INVANZ

LOE Approaching

ertapenem sodium

NDAINTRAMUSCULAR, INTRAVENOUSINJECTABLE

Approved

Nov 2001

Lifecycle

LOE Approaching

Competitive Pressure

30/100

Clinical Trials

5

Mechanism of Action

12.1 Mechanism of Action Ertapenem sodium is a carbapenem antibiotic [see ]. 12.3 Pharmacokinetics Average plasma concentrations (mcg/mL) of ertapenem following a single 30-minute infusion of a 1 g intravenous (IV) dose and administration of a single 1 g intramuscular (IM) dose in healthy young…

Indications (27)

older) with complicated intra-abdominal infections due to Escherichia coli Clostridium clostridioforme Eubacterium lentum Peptostreptococcus species Bacteroides fragilis Bacteroides distasonis Bacteroides ovatus Bacteroides thetaiotaomicron Bacteroides uniformis older) with complicated skin 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 Porphyromonas asaccharolytica Prevotella bivia 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)Moraxella catarrhalis older) with complicated urinary tract infections including pyelonephritis due to Escherichia coli including cases with concurrent bacteremia older) with acute pelvic infections including postpartum endomyometritis septic abortion post-surgical gynecological infections due to Streptococcus agalactiae

Clinical Trials (5)

NCT01370616Phase 3Completed

Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)

Started Sep 2011

565 enrolled

Infection; Diabetic Foot

NCT01254344Phase 3Completed

Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)

Started Dec 2010

599 enrolled

InfectionSurgical Site Infection

NCT01014013Phase 3Completed

Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)

Started Apr 2008

271 enrolled

Urinary Tract Infection

NCT00379951Phase 3Completed

A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-048)

Started Jun 2005

107 enrolled

Urinary Tract Infection

NCT00389987Phase 3Completed

Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)

Started Sep 2001

300 enrolled

Complicated Intra-Abdominal Infections

Company

External Resources

Full prescribing information

FDA approval history

Drug nomenclature & identifiers