Delving into the Latest Updates on Cefbuperazone Sodium with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Cefbuperazone, Cefbuperazone sodium (JP17)

+ [3]

Target

PBPs

Mechanism

PBPs inhibitors(Bacterial penicillin-binding protein inhibitors), Cell wall inhibitors

Therapeutic Areas

Infectious DiseasesCardiovascular DiseasesDigestive System Disorders+ [5]

Active Indication

Bacterial InfectionsBronchiectasisBronchitis, Chronic+ [15]

Inactive Indication

Hepatobiliary infectionUrinary Tract Infections

Originator Organization-

Active Organization

Fujian Fukang Pharmaceutical Co. Ltd.

Yuekang Pharmaceutical Group Co., Ltd.Haikou Pharmaceutical Co. Ltd.

+ [1]

Inactive Organization

Guilin Pharmaceutical Group Co., Ltd.

Hainan General Sanyang Pharmaceutical Co. Ltd.

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC22H29N9O9S2

InChIKeySMSRCGPDNDCXFR-CYWZMYCQSA-N

CAS Registry76610-84-9

View All Structures (2)

选择健康志愿者进行注射用头孢拉宗钠在人体的单次和多次药代动力学试验，通过进行低、中、高剂量单次和中剂量多次药代动力学试验，测定头孢拉宗的经时血药浓度，估算其主要药代动力学参数，了解注射用头孢拉宗钠在健康人体内的吸收、分布、消除规律，为制定后期试验方案提供试验依据，为临床用药的给药剂量提供依据。

[Translation]

Healthy volunteers were selected to conduct single and multiple pharmacokinetic trials of cefuroxime sodium for injection in humans. By conducting low-, medium- and high-dose single and medium-dose multiple pharmacokinetic trials, the time-dependent blood concentration of cefuroxime sodium was determined, its main pharmacokinetic parameters were estimated, and the absorption, distribution and elimination patterns of cefuroxime sodium for injection in healthy humans were understood, providing an experimental basis for formulating subsequent test plans and a basis for clinical drug dosage.

Start Date-

Sponsor / Collaborator

Fujian Fukang Pharmaceutical Co. Ltd.

CTR20150131

/ CompletedPhase 1

注射用头孢拉宗钠在中国健康人体的单中心、随机、开放人体药代动力学试验

[Translation] A single-center, randomized, open-label pharmacokinetic trial of cefuroxime sodium for injection in healthy Chinese subjects

考察健康志愿者单次或多次静脉滴注由海南通用三洋药业有限公司开发的注射用头孢拉宗钠后血药浓度经时变化过程，估算相应的药代动力学参数，评价头孢拉宗在人体内的药代动力学特征，为II期临床试验方案制定提供试验依据，为临床用药的给药剂量提供依据。

[Translation]

To investigate the time-dependent changes in blood concentration of cefoperazone sodium for injection developed by Hainan General Sanyo Pharmaceutical Co., Ltd. in healthy volunteers after single or multiple intravenous infusions, estimate the corresponding pharmacokinetic parameters, evaluate the pharmacokinetic characteristics of cefoperazone in humans, provide experimental basis for the formulation of Phase II clinical trial plans, and provide basis for clinical drug dosage.

Start Date27 Aug 2015

Sponsor / Collaborator

Hainan General Sanyang Pharmaceutical Co. Ltd.

CTR20150130

/ CompletedPhase 3

注射用头孢拉宗钠治疗中、重度呼吸和泌尿系统急性细菌感染的随机、单盲、阳性药平行对照、多中心临床试验

[Translation] A randomized, single-blind, positive-drug parallel-controlled, multicenter clinical trial of cefuroxime sodium for injection in the treatment of moderate to severe acute bacterial infections of the respiratory and urinary systems

以注射用头孢美唑钠为对照，评价注射用头孢拉宗钠治疗中、重度呼吸和泌尿系统急性细菌感染的有效性和安全性。

[Translation]

To evaluate the efficacy and safety of cefoperazone sodium for injection in the treatment of moderate to severe acute bacterial infections of the respiratory and urinary systems, using ceftriaxone sodium for injection as a control.

Start Date04 Feb 2015

Sponsor / Collaborator

Hainan General Sanyang Pharmaceutical Co. Ltd.

100 Clinical Results associated with Cefbuperazone Sodium

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100 Translational Medicine associated with Cefbuperazone Sodium

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100 Patents (Medical) associated with Cefbuperazone Sodium

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98

Literatures (Medical) associated with Cefbuperazone Sodium

01 Sep 2021·World Allergy Organization Journal

Risk factors of beta-lactam anaphylaxis in Korea: A 6-year multicenter retrospective adult case-control study

Article

Author: Nam, Young-Hee ; Park, Chan Sun ; Park, So-Young ; Jung, Jae-Woo ; Kang, Hye-Ryun ; Park, Hye-Kyung ; Park, Hye Jung ; Kang, Dong-Yoon ; Kim, Sujeong ; Yang, Min-Suk

