Ertapenem

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. Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis. Community-acquired pneumonia. Complicated urinary tract infections including pyelonephritis. Acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecologic infections. Ertapenem for injection is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.

Ertapenem sodium is a carbapenem antibiotic.

Do not mix or co-infuse Ertapenem for injection with other medications. Do not use diluents containing dextrose (α–D–glucose). Ertapenem for injection should be infused over 30 minutes in both the Treatment and Prophylactic regimens. Dosing considerations should be made in adults with advanced or end-stage renal impairment and those on hemodialysis. Treatment regimen: Adults and pediatric patients 13 years of age and older. The dosage should be 1 gram once a day intravenously or intramuscularly. Patients 3 months to 12 years of age should be administered 15 mg/kg twice daily (not to exceed 1 g/day intravenously or intramuscularly). Intravenous infusion may be administered in adults and pediatrics for up to 14 days or intramuscular injection for up to 7 days. Prophylaxis regimen for adults: 1 gram single dose given 1 hour prior to elective colorectal surgery.

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.

Serious hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactams. Seizures and other central nervous system adverse experiences have been reported during treatment. Co-administration of ertapenem for injection with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the risk of breakthrough seizures. Clostridioides difficile -associated diarrhea (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs. Caution should be taken when administering ertapenem for injection intramuscularly to avoid inadvertent injection into a blood vessel.

The following are described in greater detail in the Warnings and Precautions section. Hypersensitivity Reactions Seizure Potential Interaction with Valproic Acid Clostridioides difficile -Associated Diarrhea (CDAD) Caution with Intramuscular Administration Development of Drug-Resistant Bacteria Laboratory Tests Adults: The most common adverse reactions (≥5%) in patients treated with ertapenem for injection, including those who were switched to therapy with an oral antimicrobial, were diarrhea, nausea, headache and infused vein complication. In the prophylaxis indication the overall adverse experience profile was generally comparable to that observed for ertapenem in other clinical trials. Pediatrics: Adverse reactions in this population were comparable to adults.

Co-administration with probenecid inhibits the renal excretion of ertapenem and is therefore not recommended. 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.

Before reconstitution Do not store lyophilized powder above 25°C (77°F). Reconstituted and infusion solutions The reconstituted solution, immediately diluted in 0.9% Sodium Chloride Injection, may be stored at room temperature (25°C) and used within 6 hours or stored for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration.