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). |
| Molecular Weight | 480.97 Da (cefepime hydrochloride; cefepime base: 480.97 Da) |
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 | Cefepime is generally considered safe during the first trimester. Animal studies have not shown reproductive toxicity. Human data are limited but no major malformations have been reported. Use only if clearly needed. |
| 2nd trimester | Second trimester use is considered safe, with no evidence of fetal harm. Standard dosing applies. |
| 3rd trimester | Third trimester use is safe. Cefepime crosses the placenta and achieves therapeutic levels in fetal tissues. No known adverse effects on the fetus or neonate. |
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 readily. In ex vivo placental perfusion models, it shows significant transfer. Fetal concentrations are approximately 50-100% of maternal serum levels, indicating substantial placental passage. |
■ 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 any other cephalosporin antibioticSevere immediate hypersensitivity (e.g., anaphylaxis) to penicillins or other beta-lactam antibioticsHistory of cephalosporin-induced severe adverse reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)Known allergy to arginine (present in some formulations as a buffer)
| 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…
| Breastfeeding | Cefepime is excreted into human breast milk in low concentrations. The dose received by the infant is typically less than 1% of the maternal dose, which is unlikely to cause adverse effects. However, caution is advised in infants with gastrointestinal disturbances or allergy to cephalosporins. Monitor for diarrhoea or candidiasis. |
| Lactation Rating | L2 (Safer) |
| 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. |
| 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. |