Cefepime
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]
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Overview
Cefepime is a antibiotic (cephalosporin) that is FDA approved for the treatment of pneumonia, febrile neutropenia, uncomplicated UTI, uncomplicated skin infection and complicated intraabdominal infections. Common adverse reactions include rash, hypophosphatemia, diarrhea, Direct Coombs test positive, ALT/SGPT level raised, AST/SGOT level raised.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cefepime in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cefepime in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Same dosification as exposed in the table on FDA - Adult Indications and Dosage.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cefepime in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cefepime in pediatric patients.
Contraindications
There is limited information regarding Cefepime Contraindications in the drug label.
Warnings
There is limited information regarding Cefepime Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Cefepime Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Cefepime Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Cefepime Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Cefepime in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cefepime in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Cefepime during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Cefepime in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Cefepime in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Cefepime in geriatric settings.
Gender
There is no FDA guidance on the use of Cefepime with respect to specific gender populations.
Race
There is no FDA guidance on the use of Cefepime with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Cefepime in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Cefepime in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Cefepime in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Cefepime in patients who are immunocompromised.
Administration and Monitoring
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 intravenous container with one of the compatible intravenous fluids listed in the compatibility and stability subsection. The resulting solution should be administered over approximately 30 minutes. Intermittent intravenous 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.
Intramuscular Administration
For intramuscular administration, cefepime for injection (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.
Monitoring
There is limited information regarding Cefepime Monitoring in the drug label.
IV Compatibility
Cefepime for injection is compatible at concentrations between 1 mg/mL and 40 mg/mL with the following intravenous 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° to 25° C (68° to 77° F) or 7 days in a refrigerator 2° to 8° C (36° to 46° F).
Cefepime for injection admixture compatibility information is summarized in the following table: none|450px
Solutions of cefepime for injection, 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 cefepime for injection is indicated, each of these antibiotics can be administered separately.
IM Administration
Cefepime for injection (cefepime hydrochloride) constituted as directed is stable for 24 hours at controlled room temperature 20° to 25° C (68° to 77° F) or for 7 days in a refrigerator 2° to 8° C (36° to 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.
Overdosage
There is limited information regarding Cefepime overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Cefepime Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Cefepime Mechanism of Action in the drug label.
Structure
There is limited information regarding Cefepime Structure in the drug label.
Pharmacodynamics
There is limited information regarding Cefepime Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Cefepime Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Cefepime Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Cefepime Clinical Studies in the drug label.
How Supplied
There is limited information regarding Cefepime How Supplied in the drug label.
Storage
There is limited information regarding Cefepime Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Cefepime Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Cefepime interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Cefepime Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Cefepime Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [4]
Overview
Cefepime is a fourth-generation cephalosporin antibiotic developed in 1994. Cefepime has an extended spectrum of activity against Gram-positive and Gram-negative bacteria, with greater activity against both Gram-negative and Gram-positive organisms than third-generation agents. Cefepime hydrochloride was first marketed in 1994 and is currently marketed under various trade names including Maxipime (Elan Pharma), Maxcef, Cepimax, Cepimex, and Axepim.
Category
Cephalosporin, Fourth-Generation
US Brand Names
MAXIPIME®
FDA Package Insert
Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings | Precautions | Adverse Reactions | Overdosage | Clinical Studies | Dosage and Administration | Compatibility, Reconstitution, and Stability | Directions For Use | How Supplied | Labels and Packages