Overview
11 DESCRIPTION Ertapenem for injection is a sterile, synthetic, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics. Chemically, ertapenem sodium is described as [4 R -[3(3 S *,5 S *),4α,5β,6β( R *)]]-3-[[5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monosodium salt.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Ertapenem sodium is a carbapenem antibiotic [see Clinical Pharmacology ( 12.4 )]. 12.3 Pharmacokinetics Average plasma concentrations (mcg/mL) of ertapenem following a single 30-minute infusion of a 1 gram intravenous (IV) dose and administration of a single 1 gram intramuscular (IM) dose in healthy young adults are presented in Table 8 . Table 8 Plasma Concentrations of Ertapenem in Adults After Single Dose Administration *Infused at a constant rate over 30 minutes Average Plasma Concentrations (mcg/mL) Dose/Route 0.
Indications
- 1 INDICATIONS AND USAGE Ertapenem for injection is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria: Complicated intra-abdominal infections. ( 1.1 ) Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis. ( 1.2 ) Community-acquired pneumonia. ( 1.3 ) Complicated urinary tract infections including pyelonephritis. ( 1.
Common Doses
- 15 mg
- 90 mL
- 30 mL
- 10 mL
Dosage
2 DOSAGE AND ADMINISTRATION Do not mix or co-infuse ertapenem for injection with other medications. Do not use diluents containing dextrose ( α –D–glucose) . ( 2.1 ) Ertapenem for injection should be infused over 30 minutes in both the Treatment and Prophylactic regimens. ( 2.1 ) Dosing considerations should be made in adults with advanced or end-stage renal impairment and those on hemodialysis. ( 2.4 , 2.5 ) Treatment regimen: Adults and pediatric patients 13 years of age and older. The dosage should be 1 gram once a day intravenously or intramuscularly. ( 2.
Contraindications
- 4 CONTRAINDICATIONS Ertapenem for injection is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams. Due to the use of lidocaine HCl as a diluent, ertapenem for injection administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type. Known hypersensitivity to product components or anaphylactic reactions to β-lactams.
Side Effects
- 6 ADVERSE REACTIONS The following are described in greater detail in the Warnings and Precautions section. Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Seizure Potential [see Warnings and Precautions ( 5.2 )] Interaction with Valproic Acid [see Warnings and Precautions ( 5.3 )] Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.4 )] Caution with Intramuscular Administration [see Warnings and Precautions ( 5.5 )] Development of Drug-Resistant Bacteria [see Warnings and Precautions ( 5.
Interactions
- 7 DRUG INTERACTIONS Co-administration with probenecid inhibits the renal excretion of ertapenem and is therefore not recommended. ( 7.1 ) The concomitant use of ertapenem and valproic acid/divalproex sodium is generally not recommended. Anti-bacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. ( 5.2 , 7.2 ) 7.1 Probenecid Probenecid interferes with the active tubular secretion of ertapenem, resulting in increased plasma concentrations of ertapenem [see Clinical Pharmacology ( 12.3 )] .