Last update 21 Nov 2024

Floxacillin sodium

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(2S,5R,6R)-6-({[3-(2-chloro-6-fluorophenyl)-5-methyl-1,2-oxazol-4-yl]carbonyl}amino)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 3-(2-Chloro-6-fluorophenyl)-5-methyl-4-isoxazolylpenicillin, Floxacillin

+ [8]

Target

PBPs

Mechanism

PBPs inhibitors(Bacterial penicillin-binding protein inhibitors)

Therapeutic Areas

Infectious Diseases

Active Indication

Bacterial Infections

Inactive Indication-

Originator Organization

Bright Future Pharmaceuticals Factory

Active Organization

Bright Future Pharmaceuticals Factory

Inactive Organization

GSK Plc

Drug Highest PhaseApproved

First Approval Date

CN (17 Apr 2002),

Bacterial Infections

Regulation-

Structure

Molecular FormulaC19H17ClFN3NaO5S

InChIKeyPWDULVAXRLDWLM-SLINCCQESA-N

CAS Registry1847-24-1

View All Structures (2)

Clinical Trials associated with Floxacillin sodium

NL-OMON56926 / SuspendedNot ApplicableIIT

Influence of flucloxacillin treatment on plasma concentration of CYP - and UGT-substrate drugs. - Flucloxacillin interaction study

Start Date01 Sep 2024

Sponsor / Collaborator

HagaZiekenhuis

NCT05655091 / RecruitingPhase 2IIT

Can Continuous Infusion Coupled With Therapeutic Drug Monitoring Optimize Flucloxacillin and Cefazolin Target Attainment Compared to Standard Intermittent Bolus Dosing in Patients With Complicated Staphylococcus Aureus Infections? A Randomized, Controlled Interventional Pilot Trial.

This prospective randomized, controlled interventional pilot trial, aims to compare the achievement of the optimal target concentration with continuously administered flucloxacillin (FLU) or cefazolin (CZO) coupled with TDM and subsequent dose adjustment versus standard of care (intermittent bolus application without TDM-guidance) in patients with complicated Staphylococcus aureus (S. aureus) infections (CSAI). The overall goal is to individualize and optimize antibiotic treatment in a very vulnerable group of patients overcoming the standard strategy of "one-dose-fits-all".

Start Date26 Oct 2023

Sponsor / Collaborator

Universitätsspital Basel

NCT05584007 / Not yet recruitingPhase 3

A Blinded, Non-inferiority Phase III Trial of 5 Versus 7 Days of Oral Flucloxacillin in Primary Care Patients With Lower Limb Cellulitis

To determine whether a short course of oral flucloxacillin (5 days) is non-inferior to a standard course (7 days) in terms of pain over days 6-14 (indicative of persistence or recurrence associated with the symptoms of most importance to patients) in adults with cellulitis of the leg presenting in primary care.

Start Date01 Jun 2023

Sponsor / Collaborator

The University of Southampton

[+4]

100 Clinical Results associated with Floxacillin sodium

100 Translational Medicine associated with Floxacillin sodium

100 Patents (Medical) associated with Floxacillin sodium

1,240

Literatures (Medical) associated with Floxacillin sodium

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

Stability of antibiotics for use in the testing of immediate drug allergy reactions

Article

Author: Wiese, Michael D. ; Wanandy, Troy ; Adriana Le, Thanh-Thao ; Turner, Malcolm E. ; Handley, Simon A. ; Turner, Malcolm E ; Wiese, Michael D ; Lau, Wun Yee ; Handley, Simon A

BACKGROUNDLimited information is available regarding the physicochemical stability of penicillins-based preparations for skin testing purposes and no information is currently available for other classes of antibiotics.OBJECTIVETo perform chemical and physical stability studies on 16 parenteral antibiotics for skin testing purposes, with an overall aim to provide practical recommendations to clinicians on suitable components, storage, and optimal shelf-life of such preparations.METHODSChemical stability was assessed via validated stability-indicating high performance liquid chromatography with ultraviolet detection assays, while absence of precipitations or haziness, significant pH shift and colour change were used to determine physical stability.RESULTSOther than amoxicillin/clavulanic acid, all of the parenteral antibiotics were found to have adequate physicochemical stability between 2 to 7 days. Amoxicillin in Water for Injection BP retained >90% stability, while amoxicillin/clavulanic acid dropped to <80%. Ampicillin remained >90% stable for 2 days, and benzylpenicillin, flucloxacillin, and piperacillin/tazobactam were stable for ≥2 days at ∼95%. Cephalosporins were stable for 2 days, except ceftazidime, which increased to >110%. Aztreonam, ciprofloxacin, and vancomycin retained >95% stability for 7 days, while meropenem was stable for 2 days. Sulfamethoxazole/trimethoprim lost 15% but stabilized at ∼85% for 7 days. No precipitation occurred, but amoxicillin/clavulanic acid changed colour by day 7. pH decreases of ≤1.0 unit were observed in penicillins, while cefepime dropped below acceptable pH limits by day 7. Absorbance shifts >100 units were seen in several antibiotics by day 7.CONCLUSIONSThis study has generated practical stability information for clinicians, allowing 15 parenteral antibiotics from 7 different classes to be aseptically prepared in advance for use in the testing of drug allergy reactions.

