIRE CONTENTS OF THE PHARMACY BULK PACKAGE PROMPTLY; ANY UNUSED PORTION MUST BE DISCARDED WITHIN 4 HOURS.

  As with other cephalosporins, cefuroxime powder as well as solutions tend to darken, depending on storage conditions, without adversely affecting potency.

  Note: Prior to administration, parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.  If particulate matter is evident in reconstituted fluids the drug solutions should be discarded.

  Table 3. Preparation of Solution For Intravenous Use Only

  Strength Amount of
  Sterile Water to
  Be Added
  (mL)

  Volume to Be
  Withdrawn

  Approximate
  Concentration
  Cefuroxime
  (mg/mL) 75-gram Pharmacy Bulk Package 770

  8 mL = 750 mg*

  95 16 mL = 1.5 grams* 95   720 7.5 mL = 750 mg* 100 15 mL = 1.5 grams* 100   225-gram Pharmacy Bulk Package 2310 8 mL = 750 mg* 95 16 mL = 1.5 grams* 95   2160  7.5 mL = 750 mg* 100 15 mL = 1.5 grams* 100

  *Cefuroxime as Cefuroxime Sodium.

  Directions for Proper Use of a Pharmacy Bulk Package

  Not for direct infusion. The Pharmacy Bulk Package is for use in the hospital pharmacy admixture service only in a suitable work area, such as a laminar flow hood. Using aseptic technique, the container closure may be penetrated only one time using a new suitable sterile dispensing set or transfer device that allows measured dispensing of the contents. Use of a syringe and needle is not recommended as it may cause leakage. The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 4 HOURS from initial port closure entries is permitted to complete fluid transfer operations. This time limit should begin with the introduction of the solvent or diluent into the Pharmacy Bulk Pack.

  Instructions for Reconstitution:  Visually examine outer (natural foil) bag for damage.  IF THE SEAL IS BROKEN OR DAMAGE IS OBSERVED, DO NOT OPEN THE OUTER BAG.  STERILITY OF THE INNER BAG SURFACE MAY BE COMPROMISED.  DISCARD BOTH BAGS IMMEDIATELY.  Using aseptic technique, open outer bag at tear notch.  Remove, unfold and lay inner bag flat in a laminar flow hood.  DO NOT USE THE INNER BAG IF PARTICULATE OR FOREIGN MATTER IS PRESENT, IF THE DRY POWDER IS DARK YELLOW OR BROWN, IF THE SEALS ARE NOT INTACT, OR IF THERE IS ANY OTHER DAMAGE TO THE BAG.  IN SUCH CASES, DISCARD THE BAG IMMEDIATELY.  Remove the translucent unthreaded cap from the reconstitution (smaller) port and discard it.  Follow the above “Directions for Proper Use of a Pharmacy Bulk Package” and proceed to reconstitute the powder through the reconstitution (smaller) port, using Sterile Water for Injection.  Mix gently by picking up the bag and gently moving from side to side or by recirculating via a tubing loop until dissolution is complete. Once the powder is completely dissolved, approximately 15 minutes for 75 grams or 25 minutes for 225 grams, hang the bag from the eyelets support. 

  If a pump is used, the following general procedure is recommended:

  1.         For the reconstitution procedure, assemble a sterile transfer tubing set, an individually packaged sterile spike, a bag of Sterile Water for Injection and the SmartPak® Pharmacy Bulk Package.  Using aseptic technique

  a.     Open the package containing the transfer tubing set.

  b.     Attach the individually packaged spike to the unspiked end of the transfer tubing set.

  c.     Insert this [removable] spike into the spike port of the bag of Sterile Water for Injection [diluent].

  d.     Attach the non removable spike of the same tubing set into the Transfer Port of the SmartPak® Pharmacy Bulk Package.

  2.         Transfer the appropriate amount of Sterile Water for Injection into the SmartPak® Pharmacy Bulk Package by pressing the reverse button of the pump.

  3.         After completing the transfer of the appropriate amount of Sterile Water for Injection, aseptically remove the spike from the bag of Sterile Water for Injection, and disconnect the spike from this end of the tubing set. 

  4.         Aseptically replace this spike with a transfer needle, and insert this needle into the Reconstitution Port of the SmartPak® Pharmacy Bulk Package.

  5.         Using the pump, circulate the reconstituted drug through the tubing set and SmartPak® Pharmacy Bulk Package to thoroughly mix (about 15 minutes for the 75 gram container and 25 minutes for the 225 gram container).

  6.         After solution is complete, aseptically remove the transfer needle from the Reconstitution Port of the SmartPak® Pharmacy Bulk Package, and replace it with a syringe filling adaptor.

