1 INDICATIONS AND USAGE
Meropenem for Injection and Sodium Chloride Injection is a penem antibacterial indicated for the treatment of:
Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.1)
Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). (1.2)
Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only). (1.3)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection USP and Sodium Chloride Injection USP and other antibacterial drugs, Meropenem for Injection USP and Sodium Chloride Injection USP should only be used to treat or preventinfections that are proven or strongly suspected to be caused by bacteria.
1.1 Complicated Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of ageand older requiring the full adult dose only)
Meropenem for Injection and Sodium Chloride Injection is indicated for the treatment of complicated skin and skin structure infections (cSSSI) due to Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species.
1.2 Complicated Intra-abdominal Infections (Adult Patients and Pediatric Patients 3 Months of age and older requiring the full adult dose only)
Meropenem for Injection and Sodium Chloride Injection is indicated for the treatment of complicated appendicitis and peritonitis caused by viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species.
1.3 Bacterial Meningitis (Pediatric Patients 3 Months of age and older requiring the full adult dose only)
Meropenem for Injection and Sodium Chloride Injection is indicated for the treatment of bacterial meningitis caused by
Haemophilus influenzae, Neisseria meningitidis
and penicillin-susceptible isolates of
Streptococcus pneumoniae.
Meropenem has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.
For information regarding use in pediatric patients (3 months of age and older) [see Indications and Usage (1.1), (1.2) or (1.3); Dosage and Administration (2.3), and Adverse Reactions (6.1)].
1.4 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and Sodium Chloride Injection and other antibacterial drugs, Meropenem for Injection and Sodium Chloride Injection should only be used to treat or preventinfections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.