VABOMERE

Plasma Concentrations At the end of a 30-minute intravenous infusion of a single dose of Meropenem for Injection, USP in healthy volunteers, mean peak plasma concentrations of meropenem are approximately 23 mcg/mL (range 14 to 26) for the 500 mg dose and 49 mcg/mL (range 39 to 58) for the 1 gram dose. A 5-minute intravenous bolus injection of Meropenem for Injection, USP in healthy volunteers results in mean peak plasma concentrations of approximately 45 mcg/mL (range 18 to 65) for the 500 mg do...

14.1 Complicated Skin and Skin Structure Infections Adult patients with complicated skin and skin structure infections including complicated cellulitis, complex abscesses, perirectal abscesses, and skin infections requiring intravenous antimicrobials, hospitalization, and surgical intervention were enrolled in a randomized, multi-center, international, double-blind trial. The study evaluated meropenem at doses of 500 mg administered intravenously every 8 hours and imipenem-cilastatin at doses of 500 mg administered intravenously every 8 hours. The study compared the clinical response between t...

The following are discussed in greater detail in other sections of labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2) ] Seizure Potential [see Warnings and Precautions (5.3) ] Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid [see Warnings and Precautions (5.4) ] Clostridium difficile – associated Diarrhea [see Warnings and Precautions (5.5) ] Development of Drug-Resistant Bacte...

Meropenem for Injection, USP 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 (β)-lactams. Known hypersensitivity to product components or anaphylactic reactions to β-lactams. ( 4 )

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactams. ( 5.1 ) Severe cutaneous adverse reactions have been reported in patients receiving Meropenem for Injection, USP. ( 5.2 ) Seizures and other adverse CNS experiences have been reported during treatment. ( 5.3 ) Co-administration of Meropenem for Injection, USP with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the...

7 DRUG INTERACTIONS Co-administration of Meropenem for Injection, USP with probenecid inhibits renal excretion of meropenem and is therefore not recommended. ( 7.1 ) The concomitant use of Meropenem for Injection, USP and valproic acid or divalproex sodium is generally not recommended. Antibacterial drugs other than carbapenems should be considered to treat infections in patients whose seizures ar...