  7.         Hang the bag from the eyelets support.  Using a pump, aseptically transfer the reconstituted solution from the SmartPak® Pharmacy Bulk Package, through the tubing set in the Transfer Port, into syringes via the syringe filling adaptor.

  It should be noted that the spike placed into the SmartPak® Pharmacy Bulk Package in Step1.d. is NEVER removed during this procedure and that the Reconstitution Port is self-sealing.   

  Solutions should be allowed to stand after dissolution to allow any foaming to dissipate in order to permit visual inspection for completed solubilization.  CAUTION:  TO AVOID POSSIBLE LEAKAGE CAUSED BY THE HEAVY WEIGHT OF THE ADDED WATER, DO NOT SHAKE VIGOROUSLY OR PULL STRONGLY ON THE BAG.

  Dispensing Reconstituted Cefuroxime/Instructions for Filling Empty Syringes:  Unscrew the clear threaded cap from the transfer (larger) port and discard it.  Using this transfer port, fill sterile empty syringes, using a new transfer device.  Syringes may be filled using aseptic technique following the usual practice of the individual institution.  Such practices may range from the use of a three-way stop cock to use of a calibrated peristaltic pump.  If reconstituted to 95 mg/mL:  dispense 8 mL for 750 mg or 16 mL for 1.5 grams.  If reconstituted to 100 mg/mL: dispense 7.5 mL for 750 mg or 15 mL for 1.5 grams.  For pediatric dosages, see Pediatric Patients Above 3 Months of Age.

  RECONSTITUTION PHASE

  1.   Remove translucent reconstitution port cap by pulling

  2.   Insert new transfer device for reconstitution

  3.   Add appropriate volume of Sterile Water for Injection

  4.   Disconnect injection transfer device

  5.   See text of Package Insert for further details

  MIXING PHASE

  1.   Mix gently: either recirculate via a tubing loop or by picking up the bag and gently moving it from side to side until dissolution is completed (15 to 25 minutes) and foam, if any, dissipates

  2.   Check for particulate matter, leaks and discoloration (dark yellow or brown)

  3.   If any of the above are found, discard bag immediately

  4.   If satisfactory, hang bag, using the eyelets

  5.   See text of Package Insert for further details

  DISPENSING PHASE

  1.   Unscrew clear transfer  port cap

  2.   Insert new transfer device

  3.   Transfer dose into sterile empty syringe

  4.   Properly label syringes

  5.   See text of Package Insert for further details

  Administration

  BEFORE ADMINISTRATION, THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION TO A CONCENTRATION OF 95 mg/mL OR 100 mg/mL AND TRANSFER INTO STERILE SYRINGES.

  Cefuroxime for Injection, USP, SmartPak® Pharmacy Bulk Packages are for intravenous use only following reconstitution and transfer into syringes.

  Intravenous Administration:  The intravenous route may be preferable for patients with bacterial septicemia or other severe or life-threatening infections or for patients who may be poor risks because of lowered resistance, particularly if shock is present or impending.

  For direct intermittent intravenous administration, slowly inject the solution into a vein over a period of 3 to 5 minutes or give it through the tubing system by which the patient is also receiving other intravenous solutions.

  For intermittent intravenous infusion with a Y-type administration set, dosing can be accomplished through the tubing system by which the patient may be receiving other intravenous solutions.  However, during infusion of the solutions containing cefuroxime, it is advisable to temporarily discontinue administration of any other solutions at the same site. 

  Solutions of cefuroxime, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.  However, if concurrent therapy with cefuroxime and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.

  Stability of Filled Syringes  

  In those situations in which the drug has been reconstituted with water and transferred to empty syringes, but not immediately administered to the patient, the syringes may be stored under the following conditions:

  24 hours at room temperature 7 days under refrigeration, 2º to 8ºC (36º to 46ºF), if immediately refrigerated after transfer. 12 weeks at –20° C, if immediately frozen after transfer.  

  THAW FROZEN SYRINGES CONTAINING CEFUROXIME AT ROOM TEMPERATURE OR UNDER REFRIGERATION.  DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.  IF, AFTER VISUAL INSPECTION, THE SOLUTION IS CLOUDY, CONTAINS PARTICULATE MATTER OR LEAKS ARE DETECTED, DISCARD THE SYRINGE AS STERILITY MAY BE IMPAIRED. DO NOT REFREEZE THAWED SYRINGES. 

