INVANZ
Clinical safety rating: caution
Comprehensive clinical and safety monograph for INVANZ (INVANZ).
Ertapenem is a carbapenem antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell death.
| Metabolism | Primarily hepatic via CYP3A4-mediated hydrolysis to inactive metabolites. |
| Excretion | Renal: ~80% unchanged in urine; biliary/fecal: ~10% as unchanged drug and the open-ring metabolite; minor hepatic metabolism. |
| Half-life | Terminal elimination half-life approximately 4 hours; prolonged to approximately 8 hours in mild to moderate renal impairment (CrCl 30-59 mL/min) and to 14 hours in severe renal impairment (CrCl <30 mL/min); clinical context: requires dosage adjustment in renal impairment. |
| Protein binding | ~92% bound, primarily to albumin. |
| Volume of Distribution | Vd approximately 0.12 L/kg in adults; indicates distribution primarily into extracellular fluid and interstitial space. |
| Bioavailability | Intramuscular: ~90% relative to IV; bioavailability near complete after IM administration. |
| Onset of Action | Intravenous: rapid, within 30 minutes after infusion begins; intramuscular: within 1 hour after injection. |
| Duration of Action | Parent drug concentrations remain above MIC90 for most target pathogens for approximately 12-24 hours post-dose; clinical meaning: supports once-daily dosing. |
1 g IV or IM once daily
| Dosage form | INJECTABLE |
| Renal impairment | CrCl >30 mL/min: no adjustment; CrCl ≤30 mL/min and not on hemodialysis: 500 mg once daily; on hemodialysis: 500 mg once daily, administer after hemodialysis on dialysis days |
| Liver impairment | No adjustment required for mild to moderate hepatic impairment (Child-Pugh class A or B); not studied in severe hepatic impairment (Child-Pugh class C) |
| Pediatric use | 3 months to 12 years: 15 mg/kg IV or IM twice daily (max 1 g/day); 13 years and older: 1 g IV or IM once daily |
| Geriatric use | No specific dose adjustment based solely on age; use renal function to guide dosing |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for INVANZ (INVANZ).
| Breastfeeding | Excreted in human milk in low concentrations. M/P ratio not established. Caution in nursing mothers; consider developmental and health benefits of breastfeeding along with mother's clinical need. Monitor infant for diarrhea, rash, and sensitization. |
| Teratogenic Risk | Pregnancy Category B: Animal reproduction studies in rats and rabbits at doses up to 3 times the human exposure revealed no evidence of fetal harm. No adequate and well-controlled studies in pregnant women. Use only if clearly needed. During organogenesis (first trimester), risk is not ruled out; second and third trimester risks are considered low based on animal data. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to ertapenem or any component of the formulation.","Hypersensitivity to other carbapenems, penicillins, or beta-lactam antibiotics (cross-sensitivity)."]
| Precautions | ["Hypersensitivity reactions: serious and occasionally fatal anaphylactic reactions.","Seizures: reported in patients with CNS disorders or renal impairment.","Clostridioides difficile-associated diarrhea (CDAD).","Reduced efficacy in patients with renal impairment requiring dose adjustment.","Prolonged use may result in superinfection."] |
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| Fetal Monitoring | Monitor for signs of hypersensitivity (rash, urticaria, anaphylaxis) in mother; monitor for seizures, Clostridioides difficile-associated diarrhea. Fetal monitoring via ultrasound if pregnancy is continued; assess for any adverse effects on fetal growth. |
| Fertility Effects | No impairment of fertility observed in animal studies at doses up to 3 times human exposure. No human data on fertility effects. Theoretical risk of altered gut flora affecting fertility, but unlikely. |