CEFEPIME HYDROCHLORIDE 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 in Gram-negative bacteria, leading to cell lysis and death.
| Metabolism | Cefepime is minimally metabolized; primarily hydrolyzed to an N-methylpyrrolidine (NMP) and deacetylated metabolites. The majority of the dose is excreted unchanged in urine via glomerular filtration and tubular secretion. |
| Excretion | Primarily renal (≈85% unchanged via glomerular filtration and tubular secretion); minimal biliary/fecal (<5%). |
| Half-life | Terminal elimination half-life ≈2.0–2.3 hours in healthy adults; prolonged to 13–26 hours in severe renal impairment (CrCl <10 mL/min); relevant for dosing interval adjustment. |
| Protein binding | ≈20% bound, primarily to albumin. |
| Volume of Distribution | 0.3–0.4 L/kg (≈18–24 L in adults); approximates extracellular fluid volume; adequate penetration into tissues and fluids. |
| Bioavailability | Intravenous: 100%; intramuscular: ≈85%. |
| Onset of Action | Intravenous: within 30 minutes; intramuscular: within 45–60 minutes. |
| Duration of Action | Approximately 12 hours for susceptible bacteria; clinical coverage extends dosing interval (every 8–12 hours) based on PK/PD target (time above MIC). |
1-2 g IV every 8-12 hours for moderate to severe infections; for febrile neutropenia, 2 g IV every 8 hours.
| Dosage form | POWDER |
| Renal impairment | For CrCl 30-60 mL/min: 1-2 g every 12 hours; CrCl 11-29 mL/min: 1-2 g every 24 hours; CrCl <11 mL/min: 500 mg every 24 hours. Hemodialysis: 1-2 g on day 1, then 500 mg-1 g every 24 hours (administer after dialysis). |
| Liver impairment | No dose adjustment required for hepatic impairment alone; monitor for safety. |
| Pediatric use | For children >2 months and <40 kg: 50 mg/kg/dose IV every 8-12 hours (max 2 g/dose). For febrile neutropenia: 50 mg/kg/dose IV every 8 hours (max 2 g/dose). For neonates (0-2 months): 30 mg/kg/dose IV every 12 hours. |
| Geriatric use | Use weight-based dosing (max 2 g/dose) and adjust for renal function based on CrCl, as elderly often have reduced renal clearance. No specific dose ceiling other than renal adjustment. |
| 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 not established. Considered compatible with breastfeeding; caution in preterm infants or those with glucose-6-phosphate dehydrogenase deficiency. |
| Teratogenic Risk | No evidence of teratogenicity in animal studies at doses up to 10 times the human dose. Human data are limited; cefepime crosses the placenta. FDA Pregnancy Category B. No known fetal risk in first trimester; use only if clearly needed in all trimesters. |
■ FDA Black Box Warning
Anaphylactic reactions: Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics, including cefepime. Before therapy with cefepime is instituted, careful inquiry should be made concerning previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.
| Common Effects | Diarrhea |
| Serious Effects |
Hypersensitivity to cefepime or other cephalosporins. History of immediate-type hypersensitivity reaction (e.g., anaphylaxis) to penicillins or other beta-lactam antibiotics.
| Precautions | Hypersensitivity reactions: cross-allergy among beta-lactams; use caution in penicillin-allergic patients. Neurotoxicity: increased risk of seizures, encephalopathy, and neuromuscular excitability in patients with renal impairment or without dosage adjustment. Clostridium difficile-associated diarrhea (CDAD). Prolonged therapy may result in superinfection. Dosage adjustment required in renal impairment. |
Loading safety data…
| Fetal Monitoring | Monitor maternal renal function and CBC periodically. Monitor for signs of superinfection and hypersensitivity. Fetal monitoring not specifically required; standard prenatal care. |
| Fertility Effects | No adverse effects on fertility observed in animal studies. No human data; theoretical risk of sperm motility impairment due to β-lactam antibiotics, but not substantiated. |
| Food/Dietary | No clinically significant food interactions with intravenous cefepime. Maintain adequate hydration; no dietary restrictions. |
| Clinical Pearls | Cefepime is a fourth-generation cephalosporin with broad-spectrum activity against Gram-positive and Gram-negative organisms, including Pseudomonas aeruginosa. It is often used for empiric therapy in febrile neutropenia and severe infections. Monitor renal function and adjust dose in renal impairment (CrCl <60 mL/min). Neurotoxicity (e.g., encephalopathy, myoclonus, seizures) can occur, especially in renal impairment or high doses. Do not use in patients with anaphylactic reactions to penicillins or other cephalosporins; caution in non-anaphylactic penicillin allergy. For intravenous administration only; reconstitute and use within 24 hours at room temperature or 7 days refrigerated. Incompatible with metronidazole and aminoglycosides in same IV line. |
| Patient Advice | This medication is given intravenously to treat bacterial infections. · You may experience diarrhea, nausea, or rash; report severe diarrhea, seizures, or confusion immediately. · Tell your healthcare provider if you are allergic to penicillins or cephalosporins. · Your kidney function will be monitored with blood tests. · Do not stop taking this medication early even if you feel better. · If you miss a dose, contact your doctor for instructions. |