MAXIPIME is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms (see also PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION):

Pneumonia(moderate to severe) caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.

Empiric Therapy for Febrile Neutropenic Patients. Cefepime as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients. (See Clinical Studies)

Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis) caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.

Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (methicillin- susceptible strains only) or Streptococcus pyogenes.

Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis. (See Clinical Studies)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of MAXIPIME and other antibacterial drugs, MAXIPIME should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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.

Table 12: 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. The recommended doses of MAXIPIME in patients with renal insufficiency are presented in Table 13.

When only serum creatinine is available, the following formula (Cockcroft and Gault equation)³ may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function:

TABLE 13: Recommended Dosing Schedule for MAXIPIME in Adult Patients (Normal Renal Function, Renal Insufficiency, and Hemodialysis)

In patients undergoing continuous ambulatory peritoneal dialysis, MAXIPIME may be administered at normally recommended doses at a dosage interval of every 48 hours (see Table 13).

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 MAXIPIME for hemodialysis patients is 1 g on Day 1 followed by 500 mg q24h for the treatment of all infections except febrile neutropenia, which is 1 g q24h. MAXIPIME should be administered at the same time each day following the completion of hemodialysis on hemodialysis days (see Table 13).

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), changes in the dosing regimen proportional to those in adults (see Tables 12 and 13) are recommended for pediatric patients.

Administration

For Intravenous Infusion, 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 listed in the Compatibility and Stability subsection. 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 mL 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 (refer to Table 14).

Preparation of MAXIPIME solutions is summarized in Table 14.

TABLE 14: Preparation of Solutions of MAXIPIME

Compatibility and Stability

Intravenous: MAXIPIME is compatible at concentrations between 1 mg/mL 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 in Table 15.

Table 15: Cefepime Admixture Stability

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, tends to darken depending on storage conditions; however, when stored as recommended, the product potency is not adversely affected.

MAXIPIME® (cefepime hydrochloride, USP) for Injection is supplied as follows:

500 mg*      15 mL vial (tray of 10)                   NDC 51479-053-10
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*            ADD-Vantage® vial (tray of 10)    NDC 51479-055-10
2 g*            20 mL vial (tray of 10)                    NDC 51479-055-30
*Based on cefepime activity.

Storage

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

ADD-Vantage® is a registered trademark of Abbott Laboratories. Normosol-RTM and Normosol-MTM are trademarks of Abbott Laboratories. Aminosyn® is a registered trademark of Abbott Laboratories. Inpersol™ is a trademark of Abbott Laboratories. Clinitest® and Clinistix® are registered trademarks of Bayer HealthCare LLC.

Manufactured for Bristol-Myers Squibb Company Princeton, NJ 08543 USA Distributed by Elan Pharmaceuticals, Inc. San Diego, CA 92121, USA. Revised January 2007. FDA Rev date: 9/14/2007

Bookmark this page: