Complicated Appendicitis and Peritonitis

Merrem I.V. is on the side of the patient…when facing complicated appendicitis and peritonitis caused by susceptible isolates of the indicated pathogens.

Proven carbapenem efficacy against complicated appendicitis and peritonitis¹

Presumptive microbiologic eradication and clinical cure rates^† following ≥7 days of treatment of complicated appendicitis and peritonitis¹
Treatment	Number evaluable/ number enrolled (%)	Microbiologic eradication rate (%)	Clinical cure rate (%)	Outcome
Merrem I.V.	146/516 (28)	98/146 (67)	101/146 (69)
Imipenem	65/220 (30)	40/65 (62)	42/65 (65)	Merrem I.V. equivalent to control
Cefotaxime/ metronidazole	26/85 (30)	22/26 (85)	22/26 (85)	Merrem I.V. not equivalent to control^‡
Clindamycin/ tobramycin	50/212 (24)	38/50 (76)	38/50 (76)	Merrem I.V. equivalent to control

—Adapted from Merrem I.V. full Prescribing Information.¹

^†Using strict evaluability criteria and microbiologic eradication and clinical cures at follow-up, which occurred ≥7 days after completion of therapy.
^‡The finding that Merrem I.V. was not statistically equivalent to cefotaxime/metronidazole may have been due to uneven assignment of more seriously ill patients to Merrem I.V. Currently, there is no additional information to further interpret this observation.

Merrem I.V. is indicated as single-agent therapy for the treatment of complicated appendicitis and peritonitis, when caused by susceptible isolates of the indicated pathogens (for list of indicated pathogens, see below).

The clinical trial program evaluating Merrem I.V. in complicated appendicitis and peritonitis included

Merrem I.V. being compared with clindamycin/tobramycin in a controlled study performed in the US
Merrem I.V. being compared with imipenem in 2 controlled studies performed in Europe
Merrem I.V. being compared with cefotaxime/metronidazole in a controlled study performed in Europe

Active against complicated appendicitis and peritonitis¹

Demonstrated activity against

Viridans group streptococci
Escherichia coli
Klebsiella pneumoniae
Pseudomonas aeruginosa
Bacteroides fragilis
Bacteroides thetaiotaomicron
Peptostreptococcus species

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 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).

Important Pages:
Important Safety Information
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.