Overview
Meropenem is a broad-spectrum carbapenem antibiotic. It is active against Gram-positive and Gram-negative bacteria. Meropenem exerts its action by penetrating bacterial cells readily and interfering with the synthesis of vital cell wall components, which leads to cell death. In August 2017, a combination antibacterial therapy under the market name vabomere was approved for treatment of adult patients with complicated urinary tract infections (cUTI). Vabomere consists of meropenem and Vaborbactam and is intravenously admininstered. The treatment aims to resolve infection-related symptoms and achieve negative urine culture, where the infections are proven or strongly suspected to be caused by susceptible bacteria.
Indication
For use as single agent therapy for the treatment of the following infections when caused by susceptible isolates of the designated microorganisms: complicated skin and skin structure infections due to Staphylococcus aureus (b-lactamase and non-b-lactamase producing, methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (excluding vancomycin-resistant isolates), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis and Peptostreptococcus species; complicated appendicitis and peritonitis caused by viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species. Also for use in the treatment of bacterial meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (b-lactamase and non-b-lactamase-producing isolates), and Neisseria meningitidis.
Associated Conditions
- Bacterial Infections
- Complicated Intra-Abdominal Infections (cIAIs)
- Meningitis, Bacterial
- Complicated Urinary Tract Infection caused by susceptible bacteria
- Complicated skin infection bacterial
Research Report
A Comprehensive Monograph on Meropenem: Pharmacology, Clinical Efficacy, and Safety
Section 1: Introduction and Drug Identification
1.1. Overview
Meropenem is a potent, broad-spectrum antibiotic administered intravenously and classified within the carbapenem subclass of β-lactam agents.[1] As a "small molecule" drug, it represents a critical tool in the modern medical armamentarium for combating severe and complex bacterial infections, particularly those acquired in hospital settings.[3] Its clinical utility extends to a wide array of life-threatening conditions, including complicated intra-abdominal infections, complicated skin and skin structure infections, bacterial meningitis, sepsis, and pneumonia.[1] Marketed under primary brand names such as Merrem, Meronem, and others globally, Meropenem is often reserved as a last-resort therapy when infections are caused by multidrug-resistant (MDR) pathogens that have developed resistance to other classes of antibiotics, such as penicillins and cephalosporins.[1] This strategic positioning underscores its importance in critical care medicine but also places it at the forefront of the global challenge of antimicrobial resistance, necessitating stringent antibiotic stewardship to preserve its efficacy for future generations.[5]
1.2. Chemical and Physical Properties
Meropenem is chemically defined as a carbapenemcarboxylic acid and is classified by the U.S. Food and Drug Administration (FDA) as a penem antibacterial agent.[7] In its commercial form, it is supplied as a sterile, white to light yellow or off-white crystalline powder for reconstitution.[1] This formulation is not pure meropenem but rather a carefully prepared blend of meropenem trihydrate and anhydrous sodium carbonate.[1] The sodium carbonate serves as an essential buffering agent, enhancing the drug's stability in solution after it is reconstituted for intravenous administration. The molecular formula of meropenem is
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/08/14 | Not Applicable | Completed | Pakistan Navy Station Shifa Hospital | ||
2025/08/11 | Not Applicable | Completed | Karl Landsteiner Insitute for Nephrology and Haemato-Oncology | ||
2025/07/28 | Not Applicable | Recruiting | |||
2025/04/08 | Phase 1 | Recruiting | |||
2025/02/24 | Phase 2 | Recruiting | |||
2025/02/10 | Not Applicable | Not yet recruiting | |||
2024/10/09 | Phase 3 | Not yet recruiting | |||
2024/07/30 | Phase 1 | Completed | |||
2024/04/02 | Phase 4 | Recruiting | |||
