Cefepime Hydrochloride for Injection

Pneumonia

MAXIPIME is indicated in the treatment of pneumonia (moderate to severe) caused by susceptible strains of Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.

Empiric Therapy For Febrile Neutropenic Patients

MAXIPIME 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)

MAXIPIME is indicated in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by susceptible isolates of 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 bacteria.

Uncomplicated Skin And Skin Structure Infections

MAXIPIME is indicated in the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes.

Complicated Intra-Abdominal Infections (Used In Combination With Metronidazole)

MAXIPIME is indicated in the treatment of complicated intra-abdominal infections (used in combination with metronidazole) in adults caused by susceptible isolates of Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis [see Clinical Studies].

Usage

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 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.

Dosage Forms And Strengths

MAXIPIME for Injection is a sterile white to pale yellow powder of cefepime in single-dose vials or ADD-Vantage vials for reconstitution and it is available in the following strengths:

• 0.5 gram per vial
• 1 g per vial
• 2 g per vial
• 1 g per ADD-Vantage vial
• 2 g per ADD-Vantage vial

Storage And Handling

MAXIPIME for injection is supplied as follows: MAXIPIME for Injection in the dry state, is a white to pale yellow powder. Constituted solution of MAXIPIME can range in color from pale yellow to amber.

MAXIPIME for injection in the dry state should be stored at 20 to 25° C (68 to 77° F) [see USP controlled room temperature.] and protected from light.

REFERENCES

4. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976; 16:31-41.

Manufactured for: Hospira, Inc. Lake Forest, IL 60045 USA. Revised: April 2017

• Impetigo
• Urinary Tract Infections (UTIs)