Ertapenem

It 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 It is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery

Beta-lactam Antibiotics

Ertapenem for Injection is a sterile, synthetic, long-acting, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics, such as penicillins and cephalosporins, with activity against a wide range of Gram-positive and Gram-negative aerobic and anaerobic bacteria. Ertapenem exhibits a bactericidal mode of action. It works by binding to and inhibiting bacterial penicillin-binding proteins (PBPs). In Escherichia coli, it has a strong affinity toward PBPs 1a, 1b, 2, 3, 4 and 5 with preferential binding to PBPs 2 and 3. Upon binding to PBPs, ertapenem inhibits bacterial cell wall synthesis by interfering with the lengthening and strengthening of the peptidoglycan portion of the cell wall, thereby inhibiting cell wall synthesis.

It should be infused over 30 minutes in both the Treatment and Prophylactic regimens. Dosing considerations should be made in adults with advanced or endstage 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. ? 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. (2.1) Prophylaxis regimen for adults: ? 1 gram single dose given 1 hour prior to elective colorectal surgery.

When Ertapenem is administered with probenecid, probenecid competes for active tubular secretion and thus inhibits the renal excretion of Ertapenem. This leads to small but statistically significant increases in the elimination half-life (19%) and in the extent of systemic exposure (25%). No dosage adjustment is necessary when Ertapenem is given with probenecid. Because of the small effect on half-life, the co-administration with probenecid to extend the half-life of Ertapenem is not recommended. Other than with probenecid, no specific clinical drug interaction studies have been conducted. Decreased serum levels of valproic acid with co-administration of Ertapenem have been reported. Careful monitoring of serum levels of valproic acid should be considered if Ertapenem is to be co-administered with valproic acid.

? Known hypersensitivity to product components or anaphylactic reactions to ?-lactams

Diarrhea, nausea, headache and infused vein complication.

Pregnancy Category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester

No specific information is available on the treatment of overdosage with Ertapenem. Intravenous administration of Ertapenem at a 3 g daily dose for 8 days to healthy adult volunteers did not result in significant toxicity. In pediatric clinical studies, a single IV dose of 40 mg/kg up to a maximum of 2 g did not result in toxicity. In the event of an overdose, Ertapenem should be discontinued and general supportive treatment given until renal elimination takes place. Ertapenem can be removed by haemodialysis; however, no information is available on the use of haemodialysis to treat overdosage.

For injection: Store at 2-8°C. Keep away from light and out of the reach of children. For auxiliaries pack: Do not store above 30°C. Keep away from light and out of the reach of children.