Ertapenem

Ertapenem may be administered by intravenous infusion for up to 14 days or intramuscular injection for up to 7 days. When administered intravenously, this drug should be infused over a period of 30 minutes. Intramuscular administration of ertapenem 1gm may be used as an alternative to intravenous administration to treat those infections for which intramuscular therapy is appropriate.
Moderate to severe infections caused by susceptible bacteria:

• The recommended dose for adults and pediatric patients aged 13 years and older is 1 gram should be administered once daily intravenously or intramuscularly.
• The recommended dose for patients aged 3 months to 12 years is 15 mg/kg should be administered twice daily (not to exceed 1 g/day intravenously or intramuscularly.)

Prophylaxis regimen for adults: The recommended dose is 1 gram single dose administered 1 hour prior to elective colorectal surgery.

Note: Do not mix or co-infuse ertapenem 1gm injection with other medicines. Do not use diluents containing dextrose (–D–glucose).

The most commonly reported side effects due to Ertapenem include:

• Adult Patients: infused vein complication, diarrhea, nausea, and headache.
• Pediatric Patients: Diarrhea, vomiting and infusion site pain.

• Serious and fatal (occasionally) hypersensitivity reactions have been observed in patients with beta-lactams therapy. These reactions are more likely to appear in individuals with a history of sensitivity to multiple allergens.
• Prior to initiating therapy with ertapenem inj 1gm, careful inquiry needs to be made concerning previous hypersensitivity reactions to cephalosporins, penicillins, other beta-lactams and other allergens.
• Seizures and other CNS (Central Nervous System) adverse experiences have occurred while on therapy with Ertapenem.
• Caution should be considered when administering ertapenem antibiotics intramuscularly in order to avoid inadvertent injection into a blood vessel.
• CDAD has occurred with the use of almost all antibacterial agents, including ertapenem, and may range in severity from mild diarrhea to fatal colitis. Treatment through antibacterial agents alters the normal flora of the colon leading to excess growth of Clostridium difficile.
• As with other existing antibiotics, prolonged use of ertapenem 1gm may result in overgrowth of non-susceptible organisms. Repeated assessment of the patient’s condition is crucial. In case superinfection occurs while on therapy, apt measures need to be taken.
• Prescribing ertapenem therapy in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to offer benefit to the patient and increases the danger of the development of drug-resistant bacteria.
• While ertapenem 1g possesses toxicity identical to the beta-lactam group of antibiotics, periodic evaluation of organ system function, including hepatic, renal, and hematopoietic, is advisable while on prolonged therapy.

Do not store the lyophilized powder above 25°C (77°F). The reconstituted solution, promptly diluted in 0.9% Sodium Chloride Injection, may be stored at 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. Solutions of ertapenem 1gm injection should not be frozen.