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

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

US (23 Dec 1991),

Gram-Negative Bacterial InfectionsGram-Positive Bacterial Infections

Regulation-

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Structure

Molecular FormulaC18H19N3O5S

InChIKeyWDLWHQDACQUCJR-PBFPGSCMSA-N

CAS Registry92665-29-7

View All Structures (2)

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 Date01 Jul 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.

CTR20231911 / CompletedNot Applicable

头孢丙烯片随机、开放、单剂量、两制剂、交叉设计在中国健康受试者中的生物等效性正式试验

[Translation] A randomized, open-label, single-dose, two-dose, crossover design formal bioequivalence trial of cefprozil tablets in Chinese healthy subjects

以温岭市创新生物医药科技股份有限公司提供的头孢丙烯片为受试制剂，按生物等效性试验的有关规定，与Lupin Limited生产的头孢丙烯片（参比制剂）对比在健康人体内的吸收速度及吸收程度，考察两制剂的人体生物等效性。

[Translation]

Cefprozil Tablets provided by Wenling Innovation Biotechnology Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence test, the absorption rate and degree of the two preparations in healthy humans were compared with those of Cefprozil Tablets (reference preparation) produced by Lupin Limited to investigate the bioequivalence of the two preparations in humans.

Start Date29 Jun 2023

Sponsor / Collaborator

Wenling City Innovation Biotechnology 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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339

Literatures (Medical) associated with Cefprozil

01 Feb 2024·Therapeutic Delivery

Aquasomes Nanoformulation for Controlled Release of Drug and Improved Effectiveness Against Bacterial Infections

Article

Author: Srinivasan, Umashankar Marakanam ; Shanmugam, Bhuvaneshwari

Aim: The study aimed to develop and evaluate an aquasome drug-delivery system for controlled drug delivery of cefprozil monohydrate. Materials & methods: Aquasomes were prepared by the spinal method with a calcium phosphate core, sugar-coated using cellobiose and drug-loaded by adsorption. The formulations were characterized for size, morphology and drug release. An antibacterial study was conducted for Gram-positive and -negative bacteria. Results: It showed particle size of 2791.9 nm, zeta potential of -0.3 mV with good stability, and 99.08% of drug loading and drug release were controlled and prolonged, achieving 56% within 8 h and possessing potential for 100% release beyond 12 h. Conclusion: An aquasome drug-delivery system was developed for novel controlled drug delivery for pharmaceutical antibiotic therapeutics.

01 Jan 2024·SiSli Etfal Hastanesi Tip Bulteni / The Medical Bulletin of Sisli Hospital

Evaluation of Cross-Reactivity Between Penicillins and Cephalosporins in Children with a History of Cephalosporin Allergy

Article

Author: Cetinkaya, Feyzullah ; Eker, Nursah ; Kutluk, Gunsel

ObjectivesThe cross-reactivity problem between cephalosporins and penicillins has mainly been evaluated in the context of patients allergic to penicillins. However, we have little data regarding the opposite aspect of the problem, i.e. the cross-reactivity in subjects primarily sensitized to cephalosporins. This prospective study aims to evaluate the cross-reactivity to penicillins and some other cephalosporins in patients with immediate allergic reactions to cephalosporins.MethodsThe study included 21 children with immediate allergic reactions to at least one cephalosporin. Skin testing was performed with a panel of minor and major determinant mixtures of penicillins and three commonly used cephalosporins (cephazoline, cefuroxime and ceftriaxone).ResultsThe children had used 5.14±4.91 (1-15) times any beta-lactam antibiotic in the previous year and the most common cephalosporins accused were ceftriaxone (42.92%), and cefuroxime, cefazolin, cefixime, cefprozil and cefotaxime (9.5% each). Skin tests were positive for any cephalosporin in 14 (66.7%) subjects and penicillin allergens in 15 (71.4%) subjects. Totally, 85.7% of children with a positive allergy history to cephalosporins were found to be sensitive to either penicillin or any one of three cephalosporins.ConclusionThere seems to be a high risk of adverse reactions to penicillins and other cephalosporins in children with a history of type I hypersensitivity reaction to cephalosporins. Therefore, skin testing with both cephalosporins and penicillins should be performed in patients with a history of cephalosporin allergy.

