INVANZ (ertapenem sodium)

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 adults are presented in Table 8 .

Table 8Plasma Concentrations of Ertapenem in Adults After Single Dose Administration Average Plasma Concentrations (mcg/mL) Dose/Route 0.5 hr 1 hr 2 hr 4 hr 6 hr 8 hr 12 hr 18 hr 24 hr 1 g IV Infused at a constant rate over 30 minutes 155 115 83 48 31 20 9 3 1 1 g IM ...

14.1 Adults Complicated Intra-Abdominal Infections Ertapenem was evaluated in adults for the treatment of complicated intra-abdominal infections in a randomized, double-blind, non-inferiority clinical trial. This trial compared ertapenem (1 g intravenously once a day) with piperacillin/tazobactam (3.375 g intravenously every 6 hours) for 5 to 14 days and enrolled 665 patients with localized complicated appendicitis, and any other complicated intra-abdominal infection including colonic, small intestinal, and biliary infections and generalized peritonitis. The combined clinical and microbiologic...

The following are described in greater detail in the Warnings and Precautions section. Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Seizure Potential [see Warnings and Precautions (5.2) ] Interaction with Valproic Acid [see Warnings and Precautions (5.3) ] Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions (5.4) ] Caution with Intramuscular Administration [see Warnings and Precautions (5.5) ] Development of Drug-Resistant Bacteria [see Warnings...

INVANZ is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams. Due to the use of lidocaine HCl as a diluent, INVANZ administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type. Known...

Serious hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactams. ( 5.1 ) Seizures and other central nervous system adverse experiences have been reported during treatment. ( 5.2 ) Co-administration of INVANZ with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the risk of breakthrough seizures. ( 5.3 ) Clostridioides difficile -associated diarrhea (ranging from mild diarrhea to fatal colitis): Evaluat...

7 DRUG INTERACTIONS Co-administration with probenecid inhibits the renal excretion of ertapenem and is therefore not recommended. ( 7.1 ) The concomitant use of ertapenem and valproic acid/divalproex sodium is generally not recommended. Anti-bacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodiu...