ertapenem sodium: clinical use

Prescribing considerations

• Confirm that the infection and likely pathogen fit the licensed indication and susceptibility profile; obtain microbiology samples where appropriate.
• Review renal function and neurological history because renal impairment, pre-existing CNS disease and older age increase the risk of seizures or encephalopathy.
• Do not assume activity against MRSA, enterococci, Pseudomonas aeruginosa or other inherently resistant organisms.
• Efficacy has not been established for diabetic foot infection with concurrent osteomyelitis.
• There are no efficacy or safety data for children under 3 months, and experience below 2 years is limited.
• Review sodium exposure where clinically relevant.

Contraindications and cautions

• Hypersensitivity to ertapenem or any excipient
• Hypersensitivity to another carbapenem
• Previous severe hypersensitivity, such as anaphylaxis or a severe skin reaction, to another beta-lactam antibiotic

Monitoring

• Clinical response and microbiology results
• Renal function, particularly where neurological toxicity is a concern
• Mental state, myoclonus and seizure activity in at-risk patients
• Blood count and liver-function tests during ongoing parenteral treatment
• Bowel symptoms during and after treatment where antibiotic-associated colitis is suspected
• Intravenous access site and line function in outpatient therapy

Clinical pharmacology

Ertapenem is a highly protein-bound carbapenem that inhibits bacterial cell-wall synthesis through penicillin-binding proteins. It undergoes limited hepatic metabolism and is eliminated mainly through the kidneys; exposure rises as renal function declines.

Formulation and product differences

• The selected product is a single-use powder for concentrate for intravenous infusion and must be reconstituted and diluted before administration.
• Use only compatible diluents and the specified preparation method; dextrose-containing fluids must not be used.
• Prepared solution may range from colourless to pale yellow but must be checked for particles and unexpected discolouration.
• The formulation contains sodium hydrogen carbonate, sodium hydroxide and approximately 137 mg sodium per vial.

Solution for infusion

Route: Intravenous

Strengths: 1 g