BACKGROUNDBeta-lactams (BLs) are commonly used antibiotics and leading causative agents of drug-induced anaphylaxis. Few studies on the culprit drugs and risk factors of BL-induced anaphylaxis are available. Our goal was to evaluate the culprit drugs and compare the risk factors in patients with BL-induced anaphylaxis to matched tolerant controls in a hospital setting.METHODSWe retrospectively enrolled all patients who developed anaphylaxis from intravenous BL during hospitalization from 9 Korean hospitals. We compared clinical parameters between patients with BL-induced anaphylaxis and 4-fold BL-tolerant controls matched by age, sex, BL use, and the purpose of BL administration.RESULTSSeventy-four cases of BL-induced anaphylaxis and 296 BL-tolerant controls were enrolled. Cephalosporin accounted for 77% of total BL-induced anaphylaxis, and the top derivatives were ceftriaxone (23.0%), cefazedone (10.8%), and cefbuperazone (9.5%). Among penicillin derivatives, piperacillin (16.2%) was the most common, followed by ampicillin (2.7%). History of drug allergy (odds ratio [OR], 19.91; 95% confidence interval [CI] 5.33-74.44), previous exposure to the causative BL (OR, 7.71; 95% CI, 1.62-36.76), and concurrent administration of angiotensin-converting enzyme inhibitors (ACEIs) (OR, 5.97; 95% CI, 1.28-27.91) were independent risk factors associated with BL-induced anaphylaxis. Food allergy (OR, 13.93; 95% CI 1.31-148.9) and previous exposure to BL (OR, 6.59; 95% CI, 1.30-33.31) were identified as risk factors for cephalosporin-induced anaphylaxis.CONCLUSIONSTo prevent BL-induced anaphylaxis, attention should be paid to histories of drug or food allergy, previous exposure to BLs, and ACEI use. The risk factors and clinical outcomes might vary according to the BL classes.

01 Sep 2016·Journal of Pharmaceutical and Biomedical AnalysisQ3 · MEDICINE

Pharmacokinetic profile of cefbuperazone in healthy Chinese volunteers after single and multiple drip intravenous infusion by HPLC–MS/MS

Q3 · MEDICINE

Article

Author: Ding, Li ; Geng, Taohua ; Wang, Yiya ; Liu, Dongbo

A selective and reproducible HPLC-MS/MS method was developed and fully validated for the determination of cefbuperazone in human plasma and urine. Samples were prepared using protein precipitation and separated on a Zorbax Eclipse Plus C18 column (2.1×50mm, 3.5μm). The API-4000 mass spectrometer was operated under multiple reaction monitoring mode (MRM) using the electrospray ionization technique. Linearity was achieved from 0.250 to 250μg/mL in plasma and 20.0-5000μg/mL in urine. The method was successfully applied to a pharmacokinetic study of cefbuperazone in healthy Chinese volunteers after drip intravenous infusion of 0.5, 1.0, 2.0g cefbuperazone sodium injection. Cefbuperazone reached a maximum concentration (Cmax) of 44.7±8.1μg/mL, 86.7±12.7μg/mL and 168±14μg/mL in 0.5, 1.0 and 2.0g dose groups respectively, at 60min after the start of infusion. The half-life (t1/2) was between 1.8-1.9h, and the elimination constant (kel) was between 0.36-0.39h(-1). The results proved that cefbuperazone showed linear pharmacokinetic profile in the dose range of 0.5-2.0g without gender difference. Drug accumulation was not observed. Cefbuperazone reached the maximum excretion rate in urine 2h after the start of infusion. About 60.0% of the administered drug was excreted via urine as unchanged form within 12h. The cumulative excretion of cefbuperazone after single drip intravenous infusion was proportional to the administered dose within the range from 0.5g to 2.0g.

31 Mar 2015·Journal of Lifestyle Medicine

Suspected Anaphylactic Reaction Prior to Induction of Anesthesia

Author: Do, Hye Jin ; Jeon, Yeong Gwan ; Park, Ji Hyoung ; Lim, Hyun Kyo ; Lee, Kwang Ho

Although uncommon, anaphylactic reactions during surgery are very dangerous and can result in serious morbidity. Various anesthetics can trigger anaphylactic reactions, and incidents with cephalosporin antibiotics are on the rise. In the case presented, an 84-year-old woman scheduled for calcaneus fracture surgery, was injected with cefbuperazone as a prophylactic antibiotic. On the way to the operating room, before induction of anesthesia, the patient lost consciousness and showed signs of hypoxemia, and anaphylactic reaction, which included hypotension, bronchospasm, and rash. Five hours after immediate intubation and fluid resuscitation, the patient was extubated and transferred to the general ward. Eight weeks later, the skin prick test confirmed a positive reaction to cefbuperazone.

100 Deals associated with Cefbuperazone Sodium

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External Link

KEGG	Wiki	ATC	Drug Bank
D01736	Cefbuperazone Sodium	J01DC13	DB13638

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bacterial Infections	-	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Respiratory Tract Infections	IND Application	CN	Hainan General Sanyang Pharmaceutical Co. Ltd.	04 Feb 2015
Urinary Tract Infections	IND Application	CN	Hainan General Sanyang Pharmaceutical Co. Ltd.	04 Feb 2015
Cholangitis	IND Application	CN	Guilin Pharmaceutical Group Co., Ltd.	02 Apr 2014
Cholecystitis	IND Application	CN	Guilin Pharmaceutical Group Co., Ltd.	02 Apr 2014
Endocarditis	IND Application	CN	Guilin Pharmaceutical Group Co., Ltd.	02 Apr 2014
Lung Abscess	IND Application	CN	Guilin Pharmaceutical Group Co., Ltd.	02 Apr 2014
Pelvic Inflammatory Disease	IND Application	CN	Guilin Pharmaceutical Group Co., Ltd.	02 Apr 2014
Peritonitis	IND Application	CN	Guilin Pharmaceutical Group Co., Ltd.	02 Apr 2014
Pneumonia	IND Application	CN	Guilin Pharmaceutical Group Co., Ltd.	02 Apr 2014
Pyelonephritis	IND Application	CN	Guilin Pharmaceutical Group Co., Ltd.	02 Apr 2014