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. |
| Molecular Weight | 480.56 |
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 | No adequate studies in pregnant women; animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Use only if clearly needed. |
| 2nd trimester | No evidence of teratogenicity in animal studies; risk to fetus cannot be ruled out in humans. Use if benefit outweighs risk. |
| 3rd trimester | Considered safe for use during pregnancy for treatment of infections; no known adverse fetal effects. |
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 |
| Placental transfer | Cefepime crosses the placenta and is found in fetal serum and amniotic fluid. Placental transfer is moderate, with fetal exposures approximately 1-10% of maternal serum levels. |
■ 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 |
Hypersensitivity to cefepime or any other cephalosporin antibioticImmediate-type hypersensitivity reaction to penicillins (severe anaphylaxis)
| 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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| Breastfeeding | Cefepime is excreted into human breast milk in small amounts. The American Academy of Pediatrics considers cephalosporins compatible with breastfeeding. Monitor infant for possible gastrointestinal effects (diarrhea, candidiasis). Use caution in breastfeeding women. |
| Lactation Rating | L2 (Safer) |
| 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. |
| 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. |