Overview
Antibiotic analog of cloxacillin.
Indication
Used to treat bacterial infection by susceptible microorganisms.
Associated Conditions
- Susceptible infections
Research Report
An Expert-Level Report on Flucloxacillin
1. Executive Summary
Flucloxacillin, also known as floxacillin, is a narrow-spectrum, semisynthetic beta-lactam antibiotic belonging to the penicillin class. It is distinguished by its stability against staphylococcal beta-lactamases, which makes it particularly effective for treating infections caused by penicillinase-producing Gram-positive bacteria, most notably methicillin-sensitive Staphylococcus aureus (MSSA) and Streptococcus species. Its primary clinical applications include the treatment of a wide range of skin, soft tissue, bone, and respiratory infections. While generally well-tolerated, its safety profile warrants careful consideration due to the risk of rare but severe idiosyncratic adverse effects, including cholestatic liver injury and a potentially fatal interaction leading to high anion gap metabolic acidosis (HAGMA). A comprehensive understanding of its unique pharmacokinetic properties, its immune-mediated hepatotoxicity pathway, and its critical drug interactions is essential for its safe and effective clinical use.
The medication's regulatory and clinical use varies significantly by region. Its historical development in the United Kingdom led to its widespread adoption there, in Australia, and in New Zealand, in contrast to its limited use in the United States and Canada where similar agents like oxacillin and dicloxacillin are more prevalent. This report synthesizes available information to provide a detailed reference document covering Flucloxacillin's chemical properties, pharmacology, therapeutic applications, pharmacokinetics, and a detailed analysis of its complex safety profile.
2. Introduction to Flucloxacillin
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/06/12 | Not Applicable | Completed | Al-Rasheed University College | ||
2022/10/18 | Phase 3 | Recruiting | |||
2021/04/12 | Phase 1 | Completed | |||
2018/08/15 | Phase 4 | Withdrawn | |||
2016/12/15 | N/A | Completed | |||
2016/10/04 | Phase 4 | UNKNOWN | Royal College of Surgeons, Ireland | ||
2016/06/28 | Phase 3 | Completed | |||
2015/01/08 | Not Applicable | Completed | |||
2014/01/10 | Phase 4 | Terminated | |||
2013/06/12 | Phase 4 | Completed |
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
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. | |||||
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