01 Nov 2024·BMJ Open

Trends and patterns of antimicrobial consumption at Benjamin Mkapa Zonal Referral Hospital, Dodoma, Tanzania: a cross-sectional retrospective analysis

Article

Author: Kiwelu, Humphrey Sawira ; Yona, Yusto Julius ; Shabani, Moshi Moshi ; Chandika, Alphonce Bilola ; Chiwambo, Charity Alphonce ; Zimbwe, Kauke Bakari

ObjectiveThis study assessed the trends and patterns of antimicrobial consumption (AMC) from 2020 to 2021, 2021–2022 and 2022–2023 at the Benjamin Mkapa Zonal Referral Hospital (BMH) in Dodoma, Tanzania.DesignA retrospective cross-sectional study was conducted to collect AMC data for three financial years with respective denominators. The data were computed using the AMC Tool 2019 v1.9.0 and defined daily dose per 1000 inhabitants per day (DID).SettingThe BMH, Dodoma, Tanzania.ParticipantsThis study surveyed quantities of antimicrobials procured at the BMH. It did not have any human participants.Outcome measuresAMC was quantified in DID. The comparisons were made based on the DID of all surveyed antimicrobials, taking into account oral and parenteral administration and based on pharmacological classes. Further, DIDs were presented based on the 2023 WHO Access (A), Watch (W) and Reserve (R) (AWaRe) classification.ResultsIn 29 assessed antimicrobials, the DIDs for 2020–2021, 2021–2022 and 2022–2023 were 3.0852, 3.5892 and 3.9213, respectively. The average DID per year was 3.5319, with a mean of 2.4207±1.9765 DID per year. The topmost consumed antimicrobials over the 3 years (doxycycline, azithromycin, amoxicillin/beta-lactamase inhibitors, ampicillin/cloxacillin, amoxicillin/flucloxacillin, ceftriaxone, nitrofurantoin and clarithromycin) account over 90% of consumption. The most highly consumed therapeutic classes were beta-lactam antibacterial penicillins (34.71%), macrolides, lincosamides, streptogramins and others (25.75%), followed by tetracycline (23.88%). The AWaRe categorisation and antimicrobials not recommended (ANR) distribution were as follows: Access-51.61%, Watch-31.96%, Reserve-0.00%, and ANR-16.43%, respectively.ConclusionFor every 1000 patients attending the BMH per day, our study found 2.4207±1.9765 DIDs of an antimicrobial were consumed. The most consumed antimicrobials include doxycycline, azithromycin, amoxicillin/beta-lactamase inhibitor, ceftriaxone and metronidazole. To combat antimicrobial resistance effectively, it is imperative to institute a hospital policy for antimicrobial stewardship that prioritises the utilisation of a hospital formulary and antibiograms for the procurement of antimicrobials at the BMH.

01 Nov 2024·British Journal of Clinical Pharmacology

Flucloxacillin instantly decreases serum levels of valproic acid: A case report

Article

Author: van der Meer, Douwe H. ; van Egmond, Pleun S. ; Elting, Lisa J.

