MAXIPIME
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MAXIPIME (MAXIPIME).
Cefepime is a fourth-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), thereby disrupting peptidoglycan cross-linking. It has enhanced activity against Gram-negative bacteria due to rapid penetration through the outer membrane and low affinity for β-lactamases.
| Metabolism | Cefepime is minimally metabolized. It is primarily eliminated unchanged by the kidneys via glomerular filtration and tubular secretion. Renal clearance accounts for approximately 85% of total clearance. |
| Excretion | Primarily renal (approximately 80-90% as unchanged drug) via glomerular filtration and tubular secretion; biliary/fecal excretion is minimal (< 1%). |
| Half-life | Terminal elimination half-life is approximately 2-2.5 hours in adults with normal renal function; extends to 8-12 hours in moderate renal impairment (CrCl 30-60 mL/min) and up to 20-24 hours in severe impairment (CrCl < 30 mL/min). |
| Protein binding | Low, approximately 20% bound primarily to albumin. |
| Volume of Distribution | Volume of distribution (Vd) is approximately 0.2-0.3 L/kg, indicating distribution primarily into extracellular fluid (ECF). |
| Bioavailability | Intramuscular (IM): Approximately 100% bioavailability. |
| Onset of Action | Intravenous (IV): Immediate (within minutes) due to rapid distribution; Intramuscular (IM): Approximately 30-60 minutes. |
| Duration of Action | Approximately 8-12 hours for susceptible organisms due to time-dependent killing; requires multiple daily dosing (every 8-12 hours) to maintain bactericidal concentrations. |
| Action Class | Cephalosporins: 4th generation |
| Brand Substitutes | Cefpy 1000mg Injection, Winpime 1000mg Injection, Corpime 1000mg Injection, Kefage 1000mg Injection, Sepin 1000mg Injection |
1-2 g IV every 8-12 hours for most indications; maximum 2 g every 8 hours for severe infections.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 30-59 mL/min: 1-2 g every 12-24 hours; GFR 11-29 mL/min: 1-2 g every 24-48 hours; GFR <10 mL/min: 500 mg-1 g every 48 hours; hemodialysis: 1 g after each session. |
| Liver impairment | No dosage adjustment required for hepatic impairment alone; adjustment based on renal function. |
| Pediatric use | Neonates: 30 mg/kg IV every 12 hours; Infants/children: 50 mg/kg IV every 8 hours; maximum 2 g per dose. |
| Geriatric use | Adjust dose based on renal function; consider age-related decline in GFR; initial dose based on creatinine clearance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MAXIPIME (MAXIPIME).
| Breastfeeding | Cefepime is excreted in human milk in low concentrations. The M/P ratio is not established. Based on limited data, it is considered compatible with breastfeeding; however, monitor infant for potential gastrointestinal disturbances or allergic reactions. |
| Teratogenic Risk | Cefepime (MAXIPIME) is classified as Pregnancy Category B. Animal studies have not demonstrated fetal risk, but adequate human studies in pregnant women are lacking. There is no evidence of teratogenicity in first, second, or third trimester. However, caution is advised due to unknown risks. |
■ FDA Black Box Warning
Cefepime has not been associated with a specific FDA black box warning. However, there have been concerns about neurotoxicity (e.g., encephalopathy, myoclonus, seizures) especially in patients with renal impairment.
| Serious Effects |
["Hypersensitivity to cefepime, any cephalosporin, or other β-lactam antibiotics (e.g., penicillins, carbapenems) with serious allergic reactions.","Patients with a history of anaphylaxis or severe immediate-type hypersensitivity to penicillins (cross-sensitivity risk)."]
| Precautions | ["Neurotoxicity: encephalopathy, myoclonus, seizures, and nonconvulsive status epilepticus, particularly in patients with renal impairment or underlying CNS disorders.","Hypersensitivity reactions: including anaphylaxis and severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome).","Clostridioides difficile-associated diarrhea (CDAD).","Hematologic effects: positive direct Coombs test without hemolysis, rare cases of hemolytic anemia.","Renal impairment: dosage adjustment required based on creatinine clearance.","Superinfection: prolonged use may result in overgrowth of nonsusceptible organisms.","Prothrombin activity: risk of bleeding in patients with renal or hepatic impairment, poor nutritional status, or prolonged therapy; monitor and administer vitamin K if needed."] |
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| Fetal Monitoring |
| Monitor maternal renal function (creatinine clearance) due to cefepime elimination. No specific fetal monitoring required, but standard pregnancy monitoring is recommended. Observe for maternal adverse effects such as hypersensitivity or diarrhea. |
| Fertility Effects | No evidence of impaired fertility in animal studies. Human data on fertility effects are absent. No expected impact on fertility based on available safety profile. |