Meropenem

FDA Drug Profile — Meropenem

Meropenem is listed in the FDA National Drug Code directory with 39 NDC codes, marketed under brand name including Meropenem. Available dosage forms: injection, injection, powder, for solution, powder.

Drug Details

Generic Name
Meropenem
Brand Names
Meropenem
Application Number
ANDA219084
Sponsor
BROOKS STERISCIENCE LIMITED
NDC Codes
39
Dosage Forms
INJECTION, INJECTION, POWDER, FOR SOLUTION, POWDER
Routes
INTRAVENOUS
Active Ingredients
MEROPENEM ANHYDROUS, MEROPENEM

Indications and Usage

1 INDICATIONS AND USAGE Meropenem for Injection is a penem antibacterial indicated for the treatment of bacterial meningitis in pediatric patients 3 months of age and older only. ( 1.1 ) 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. ( 1.2 ) 1.1 Bacterial Meningitis (Pediatric Patients 3 Months of Age and Older Only) Meropenem for Injection is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae , Neisseria meningitidis andpenicillin-susceptible isolates of Streptococcus pneumoniae, in pediatric patients 3 months of age and older. Meropenem for injection has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis. 1.2 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.