Delving into the Latest Updates on Cefprozil with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Brisoral, Cefprozil (USP), Cefprozil For Dry Suspension

+ [16]

Target

PBPs

Action

inhibitors

Mechanism

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

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Respiratory Tract InfectionsBacterial Infections

Inactive Indication

Gram-Negative Bacterial InfectionsGram-Positive Bacterial InfectionsLower Respiratory Tract Infections

Originator Organization

Corden Pharma Latina SpA

Active Organization

Sino-American Shanghai Squibb Pharmaceuticals Ltd.

Inactive Organization

Corden Pharma Latina SpA

Drug Highest PhaseApproved

First Approval Date

United States (23 Dec 1991),

Gram-Negative Bacterial InfectionsGram-Positive Bacterial Infections

Regulation-

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Structure/Sequence

Molecular FormulaC18H19N3O5S

InChIKeyWDLWHQDACQUCJR-PBFPGSCMSA-N

CAS Registry92665-29-7

View All Structures (2)

观察健康受试者空腹及餐后状态下单剂量口服受试制剂头孢丙烯干混悬剂（生产厂家：万邦德制药集团有限公司）后血药浓度的经时过程，估算相应的药代动力学参数；并以头孢丙烯干混悬剂（规格：250mg/5ml，持证商：Lupin LTD）为参比制剂，进行人体生物等效性正式试验，为该药注册申报和临床应用提供参考依据。

[Translation]

The time course of blood drug concentration after a single oral dose of the test preparation cefprozil dry suspension (manufacturer: Wanbangde Pharmaceutical Group Co., Ltd.) in healthy subjects under fasting and postprandial states was observed, and the corresponding pharmacokinetic parameters were estimated. Cefprozil dry suspension (specification: 250mg/5ml, licensee: Lupin LTD) was used as the reference preparation for a formal human bioequivalence trial, which provided a reference for the drug registration application and clinical application.

Start Date20 Nov 2024

Sponsor / Collaborator

Wenling City Innovation Biotechnology Co., Ltd.

NCT06494072

/ RecruitingPhase 4IIT

Short Versus Standard of Care Antibiotic Duration for Hospitalized Children With Uncomplicated Community-acquired Pneumonia: a Non-inferiority, Randomized Controlled Trial.

The goal of this open label, randomized, non-inferiority clinical trial is to compare the treatment success of a 5 day antibiotic course versus a standard antibiotic course (usually 7-14 days of antibiotics) in hospitalized children aged 3 months to 18 years, with uncomplicated community acquired pneumonia.
The main questions it aims to answer are:
* Does a 5 day course work as well as standard (longer) courses of antibiotics for treating community acquired pneumonia in children?
* Does a 5 day course cause less antibiotic side effects compared to a standard (longer) course of antibiotics in children with community acquired pneumonia?
Participants will
* be randomly assigned to either receive 5 total days or a total duration decided by the treating physician
* receive a brief follow up questionnaire regarding clinical symptoms, follow up care/antibiotics, and side effects via phone or email at days 5 and 14 from the start of antibiotics
Researchers will compare the experimental group (receiving 5 days duration) with the control group (standard duration) to see if 5 days is as successful as a standard duration.

Start Date22 Aug 2024

Sponsor / Collaborator

Medical College of Wisconsin

CTR20240949

/ CompletedNot Applicable

头孢丙烯片在中国健康受试者中单中心、随机、开放、单剂量、两制剂、两周期、两序列、双交叉、空腹/餐后状态下生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence, double-crossover, fasting/fed bioequivalence study of cefprozil tablets in healthy Chinese subjects

主要研究目的本研究为健康受试者空腹或餐后状态下，单次口服华北制药河北华民药业有限责任公司生产的受试制剂头孢丙烯片（规格：0.25g/片）或Lupin Limited生产的参比制剂头孢丙烯片（英文名称：Cefprozil Tablets；规格：250mg/片），考察空腹或餐后状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数，评价两制剂的生物等效性。次要研究目的考察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main study purpose This study is to investigate the pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects in the fasting or postprandial state by taking a single oral dose of the test preparation Cefprozil Tablets (specification: 0.25g/tablet) produced by North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd. or the reference preparation Cefprozil Tablets (English name: Cefprozil Tablets; specification: 250mg/tablet) produced by Lupin Limited to evaluate the bioequivalence of the two preparations. Secondary study purpose To investigate the safety of the test preparation and the reference preparation in healthy subjects.

Start Date01 Apr 2024

Sponsor / Collaborator

NCPC Hebei Huamin Pharmaceutical Co. Ltd.

