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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
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 | Recruiting | |||
2024/04/02 | Phase 4 | Recruiting | |||
2024/01/10 | Phase 3 | Recruiting | |||
2023/12/28 | Phase 4 | Recruiting | |||
2023/12/13 | Phase 3 | Withdrawn | |||
2023/10/10 | Phase 1 | Completed | King Abdul Aziz Specialist Hospital |
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 |
|---|---|---|---|---|---|
| Meropenem for Injection and Sodium Chloride Injection | 国药准字H20244512 | 化学药品 | 注射剂 | 7/30/2024 | |
| Meropenem for Injection and Sodium Chloride Injection | 国药准字H20244497 | 化学药品 | 注射剂 | 7/30/2024 | |
| Meropenem for Injection | 国药准字H20233961 | 化学药品 | 注射剂 | 7/25/2023 | |
| Meropenem for Injection | 国药准字H20143080 | 化学药品 | 注射剂 | 9/19/2023 | |
| Meropenem for Injection | 国药准字H20243623 | 化学药品 | 注射剂 | 4/30/2024 | |
| Meropenem for Injection | 国药准字H20093466 | 化学药品 | 注射剂 | 4/7/2024 | |
| Meropenem for Injection | 国药准字H20067906 | 化学药品 | 注射剂 | 3/13/2020 | |
| Meropenem for Injection | 国药准字H20243624 | 化学药品 | 注射剂 | 4/30/2024 | |
| Meropenem for Injection | 国药准字H20233959 | 化学药品 | 注射剂 | 7/25/2023 | |
| Meropenem for Injection | 国药准字H20093465 | 化学药品 | 注射剂 | 4/7/2024 |
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. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.