ERTAPENEM

ERTAPENEM- ertapenem sodium injection, powder, lyophilized, for solution
Par Pharmaceutical Inc.

1 INDICATIONS AND USAGE

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.

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.

Table 1 Treatment Guidelines for Adults and Pediatric Patients With Normal Renal Function * and Body Weight

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
* defined as creatinine clearance >90 mL/min/1.73 m2 † due to the designated pathogens [see Indications and Usage (1)] ‡ not to exceed 1 g/day § Ertapenem for injection has not been studied in diabetic foot infections with concomitant osteomyelitis [see Clinical Studies (14.1)]. ¶ adult patients with diabetic foot infections received up to 28 days of treatment (parenteral or parenteral plus oral switch therapy) # duration includes a possible switch to an appropriate oral therapy, after at least 3 days of parenteral therapy, once clinical improvement has been demonstrated.
Complicated intra-abdominal infections	1 g	15 mg/kgtwice daily ‡	5 to 14 days
Complicated skin and skin structure infections, including diabetic foot infections §	1 g	15 mg/kgtwice daily ‡	7 to 14 days ¶
Community acquired pneumonia	1 g	15 mg/kgtwice daily ‡	10 to 14 days #
Complicated urinary tract infections, including pyelonephritis	1 g	15 mg/kgtwice daily ‡	10 to 14 days #
Acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecologic infections	1 g	15 mg/kgtwice daily ‡	3 to 10 days

2.3 Prophylactic Regimen in Adults

Table 2 presents prophylaxis guidelines for ertapenem for injection.

Table 2 Prophylaxis Guidelines for Adults

Indication	Daily Dose(IV)Adults	Recommended Duration of Total Antimicrobial Treatment
Prophylaxis of surgical site infection following elective colorectal surgery	1 g	Single intravenous dose given 1 hour prior to surgical incision