Cefepime Hydrochloride And Dextrose

Cefepime Hydrochloride And Dextrose Manufacturers

• B. Braun Medical Inc.
  

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  Cefepime Hydrochloride And Dextrose | B. Braun Medical Inc.

  

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  2.1 Adult and Pediatric Population

  Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® Container should be used only in patients who require the entire 1 or 2 gram dose and not any fraction thereof. The recommended adult and pediatric dosages and routes of administration are outlined in Table 1. Cefepime for Injection USP and Dextrose Injection USP should be administered intravenously (IV) over approximately 30 minutes.

  Table 1: Recommended Dosing Schedule for Cefepime for Injection USP and Dextrose Injection USP in Patients with CrCL Greater Than 60 mL/min*  Site and Type of Infection Dose Frequency Duration (days) Adults *

  Adjust dose in patients with CrCL less than or equal to 60 mL/min (2.2)

  † Including cases associated with concurrent bacteremia ‡

  ForPseudomonas aeruginosa, use 2 g IV every 8 hours (50 mg per kg per dose in pediatric patients 2 months up to 16 years).

  § Or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re-evaluated frequently.  Moderate to Severe Pneumonia due to S. pneumoniae†, P. aeruginosa‡, K. pneumoniae, or Enterobacter species  1-2 g IV  Every 8-12 hours  10  Empiric therapy for febrile neutropenic patients [see Indications and Usage (1) and Clinical Studies (14)]  2 g IV  Every 8 hours  7§  Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis†  0.5-1 g IV  Every 12 hours  7–10  Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae†  2 g IV  Every 12 hours  10  Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes  2 g IV  Every 12 hours  10  Complicated intra-abdominal infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa‡, K. pneumoniae, Enterobacter species, or B. fragilis. [see Clinical Studies (14)]  2 g IV  Every 8-12 hours  7–10 Pediatric Patients (2 months up to 16 years) The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg per kg per dose, administered every 12 hours (50 mg per kg per dose, every 8 hours for febrile neutropenic patients), for durations as given above. Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is designed to deliver a 1 g or 2 g dose of cefepime. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of cefepime. 2.2 Patients with Renal Impairment

  In patients with creatinine clearance less than or equal to 60 mL/min, the dose of Cefepime for Injection USP and Dextrose Injection USP should be adjusted to compensate for the slower rate of renal elimination. The recommended initial dose of Cefepime for Injection USP and Dextrose Injection USP should be the same as in patients with normal renal function except in patients undergoing hemodialysis. The recommended maintenance doses of Cefepime for Injection USP and Dextrose Injection USP in patients with renal impairment are presented in Table 2. Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® Container should be used only in patients who require the entire 1 or 2 gram dose and not any fraction thereof.

  When only serum creatinine is available, the following formula (Cockcroft and Gault equation)1 may be used to estimate creatinine clearance [see References (15)]. The serum creatinine should represent a steady state of renal function:

   Males:  Creatinine Clearance (mL/min) =  Weight (kg) × (140-age)      72 × serum creatinine (mg/dL)  Females:  0.85 × above value   Table 2: Recommended Dosing Schedule for Cefepime for Injection USP and Dextrose Injection USP in Adult Patients (Normal Renal Function, Renal Impairment, and Hemodialysis) Creatinine Clearance
  (mL/min) Recommended Maintenance Schedule * On hemodialysis days, Cefepime for Injection USP and Dextrose Injection USP should be administered following hemodialysis. Whenever possible, Cefepime for Injection USP and Dextrose Injection USP should be administered at the same time each day.  Greater than 60 (Normal recommended dosing schedule)  500 mg every 12 hours  1 g every 12 hours  2 g every 12 hours  2 g every 8 hours  30–60  500 mg every 24 hours  1 g every 24 hours  2 g every 24 hours  2 g every 12 hours  11–29  500 mg every 24 hours  500 mg every 24 hours  1 g every 24 hours  2 g every 24 hours  Less than 11  250 mg every 24 hours  250 mg every 24 hours  500 mg every 24 hours  1 g every 24 hours  CAPD  500 mg every 48 hours  1 g every 48 hours  2 g every 48 hours  2 g every 48 hours  Hemodialysis*  1 g on day 1, then 500 mg every 24 hours thereafter  1 g every 24 hours

  In patients undergoing continuous ambulatory peritoneal dialysis, Cefepime for Injection USP and Dextrose Injection USP may be administered at normally recommended doses at a dosage interval of every 48 hours (see Table 2).

  In patients undergoing hemodialysis, approximately 68% of the total amount of cefepime present in the body at the start of dialysis will be removed during a 3-hour dialysis period. The dosage of Cefepime for Injection USP and Dextrose Injection USP for hemodialysis patients is 1 g on Day 1 followed by 500 mg every 24 hours for the treatment of all infections except febrile neutropenia, which is 1 g every 24 hours. Cefepime for Injection USP and Dextrose Injection USP should be administered at the same time each day and following the completion of hemodialysis on hemodialysis days (see Table 2).

  2.3 Preparation for Use of Cefepime for Injection USP and Dextrose Injection USP in DUPLEX® Container

  This reconstituted solution is for intravenous use only.

  Do not use plastic containers in series connections. Such use would 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. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Use only if solution is clear and container and seals are intact.

  DUPLEX® Drug Delivery System Storage To avoid inadvertent activation, the DUPLEX® Container should remain in the folded position until activation is intended. Patient Labeling and Drug Powder/Diluent Inspection Apply patient-specific label on foil side of container. Use care to avoid activation. Do not cover any portion of foil strip with patient label. Unlatch side tab and unfold DUPLEX® Container (see Diagram 1).
  Visually inspect diluent chamber for particulate matter. Use only if container and seals are intact. To inspect the drug powder for foreign matter or discoloration, peel foil strip from drug chamber (see Diagram 2).
  Protect from light after removal of foil strip.
  Note: If foil strip is removed, the container should be re-folded and the side tab latched until ready to activate. The product must then be used within 7 days, but not beyond the labeled expiration date. Reconstitution (Activation) Do not use directly after storage by refrigeration, allow the product to equilibrate to room temperature before patient use. Unfold the DUPLEX® container and point the set port in a downward direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the diluent meniscus trapping all air above the fold. To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber (see Diagram 3).
  Agitate the liquid-powder mixture until the drug powder is completely dissolved.
  Note: Following reconstitution (activation), product must be used within 12 hours if stored at room temperature or within 5 days if stored under refrigeration. Administration Visually inspect the reconstituted solution for particulate matter. Point the set port in a downwards direction. Starting at the hanger tab end, fold the DUPLEX® Container just below the solution meniscus trapping all air above the fold. Squeeze the folded DUPLEX® Container until the seal between reconstituted drug solution and set port opens, releasing liquid to set port (see Diagram 4).
  Prior to attaching the IV set, check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be compromised. Using aseptic technique, peel foil cover from the set port and attach sterile administration set (see Diagram 5).
  Refer to directions for use accompanying the administration set. Important Administration Instructions Do not use in series connections. Do not introduce additives into the DUPLEX® Container. Administer Cefepime for Injection USP and Dextrose Injection USP intravenously over approximately 30 minutes. Intermittent intravenous infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of Cefepime for Injection USP and Dextrose Injection USP, it is advisable to discontinue the other solution. Solutions of cefepime should not be added to solutions of ampicillin at a concentration greater than 40 mg/mL, and should not be added to metronidazole, vancomycin, gentamicin, tobramycin, netilimicin sulfate or aminophylline because of potential interaction. However, if concurrent therapy with cefepime is indicated, each of these antibiotics can be administered separately.

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