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References

Merrem I.V. (meropenem for injection) Prescribing Information.
Fabian TC, File TM, Embil JM, et al. Meropenem versus imipenem-cilastatin for the treatment of hospitalized patients with complicated skin and skin structure infections: results of a multicenter, randomized, double-blind comparative study. Surg Infect (Larchmt). 2005;6(3):269-282.
Mutnick AH, Rhomberg PR, Sader HS, Jones RN. Antimicrobial usage and resistance trend relationships from the MYSTIC Programme in North America (1999-2001). J Antimicrob Chemother. 2004;53(2):290-296.
Rhomberg PR, Jones RN, Sader HS, Fritsche TR; 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(4):273-281.
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(2):207-215.
Hoban DJ, Biedenbach DJ, Mutnick AH, Jones RN. 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(4):279-285.
Data on file, DA-MER-06, AstraZeneca Pharmaceuticals LP.
Ednie LM, Jacobs MR, Appelbaum PC. Anti-anaerobic activity of AZD2563, a new oxazolidinone, compared with eight other agents. J Antimicrob Chemother. 2002;50(1):101-105.
Snydman DR, Jacobus NV, McDermott LA, et al. National survey on the susceptibility of Bacteroides fragilis group: report and analysis of trends in the United States from 1997-2004. Antimicrob Agents Chermother. 2007;51(5):1649-1655.
Bax RP, Bastain W, Featherstone A, Wilkinson DM, Hutchison M, Haworth SJ. The pharmacokinetics of meropenem in volunteers. J Antimicrob Chemother. 1989;24(suppl A):311-320.
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Indications and Important Safety Information

Indications

Merrem I.V. is indicated as single-agent therapy for the treatment of:

Complicated appendicitis and peritonitis caused by susceptible isolates of viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species.
Complicated skin and skin structure infections caused by susceptible isolates of Staphylococcus aureus (beta-lactamase and non-beta-lactamase-producing, methicillin-susceptible isolates only), Streptococcus pyogenes, S. agalactiae, viridans group streptococci, Enterococcus faecalis (excluding vancomycin-resistant isolates), P. aeruginosa, E. coli, Proteus mirabilis, B. fragilis, and Peptostreptococcus species.
Pediatric (≥3 months of age) bacterial meningitis caused by susceptible isolates of S. pneumoniae*, Haemophilus influenzae (beta-lactamase and non-beta-lactamase-producing isolates), and Neisseria meningitidis.

* The efficacy of meropenem as monotherapy in the treatment of meningitis caused by penicillin nonsusceptible isolates of S. pneumoniae has not been established.

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.

Important Safety Information

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.
Co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium may reduce serum valproic acid concentrations to below the therapeutic range, increasing the risk of breakthrough seizures. Increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction. Antibacterials other than carbapenems should be considered in patients whose seizures are well controlled on valproic acid or divalproex sodium. If administration of Merrem I.V. is necessary, supplemental anticonvulsant therapy should be considered.
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.

Please click here for full Prescribing Information(PDF - 1.3MB).

This product information is intended for US health care professionals only.

Merrem I.V. is a registered trademark of the AstraZeneca group of companies.