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CEFEPIME HCL (MAXIPIME ®)
The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgement. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.    PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.

Usual Diluents
D5W, NS

Standard Dilutions   [Amount of drug] [Infusion volume] [Infusion rate]
[0 to 2 grams] [50 ml] [30 min]

Stability / Miscellaneous
Label: Refrigerate.
Stability data (below)




DOSAGE AND ADMINISTRATION
The recommended adult and pediatric dosages and routes of administration are outlined in the following table. MAXIPIME should be administered intravenously over approximately 30 minutes.




Recommended Dosage Schedule for MAXIPIME in Patients with CrCL >60 mL/min.
Site and Type of Infection Dose Frequency Duration
(days)
Adults
*including cases associated with concurrent bacteremia
**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.
***IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTI’s due to E. coli when the IM route is considered to be a more appropriate route of drug administration.
Moderate to Severe Pneumonia due to S. pneumoniae*, P. aeruginosa, K. pneumoniae, or Enterobacter species 1-2 g IV q12h 10
Empiric therapy for febrile neutropenic patients 2 g IV q8h 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/IM*** q12h 7-10
Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae* 2 g IV q12h 10
Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes 2 g IV q12h 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. 2 g IV q12h 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/kg/dose, administered q12h (50 mg/kg/dose, q8h for febrile neutropenic patients), for durations as given above.

Impaired Hepatic Function
No adjustment is necessary for patients with impaired hepatic function.

Impaired Renal Function
In patients with impaired renal function (creatinine clearance ≤60 mL/min), the dose of MAXIPIME should be adjusted to compensate for the slower rate of renal elimination. The recommended initial dose of MAXIPIME should be the same as in patients with normal renal function except in patients undergoing hemodialysis.

Recommended Dosing Schedule for MAXIPIME in Adult Patients (Normal Renal Function, Renal Insufficiency, and Hemodialysis)

Creatinine
Clearance (mL/min)		 Recommended Maintenance Schedule
*On hemodialysis days, cefepime should be administered following hemodialysis. Whenever possible, cefepime should be administered at the same time each day.
>60 Normal
recommended
dosing schedule		 500 mg q12h 1 g q12h 2 g q12h 2 g q8h
30-60 500 mg q24h 1 g q24h 2 g q24h 2 g q12h
11-29 500 mg q24h 500 mg q24h 1 g q24h 2 g q24h
<11 250 mg q24h 250 mg q24h 500 mg q24h 1 g q24h
CAPD 500 mg q48h 1 g q48h 2 g q48h 2g q48h
Hemodialysis* 1 g on day 1, then 500 mg q24h thereafter 1 g q24h

Administration
For Intravenous Infusion, constitute the 1 g or 2 g piggyback (100 mL) bottle with 50 or 100 mL of a compatible IV fluid listed in the Compatibility and Stability subsection. Alternatively, constitute the 500 mg, 1 g, or 2 g vial, and add an appropriate quantity of the resulting solution to an IV container with one of the compatible IV fluids. THE RESULTING SOLUTION SHOULD BE ADMINISTERED OVER APPROXIMATELY 30 MINUTES.

Intermittent IV infusion with a Y-type administration set can be accomplished with compatible solutions. However, during infusion of a solution containing cefepime, it is desirable to discontinue the other solution.

ADD-Vantage® vials are to be constituted only with 50 or 100 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection in Abbott ADD-Vantage® flexible diluent containers. (See ADD-Vantage® Vial Instructions for Use.)

Intramuscular Administration: For IM administration, MAXIPIME (cefepime hydrochloride) should be constituted with one of the following diluents: Sterile Water for Injection, 0.9% Sodium Chloride, 5% Dextrose Injection, 0.5% or 1.0% Lidocaine Hydrochloride, or Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol .

Preparation of Solutions of MAXIPIME
Single-Dose Vials for
Intravenous/Intramuscular
Administration		 Amount of Diluent to
be added (mL)		 Approximate Available
Volume (mL)		 Approximate
Cefepime
Concentration
(mg/mL)
cefepime vial content
500 mg (IV)
500 mg (IM)
1 g (IV)
1 g (IM)
2 g (IV)
 5.0
 1.3
10.0
 2.4
10.0
 5.6
 1.8
11.3
 3.6
12.5
100
280
100
280
160
Piggyback (100 mL)
1 g bottle
1 g bottle
2 g bottle
2 g bottle
 50
100
 50
100
 50
100
 50
100
20
10
40
20
ADD-Vantage®
1 g vial
1 g vial
2 g vial
2 g vial
 50
100
 50
100
 50
100
 50
100
20
10
40
20

