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. (1.4)
Acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecologic infections. (1.5)
Ertapenem for Injection is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery. (1.6)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ertapenem for Injection and other antibacterial drugs, Ertapenem for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.7)
1.1 Complicated Intra-Abdominal Infections
Ertapenem for Injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with complicated intra-abdominal infections due to Escherichia coli, Clostridium clostridioforme, Eubacterium lentum, Peptostreptococcus species, Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, or Bacteroides uniformis.
1.2 Complicated Skin and Skin Structure Infections, Including Diabetic Foot Infections without Osteomyelitis
Ertapenem for Injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis due to Staphylococcus aureus (methicillin susceptible isolates only), Streptococcus agalactiae, Streptococcus pyogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Bacteroides fragilis, Peptostreptococcus species, Porphyromonas asaccharolytica, or Prevotella bivia. Ertapenem for Injection has not been studied in diabetic foot infections with concomitant osteomyelitis
[see Clinical Studies (14)].
1.3 Community Acquired Pneumonia
Ertapenem for Injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with community acquired pneumonia due to Streptococcus pneumoniae (penicillin susceptible isolates only) including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative isolates only), or Moraxella catarrhalis.
1.4 Complicated Urinary Tract Infections Including Pyelonephritis
Ertapenem for Injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with complicated urinary tract infections including pyelonephritis due to Escherichia coli, including cases with concurrent bacteremia, or Klebsiella pneumoniae.
1.5 Acute Pelvic Infections Including Postpartum Endomyometritis, Septic Abortion and Post-Surgical Gynecologic Infections
Ertapenem for Injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecological infections due to Streptococcus agalactiae, Escherichia coli, Bacteroides fragilis, Porphyromonas asaccharolytica, Peptostreptococcus species, or Prevotella bivia.
1.6 Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery
Ertapenem for Injection is indicated in adults for the prevention of surgical site infection following elective colorectal surgery.
1.7 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ertapenem for Injection and other antibacterial drugs, Ertapenem for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.