Treating Serious Bacterial Infections with Merrem I.V.

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. Outpatients should not operate machinery or motorized vehicles until it is reasonably well established that Merrem I.V. is well tolerated
• Co-administration of carbapenems, including MERREM I.V., to patients receiving valproic acid or divalproex sodium reduces serum valproic acid concentrations, which may drop below the therapeutic range and increase the risk of breakthrough seizures. Increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction. The concomitant use of MERREM I.V. and valproic acid or divalproex sodium is generally not recommended. 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
• In patients with renal impairment, thrombocytopenia has been observed but no clinical bleeding reported
• Co-administration of MERREM I.V. with probenecid is not recommended, since probenecid inhibits renal excretion of meropenem
• Dosage adjustment is needed in adult patients with renal impairment (creatinine clearance 50 mL/min or less). There is no experience in pediatric patients with renal impairment
• The most common adverse events reported across clinical trials with Merrem I.V. were diarrhea, nausea/vomiting, headache, constipation, anemia, pain, and rash. These events occurred in 3% to 8% of patients

Indications for MERREM I.V.

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

• Adult and pediatric patients (≥3 months of age) with 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
• Adult and pediatric patients (≥3 months of age) with 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 patients (≥3 months of age) with bacterial meningitis caused by susceptible isolates of S. pneumoniae*, Haemophilus influenzae (beta-lactamase- and non–beta-lactamase-producing isolates), and Neisseria meningitides

* 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 susceptible bacteria.

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.

©2012 AstraZeneca

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