100 Clinical Results associated with Cefprozil

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100 Translational Medicine associated with Cefprozil

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100 Patents (Medical) associated with Cefprozil

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811

Literatures (Medical) associated with Cefprozil

01 Feb 2025·Infectious Disorders - Drug Targets

A Case Report of Salmonella enterica Meningitis in an Infant: A Rare Entity not to Forget

Article

Author: Tzanoudaki, Marianna ; Varvarigou, Anastasia ; Dimitriou, Gabriel ; Farmaki, Evangelia ; Syrogiannopoulos, George ; Palyvou, Maria ; Gkentzi, Despoina ; Angeli, Evangelia

Introduction:Salmonellae are gram-negative, facultatively anaerobic Enterobacteri-aceae consisting of two species, Salmonella enterica and Salmonella bongori. Invasive diseases, such as meningitis, result in hospitalization, short and long-term complications, and high mortality rates.Case Presentation:A 4-month-old baby girl was admitted to a district hospital because of diarrhea and fever. WBC count, urinalysis, urine cultures, and stool cultures were normal. She was treated with intravenous cefuroxime for 5 days. She was discharged on oral cefprozil for 5 days. After the end of therapy, she was admitted again to the same hospital with fever, diarrhea, vomits, and irri-tability. Cerebrospinal fluid examination revealed pleocytosis, while S. enterica was isolated. Em-pirical therapy with ceftriaxone, amikacin, and dexamethasone was started. Because of intracranial hypertension signs, she was transferred to the pediatric intensive care unit of our tertiary hospital. Therapy continued with intravenous ceftriaxone. Brain MRI revealed subarachnoid space dilata-tion. Increased head circumference and pulsating bregmatic fontanel led to a new cerebral MRI, in which ventricular dilatation and extraparenchymal subdural collection were noted. Ceftriaxone was changed to cefotaxime and ciprofloxacin was added. She remained clinically well; her brain MRI, a week later, showed marked improvement, and the course of intravenous antibiotics for 5 weeks was completed. Her baseline immunodeficiency screening tests were normal and repeat MRI two months post-treatment cessation did not reveal the previous abnormalities.Conclusion:Invasive Salmonella diseases, such as meningitis, are very uncommon in industrial countries nowadays, and the optimal management is yet not well established. Late onset of com-plications from Salmonella meningitis warrants more thorough neurodevelopmental follow-ups.

04 Nov 2024·Journal of Antimicrobial Chemotherapy

Comparative evaluation of early treatment with ceftolozane/tazobactam versus ceftazidime/avibactam for non-COVID-19 patients with pneumonia due to multidrug-resistant Pseudomonas aeruginosa

Article

Author: Watanabe, Alexandre H ; Nathanson, Brian H ; Lodise, Thomas P ; Min, Jae ; Yucel, Emre ; Obi, Engels N

AbstractBackgroundCeftolozane/tazobactam and ceftazidime/avibactam are commonly used in patients with MDR-Pseudomonas aeruginosa (PSA) pneumonia (PNA). This study compared outcomes between non-COVID-19 hospitalized patients with MDR-PSA PNA who received ceftolozane/tazobactam or ceftazidime/avibactam.MethodsThe study included non-COVID-19 adult hospitalized patients with MDR-PSA PNA in the PINC AI Healthcare Database (2016–22) who received ceftolozane/tazobactam or ceftazidime/avibactam within 3 days of index culture for ≥2 days. Outcomes were mortality, recurrent MDR-PSA PNA, discharge destination, post-index culture day length of stay (LOS) and costs (in US dollars, USD), and hospital readmission.ResultsThe final sample included 197 patients (117 ceftolozane/tazobactam, 80 ceftazidime/avibactam). No significant differences were observed in mortality and post-index culture LOS and costs between groups. In the multivariable analyses, patients who received ceftolozane/tazobactam versus ceftazidime/avibactam had lower recurrent MDR-PSA PNA (7.9% versus 18.0%, P = 0.03) and 60 day PNA-related readmissions (11.1% versus 28.5%, P = 0.03) and were more likely to be discharged home (25.8% versus 9.8%, P = 0.03). Compared with ceftazidime/avibactam patients, ceftolozane/tazobactam patients had lower adjusted median total antibiotic costs (5052 USD versus 8099 USD, P = 0.003) and lower adjusted median comparator (ceftolozane/tazobactam or ceftazidime/avibactam) antibiotic costs (3938 USD versus 6441 USD, P = 0.005). In the desirability of outcome ranking (DOOR) analysis, a ceftolozane/tazobactam-treated patient was more likely to have a more favourable outcome than a ceftazidime/avibactam-treated patient [DOOR probability: 59.6% (95% CI: 52.5%–66.8%)].ConclusionsEarly treatment with ceftolozane/tazobactam may offer some clinical and cost benefits over ceftazidime/avibactam in patients with MDR-PSA PNA. Further large-scale studies are necessary to comprehensively understand the outcomes associated with these treatments for MDR-PSA PNA.