  RECONSTITUTION PHASE

  1.   Remove translucent reconstitution port cap by pulling

  2.   Insert new transfer device for reconstitution

  3.   Add appropriate volume of Sterile Water for Injection

  4.   Disconnect injection transfer device

  5.   See text of Package Insert for further details

  MIXING PHASE

  1.   Mix gently: either recirculate via a tubing loop or by picking up the bag and gently moving it from side to side until dissolution is completed (15 to 25 minutes) and foam, if any, dissipates

  2.   Check for particulate matter, leaks and discoloration (dark yellow or brown)

  3.   If any of the above are found, discard bag immediately

  4.   If satisfactory, hang bag, using the eyelets

  5.   See text of Package Insert for further details

  DISPENSING PHASE

  1.   Unscrew clear transfer  port cap

  2.   Insert new transfer device

  3.   Transfer dose into sterile empty syringe

  4.   Properly label syringes

  5.   See text of Package Insert for further details

  Administration

  BEFORE ADMINISTRATION, THIS PHARMACY BULK PACKAGE REQUIRES RECONSTITUTION TO A CONCENTRATION OF 95 mg/mL OR 100 mg/mL AND TRANSFER INTO STERILE SYRINGES.

  Cefuroxime for Injection, USP, SmartPak® Pharmacy Bulk Packages are for intravenous use only following reconstitution and transfer into syringes.

  Intravenous Administration:  The intravenous route may be preferable for patients with bacterial septicemia or other severe or life-threatening infections or for patients who may be poor risks because of lowered resistance, particularly if shock is present or impending.

  For direct intermittent intravenous administration, slowly inject the solution into a vein over a period of 3 to 5 minutes or give it through the tubing system by which the patient is also receiving other intravenous solutions.

  For intermittent intravenous infusion with a Y-type administration set, dosing can be accomplished through the tubing system by which the patient may be receiving other intravenous solutions.  However, during infusion of the solutions containing cefuroxime, it is advisable to temporarily discontinue administration of any other solutions at the same site. 

  Solutions of cefuroxime, like those of most beta-lactam antibiotics, should not be added to solutions of aminoglycoside antibiotics because of potential interaction.  However, if concurrent therapy with cefuroxime and an aminoglycoside is indicated, each of these antibiotics can be administered separately to the same patient.

  Stability of Filled Syringes  

  In those situations in which the drug has been reconstituted with water and transferred to empty syringes, but not immediately administered to the patient, the syringes may be stored under the following conditions:

  24 hours at room temperature 7 days under refrigeration, 2º to 8ºC (36º to 46ºF), if immediately refrigerated after transfer. 12 weeks at –20° C, if immediately frozen after transfer.  

  THAW FROZEN SYRINGES CONTAINING CEFUROXIME AT ROOM TEMPERATURE OR UNDER REFRIGERATION.  DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.  IF, AFTER VISUAL INSPECTION, THE SOLUTION IS CLOUDY, CONTAINS PARTICULATE MATTER OR LEAKS ARE DETECTED, DISCARD THE SYRINGE AS STERILITY MAY BE IMPAIRED. DO NOT REFREEZE THAWED SYRINGES. 

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• Sagent Pharmaceuticals
  

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  Cefuroxime Sodium | Sagent Pharmaceuticals

  

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  Dosage

  Adults: The usual adult dosage range for cefuroxime is 750 mg to 1.5 grams every 8 hours, usually for 5 to 10 days. In uncomplicated urinary tract infections, skin and skin-structure infections, disseminated gonococcal infections, and uncomplicated pneumonia, a 750 mg dose every 8 hours is recommended. In severe or complicated infections, a 1.5 gram dose every 8 hours is recommended.

  In bone and joint infections, a 1.5 gram dose every 8 hours is recommended. In clinical trials, surgical intervention was performed when indicated as an adjunct to therapy with cefuroxime. A course of oral antibiotics was administered when appropriate following the completion of parenteral administration of cefuroxime.

  In life-threatening infections or infections due to less susceptible organisms, 1.5 grams every 6 hours may be required. In bacterial meningitis, the dosage should not exceed 3 grams every 8 hours. The recommended dosage for uncomplicated gonococcal infection is 1.5 grams given intramuscular as a single dose at 2 different sites together with 1 gram of oral probenecid. For preventive use for clean-contaminated or potentially contaminated surgical procedures, a 1.5 gram dose administered intravenously just before surgery (approximately one-half to 1 hour before the initial incision) is recommended. Thereafter, give 750 mg intravenously or intramuscularly every 8 hours when the procedure is prolonged.

  For preventive use during open heart surgery, a 1.5 gram dose administered intravenously at the induction of anesthesia and every 12 hours thereafter for a total of 6 grams is recommended.

