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Western Medicine Cefepime for Injection USP I.M./I.V. (INJECTABLE VIAL)
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For the use only of a Registered Medical Practitioner or a Hospital or Laboratort only.
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Composition
Each vial contains:
Cefepime.......................................................................1gm
(As sterile dry mixture of Cefepime hydrochioride USP and L-arginine)
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DESCRIPTION
Cefepime belongs to fourth generation cephalosporin available for parenteral administration.
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.
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Aerobic Gram-Negative Microorganisms:
Enterobacter,Escherichia coli,Klebisella pNEUMONIAE. Proteus mirabilis,?
Pseudomonas aeruginosa,
Aerobic Gram-Positive Microorganisms:
Staphylococcus aureus (methicillin-susceptible strains only),Stretococcus pneumoniae,
Streptococcus pyogenes (Lancefield& acute;s Group A streptococci)
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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 well-controlled tnals.
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Aerobic Gram-Positive Microorganisms:
Staphylococcus epidermidis (methicillin-susceptible strains only),Staphylococcus saprophyticus,
Streptococcus agalactiae (Lancefield& acute;s Group B streptococci),Viridans group streptococci.
NOTE:Most strains of Enterococci,e.g.Enterococcus faecails,and methicillin-resistant staphyiococci are resistant to cefepime.
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INDICATIONS
Cefepime hydrochloride is indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms:
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Pneu monia(moderate to severe)caused by Streptococcus pneumoniae,including cases associated with concurrentbacteremia,Pseudomonas aeruginosa,Klebsiella pneumoniae,or Enterobacterspecies.
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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.
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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 microorganisms.
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Uncomplicated Skin and Skin Structure Infection caused by ?Staphylococcus aureus(methicillin-susceptible strains only) or Streptococcus pyogenes.
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Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by Escherichia oil,viridans group streptococci,Pseudomonas aeruginosa,Klebsiella pneumoniae,Enterobacter species,or Baceteroides fragilis.
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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.
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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.

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Recommended Dosage Schudule for Cefepime |
Stie and Type of Infection | Dose | Frequency | Duration (days) |
Moderate to Severe Pneumonia due to S.pneumoniae*,P.aeruginosam,K.pneumoniaee,or Enterobacter sprcies | 1-2gIV | q12h | 10 |
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* | 0.5-1g
IV/IM** | q12h | 7-10 |
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 or S.pyogenes | 2gIV | q12h | 10 |
Complicated Intra-abdominal Infections(used in combination with metronidazole) caused by E.coli,viridans group streptococci,P.aeruginosa,K.pneumoniae,Enterobacter species,or B.fragilis | 2gIV | q12h | 7-10 |
*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 frequently.
***IM route of administration is indicated only for mild to moderate,uncomplicated or complicated UTI& acute;s due to E.coli when the IM route is considered to be more appropriate route of drug administration. |
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ADMINISTRATION:
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.
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CONTRAINDICATIONS
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 antibiotics.
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WARNINGS
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 oxygen.corticosteroids,intravenous fluids,intravenous antihistamines,pressor amines,pressore amines, and airway management,as clinically indicated.
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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.
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OVERDOSAGE
Patients who receive an overdose should be carefully observed and given supportive treatment.
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STORAGE
Store in a dry place below 25°C
Protect from light.
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