Application Nr Approved Date Route Status External Links
NDA202106 2015-04-30 Intravenous RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Meropenem For Injection Usp And Sodium Chloride Injection Usp 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. Meropenem For Injection Usp And Sodium Chloride Injection Usp Is A Penem Antibacterial Indicated As Single Agent Therapy 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 Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. 1.1 Skin And Skin Structure Infections (adult Patients And Pediatric Patients 3 Months Of Age And Older Requiring The Full Adult Dose Only) Meropenem For Injection Usp And Sodium Chloride Injection Usp 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 Patients And Pediatric Patients 3 Months Of Age And Older Requiring The Full Adult Dose Only) Meropenem For Injection Usp And Sodium Chloride Injection Usp 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 Requiring The Full Adult Dose Only) Meropenem For Injection Usp And Sodium Chloride Injection Usp Is Indicated As A Single Agent Therapy For The Treatment Of Bacterial Meningitis Caused By Streptococcus Pneumoniaethe Efficacy Of Meropenem As Monotherapy In The Treatment Of Meningitis Caused By Penicillin Nonsusceptible Isolates Of Streptococcus Pneumoniae Has Not Been Established., Haemophilus Influenzae, And Neisseria Meningitidis. 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 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 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.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Meropenem MEROPENEM ZINC3808779
2. Sodium Chloride

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