ERTAPENEM SODIUM
Clinical safety rating: safe
Animal studies have demonstrated safety
Ertapenem inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to cell death. It is a carbapenem antibiotic with broad-spectrum activity against Gram-positive and Gram-negative aerobes and anaerobes.
| Metabolism | Ertapenem is not significantly metabolized; approximately 94% is excreted unchanged in urine via glomerular filtration and tubular secretion, with a small amount (about 1%) excreted in feces. |
| Excretion | Renal: ~80% unchanged in urine; fecal: ~10% as metabolites; biliary: minimal (<1%) |
| Half-life | Terminal half-life: ~4 hours (range 3.5-5.3) in young adults; prolonged in renal impairment (e.g., ~7.5 hours in moderate impairment, ~13 hours in end-stage renal disease) |
| Protein binding | ~85-95% bound to human plasma proteins, primarily albumin |
| Volume of Distribution | ~0.12 L/kg (~8 L in adults), indicating predominantly extracellular fluid distribution; low tissue penetration |
| Bioavailability | IM: ~90-100% (absolute bioavailability after single 1 g dose) |
| Onset of Action | IV: Rapid, within 1 hour after infusion; IM: Peak concentrations achieved at ~2 hours, clinical onset within several hours |
| Duration of Action | IV: Dosing every 24 hours provides continuous bactericidal levels above MIC for susceptible organisms throughout the interval; IM: Similar duration due to slow absorption |
1 g IV or IM once daily.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl >30 mL/min: no adjustment; CrCl ≤30 mL/min and hemodialysis: 500 mg once daily; after hemodialysis: give 150 mg supplemental dose if within 6 hours of next scheduled dose; peritoneal dialysis: 500 mg once daily; continuous renal replacement therapy: 500 mg every 12-24 hours. |
| Liver impairment | No adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). No data for severe hepatic impairment (Child-Pugh C). |
| Pediatric use | 3 months to 12 years: 15 mg/kg/dose (max 1 g) IV/IM every 12 hours; 13 years and older: 1 g IV/IM once daily. |
| Geriatric use | Age-related renal function decline common; use CrCl-based dosing as per renal adjustment. No specific age-related dose changes if normal renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Valproic acid levels may be significantly reduced Can cause seizures and hypersensitivity reactions.
| Breastfeeding | Ertapenem is excreted in human milk in low concentrations; M/P ratio not established. Use with caution in breastfeeding; consider risk vs benefit. |
| Teratogenic Risk | No evidence of teratogenicity in animal studies; limited human data. Category B: no documented fetal risk in any trimester based on available data. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA black box warning.
| Common Effects | Diarrhea |
| Serious Effects |
["Hypersensitivity to ertapenem or any component of the formulation","Hypersensitivity to other carbapenems or beta-lactam antibiotics (e.g., penicillins, cephalosporins) due to potential cross-sensitivity","Use in patients with known anaphylactic reactions to beta-lactams"]
| Precautions | ["Hypersensitivity reactions: Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported. Cross-sensitivity with other beta-lactam antibiotics may occur.","Seizures: Central nervous system adverse events, including seizures, have been reported, particularly in patients with CNS disorders (e.g., brain lesions, history of seizures) or renal impairment.","Clostridioides difficile-associated diarrhea: Consider in patients who develop diarrhea during or after therapy.","Renal impairment: Dose adjustment is required in patients with creatinine clearance ≤30 mL/min."] |
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| Monitor for maternal adverse effects (e.g., diarrhea, rash, seizures) and fetal assessments as per standard obstetrical care. |
| Fertility Effects | No known adverse effects on fertility in animal studies; human data lacking. |
| Food/Dietary | No significant food-drug interactions. Ertapenem is administered intravenously and does not require dietary restrictions. However, maintain adequate hydration to support renal function. Avoid alcohol intake to reduce risk of disulfiram-like reaction, though not well documented with ertapenem. |
| Clinical Pearls | Ertapenem has a long half-life (4 hours) allowing once-daily dosing. It is not active against Pseudomonas aeruginosa or Enterococcus spp. Use caution in patients with a history of beta-lactam allergy; cross-reactivity with penicillins is low but possible. Requires dose adjustment for CrCl ≤30 mL/min: reduce to 500 mg daily. Monitor for seizures, especially in elderly or those with CNS disorders, as imipenem-class neurotoxicity is a class effect. Consider ertapenem for community-acquired infections including complicated intra-abdominal, acute pelvic, and diabetic foot infections due to its broad anaerobic coverage. |
| Patient Advice | Take this medication exactly as prescribed, usually once daily by intravenous infusion. · Report any signs of allergic reaction such as rash, itching, or difficulty breathing immediately. · Notify your doctor if you have a history of seizures, kidney disease, or allergies to penicillins or other beta-lactam antibiotics. · Inform your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding. · Do not stop treatment early even if you feel better; complete the full course to prevent resistance. · Tell your doctor about all medications you are taking, especially valproic acid, as ertapenem can decrease its effectiveness. · If you experience severe diarrhea, especially with blood or mucus, contact your doctor as this may be Clostridium difficile infection. |