MAXIPIME SUMMARY
MAXIPIME (cefepime hydrochloride, USP) is a semi-synthetic, broad spectrum, cephalosporin antibiotic for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.
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.
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