CEFMAX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CEFMAX (CEFMAX).
CEFMAX (cefepime) is a fourth-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), specifically PBP-3 in Gram-negative bacteria and PBP-1a/1b in Gram-positive bacteria, thereby disrupting peptidoglycan cross-linking and leading to cell lysis. It has zwitterionic properties facilitating rapid penetration through Gram-negative outer membranes and is relatively resistant to hydrolysis by many beta-lactamases, including AmpC beta-lactamases.
| Metabolism | Cefepime undergoes minimal hepatic metabolism; it is primarily eliminated unchanged by the kidneys via glomerular filtration and tubular secretion. No significant cytochrome P450 metabolism. |
| Excretion | Primarily renal (80–90% unchanged via glomerular filtration and tubular secretion); biliary/fecal elimination accounts for <5%. |
| Half-life | 2–4 hours in adults with normal renal function; prolonged to 20–40 hours in severe renal impairment (CrCl <10 mL/min). |
| Protein binding | 80–95% bound to serum albumin. |
| Volume of Distribution | 0.15–0.3 L/kg, indicating limited extravascular distribution; primarily confined to extracellular fluid. |
| Bioavailability | IM: ~90%. |
| Onset of Action | IV: Immediate; IM: 15–30 minutes. |
| Duration of Action | 6–8 hours (dose-dependent); extended with renal impairment. |
| Action Class | Cephalosporins: 3 generation |
| Brand Substitutes | Gudcef 200 Tablet, Zipod 200mg Tablet, Brotacef 200mg Tablet, Oxipod 200mg Tablet, Monocef-O 200 Tablet |
1-2 g IV/IM every 8-12 hours; maximum 6 g/day.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl 30-50 mL/min: 1-2 g every 12 hours; CrCl 10-29 mL/min: 1-2 g every 24 hours; CrCl <10 mL/min: 1-2 g every 48 hours. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B or C: reduce dose by 50% or increase dosing interval to every 12-24 hours. |
| Pediatric use | Neonates: 50-100 mg/kg/day divided every 12 hours; Infants and children: 100-200 mg/kg/day divided every 8 hours; maximum 6 g/day. |
| Geriatric use | No specific dose adjustment but renal function should be assessed; use renal adjustment guidelines based on CrCl. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CEFMAX (CEFMAX).
| Breastfeeding | Cefpodoxime is excreted into breast milk in low concentrations. The milk-to-plasma (M/P) ratio is approximately 0.1–0.2. In full-term infants, the dose received is less than 1% of the maternal weight-adjusted dose, which is considered safe. However, caution is advised in premature infants or those with glucose-6-phosphate dehydrogenase deficiency due to potential for hemolysis or alteration of gut flora. |
| Teratogenic Risk | Cefpodoxime proxetil (CEFMAX) is a cephalosporin antibiotic classified as FDA Pregnancy Category B. Animal studies have not demonstrated teratogenic effects. In the first trimester, risk is low based on limited human data; no structural anomalies are consistently associated. Second and third trimester use is considered safe for the fetus, as cephalosporins are not known to cause fetal harm. However, theoretical risk of fetal gut flora alteration exists with prolonged use. |
■ FDA Black Box Warning
None
| Serious Effects |
["History of immediate hypersensitivity reaction (e.g., anaphylaxis) to cefepime or any cephalosporin","History of severe hypersensitivity (e.g., anaphylaxis) to any other beta-lactam antibiotic (cross-sensitivity may occur)"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis, Stevens-Johnson syndrome, and toxic epidermal necrolysis","Clostridium difficile-associated diarrhea (CDAD) ranging from mild diarrhea to fatal colitis","Neurologic adverse reactions including encephalopathy, myoclonus, seizures, and nonconvulsive status epilepticus, especially in patients with renal impairment or overdose","Dose adjustment required in patients with creatinine clearance ≤60 mL/min to avoid neurotoxicity","Superinfection with non-susceptible organisms","Potential for hemolytic anemia (positive direct Coombs test)"] |
| Food/Dietary | Administration with food increases absorption. Avoid alcohol during treatment and for 72 hours after completion to reduce risk of disulfiram-like reaction. Separate from oral iron supplements by at least 2 hours. |
Loading safety data…
| Fetal Monitoring | Maternal monitoring: Assess for allergic reactions (rash, urticaria, anaphylaxis); monitor renal function (cephalosporins may cause nephrotoxicity); monitor for Clostridioides difficile-associated diarrhea. Fetal monitoring: None specific, but consider growth ultrasound if infection is severe or prolonged. During pregnancy, no special fetal heart rate monitoring is required beyond usual prenatal care. |
| Fertility Effects | No known adverse effects on fertility in animal studies. There are no controlled human studies regarding impact on spermatogenesis or oocyte maturation. Cefpodoxime has not been associated with reduced fertility in clinical practice. |
| Clinical Pearls | Cefmax (cefuroxime axetil) is a second-generation cephalosporin with activity against respiratory pathogens including Streptococcus pneumoniae and Haemophilus influenzae. Cross-allergy risk with penicillins is ~10%. Administer with food to enhance absorption. Avoid in neonates due to risk of kernicterus. |
| Patient Advice | Take this medication exactly as prescribed, even if you feel better. · Swallow the tablet whole; do not crush or chew. · If you are taking antacids or iron supplements, separate by at least 2 hours. · Common side effects include diarrhea, nausea, and headache. · Seek medical attention if you develop severe diarrhea, rash, or difficulty breathing. |