Imipenem-Cilastatin

Overview

No overview information available.

Indication

本品适用于： 1.病原菌多重耐药，而对本品呈现敏感的需氧革兰氏阴性杆菌所致的严重感染，包括肺炎克雷伯菌、大肠埃希菌阴沟肠杆菌、产气肠杆菌、柠檬酸菌属、黏质沙雷菌等肠杆菌科细菌、不动杆菌属等所致的败血症、下呼吸道感染、尿路感染、腹腔感染、盆腔感染、骨关节感染、皮肤软组织感染等；用于铜绿假单胞菌所致感染时需注意在使用本品过程中某些菌株可出现耐药，必要时治程中监测药敏； 2.用于对脆弱拟杆菌等厌氧菌与需氧菌混合感染的重症患者； 3.病原菌尚不明的严重感染、免疫缺陷者感染的经验治疗。　　由于抽搐等严重中枢神经系统不良反应，本品不用于中枢神经系统感染的治疗。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)	2023/09/29	NCT06059846	Phase 3	Completed	Spero Therapeutics
Efficacy and Safety of Colistin Based Antibiotic Therapy	2021/02/21	NCT04764058	Phase 1	UNKNOWN	Ain Shams University
Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections	2018/02/26	NCT03445195	Phase 2	Completed	Entasis Therapeutics
Short Versus Extended Antibiotic Treatment With a Carbapenem for High-risk Febrile Neutropenia in Hematology Patients With FUO	2014/05/29	NCT02149329	Phase 4	Completed	Amsterdam UMC, location VUmc
GSK2251052 in Complicated Urinary Tract Infection	2011/06/27	NCT01381549	Phase 2	Terminated	GlaxoSmithKline
Complicated Skin and Skin Structure Infections	2008/02/21	NCT00619710	Phase 3	Completed	Pfizer
To Compare Safety and Efficacy of Doripenem Versus Imipenem-Cilastatin in Patients With Ventilator-Associated Pneumonia	2008/01/10	NCT00589693	Phase 3	Terminated	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
No HSA approvals found for this drug.

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.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

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.

Related News

GSK's Tebipenem HBr Phase III Trial Stopped Early for Efficacy in Complicated UTI Treatment

4 months ago

GSK and Spero Therapeutics announced the pivotal Phase III PIVOT-PO trial for tebipenem HBr was stopped early for efficacy following a recommendation from an Independent Data Monitoring Committee based on data from 1,690 patients.

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