2024/01/10 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
WG Critical Care, LLC | 44567-400 | INTRAVENOUS | 500 mg in 1 1 | 5/1/2020 | |
Hospira, Inc. | 0409-1390 | INTRAVENOUS | 500 mg in 10 mL | 10/9/2019 | |
BluePoint Laboratories | 68001-323 | INTRAVENOUS | 500 mg in 20 mL | 10/22/2019 | |
Fresenius Kabi USA, LLC | 63323-507 | INTRAVENOUS | 500 mg in 10 mL | 11/17/2019 | |
Fresenius Kabi USA, LLC | 63323-507 | INTRAVENOUS | 500 mg in 10 mL | 7/31/2020 | |
ARMAS PHARMACEUTICALS INC | 72485-411 | INTRAVENOUS | 500 mg in 20 mL | 8/7/2023 | |
Fresenius Kabi USA, LLC | 63323-507 | INTRAVENOUS | 500 mg in 10 mL | 3/12/2021 | |
WG Critical Care, LLC | 44567-145 | INTRAVENOUS | 500 mg in 1 1 | 6/30/2021 | |
Sandoz Inc | 0781-3000 | INTRAVENOUS | 500 mg in 20 mL | 6/23/2025 | |
Xellia Pharmaceuticals USA LLC | 70594-075 | INTRAVENOUS | 500 mg in 20 mL | 7/8/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
MEROGRAM 1000 POWDER FOR SOLUTION FOR INJECTION 1000MG/VIAL | SIN16309P | INJECTION, POWDER, FOR SOLUTION | 1000 mg/vial | 8/26/2021 | |
MEROPENEM-AFT POWDER FOR INJECTION 1G | SIN14858P | INJECTION, POWDER, FOR SOLUTION | 1g/vial | 10/5/2015 | |
MEPRONEM POWDER FOR SOLUTION FOR INJECTION OR INFUSION 1G/VIAL | SIN16332P | INJECTION, POWDER, FOR SOLUTION | 1000 mg/vial | 9/27/2021 | |
Meronem Powder for Solution for Intravenous Injection or Infusion 500mg | SIN14471P | INJECTION, POWDER, FOR SOLUTION | 500mg | 12/30/2013 | |
ARCHIFAR POWDER FOR SOLUTION FOR INJECTION/INFUSION 500MG/VIAL | SIN14445P | INJECTION, POWDER, FOR SOLUTION | 500mg | 11/25/2013 | |
Meropenem Mevon Powder for Solution for Injection or Infusion 1 g/vial | SIN14014P | INJECTION, POWDER, FOR SOLUTION | 1000 mg | 9/19/2011 | |
MEROPENEM KABI POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/VIAL | SIN15002P | INJECTION, POWDER, FOR SOLUTION | 500mg/vial | 5/4/2016 | |
Meropenem Mevon Powder for Solution for Injection or Infusion 500 mg/vial | SIN14039P | INJECTION, POWDER, FOR SOLUTION | 500 mg | 10/27/2011 | |
ARCHIFAR POWDER FOR SOLUTION FOR INJECTION/INFUSION 1G/VIAL | SIN14844P | INJECTION, POWDER, FOR SOLUTION | 1 g | 9/9/2015 | |
MEROPENEM-AFT POWDER FOR INJECTION 500MG | SIN14857P | INJECTION, POWDER, FOR SOLUTION | 500mg | 10/5/2015 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
MEROPENEM AFT POWDER FOR SOLUTION FOR INJECTION/INFUSION 1000MG | N/A | N/A | N/A | 8/16/2024 | |
MEROPENEM AFT POWDER FOR SOLUTION FOR INJECTION/INFUSION 500MG | N/A | N/A | N/A | 8/16/2024 | |
VABOREM POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1G/1G | N/A | N/A | N/A | 4/30/2024 | |
MEROPENEM ALVOGEN POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG | N/A | N/A | N/A | 3/15/2016 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
MEROPENEM FOR INJECTION, USP | fresenius kabi canada ltd | 02415224 | Powder For Solution - Intravenous | 1 G / VIAL | 6/5/2014 |
MEROPENEM FOR INJECTION, USP | fresenius kabi canada ltd | 02415216 | Powder For Solution - Intravenous | 500 MG / VIAL | 10/20/2014 |
MERREM | 02219026 | Powder For Solution - Intravenous | 1 G / VIAL | N/A | |
MERREM | 02218496 | Powder For Solution - Intravenous | 1 G / VIAL | 11/12/1996 | |
MEROPENEM FOR INJECTION USP AND SODIUM CHLORIDE INJECTION USP | b. braun medical inc | 02544334 | Powder For Solution - Intravenous | 500 MG / CONTAINER | 3/25/2025 |
MERREM | 02219018 | Powder For Solution - Intravenous | 500 MG / VIAL | N/A | |
MERREM | 02218488 | Powder For Solution - Intravenous | 500 MG / VIAL | 11/8/1996 | |
MEROPENEM FOR INJECTION USP AND SODIUM CHLORIDE INJECTION USP | b. braun medical inc | 02544342 | Powder For Solution - Intravenous | 1 G / CONTAINER | 3/25/2025 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
MEROPENEM ACCORDPHARMA 500 mg POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION EFG | 75815 | POLVO PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
MEROPENEM ACCORDPHARMA 1 g POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION EFG | 75816 | POLVO PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
MEROPENEM HIKMA 2 G POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | 89034 | POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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