Western Medicine Cefepime for Injection USP I.M./I.V. (INJECTABLE
For the use only of a Registered Medical Practitioner or a Hospital
or Laboratort only.
Each vial contains:
(As sterile dry mixture of Cefepime hydrochioride USP and
Cefepime belongs to fourth generation cephalosporin available for
Cefepime is a bactericidal agent that acts by inhibition of
bacterial cell wall synthesis.Cefepime has a broad spectrum of in
vitro activity that encompa sses a wide range of gram-positive and
gram-negative bacteria.Cefepime has a low affinity for
chromosomally-encoded beta-lactamases. Cefepime is highly resistant
to hydrolysis by most beta-lactamases and exhibits rapid
penetration into gram-negative bactenal cells. Within bacterial
cells, the molecular targets o cefepime are the penicillin binding
proteins(PBP).Cefepime has been shown to be active against most
strains of the following mircoorganisms,both in vitro and in
clinical infections as described in th indications.
Aerobic Gram-Negative Microorganisms:
Enterobacter,Escherichia coli,Klebisella PNEUMONIAE. Proteus
Aerobic Gram-Positive Microorganisms:
Staphylococcus aureus (methicillin-susceptible strains
Streptococcus pyogenes (Lancefield's Group A streptococci)
Cefepime has been shown to have in vitroactivity against most
strains of the following microorganisms:however, the safety and
effectiveness of cefepime in treating clinical infections due to
these microorganisms have not been established in adequate and
Aerobic Gram-Positive Microorganisms:
Staphylococcus epidermidis (methicillin-susceptible strains
Streptococcus agalactiae (Lancefield's Group B
streptococci),Viridans group streptococci.
NOTE:Most strains of Enterococci,e.g.Enterococcus faecails,and
methicillin-resistant staphyiococci are resistant to cefepime.
Cefepime hydrochloride is indicated in the treatment of the
following infections caused by susceptible strains of the
Pneu monia(moderate to severe)caused by Streptococcus
pneumoniae,including cases associated with
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 atpresentation,with an underlying
hematologic malignancy,or with severe or prolonged
neutropenia),antimicrobial monotherapy may not be appropriate.
Insufficient date exist to support the efficacy of cefepime
monotherapy in such patients.
Uncomplicated and Complicated Urinary Tract Infections (including
pyelonephritis) caused by Escherichia coil or Klebsiella pneumoniae,when the infection is
severe,or caused by Escherichia coil, Klebsiella pneumoniae,or
Proteus mirabilis,when then infection is mild to moderate,including
cases associated with concurrent bacteremia with these
Uncomplicated Skin and Skin Structure Infection caused by
Staphylococcus aureus(methicillin-susceptible strains only) or
Complicated Intra-abdominal Infections (used in combination with
metronidazole) caused by Escherichia oil,viridans group
pneumoniae,Enterobacter species,or Baceteroides fragilis.
Therapy with cefepime may be instituted before results of
susceptibility studies are known;however,once these results become
available,the antibiotic treatment should be adjusted accordingly.
Insufficient data exist to support the efficacy of cefepime
monotherapy in patients at high risk for severe infection
(including patients with a history of recent bone marrow
transplantation,with hypotension at presentetion,with an underlying
hematologic malignancy,or with severe or prolonged neutropenia). NO
data are avaliable in patients with septic shock.
DOSAGE AND ADMINISTRATION
The recommended adult dosage and routes of administration are
outlined in the following table.Cefepime should be administered
intravenously over approximately 30 minutes.
|Recommended Dosage Schudule for Cefepime|
|Stie and Type of Infection||Dose||Frequency|
|Moderate to Severe Pneumonia due to S.pneumoniae*,P.aeruginosam,K.pneumoniaee,or
|Empiric therapy for febrile neutropenic patients||2gIV||q8h||7**|
|Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections,including
pyelonephritis,due to E.coli,K.pneumoniae,or P.mirabilis*|
|Severe Uncomplicated or Complicated Urinary Tract Infections,including
pyelonephritis,due to E.coli,K.pneumoniae*||2gIV||q12h||10|
|Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S.aureus
|Complicated Intra-abdominal Infections(used in combination with
metronidazole) caused by E.coli,viridans group
*including cases associated with concurrent bacteremia
**or until resolution of neutropenia.In patients whose fever
resolve but who remain neutropenic for more than 7 days,the need
for continued antimicrobial therapy should be re-evaluated
***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 more appropriate route of drug
Dor Intravenous Infusion,constitute the 1g or 2g with 50 or 100 mL
of a compatible IV fluid listed in the Vompatibility and Stability
subsection.Alternativaly,constitute the 500mg,1g,or 2g 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 beadministered over approximately 30 minutes.
Cefepime hydrochloride is contraindicated in patients who have
shown immediate hypersensitivity reactions to cefepime or the
cephalosporin class of antibiotics,penicillins or other beta-lactam
Before therapy with cefepime hydrochloride for injection is
instituted,careful inquiry should be made to determine whether the
patient has had previous immediate hyoersensitivity reactions to
cefepime,cephalosporine,penicillins,or other drugs.if this product
is to be given to pencillin-sensitive patients,caution should be
exercised because cross-hypersensitivity among beta0lactam
antibiotics has been clearly documented and may occure in up to 10%
of patients with a history of penicillin allergy.if an allergic
treatment with epinephrine and other emergency measures including
antihistamines,pressor amines,pressore amines, and airway
management,as clinically indicated.
Pseudomembranous colitis has been reported with nearly all
antibacterial agents.including cefepime,and mayrange in
severityfrom mildto life-threatening.Therefore,it is important
toconsider this diagnosis in patients who present with diarrhea
subsequent to the administration of antibacterial agents.
Patients who receive an overdose should be carefully observed and
given supportive treatment.
Store in a dry place below 25°C
Protect from light.