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. |
| Molecular Weight | 446.37 Da (cefuroxime axetil) |
| 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 | Cefuroxime (the active component of CEFMAX) crosses the placenta. Animal studies have not shown risks to the fetus, but there are no adequate controlled studies in pregnant women during the first trimester. Should be used only if clearly needed. |
| 2nd trimester | Generally considered safe during the second trimester, as there is no evidence of teratogenicity. However, use only when clinically indicated. |
| 3rd trimester | Considered safe in the third trimester. Cefuroxime is commonly used for intrapartum prophylaxis against group B streptococcus and for cesarean section prophylaxis. |
Clinical note
Comprehensive clinical and safety monograph for CEFMAX (CEFMAX).
| Placental transfer | Cefuroxime crosses the placenta and reaches therapeutic concentrations in fetal serum, amniotic fluid, and cord blood. Transfer is moderate and increases with advanced gestation. |
| Breastfeeding | Cefuroxime is excreted into breast milk in low concentrations. It is generally considered compatible with breastfeeding, but caution should be exercised in infants with a history of allergy to cephalosporins or with gastrointestinal disturbances. |
■ FDA Black Box Warning
None
| Serious Effects |
Known hypersensitivity to cephalosporins or any component of the formulationPrevious immediate hypersensitivity reaction (e.g., anaphylaxis) to penicillins or other beta-lactams
| 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. |
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| Lactation Rating | L1 (Compatible) |
| 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. |
| 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. |