CEFEPIME AND DEXTROSE IN DUPLEX 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, leading to cell lysis and death. It has activity against both gram-positive and gram-negative bacteria.
| Metabolism | Cefepime is minimally metabolized (<15%) in the liver; it is primarily excreted unchanged in the urine by glomerular filtration and tubular secretion. No significant hepatic metabolism or CYP450 involvement. |
| Excretion | Primarily renal (≥85% unchanged in urine via glomerular filtration and tubular secretion); biliary/fecal excretion minimal (<1%). |
| Half-life | Approximately 2 hours in adults with normal renal function; prolonged to 4–8 hours in mild-to-moderate renal impairment and up to 13–30 hours in severe impairment (CrCl <30 mL/min). |
| Protein binding | Low, approximately 16–19%; primarily bound to albumin. |
| Volume of Distribution | 0.3–0.4 L/kg in adults; increases with inflammation (e.g., sepsis) up to 0.6 L/kg, indicating distribution into extracellular fluid. |
| Bioavailability | Intravenous: 100%; Intramuscular: approximately 82–84%. |
| Onset of Action | Intravenous: Immediate upon completion of infusion; Intramuscular: within 1–2 hours. |
| Duration of Action | Approximately 12 hours; dosing interval adjusted to every 12 hours (or every 8 hours for febrile neutropenia) based on renal function. |
1-2 g intravenously every 8-12 hours; typical dose 1 g IV q12h for most infections, 2 g IV q8h for severe infections.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl >60 mL/min: no adjustment; CrCl 30-60 mL/min: 1-2 g every 24 hours; CrCl 11-29 mL/min: 0.5-1 g every 24 hours; CrCl <10 mL/min: 0.5-1 g every 48 hours; hemodialysis: 1 g on dialysis day then 0.5-1 g every 48 hours. |
| Liver impairment | No specific Child-Pugh based dose adjustments required; use standard dosing with monitoring. |
| Pediatric use | Neonates <1 month: 30 mg/kg IV q12h; Infants 1-2 months: 30 mg/kg IV q12h; Children 2 months to 16 years: 50 mg/kg IV q8h up to 2 g per dose. |
| Geriatric use | Use renal function-based dosing; elderly often require dose adjustment due to age-related decline in 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.
| FDA category | Human |
| Breastfeeding | Cefepime is excreted into human breast milk in low concentrations. M/P ratio not determined. Considered compatible with breastfeeding; however, monitor infant for diarrhea, candidiasis, or allergic reactions. |
| Teratogenic Risk | FDA Pregnancy Category B. No evidence of teratogenicity in animal studies; however, adequate human studies in pregnant women are lacking. Use only if clearly needed. Cefepime crosses the placenta, fetal serum levels are approximately 50-100% of maternal levels. No known fetal risks in any trimester. |
■ FDA Black Box Warning
None. Cefepime does not have an FDA black box warning.
| Common Effects | Diarrhea |
| Serious Effects |
["Absolute: Hypersensitivity to cefepime, any cephalosporin, or any component of the product.","Relative: Hypersensitivity to penicillins or other beta-lactams (cross-hypersensitivity possible). Use with caution in patients with gastrointestinal disease, particularly colitis."]
| Precautions | ["Hypersensitivity reactions (including anaphylaxis and serious skin reactions) in patients with penicillin or other beta-lactam allergy.","Neurotoxicity including altered mental status, myoclonus, seizures, and encephalopathy, especially in patients with renal impairment or those receiving higher doses.","Clostridioides difficile-associated diarrhea (CDAD) ranging from mild diarrhea to fatal colitis.","Renal function monitoring and dose adjustment required in patients with reduced creatinine clearance.","Coagulation abnormalities (rare) have been reported."] |
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| Fetal Monitoring | Monitor for signs of hypersensitivity, superinfection, and diarrhea in both mother and neonate. In neonates, monitor renal and hepatic function if prolonged exposure. No specific fetal monitoring required. |
| Fertility Effects | No known adverse effects on fertility based on animal studies. No human studies available. |
| Food/Dietary | No specific food interactions. Alcohol may increase risk of disulfiram-like reaction (rare with cefepime). Maintain adequate hydration. |
| Clinical Pearls | Cefepime is a fourth-generation cephalosporin with enhanced activity against Gram-negative bacteria, including Pseudomonas aeruginosa, and Gram-positive cocci. The duplex container provides a ready-to-use solution; do not add other drugs. Administer over 30 minutes; incompatibility with metronidazole, vancomycin, and aminoglycosides. Monitor renal function and adjust dose in creatinine clearance <60 mL/min. Neurotoxicity risk (encephalopathy, myoclonus, seizures) especially in elderly or renal impairment; discontinue if occurs. |
| Patient Advice | This medication is given intravenously to treat bacterial infections. · Complete the full course even if you feel better. · Report any signs of allergic reaction: rash, itching, swelling, trouble breathing. · Tell your doctor if you have kidney problems or are on dialysis. · If you experience confusion, muscle twitching, or seizures, seek immediate medical attention. · Avoid alcohol while on this medication. |