ZINACEF IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ZINACEF IN PLASTIC CONTAINER (ZINACEF IN PLASTIC CONTAINER).
Cefuroxime is a second-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), thereby blocking transpeptidation and leading to cell lysis and death.
| Metabolism | Cefuroxime is not significantly metabolized; it is excreted unchanged primarily by the kidneys via glomerular filtration and tubular secretion. |
| Excretion | Approximately 80-90% of the dose is excreted unchanged in the urine via glomerular filtration and tubular secretion; the remainder is eliminated via bile and feces. |
| Half-life | Terminal elimination half-life is approximately 1.5 hours in adults with normal renal function; prolonged to 3-4 hours in neonates and up to 20-30 hours in end-stage renal disease. |
| Protein binding | Approximately 33-50% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution is 0.2-0.3 L/kg, indicating distribution primarily into extracellular fluid; higher in neonates (0.3-0.5 L/kg). |
| Bioavailability | Bioavailability is negligible orally (<5%); intramuscular administration provides nearly 100% bioavailability. |
| Onset of Action | Intravenous administration achieves therapeutic serum concentrations within minutes; intramuscular injection reaches peak levels in 30-60 minutes. |
| Duration of Action | Serum levels above the MIC for susceptible pathogens persist for approximately 6-8 hours after a standard dose; clinical effect duration correlates with dosing interval (usually every 8 hours). |
750 mg intravenously or intramuscularly every 8 hours; for severe infections, 1.5 g intravenously every 8 hours.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl 30-50 mL/min: 750 mg every 12 hours; CrCl 10-29 mL/min: 750 mg every 24 hours; CrCl <10 mL/min: 750 mg every 48 hours; hemodialysis: 750 mg after each dialysis session. |
| Liver impairment | No dose adjustment required for hepatic impairment; dose based on renal function. |
| Pediatric use | Children 1 month to 12 years: 50-100 mg/kg/day intravenously divided every 6-8 hours; neonates: 100 mg/kg/day intravenously divided every 12 hours. |
| Geriatric use | Dose adjustment based on renal function; monitor creatinine clearance; use lowest effective dose. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ZINACEF IN PLASTIC CONTAINER (ZINACEF IN PLASTIC CONTAINER).
| Breastfeeding | Cefuroxime is excreted into human breast milk in low concentrations. The milk-to-plasma (M/P) ratio is approximately 0.1–0.3. Based on limited data, the estimated daily infant dose from breast milk is less than 1% of the therapeutic pediatric dose, which is unlikely to cause adverse effects in nursing infants. However, cautious use is recommended due to potential disruption of infant gastrointestinal flora. The American Academy of Pediatrics considers cephalosporins compatible with breastfeeding. |
| Teratogenic Risk | ZINACEF (cefuroxime) is a cephalosporin antibiotic classified as FDA Pregnancy Category B. Animal reproduction studies have not demonstrated a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. No teratogenic effects have been observed in first trimester exposures; however, as with all antibiotics, use during pregnancy should be limited to clearly indicated cases. Routine use in the third trimester is considered safe, but caution is advised due to potential alteration of neonatal gut flora. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to cefuroxime or any component of the formulation","Hypersensitivity to other cephalosporin antibiotics"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis: Cross-sensitivity among cephalosporins and penicillins; use caution in penicillin-allergic patients.","Clostridioides difficile-associated diarrhea: Consider in patients who develop diarrhea during or after therapy.","Seizures: Risk increased in patients with renal impairment receiving high doses; dose adjustment required.","Coagulation abnormalities: Monitor prothrombin time in patients at risk (e.g., renal/hepatic impairment, prolonged therapy).","Superinfection: Prolonged use may result in overgrowth of nonsusceptible organisms (e.g., fungi, Enterococci).","Renal impairment: Dose adjustment necessary based on creatinine clearance."] |
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| Fetal Monitoring | Monitor for hypersensitivity reactions (rash, urticaria, anaphylaxis) in the mother. Assess renal function periodically, especially in patients with preexisting impairment. For prolonged therapy, monitor for signs of superinfection or Clostridium difficile-associated diarrhea. Fetal monitoring is not specifically required unless maternal infection poses a risk (e.g., chorioamnionitis). Standard obstetric monitoring per gestational age is adequate. |
| Fertility Effects | No specific adverse effects on fertility have been reported in animal or human studies with cefuroxime. Cephalosporins are not known to impair male or female reproductive function. However, any severe infection may temporarily affect fertility due to systemic illness. |