Imipenem

Overview

Imipenem is a semisynthetic thienamycin that has a wide spectrum of antibacterial activity against gram-negative and gram-positive aerobic and anaerobic bacteria, including many multiresistant strains. It is stable to many beta-lactamases. Similar compounds include meropenem, known for having greater activity against Gram negative bacteria, and the newer ertapenem which exhibits a longer half-life due to increased binding to plasma proteins. Imipenem is commonly used in combination with cilastatin and is now available in a triple-drug product with cilastatin and relebactam which was recently approved by the FDA. Imipenem was first approved by the FDA in November 1985 as the combination product Primaxin marketed by Merck & Co.

Background

Indication

Imipenem is indicated, in combination with cilastatin with or without relebactam, for the treatment of bacterial infections including respiratory, skin, bone, gynecologic, urinary tract, and intra-abdominal as well as septicemia and endocarditis.

Associated Conditions

Bacterial Septicemia
Bone and Joint Infections
Complicated Intra-Abdominal Infections (cIAIs) caused by Gram-negative Bacteria
Complicated Urinary Tract Infection
Complicated Urinary Tract Infection caused by Gram-negative Bacteria
Endocarditis caused by staphylococcus aureus
Gynecological Infection
Intraabdominal Infections
Lower respiratory tract infection bacterial
Nosocomial Pneumonia caused by Gram-negative Bacteria
Pyelonephritis
Skin and Subcutaneous Tissue Bacterial Infections
Uncomplicated Urinary Tract Infections
Ventilator Associated Bacterial Pneumonia caused by Gram-negative Bacteria

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis	2024/08/23	NCT06569056	Phase 3	Recruiting	Jiangsu HengRui Medicine Co., Ltd.
A Trial of Intravenous HRS-8427 in the Treatment of Adults With Complicate Urinary Tract Infection, Including Acute Pyelonephritis	2023/11/22	NCT06144060	Phase 2	Not yet recruiting	Jiangsu HengRui Medicine Co., Ltd.
Finding the Optimal Regimen for Mycobacterium Abscessus Treatment	2020/03/17	NCT04310930	Phase 2	Recruiting	The University of Queensland
A Randomized Controlled Trial Comparing Imipenem and Tigecycline Versus Imipenem and Tigecycline With GM-CSF for the Management of Spontaneous Bacterial Peritonitis Presenting With Septic Shock.	2019/12/23	NCT04208763	Not Applicable	UNKNOWN	Institute of Liver and Biliary Sciences, India
PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients	2019/02/28	NCT03858387	N/A	UNKNOWN	Prince of Songkla University
Imipenem in Critically Ill Patients	2018/12/14	NCT03776305	Phase 4	UNKNOWN	Prince of Songkla University
Antibacterial Prophylaxis vs no Prophylaxis for Hematological Malignancies Patients Before Allo-HSCT	2018/11/07	NCT03733340	Phase 2	UNKNOWN	Nanfang Hospital, Southern Medical University
The Analysis of Factors Influencing the Vd of Imipenem in Septic Shock Patients	2017/10/12	NCT03308214	N/A	Completed	Southeast University, China
Evaluation of Innovative Tools in Development of Antibiotics	2017/06/06	NCT03177720	Phase 1	Completed	Medical University of Vienna
Efficacy of Betalactam Antibiotics in Prolonged Infusion Compared to Intermittent in Pediatric Patients With Sepsis	2017/01/13	NCT03019965	Not Applicable	Completed	Coordinación de Investigación en Salud, Mexico

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Imipenem and Cilastatin	Fresenius Kabi USA, LLC	63323-349	INTRAVENOUS	250 mg in 20 mL	8/31/2020
PRIMAXIN IV	Merck Sharp & Dohme LLC	0006-3551	INTRAVENOUS	250 mg in 100 mL	5/24/2022
Imipenem and Cilastatin	Fresenius Kabi USA, LLC	63323-322	INTRAVENOUS	500 mg in 20 mL	8/31/2020
RECARBRIO	Merck Sharp & Dohme LLC	0006-3856	INTRAVENOUS	500 mg in 100 mL	5/5/2022
Imipenem and Cilastatin	Fresenius Kabi USA, LLC	63323-322	INTRAVENOUS	500 mg in 20 mL	11/1/2020
Imipenem and Cilastatin	Fresenius Kabi USA, LLC	63323-349	INTRAVENOUS	250 mg in 20 mL	8/31/2020
Imipenem and Cilastatin	Fresenius Kabi USA, LLC	63323-349	INTRAVENOUS	250 mg in 20 mL	11/1/2020
PRIMAXIN IV	Merck Sharp & Dohme LLC	0006-3516	INTRAVENOUS	500 mg in 100 mL	5/24/2022
Imipenem and Cilastatin	Fresenius Kabi USA, LLC	63323-322	INTRAVENOUS	500 mg in 20 mL	8/31/2020
PRIMAXIN IV	Merck Sharp & Dohme LLC	0006-3552	INTRAVENOUS	500 mg in 100 mL	5/24/2022

Showing 10 of 12 FDA approvals

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Recarbrio	Merck Sharp & Dohme B.V.,Waarderweg 39,2031 BN Haarlem,The Netherlands	Authorised	2/13/2020

Showing 1 of 1 EMA approvals

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Imipenem + Cilastatin Mevon Powder for solution for Injection 500 mg + 500 mg	ACS DOBFAR S.p.A (Filling of Drug product sterile bulk), ACS Dobfar S.p.A. 2: Addetta Plant (Drug product bulk)	SIN14329P	INJECTION, POWDER, FOR SOLUTION	500mg	3/20/2013
Imipenem/Cilastatin Labatec IV powder for Injection 500mg/500mg	ACS Dobfar S.p.A, ACS Dobfar SpA (Intermediate)	SIN14589P	INJECTION, POWDER, FOR SOLUTION	500mg	8/13/2014
IMCIL POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500MG/500MG PER VIAL	ANFARM HELLAS S.A., ACS DOBFAR S.P.A (DP INTERMEDIATE)	SIN16280P	INJECTION, POWDER, FOR SOLUTION	500mg	7/21/2021
IMIPENEM /CILASTATIN KABI POWDER FOR SOLUTION FOR INFUSION 500MG/500MG	ACS Dobfar S.p.A (primary and secondary packager), ACS Dobfar SpA (sterile bulk blend)	SIN14765P	INJECTION, POWDER, FOR SOLUTION	500mg/ vial	3/26/2015

Showing 4 of 4 HSA approvals

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
No PPB 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.

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