CEFEPIME HYDROCHLORIDE
Clinical safety rating: safe
Human studies have proved safety
Bactericidal; inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), inhibiting transpeptidase and carboxypeptidase activity, leading to cell lysis.
| Metabolism | Minimally metabolized; primarily eliminated by renal excretion as unchanged drug (>80%). Not significantly metabolized by liver. |
| Excretion | Primarily renal (≈85% unchanged via glomerular filtration and tubular secretion); biliary/fecal <1%. |
| Half-life | 2-2.3 hours in healthy adults (prolonged to 13-15 hours in severe renal impairment; requires dosage adjustment). |
| Protein binding | ≈16-19%, primarily to albumin (low binding, high free fraction). |
| Volume of Distribution | 0.3-0.4 L/kg (extensive distribution into extracellular fluid; penetrates well into tissues and CSF). |
| Bioavailability | IM: ≈100% (complete absorption); IV: 100% (intravenous administration). |
| Onset of Action | IV: immediate; IM: 1-2 hours (therapeutic concentrations achieved within first dose). |
| Duration of Action | Approximately 12 hours (bactericidal activity persists while concentrations exceed MIC; q12h dosing maintains efficacy). |
| Molecular Weight | 480.57 |
1-2 g IV every 8-12 hours; for uncomplicated urinary tract infections, 500 mg IV every 12 hours.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl >60 mL/min: no adjustment; CrCl 30-60 mL/min: 1-2 g every 12-24 hours; CrCl 11-29 mL/min: 500 mg-1 g every 24 hours; CrCl <11 mL/min: 250-500 mg every 24 hours; hemodialysis: 1 g on day 1, then 500 mg every 24 hours (supplement 1 g after dialysis). |
| Liver impairment | No adjustment required for hepatic impairment; dose adjustments based solely on renal function. |
| Pediatric use | Neonates <1 month: 30 mg/kg every 12 hours; Infants and children >1 month: 50 mg/kg every 8 hours (max 2 g per dose) for severe infections; for uncomplicated UTI: 50 mg/kg every 12 hours. |
| Geriatric use | Initiate at lower end of dosing range (e.g., 1 g every 12-24 hours) based on renal function; monitor renal function closely and adjust according to CrCl. |
| 1st trimester | Cefepime crosses the placenta. Human data limited; no evidence of fetal harm in animal studies. Use only if clearly needed. |
| 2nd trimester | Similar to T1; limited human data but considered low risk. Use when benefit outweighs risk. |
| 3rd trimester | Considered safe; commonly used for maternal infections. No known fetal/neonatal adverse 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.
| Placental transfer | Crosses placenta; fetal concentrations approximately 10-20% of maternal serum levels. |
| Breastfeeding | Cefepime is excreted into breast milk in low concentrations. It is considered compatible with breastfeeding due to poor oral bioavailability in infants, but may alter infant gut flora. Monitor for diarrhea or rash. |
■ FDA Black Box Warning
No FDA black box warning.
| Common Effects | Diarrhea |
| Serious Effects |
Hypersensitivity to cefepime or any cephalosporinSevere immediate hypersensitivity reaction to penicillins (anaphylaxis, Stevens-Johnson syndrome)
| Precautions | Hypersensitivity reactions (including anaphylaxis, serious skin reactions), Neurotoxicity (seizures, encephalopathy) especially in renal impairment or excessive doses, Clostridioides difficile-associated diarrhea (CDAD), Renal impairment requires dose adjustment, Potential for superinfection, Increased risk of bleeding (rare, monitor prothrombin time) |
| Food/Dietary | Avoid alcohol during therapy and for 48 hours after completion to reduce risk of disulfiram-like reaction. No other significant food interactions. |
Loading safety data…
| Lactation Rating | L1 (Safe) |
| Teratogenic Risk | Pregnancy Category B. Animal studies have not demonstrated fetal risk, but no adequate human studies in pregnant women. Use only if clearly needed. First trimester: no evidence of teratogenicity. Second and third trimesters: no documented adverse fetal effects. |
| Fetal Monitoring | Monitor maternal renal function, complete blood count, and signs of superinfection or allergic reactions. For prolonged therapy, monitor prothrombin time. Fetal monitoring as clinically indicated for maternal infection. |
| Fertility Effects | No evidence of impaired fertility in animal studies at doses up to 10 times the human dose. No human data available; unlikely to affect fertility. |
| Clinical Pearls | Adjust dose in renal impairment (CrCl <60 mL/min) using Cockcroft-Gault formula. Therapeutic drug monitoring not routinely required but may be considered in critically ill or obese patients. Consider prolonging infusion time to 3-4 hours for resistant organisms. Observe for neurotoxicity (myoclonus, encephalopathy) especially in elderly or renal impairment. Cefepime is stable in elastomeric pumps for up to 24 hours at room temperature. |
| Patient Advice | Take exactly as prescribed; do not skip doses. · Complete the full course even if you feel better. · Report any signs of allergic reaction (rash, itching, difficulty breathing) immediately. · Diarrhea, especially watery or bloody, may indicate a serious infection; contact your doctor. · Inform your doctor if you have kidney problems, are on dialysis, or have a history of seizures. · Avoid alcohol during treatment and for 48 hours after last dose to prevent disulfiram-like reaction. · Cefepime may cause dizziness; avoid driving or operating machinery if affected. |