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Complicated Skin and Skin Structure Infection (CSSSI)Merrem I.V. is on the side of the patient…when facing complicated skin and skin structure infection (cSSSI)*

Active against cSSSIs¹
Treatment Group	Clinical success rate (%)
Merrem I.V. 500 mg q8h (n=261)	86
Imipenem/cilastatin 500 mg q8h (n=287)	83

Active against cSSSIs in patients with diabetes1
Treatment Group	Clinical success rate (%)
Merrem I.V. 500 mg q8h (n=97)	86
Imipenem/cilastatin 500 mg q8h (n=105)	72

n = number of patients

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

Study design and patient characteristics

Adult patients with complicated skin and skin structure infections (cSSSIs) were enrolled in a randomized, multicenter, international, double-blind trial. The study evaluated meropenem at doses of 500 mg every 8 hours and imipenem/cilastatin at doses of 500 mg every 8 hours and compared the clinical response between treatment groups in the clinically evaluable population at the follow-up (test-of-cure) visit.

At enrollment, approximately 37% of the patients had underlying diabetes, 12% had underlying peripheral vascular disease, and 67% had a surgical intervention.¹

cSSSIs of patients in this study included²

Complex abscess
Surgical site or traumatic wound infection
Complicated cellulitis, which included the following types of cellulitis
- In patients with diabetes
- Of the perineum
- With deep tissue involvement
Infected ischemic or diabetic ulcer
Perirectal abscess

Clinical success rate by organism: cSSSIs^{1 †}
	Merrem I.V. 500 mg q8h (n/N)^‡	Imipenem/cilastatin 500 mg q8h (n/N)^‡
Gram-positive aerobes
Staphylococcus aureus (methicillin-susceptible)	93% (82/88)	84% (84/100)
Streptococcus pyogenes (Group A)	90% (26/29)	88% (28/32)
Streptococcus agalactiae (Group B)	71% (12/17)	84% (16/19)
Enterococcus faecalis	75% (9/12)	70% (14/20)
Viridans group streptococci	92% (11/12)	83% (5/6)
Gram-negative aerobes and facultative anaerobes
Escherichia coli	80% (12/15)	71% (15/21)
Pseudomonas aeruginosa	73% (11/15)	87% (13/15)
Proteus mirabilis	85% (11/13)	86% (6/7)
Anaerobes
Bacteroides fragilis	91% (10/11)	90% (9/10)
Peptostreptococcus species	77% (10/13)	88% (14/16)

^†Patients may have more than 1 pretreatment pathogen.
^‡n=number of patients with satisfactory response; N=number of patients in the clinically evaluable population or subgroup within treatment groups.

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.