References

  1. MERREM® I.V. (meropenem for injection) Prescribing Information.
  2. Bax RP, Bastain W, Featherstone A, et al. The pharmacokinetics of meropenem in volunteers. J Antimicrob Chemother. 1989;24:311-320.
  3. Pfaller MA, Jones RN. A review of the in vitro activity of meropenem and comparative antimicrobial agents tested against 30,254 aerobic and anaerobic pathogens isolated world wide. Diagn Microbiol Infect Dis. 1997;28:157-163.
  4. Mutnick AH, Rhomberg PR, Sader HS, et al. Antimicrobial usage and resistance trend relationships from the MYSTIC Programme in North America (1999-2001). J Antimicrob Chemother. 2004;53:290-296.
  5. Rhomberg PR, Jones RN, Sader HS, et al. The MYSTIC Programme Study Group. Antimicrobial resistance rates and clonality results from the meropenem yearly susceptibility test information collection (MYSTIC) programme: report of year five (2003). Diagn Microbiol Infect Dis. 2004;49:273-281.
  6. Rhomberg PR, Jones RN. Contemporary activity of meropenem and comparator broad-spectrum agents: MYSTIC program report from the United States component (2005). Diagn Microbiol Infect Dis. 2007;57:207-215.
  7. Hoban DJ, Biedenbach DJ, Mutnick AH, et al. Pathogen of occurrence and susceptibility patterns associated with pneumonia in hospitalized patients in North America: results of the SENTRY Antimicrobial Surveillance Study (2000). Diagn Microbiol Infect Dis. 2003;45:279 285.
  8. Data on file, DA-MER-06.
  9. Ednie LM, Jacobs MR, Appelbaum PC. Anti-anaerobic activity of AZD2563, a new oxazolidinone, compared with eight other agents. J Antimicrob Chemother. 2002;50:101-105.
  10. Snydman DR, Jacobus NV, McDermott LA, et al. National survey on the susceptibility of Bacteroides fragilis Group: report and analysis of trends for 1997-2000. Clin Infect Dis. 2002;35(suppl I):S126-S134.

Indications and Important Safety Information

MERREM I.V. is indicated as single-agent therapy for the treatment of complicated appendicitis and peritonitis, complicated skin and skin structure infections, and pediatric (≥3 months of age) bacterial meningitis, when caused by susceptible isolates of the indicated pathogens.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of MERREM I.V. and other antibacterial drugs, MERREM I.V. should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

MERREM I.V. is contraindicated in patients with known hypersensitivity to any component of the product, or to other drugs in the same class, or in patients who have demonstrated anaphylactic reactions to beta-lactams.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens.

There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another beta-lactam.

Seizures and other CNS adverse experiences have been reported during treatment with MERREM I.V.

Carbapenems, including meropenem, may reduce serum valproic acid concentrations to subtherapeutic levels, resulting in loss of seizure control. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including MERREM I.V., and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use.

The most common adverse events reported across clinical trials with MERREM I.V. were diarrhea, nausea/vomiting, headache, constipation, anemia, and pain. These events occurred in 3% to 8% of patients.

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