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Pediatric Bacterial Meningitis (Patients ≥3 Months of Age)Merrem I.V. is on the side of the patient…when facing pediatric bacterial meningitis (patients ≥3 months of age)*¹

Merrem I.V. is active against pediatric bacterial meningitis

†Sequelae were the most common reason patients were assessed as “not clinically cured.”

*Merrem I.V. is indicated as single-agent therapy for the treatment of pediatric (≥3 months of age) bacterial meningitis, when caused by susceptible isolates of the indicated pathogens (for list of indicated pathogens, see below).

Patients with bacterial meningitis, predominantly (397) pediatric patients (≥3 months of age to <17 years of age), were enrolled in 4 separate trials in which 225 patients were randomized to meropenem, 187 to cefotaxime, and 34 to ceftriaxone in the approved dosing regimens. Of the 446 total patients enrolled, 271 were found to be clinically evaluable.¹

Clinical efficacy rate by organism

The following efficacy rates were obtained, per organism. The values represent the number of patients clinically cured/number of clinically evaluable patients, with the percent cure rate in parentheses.¹

Microorganisms	Merrem I.V.	Comparator
Streptococcus pneumoniae	17/24 (71%)	19/30 (63%)
Haemophilus influenzae (+)^‡	8/10 (80%)	6/6 (100%)
Haemophilus influenzae (-/NT)^§	44/59 (75%)	44/60 (73%)
Neisseria meningitidis	30/35 (86%)	35/39 (90%)

^‡(+) ß-lactamase-producing.
^§(-/NT) non-ß-lactamase-producing or not tested.

Low incidence of seizures

In these meningitis studies, rates of seizure activity during therapy were comparable between patients with no CNS abnormalities who received meropenem and those who received comparator agents. 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

Well tolerated at highest recommended dose

Safety profile proven from 500 mg q8h to 2 g q8h¹

Safety profile similar to the cephalosporins, cefotaxime and ceftriaxone

In clinical trials evaluating pediatric patients with bacterial meningitis, adverse events were comparable between meropenem- and cephalosporin-treated groups in both type and frequency¹
The meropenem group did have a statistically higher number of patients with transient elevation of liver enzymes¹

Merrem I.V. is the only carbapenem approved for pediatric bacterial meningitis

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.

Pediatric Bacterial Meningitis (Patients ≥3 Months of Age)Merrem I.V. is on the side of the patient…when facing pediatric bacterial meningitis (patients ≥3 months of age)*1