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Safety Profile

Consider the well-established safety profile of Merrem I.V.

Low incidence of seizures in adults¹

seizure rate in clinical trials
Number of adult patients	Patients experiencing seizures
2904	20 (0.7%)

During clinical investigations, 2904 immunocompetent adult patients were treated with meropenem for non-CNS infections, with the overall seizure rate being 0.7%¹
All meropenem-treated patients with seizures had preexisting contributing factors, including a history of seizures or CNS abnormality and concomitant medications with seizure potential¹
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.

Low incidence of seizures in pediatric patients (≥3 months of age) with bacterial meningitis

In clinical trials of 397 pediatric patients (≥3 months of age to <17 years of age) with bacterial meningitis, rates of seizure activity during therapy were comparable between patients with no CNS abnormalities who received Merrem I.V. and those who received comparator agents (cefotaxime or ceftriaxone) at approved dosing regimens. In the group treated with Merrem I.V., 12 of 15 patients with seizures had late-onset seizures (defined as occurring on day 3 or later) versus 7 of 20 in the comparator arm.¹

See below for additional important safety information about Merrem I.V.

Indications for MERREM I.V.

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 Risk Information for MERREM I.V.

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).

Important Pages:
Dosing with MERREM I.V.
Complicated Skin and Skin Structure Infections

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

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