MEROPENEM- meropenem injection, powder, for solution
Sagent Pharmaceuticals
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and other antibacterial drugs, Meropenem for Injection should only be used to treat or prevent infections 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.
Meropenem for Injection is useful as presumptive therapy in the indicated condition (e.g., intra-abdominal infections) prior to the identification of the causative organisms because of its broad spectrum of bactericidal activity.
For information regarding use in pediatric patients [see Indications and Usage (1.1) , (1.2) , (1.3) , Dosage and Administration (2.3) , Adverse Reactions (6.1) , and Clinical Pharmacology (12.3)].
1.1 Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of Age and Older Only)
Meropenem for Injection is indicated as a single agent therapy for the treatment of complicated skin and skin structure infections 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 Intra-abdominal Infections (Adult and Pediatric Patients)
Meropenem for Injection is indicated as a single agent therapy 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 Only)
Meropenem for Injection is indicated as a single agent therapy for the treatment of bacterial meningitis caused by Streptococcus pneumoniae� , Haemophilus influenzae , and Neisseria meningitidis.
� The efficacy of meropenem as monotherapy in the treatment of meningitis caused by penicillin nonsusceptible isolates of Streptococcus pneumoniae has not been established.
Meropenem for Injection has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.
2 DOSAGE AND ADMINISTRATION
2.1 Adult Patients
The recommended dose of meropenem for injection is 500 mg given every 8 hours for skin and skin structure infections and 1 gram given every 8 hours for intra-abdominal infections. When treating complicated skin and skin structure infections caused by P. aeruginosa , a dose of 1 gram every 8 hours is recommended.
Meropenem for injection should be administered by intravenous infusion over approximately 15 minutes to 30 minutes. Doses of 1 gram may also be administered as an intravenous bolus injection (5 mL to 20 mL) over approximately 3 minutes to 5 minutes.
