CEFEPIME HCL (MAXIPIME ®)

Usual Diluents

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

Stability / Miscellaneous

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.

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)

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

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:

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