Valproic acid (VPA) is used for epilepsy and bipolar disorder. It has near‐complete bioavailability and is primarily metabolized by glucuronosyltransferases and mitochondrial oxidation. This case highlights a 79‐year‐old male with bipolar disorder on VPA therapy that started with flucloxacillin for Staphylococcus aureus bacteraemia and exhibited significantly reduced VPA serum levels. During hospitalization, flucloxacillin treatment correlated with a sharp decline of 75% in VPA total serum levels, a novel drug–drug interaction not previously reported. Nonadherence and absorption issues of VPA were ruled out, confirming flucloxacillin's role in reducing VPA levels. Because free‐fraction serum levels of VPA remained within therapeutic range (5–25 mg/L) and our patient's bipolar disorder remained stable at 1000 mg twice daily, a dose increase was not necessary. Previous reports described cytochrome P450 enzyme induction as the mechanism of flucloxacillin lowering serum levels of immunosuppressants and antimycotics. Because only 10% of VPA is metabolized by cytochrome P450 enzymes, this is not plausible for this case. The proposed mechanism for the VPA–flucloxacillin drug–drug interaction is flucloxacillin as inducer of glucuronosyltransferase enzymes via the pregnane X receptor pathway, accelerating VPA metabolism. Because this case showed that free‐fraction serum levels remained within therapeutic range, it underscores the need for free‐fraction VPA monitoring in bipolar disorder and flucloxacillin therapy. When VPA is used for epilepsy, it is advised to consider alternative antibiotics to avoid this interaction.

News (Medical) associated with Floxacillin sodium

13 Dec 2022

·www.prnewswire.com

InsightRX Provides Máxima Medical Center with Precision Dosing Guidance

Large teaching hospital in the Netherlands relies on precision dosing platform for point-of-care decision support and immunology research SAN FRANCISCO, Dec. 13, 2022 /PRNewswire/ -- Today InsightRX, a precision dosing intelligence company, announced that Máxima Medical Center (MMC), a 600-bed teaching hospital in the Netherlands, is using its cloud-based precision dosing platform to support its clinical practice and immunology research. The center relies on the InsightRX Nova platform to support accurate therapeutic drug monitoring of the antibiotic drugs vancomycin and aminoglycoside for adults, children, and neonates. Through an innovative research partnership, InsightRX Nova also provides MMC with precision dosing support and analytics for the monoclonal antibodies infliximab and adalimumab, used in the treatment of Inflammatory Bowel Disease (IBD). InsightRX Nova relies on patient-specific data, pharmacokinetic/pharmacodynamic (PK/PD) models, and Bayesian forecasting to help clinicians make treatment decisions that reflect each patient's unique pharmacological profile. By using precision dosing on the InsightRX Nova platform to recommend optimal doses from just one blood sample, MMC's hospital pharmacists can rapidly achieve the correct therapeutic exposure for drugs like vancomycin, improving treatment efficacy and impacting patient safety. Inadequate dosages of vancomycin can be ineffective and lead to possible resistance, while excessive dosages can cause acute kidney injuries. "Ten years ago, many physicians still believed in the one-dose-fits-all principle. Now, the days of simply doubling the dose when patients prove nonresponsive to treatment are over," said Luc Derijks, PharmD, PhD, clinical pharmacologist at Máxima Medical Center. "We use InsightRX Nova to predict the optimal drug dose and drug interval for our patients treated with monoclonal antibodies for IBD, which is critical for improving outcomes, both in adults and in children." Founded in 2002, MMC is comprised of two hospitals in the cities of Eindhoven and Veldhoven in southern Netherlands. As a teaching facility, MMC supports 18 specialist residencies and conducts pharmacological research in various areas, with an emphasis on personalized medicine in immunology, especially IBD. In addition to its immunology research, the center's partnership with InsightRX also enables research on the immunosuppressants tacrolimus and methotrexate; the antibiotics flucloxacillin, piperacillin, and meropenem; sunitinib, a kinase inhibitor; voriconazole, an azole antifungal; and the anti-hemophilic Factor VIII. "Despite the complexity of its algorithms, InsightRX Nova is a very intuitive decision support tool, with an interface that's easy to master," said Derijks. "After residents spend time here, using the software to calculate the area under the curve and achieve target exposure, they return to their own hospitals inspired by what personalized medicine can do." In the near future, MMC plans to implement InsightRX Apollo Silver Analytics, a real-time analytics platform which allows organizations to investigate their own therapeutic drug monitoring data imported from InsightRX Nova. The MMC team will be able to compare the performance of various a priori and a posteriori PK/PD models within its own patient population to determine the optimal models to use for empiric dosing selection and level-guided dosing. "We look forward to a long partnership with Máxima Medical Center, which has embraced the benefits of both reactive and proactive therapeutic drug monitoring," said Sirj Goswami, CEO and co-founder of InsightRX. "We are fortunate to be working with such a strong international community of pharmacologists, researchers, and clinical residents to expand the impact of precision dosing on patients around the world." About InsightRX ‍InsightRX is a healthcare technology company that has developed a cloud-based platform for precision medicine and clinical analytics designed to individualize treatment at the point of care. The platform leverages patient-specific data, pharmacology models, and machine learning to understand each patient's unique pharmacological profile and can be integrated seamlessly within a clinical workflow. Media Contact Megan Moriarty Amendola Communications for InsightRX 913.515.7530 [email protected] SOURCE InsightRX

