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). |
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 | 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.
| Breastfeeding | Cefepime is excreted into human breast milk in low concentrations. M/P ratio not established. Considered compatible with breastfeeding by the American Academy of Pediatrics; monitor infant for possible gastrointestinal disturbances or allergic reactions. |
| 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. |
■ FDA Black Box Warning
No FDA black box warning.
| Common Effects | Diarrhea |
| Serious Effects |
["Hypersensitivity to cefepime or other cephalosporins","Severe immediate hypersensitivity reaction (e.g., anaphylaxis) to penicillins or other beta-lactams"]
| 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. |
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| 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. |