  Impaired Renal Function: A reduced dosage must be employed when renal function is impaired. Dosage should be determined by the degree of renal impairment and the susceptibility of the causative organism (see Table 2).

  Table 2: Dosage of Cefuroxime in Adults With Reduced Renal Function

  * Since cefuroxime is dialyzable, patients on hemodialysis should be given a further dose at the end of the dialysis.

  Creatinine Clearance (mL/min) Dose Frequency > 20 750 mg to 1.5 grams q8h 10 – 20 750 mg q12h < 10 750 mg q24h*

  When only serum creatinine is available, the following formula2 (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.

  NOTE: As with antibiotic therapy in general, administration of cefuroxime should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained; a minimum of 10 days of treatment is recommended in infections caused by Streptococcus pyogenes in order to guard against the risk of rheumatic fever or glomerulonephritis; frequent bacteriologic and clinical appraisal is necessary during therapy of chronic urinary tract infection and may be required for several months after therapy has been completed; persistent infections may require treatment for several weeks; and doses smaller than those indicated above should not be used. In staphylococcal and other infections involving a collection of pus, surgical drainage should be carried out where indicated.

  Pediatric Patients Above 3 Months of Age: Administration of 50 to 100 mg/kg per day in equally divided doses every 6 to 8 hours has been successful for most infections susceptible to cefuroxime. The higher dosage of 100 mg/kg per day (not to exceed the maximum adult dosage) should be used for the more severe or serious infections.

  In bone and joint infections, 150 mg/kg per day (not to exceed the maximum adult dosage) is recommended in equally divided doses every 8 hours. In clinical trials, a course of oral antibiotics was administered to pediatric patients following the completion of parenteral administration of cefuroxime.

  In cases of bacterial meningitis, a larger dosage of cefuroxime is recommended, 200 to 240 mg/kg per day intravenously in divided doses every 6 to 8 hours.

  In pediatric patients with renal insufficiency, the frequency of dosing should be modified consistent with the recommendations for adults.

  Preparation of Solution and Suspension: The directions for preparing cefuroxime for Injection for both IV and IM use are summarized in Table 3.

  For Intramuscular Use: Each 750 mg vial of cefuroxime should be constituted with 3.0 mL of Sterile Water for Injection. Shake gently to disperse and withdraw completely the resulting suspension for injection.

  For Intravenous Use: Each 750 mg vial should be constituted with 8.3 mL of Sterile Water for Injection. Withdraw completely the resulting solution for injection.

  Each 1.5 gram vial should be constituted with 16.0 mL of Sterile Water for Injection, and the solution should be completely withdrawn for injection.

  Each 750 mg and 1.5 gram infusion pack should be constituted with 100 mL of Sterile Water for Injection, 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or any of the solutions listed under the Intravenous portion of the COMPATIBILITY AND STABILITY section.

  Table 3: Preparation of Solution and Suspension Strength
  Amount of Diluent to be Added (mL) Volume to be Withdrawn Approximate Cefuroxime Concentration (mg/mL) 750 mg Vial 3.0 (IM) Total* 220 750 mg Vial 8.3 (IV) Total 90 1.5 gram Vial 16.0 (IV) Total 90 750 mg Infusion Pack 100 (IV) --- 7.5 1.5 gram Infusion Pack 100 (IV) --- 15

  *Note: Cefuroxime is a suspension at IM concentrations.

  Administration: After constitution, Cefuroxime for Injection may be given intravenously or by deep IM injection into a large muscle mass (such as the gluteus or lateral part of the thigh). Before injecting intramuscularly, aspiration is necessary to avoid inadvertent injection into a blood vessel.

  Intravenous Administration: The IV route may be preferable for patients with bacterial septicemia or other severe or life-threatening infections or for patients who may be poor risks because of lowered resistance, particularly if shock is present or impending.

  For direct intermittent IV administration, slowly inject the solution into a vein over a period of 3 to 5 minutes or give it through the tubing system by which the patient is also receiving other IV solutions.

  For direct intermittent IV infusion with a Y-type administration set, dosing can be accomplished through the tubing system by which the patient may be receiving other IV solutions. However, during infusion of the solution containing cefuroxime, it is advisable to temporarily discontinue administration of any other solutions at the same site.

  For continuous IV infusion, a solution of cefuroxime may be added to an IV infusion pack containing one of the following fluids: 0.9% Sodium Chloride Injection; 5% Dextrose Injection; 10% Dextrose Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; or 1/6 M Sodium Lactate Injection.

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

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

  Caution

  Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

  Preparation for Administration Suspend container from eyelet support. Remove protector from outlet port at bottom of container. Attach administration set. Refer to complete directions accompanying set.

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