22 Aug 2024·Journal of Medicinal Chemistry

Interaction of Cephalosporins with Human Serum Albumin: A Structural Study

Article

Author: Doi, Yohei ; Kawai, Akito ; Otagiri, Masaki ; Yamasaki, Keishi

Modification of the R1 and R2 side chain structures has been used as the main strategy to expand the spectrum of cephalosporins and impart resistance to hydrolysis by β-lactamases. These structural modifications also result in a wide range of plasma protein binding, especially with human serum albumin (HSA). Here, we determined the crystal structures of the HSA complexes with two clinically important cephalosporins, ceftriaxone and cefazolin, and evaluated the binding of cephalosporin to HSA by susceptibility testing and competitive binding assay. Ceftriaxone and cefazolin bind to subdomain IB of HSA, and their cephem core structures are recognized by Arg117 of HSA. Tyr161 of HSA changes its rotamer depending on the cephalosporin, resulting in alterations of the cavity shape occupied by the R2 side chain of cephalosporins. These findings provide structural insight into the mechanisms underlying the HSA binding of cephalosporins.

100 Deals associated with Cefprozil

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External Link

KEGG	Wiki	ATC	Drug Bank
D00261	Cefprozil	J01DC10	DB01150

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Respiratory Tract Infections	France	-	02 Nov 1997
Bacterial Infections	Switzerland	-	28 Dec 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lower Respiratory Tract Infections	Preclinical	China	-	08 Oct 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAAAI2024	Not Applicable	Anaphylaxis	-	Cefazolin	rcdedhslxp(fqodjcauvs) = zhewargrmh fouyismahz (qmaomrbllm )	-	23 Feb 2024
				Cefoxitin	rcdedhslxp(fqodjcauvs) = ugchfbsbwx fouyismahz (qmaomrbllm )
NCT04414254 (Pubmed \| Adv Ther)	Phase 1	-	60	Cefprozil for Suspension	(yprnvwudov) = rvjisumssg umgvnzmllm (khlbjiywyz ) View more	-	01 Feb 2021
				Granule Formulation	(yprnvwudov) = ieujwvdrrb umgvnzmllm (khlbjiywyz ) View more
NCT00835614 (CTgov)	Phase 1	-	26	Cefprozil (Cefprozil (Test))	(gbzndpwrdf) = mcoeqmfwdp sqmetwifjj (yqngjpxwhj, qicqwfesrz - iveanacomg) View more	-	21 Jul 2009
				Cefzil (Cefzil® (Reference))	(gbzndpwrdf) = gtudzcnfan sqmetwifjj (yqngjpxwhj, qwjmklzfsa - jyjmeadfen) View more
NCT00840866 (CTgov)	Phase 1	-	39	Cefprozil (Cefprozil (Test))	(pemhyqkqgp) = ohgxswfoln poeffuwbdg (srkorfykpt, lovfzjrdow - qcvmrthyxh) View more	-	21 Jul 2009
				Cefzil (Cefzil® (Reference))	(pemhyqkqgp) = fzrffwkukc poeffuwbdg (srkorfykpt, dyexesmyxc - nuzypwwsde) View more
NCT00835354 (CTgov)	Phase 1	-	26	Cefprozil (Cefprozil (Test))	(ojexyqizng) = jqnwfzxuqn psdtrlnqox (trmtaabrbc, wijwztnsbj - zemxntwrrn) View more	-	21 Jul 2009
				Cefzil (Cefzil® (Reference))	(ojexyqizng) = mrkancvojn psdtrlnqox (trmtaabrbc, wvkgxtjgte - nvvtnplhct) View more
NCT00840281 (CTgov)	Phase 1	-	38	Cefprozil (Cefprozil (Test))	(snjsscqjnr) = gezlmkqjvz opkoyybokc (uswsthgfwt, aherdmghxj - tmhasmkkfv) View more	-	21 Jul 2009
				Cefzil (Cefzil® (Reference))	(snjsscqjnr) = bqhzlxgurp opkoyybokc (uswsthgfwt, rieglethfo - kpwwbvbgfo) View more