01 Jan 2024·The Journal of Allergy and Clinical Immunology: In Practice

Assessing Pediatric Cephalosporin Allergic Reactions Through Direct Graded Oral Challenges

Article

Author: Gabrielli, Sofianne ; Ben-Shoshan, Moshe ; Atkinson, Adelle ; Kim, Vy ; O'Keefe, Andrew ; McCusker, Christine ; Abrams, Elissa M ; Eiwegger, Thomas ; Sillcox, Carly ; Copaescu, Ana-Maria

BACKGROUNDCephalosporins, β-lactam antibiotics, commonly cause allergic reactions.OBJECTIVETo assess the clinical characteristics and management of pediatric patients with suspected cephalosporin allergy using direct graded oral challenges (GOCs).METHODSChildren referred for suspected cephalosporin allergy at 4 Canadian clinics were recruited over 10 years. Data on demographics, clinical reaction characteristics, and management were collected through a questionnaire. Patients underwent a direct GOC (initially 10% of the treatment dose, then 90% after 20 min), and reactions were monitored 1 week postchallenge. Families were contacted annually for up to 5 years to detect subsequent antibiotic reactions. Logistic regression analysis identified factors associated with positive GOC reactions.RESULTSAmong the 136 patients reporting cephalosporin allergy, 75 (55.1%) were males with a median age of 3.9 years (interquartile range 2.3-8.7). Cefprozil represented the most common cephalosporin linked to the index reaction (67.6% of cases). Of the 136 direct GOCs, 5.1% had an immediate and 4.4% a nonimmediate reaction, respectively. Positive GOCs conducted in children with a history of skin-limited nonsevere rashes were classified as mild, benign skin rashes. Positive GOCs were more likely in children with food allergies (adjusted odds ratio 1.14; 95% confidence interval [95% CI] 1.00-1.29).CONCLUSIONSDirect GOCs are safe and effective for diagnosing pediatric cases that report nonvesicular skin-limited symptoms while being treated with 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	FR	-	02 Nov 1997
Bacterial Infections	CH	-	28 Dec 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lower Respiratory Tract Infections	Discovery	CN	-	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	wffistzqjx(alcyckmiwi) = fzzcaiheyy sgwtejwiwz (lrhtlwtgec )	-	23 Feb 2024
				Cefoxitin	wffistzqjx(alcyckmiwi) = cotxgftyin sgwtejwiwz (lrhtlwtgec )
NCT04414254 (Pubmed \| Adv Ther)	Phase 1	-	60	Cefprozil for Suspension	(jtfcjkcpwl) = ijfqqmvdyu fqafuqwahe (gqndppdyde ) View more	-	01 Feb 2021
				Granule Formulation	(jtfcjkcpwl) = mymknrtula fqafuqwahe (gqndppdyde ) View more
NCT00840866 (CTgov)	Phase 1	-	39	Cefprozil (Cefprozil (Test))	(wvpewnqvmf) = qowimytzrw kkbbfptlpj (pqiasnleah, lbtjbbbhvk - licsxfhakj) View more	-	21 Jul 2009
				Cefzil (Cefzil® (Reference))	(wvpewnqvmf) = nfajisueen kkbbfptlpj (pqiasnleah, anvnsfzfmi - htbjymmxxi) View more
NCT00835614 (CTgov)	Phase 1	-	26	Cefprozil (Cefprozil (Test))	tntrlfpiqi(rmnwtwphny) = cbpvzkbnkq bsoecftvps (kbrdyxtwqe, uxqjymzbgc - bbmutjghbk) View more	-	21 Jul 2009
				Cefzil (Cefzil® (Reference))	tntrlfpiqi(rmnwtwphny) = pfhnbqwlby bsoecftvps (kbrdyxtwqe, tfwwxtlkgp - pqmuswmpyl) View more
NCT00840281 (CTgov)	Phase 1	-	38	Cefprozil (Cefprozil (Test))	snytufqxwp(dynfxsqacy) = evlbwgqlur smuzefrxgd (vulipanrcs, fprqhjcamm - pkukculzge) View more	-	21 Jul 2009
				Cefzil (Cefzil® (Reference))	snytufqxwp(dynfxsqacy) = zfhqvaqmdw smuzefrxgd (vulipanrcs, lhtzlykhtw - ltwurxauvc) View more
NCT00835354 (CTgov)	Phase 1	-	26	Cefprozil (Cefprozil (Test))	fogxxwjunl(ljwaxqckxt) = yrbdewkowf umzycqsmkh (rbzqmyuhwo, sgkviniqqo - qbqphdjjic) View more	-	21 Jul 2009
				Cefzil (Cefzil® (Reference))	fogxxwjunl(ljwaxqckxt) = yqgljwgmzc umzycqsmkh (rbzqmyuhwo, avzeocqikb - roqzdnxutl) View more