Immunotherapy

23 Jul 2021

·www.biospace.com

FDA Greenlights AbbVie’s Antibiotic Dalvance for Acute Skin Infections in Children

Smith Collection/Gado/Getty Images The U.S. Food and Drug Administration (FDA) approved AbbVie’s Dalvance (dalbavancin) for acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients as young as newborns. The drug is given in a single-dose as a 30-mintue intravenous infusion. This approval is specifically for the treatment of ABSSSI caused by certain susceptible Gram-positive bacteria in children, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA). This is not the only recent approval for this indication. In March 2021, the FDA approved Melinta Therapeutics’ Kimrysa for that indication, which became available this month. That is a one-hour, single-dose regimen approved for adults. ABSSSI affect about 14 million people in the U.S. annually, resulting in more than 3 million emergency room visits. They cause U.S. hospitals about $4 billion annually, with a 4-day average length of stay. ABSSSI are common, but can be life-threatening, particularly in children. The most common types of skin infections seen by pediatricians are cutaneous abscesses and cellulitis. In the U.S., ABSSSI causes 3 million pediatric visits to doctors or emergency rooms each year. “Serious infections in children can be difficult to treat and the impact of ABSSSI in children is significant, as these infections often require IV antibiotics, resulting in hospitalization,” said Margaret Burroughs, medical director, infectious diseases, AbbVie. “This pediatric approval for Dalvance as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.” The approval was built on data from a trial that evaluated Dalvance in pediatric patients from newborn to less than 18 years of age with ABSSSI, as well as three pharmacokinetic studies. In the clinical trial, the safety and efficacy were tested along with intravenous vancomycin for methicillin-resistant Gram-positive infections, or intravenous oxacillin or flucloxacillin for methicillin-susceptible Gram-positive infections. The analysis in the pediatric trial was on 183 patients with ABSSSI in the Modified Intent-to-Treat (mITT) population. That included all the patients who had been randomized to receive any dose of the drug who had ABSSSI caused by Gram-positive bacteria. They looked at an early clinical response at 48 to 72 hours based on a greater than or equal to 20% decrease in size of the lesions compared to baseline as well as on the need for rescue antibacterial therapy for children who were three months of age and older. In the study, 97.3% of patients in the Dalvance single-dose arm demonstrated an early clinical response, and 93.6% had an early clinical response in the two-dose arm, while 86.7% did in the comparator arm. The safety data in the children was similar to what was seen in adults. The drug is a second-generation, semi-synthetic lipoglycopeptide. It is made up of a lipophilic side-chain attached to an enhanced glycopeptide backbone. Dalvance is approved for adults with ABSSSI caused by susceptible Gram-positive bacterium, such as Staphylococcus aureus, including MRSA, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group, and Enterococcus faecalis. It was first approved for adults with skin infections in May 2014. At that time it was developed by Durata Therapeutics. Durata was acquired by Actavis in 2014 for $675 million. Actavis acquired Allergan in 2015 and changed the company name to Allergan. AbbVie completed its acquisition of Allergan in May 2020 in a deal worth about $63 billion.

Acquisition

100 Deals associated with Floxacillin sodium

External Link

KEGG	Wiki	ATC	Drug Bank
-	Floxacillin sodium	J01CF05	DB00301

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bacterial Infections	CN	Bright Future Pharmaceuticals Factory	17 Apr 2002

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bacterial Infections	Phase 1	DE	GSK Plc	06 Jan 2005

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACTRN12610000940077 (Pubmed \| Clin Infect Dis)	Phase 2	MRSA - Methicillin resistant Staphylococcus aureus infection	60	Vancomycin	skhegknqnq(smbengacwe) = vrtpwmhfzh cixusvzqlh (gfxwotarku )	Positive	15 Jan 2016
				Vancomycin + Flucloxacillin	skhegknqnq(smbengacwe) = gpncjpmlnv cixusvzqlh (gfxwotarku )

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