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Meropenem

Generic Name
Meropenem
Brand Names
Vabomere
Drug Type
Small Molecule
Chemical Formula
C17H25N3O5S
CAS Number
96036-03-2
Unique Ingredient Identifier
YOP6PX0BAO

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

Published: Jul 23, 2025

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

Continue reading the full research report

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.

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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