CEFEPIME IN PLASTIC CONTAINER
Clinical safety rating: safe
Nephrotoxic drugs may increase the risk of kidney damage May cause neurotoxicity including encephalopathy and nonconvulsive status epilepticus especially in renal impairment.
Cefepime is a fourth-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), particularly PBP 3. It demonstrates broad-spectrum activity against gram-positive and gram-negative bacteria, including Pseudomonas aeruginosa.
| Metabolism | Cefepime is minimally metabolized in the liver. The primary metabolic pathway is hydrolysis of the beta-lactam ring to inactive metabolites. Approximately 85% of the dose is excreted unchanged in the urine via glomerular filtration and tubular secretion. No significant cytochrome P450 metabolism. |
| Excretion | Renal: approximately 85% of the dose excreted unchanged in urine; biliary/fecal: less than 1%. |
| Half-life | 2.0–2.3 hours in adults with normal renal function; prolonged to 13–26 hours in end-stage renal disease. |
| Protein binding | Approximately 16% bound to plasma proteins, mainly albumin. |
| Volume of Distribution | 0.3–0.4 L/kg; indicates distribution primarily into extracellular fluid. |
| Bioavailability | Intramuscular: ~82% absolute bioavailability. |
| Onset of Action | Intravenous: immediate; intramuscular: peak serum concentrations at 1–2 hours. |
| Duration of Action | Approximately 12 hours; clinical effect sustained for the dosing interval (every 12 hours) due to post-antibiotic effect. |
1-2 g intravenously every 8-12 hours for moderate to severe infections; up to 2 g every 8 hours for severe infections or febrile neutropenia.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl 30-60 mL/min: 1-2 g every 12-24 hours; CrCl 11-29 mL/min: 1-2 g every 24-48 hours; CrCl <10 mL/min: 500 mg-1 g every 48 hours; hemodialysis: administer after dialysis and then every 48 hours. |
| Liver impairment | No dosage adjustment required for hepatic impairment; cefepime is primarily renally eliminated. |
| Pediatric use | 2 months to 16 years: 50 mg/kg/dose intravenously every 8-12 hours, not to exceed adult doses; for febrile neutropenia: 50 mg/kg/dose every 8 hours; maximum 2 g per dose. |
| Geriatric use | Dose adjustment based on renal function is recommended; age-related decline in CrCl should be considered; initial dose based on renal function, then monitor renal function and adjust accordingly. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Nephrotoxic drugs may increase the risk of kidney damage May cause neurotoxicity including encephalopathy and nonconvulsive status epilepticus especially in renal impairment.
| FDA category | Human |
| Breastfeeding | Cefepime is excreted into human milk in low concentrations. M/P ratio is not determined. Likely compatible with breastfeeding due to poor oral bioavailability, but monitor infant for diarrhea, thrush, or rash. |
| Teratogenic Risk | No adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted with cefepime. Cefepime crosses the placenta. Generally considered low risk during all trimesters; use only if clearly needed. |
■ FDA Black Box Warning
No FDA black box warning is specified for cefepime. However, it carries a warning for neurotoxicity, including encephalopathy, myoclonus, seizures, and nonconvulsive status epilepticus, particularly in patients with renal impairment or those receiving high doses.
| Common Effects | Diarrhea |
| Serious Effects |
Absolute: Known hypersensitivity to cefepime, other cephalosporins, or any component of the formulation; history of severe immediate hypersensitivity reaction (e.g., anaphylaxis) to penicillins or other beta-lactam antibiotics. Relative: Use with caution in patients with penicillin allergy (cross-reactivity risk), renal impairment (dose adjustment), and history of gastrointestinal disease (especially colitis).
| Precautions | Neurotoxicity (seizures, encephalopathy) especially with renal impairment; hypersensitivity reactions (cross-allergenicity with penicillins and other cephalosporins); Clostridioides difficile-associated diarrhea; superinfection; hemolytic anemia; prothrombin activity reduction in patients with renal or hepatic impairment; dosage adjustment required in renal impairment; false-positive urine glucose test; potential for bleeding. |
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| Fetal Monitoring | Monitor maternal renal function, signs of hypersensitivity, and superinfection. Fetal monitoring as clinically indicated. |
| Fertility Effects | No known adverse effects on fertility based on animal studies. |
| Food/Dietary | No significant food interactions, but high-fat meals may delay absorption; this is not applicable as the drug is administered intravenously. Avoid alcohol to prevent potential disulfiram-like reaction. No specific dietary restrictions. |
| Clinical Pearls | Cefepime is a fourth-generation cephalosporin with broad-spectrum activity including Pseudomonas aeruginosa. It exhibits time-dependent killing; optimize by extending infusion times (e.g., 3-4 hours) for resistant organisms. Dose adjustment required for renal impairment (CrCl <60 mL/min); monitor for neurotoxicity (myoclonus, seizures) especially in elderly or renal failure. Avoid use in patients with severe penicillin allergy (type I hypersensitivity). Cefepime can cause false-positive urine glucose tests (Clinitest) but not glucose oxidase methods. |
| Patient Advice | This medication is given intravenously; report any pain, redness, or swelling at the injection site. · Complete the full course even if you feel better. · Tell your doctor if you have diarrhea (especially watery or bloody), rash, or seizures. · Avoid alcohol while on this medication and for 3 days after stopping to prevent disulfiram-like reaction. · If you have kidney problems, your dose may be adjusted; ensure kidney function monitoring. |