Mestinon

Mestinon Manufacturers

• Valeant Pharmaceuticals North America Llc
  

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  Mestinon | Baxter Healthcare Corporation

  

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  2.1 Adults and Pediatric Population

  The recommended adult and pediatric dosages and routes of administration are outlined in Table 1. Cefepime Injection should be administered intravenously over approximately 30 minutes.

  Table 1: Recommended Dosage Schedule for Cefepime Injection in Patients with CrCL Greater Than 60 mL/min* Site and Type of Infection Dose Frequency Duration
  (days) * Adjust dose in patients with CrCL less than or equal to 60 mL/min ( 2.3) † including cases associated with concurrent bacteremia ‡ For Pseudomonas aeruginosa, use 2 g IV every 8 hours (50 mg per kg per dose in pediatric patients 2 months up to 16 years. Ω § 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.

  Adults

  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 Injection in GALAXY Container should be used only in pediatric patients who require the entire 1 or 2 g dose and not any fraction thereof.

  2.2 Patients with Hepatic Impairment

  No adjustment is necessary for patients with hepatic impairment.

  2.3 Patients with Renal Impairment

  In patients with creatinine clearance less than or equal to 60 mL/min, the dose of Cefepime Injection should be adjusted to compensate for the slower rate of renal elimination. The recommended initial dose of Cefepime Injection should be the same as in patients with normal renal function except in patients undergoing hemodialysis. The recommended doses of Cefepime Injection in patients with renal impairment are presented in Table 2.

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

  Males: Creatinine Clearance (mL/min) =

       

  Weight (kg) x (140 – age)

       

  72 x serum creatinine (mg/dL)

  Females: 0.85 x above value

  Table 2: Recommended Dosing Schedule for Cefepime Injection in Adult Patients (Normal Renal Function, Renal Impairment, and Hemodialysis) Creatinine Clearance
  (mL/min) Recommended Maintenance Schedule * On hemodialysis days, Cefepime Injection should be administered following hemodialysis. Whenever possible, Cefepime Injection 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 Injection 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 Injection 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 Injection should be administered at the same time each day following the completion of hemodialysis on hemodialysis days (see Table 2).

  Data in pediatric patients with impaired renal function are not available; however, since cefepime pharmacokinetics are similar in adults and pediatric patients [see Clinical Pharmacology (12)], changes in the dosing regimen proportional to those in adults (see Table 1 and Table 2) are recommended for pediatric patients.

  2.4 Directions for Use of Cefepime Injection in GALAXY Container

  Cefepime Injection in GALAXY Container (PL 2040 Plastic) is for intravenous administration using sterile equipment after thawing to room temperature.

  Thawing of Plastic Container

  Thaw frozen container at room temperature 25°C (77°F) or under refrigeration 5°C (41°F). Do not force thaw by immersion in water baths or by microwave irradiation. [See How Supplied/Storage and Handling (16).]

  Check for minute leaks by squeezing container firmly. If leaks are detected, discard solution as sterility may be impaired.

  Do not add supplementary medication.

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

  Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if any seals are not intact, the container should be discarded.

  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 intravenous administration.

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

  Cefepime Injection should be administered 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 Injection, it is desirable to discontinue the other solution.

  Solutions of cefepime, like those of most beta-lactam antibiotics, should not be added to solutions of ampicillin at a concentration greater than 40 mg per mL, and should not be added to metronidazole, vancomycin, gentamicin, tobramycin, netilmicin 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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