Ertapenem
ERTAPENEM- ertapenem sodium injection
BluePoint Laboratories
1 INDICATIONS AND 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.
Treatment
Ertapenem for injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with the following moderate to severe infections caused by susceptible isolates of the designated microorganisms [see Dosage and Administration (2)].
1.1 Complicated Intra-Abdominal Infections
Ertapenem for injection is indicated for the treatment of 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 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 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 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 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.
Prevention
Ertapenem for injection is indicated in adults for:
1.6 Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery
Ertapenem for injection is indicated for the prevention of surgical site infection following elective colorectal surgery.
2 DOSAGE AND ADMINISTRATION
2.1 Instructions for Use in All Patients
For Intravenous or Intramuscular Use
DO NOT MIX OR CO-INFUSE ERTAPENEM FOR INJECTION WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE ( α-D-GLUCOSE).
Ertapenem for injection may be administered by intravenous infusion for up to 14 days or intramuscular injection for up to 7 days. When administered intravenously, Ertapenem for injection should be infused over a period of 30 minutes. Intramuscular administration of Ertapenem for injection may be used as an alternative to intravenous administration in the treatment of those infections for which intramuscular therapy is appropriate.
2.2 Treatment Regimen
13 years of age and older
The dose of Ertapenem for injection in patients 13 years of age and older is 1 gram (g) given once a day [see Clinical Pharmacology (12.3)].
3 months to 12 years of age
The dose of Ertapenem for injection in patients 3 months to 12 years of age is 15 mg/kg twice daily (not to exceed 1 g/day).
Table 1 presents treatment guidelines for Ertapenem for injection.
Infection † | Daily Dose (IV or IM) Adults and Pediatric Patients 13 years of age and older | Daily Dose (IV or IM) Pediatric Patients 3 months to 12 years of age | Recommended Duration of Total Antimicrobial Treatment |
---|---|---|---|
| |||
Complicated intra-abdominal infections | 1 g | 15 mg/kg twice daily ‡ | 5 to 14 days |
Complicated skin and skin structure infections, including diabetic foot infections § | 1 g | 15 mg/kg twice daily ‡ | 7 to 14 days ¶ |
Community acquired pneumonia | 1 g | 15 mg/kg twice daily ‡ | 10 to 14 days # |
Complicated urinary tract infections, including pyelonephritis | 1 g | 15 mg/kg twice daily ‡ | 10 to 14 days # |
Acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections | 1 g | 15 mg/kg twice daily ‡ | 3 to 10 days |
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