Adult: 1 g once daily via IV infusion over 30 minutes or via IM inj. Usual treatment duration: 3-14 days, may vary depending on the type and severity of infection, causative pathogen, and patient’s clinical response. Switch to oral antibacterial agent when clinically indicated. Child: 3 months to 12 years 15 mg/kg bid via IV infusion over 30 minutes or via IM inj. Max: 1,000 mg/day; ≥13 years Same as adult dose. Usual treatment duration: 3-14 days, may vary depending on the type and severity of infection, causative pathogen, and patient’s clinical response. Switch to oral antibacterial agent when clinically indicated.
Intravenous Prophylaxis of infection during colorectal surgery
Adult: 1 g as a single dose via infusion over 30 minutes, given 1 hour before the surgery.
Renal Impairment
Complicated intra-abdominal infections; Complicated skin and skin structure infections; Community acquired pneumonia; Complicated urinary tract infections; Pelvic infections:
Patient undergoing haemodialysis: 500 mg once daily. Dose is given at least 6 hours before dialysis; if dose is given within 6 hours prior to dialysis, a supplemental dose of 150 mg should be administered following the dialysis session.
ESRD: 500 mg once daily.
CrCl (mL/min)
Dosage
≤30
500 mg once daily.
Reconstitution
IV infusion: Reconstitute vial labelled as containing 1 g with 10 mL of NaCl 0.9%, sterile water for inj, or bacteriostatic water for inj; further dilute with 50 mL NaCl 0.9% solution (for adults) or dilute to a final concentration of ≤20 mg/mL (for children 3 months to 12 years). IM: Reconstitute vial labelled as containing 1 g with 3.2 mL of lidocaine HCl 1% inj (without epinephrine).
Incompatibility
Do not dilute with dextrose-containing solutions or admix with other drugs.
Contraindications
Hypersensitivity to ertapenem or other carbapenems. History of severe hypersensitivity reaction (e.g. anaphylactic or severe skin reaction) to β-lactam antibiotics (e.g. penicillins, cephalosporins).
Special Precautions
Patient with CNS disorders (e.g. history of seizures, brain lesions) or known factors that may predispose to convulsion. Renal impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: CNS effects (e.g. seizures, hallucinations, altered mental status, encephalopathy); bacterial superinfection (prolonged use). Rarely, severe cutaneous adverse reactions (e.g. acute generalised exanthematous pustulosis [AGEP], drug reaction with eosinophilia and systemic symptoms [DRESS]). Gastrointestinal disorders: Diarrhoea, nausea, vomiting, abdominal pain. General disorders and administration site conditions: Fever, infusion site pain and erythema. Infections and infestations: Vaginitis. Investigations: Increased ALT, AST, alkaline phosphatase; decreased haemoglobin, haematocrit. Nervous system disorders: Headache, dizziness, insomnia. Respiratory, thoracic and mediastinal disorders: Cough, dyspnoea. Skin and subcutaneous tissue disorders: Rash, pruritus. Vascular disorders: Infused vein complication, phlebitis/thrombophlebitis. Potentially Fatal: Serious or fatal hypersensitivity reactions (e.g. anaphylaxis), Clostridioides difficile-associated diarrhoea and pseudomembranous colitis.
Perform culture and sensitivity tests prior to treatment initiation; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Perform periodic LFT, renal function, and haematologic assessment (during prolonged treatment). Monitor neurological status. Assess for signs of hypersensitivity or anaphylactic reactions during initiation of treatment.
Drug Interactions
May reduce the serum concentrations of valproic acid to subtherapeutic levels, thereby increasing the risk of breakthrough seizures. Increased plasma concentrations and prolonged elimination half-life with probenecid.
Action
Description: Mechanism of Action: Ertapenemis is a synthetic carbapenem β-lactam antibiotic. It binds to 1 or more penicillin-binding proteins (PBPs) which prevents the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis, resulting in bacterial cell lysis and death. Pharmacokinetics: Absorption: Almost completely absorbed following IM administration. Bioavailability: Approx 90% (IM). Time to peak plasma concentration: Approx 2.3 hours (IM). Distribution: Enters breast milk. Plasma protein binding: >90%, mainly to albumin. Metabolism: Partially metabolised via hydrolysis of its β-lactam ring by DHP 1 into an inactive open-ringed metabolite. Excretion: Via urine (approx 80% as unchanged drug and metabolite); faeces (approx 10%). Plasma half-life: Approx 4 hours.
Chemical Structure
Ertapenem Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 150610, Ertapenem. https://pubchem.ncbi.nlm.nih.gov/compound/Ertapenem. Accessed May 28, 2024.
Storage
Intact vial: Store below 25°C. Reconstituted solution for IV infusion: Store at 25°C for 6 hours or between 2-8°C for 24 hours. Do not freeze.
J01DH03 - ertapenem ; Belongs to the class of carbapenems. Used in the systemic treatment of infections.
References
Anon. Ertapenem Sodium. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 30/04/2024.Buckingham R (ed). Ertapenem Sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/04/2024.Ertapenem 1 g Powder for Concentrate for Solution for Infusion (Cipla [EU] Limited). MHRA. https://products.mhra.gov.uk. Accessed 30/04/2024.Ertapenem. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 30/04/2024.Invanz Injection (Merck Sharp & Dohme [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 30/04/2024.Invanz Injection, Powder, Lyophilized, for Solution (Merck Sharp & Dohme LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 30/04/2024.Joint Formulary Committee. Ertapenem. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/04/2024.Merck Sharp & Dohme (NZ) Limited. Invanz 1 g Powder for Injection data sheet 15 August 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 30/04/2024.Paediatric Formulary Committee. Ertapenem. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 30/04/2024.
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