Compatibility and Stability

---- Storage/Stability ----

Intravenous: MAXIPIME is compatible at concentrations between 1 and 40 mg/mL with the following IV infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection, Normosol-R™, and Normosol-M™ in 5% Dextrose Injection. These solutions may be stored up to 24 hours at controlled room temperature 20°–25° C (68°–77° F) or 7 days in a refrigerator 2°–8° C (36°–46° F). MAXIPIME in ADD-Vantage® vials is stable at concentrations of 10–40 mg/mL in 5% Dextrose Injection or 0.9% Sodium Chloride Injection for 24 hours at controlled room temperature 20°–25° C or 7 days in a refrigerator 2°–8° C.

MAXIPIME admixture compatibility information is summarized below:
  Stability Time for
MAXIPIME
Concentration		 Admixture and
Concentration		 IV Infusion
Solutions		 RT/L
(20°-25° C)		 Refrigeration
(2°-8° C)
NS = 0.9% Sodium Chloride Injection
D5W = 5% Dextrose Injection
na = not applicable
RT/L = Ambient room temperature and light
40 mg/mL Amikacin
6 mg/mL		 NS or D5W 24 hours 7 days
40 mg/mL Ampicillin
1 mg/mL		 D5W 8 hours 8 hours
40 mg/mL Ampicillin
10 mg/mL		 D5W 2 hours 8 hours
40 mg/mL Ampicillin
1 mg/mL		 NS 24 hours 48 hours
40 mg/mL Ampicillin
10 mg/mL		 NS 8 hours 48 hours
4 mg/mL Ampicillin
40 mg/mL		 NS 8 hours 8 hours
4-40 mg/mL Clindamycin
Phosphate
0.25-6 mg/mL		 NS or D5W 24 hours 7 days
4 mg/mL Heparin
10-50 units/mL		 NS or D5W 24 hours 7 days
4 mg/mL Potassium Chloride
10-40 mEq/L		 NS or D5W 24 hours 7 days
4 mg/mL Theophylline
0.8 mg/mL		 D5W 24 hours 7 days
1-4 mg/mL na Aminosyn® II
4.25% with
electrolytes and
calcium		 8 hours 3 days
0.125-0.25 mg/mL na Inpersol™ with
4.25% dextrose		 24 hours 7 days


Solutions of MAXIPIME, like those of most beta-lactam antibiotics, 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, netilmicin sulfate or aminophylline because of potential interaction. However, if concurrent therapy with MAXIPIME is indicated, each of these antibiotics can be administered separately.

Intramuscular: MAXIPIME (cefepime hydrochloride) constituted as directed is stable for 24 hours at controlled room temperature 20°–25° C (68°–77° F) or for 7 days in a refrigerator 2°–8° C (36°–46° F) with the following diluents: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol, or 0.5% or 1% Lidocaine Hydrochloride.

NOTE: PARENTERAL DRUGS SHOULD BE INSPECTED VISUALLY FOR PARTICULATE MATTER BEFORE ADMINISTRATION.

As with other cephalosporins, the color of MAXIPIME powder, as well as its solutions, tend to darken depending on storage conditions; however, when stored as recommended, the product potency is not adversely affected.

HOW SUPPLIED
MAXIPIME® (cefepime hydrochloride, USP) for Injection is supplied as follows:
*Based on cefepime activity
500 mg* 15 mL vial (tray of 10) NDC 51479-053-10
1 g* Piggyback bottle 100 mL (tray of 10) NDC 51479-054-10
1 g* ADD-Vantage® vial (tray of 10) NDC 51479-054-20
1 g* 15 mL vial (tray of 10) NDC 51479-054-30
2 g* Piggyback bottle 100 mL (tray of 10) NDC 51479-055-20
2 g* ADD-Vantage® vial (tray of 10) NDC 51479-055-10
2 g* 20 mL vial (tray of 10) NDC 51479-055-30

Storage
MAXIPIME IN THE DRY STATE SHOULD BE STORED BETWEEN 2°–25° C (36°–77° F) AND PROTECTED FROM LIGHT.

Manufactured by
Bristol-Myers Squibb Company
Princeton, NJ 08543 USA

Distributed by
Elan Biopharmaceuticals, a business unit of Elan Pharmaceuticals, Inc (EPI),
a member of the Elan Group, San Diego, CA 92121 USA

0055DIM-08
6001123
1095225A7
Rev December 2003
The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgement. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.    PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.