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Flustar (Flucloxacillin)

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Flustar (Flucloxacillin)

Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Flustar (Flucloxacillin)

What is Flucloxacillin? (Flustar)

Property Description
Active ingredient Flucloxacillin (typically as Flucloxacillin sodium)
Forms Capsules, Oral Solution, Powder for Injection
Pharmacological class beta-Lactam Antibiotic (Penicillin Class)
General purpose Elimination of bacterial infections
Origin Semi-synthetic compound

What Type of Medicine is Flucloxacillin?

Flucloxacillin is a semisynthetic beta-lactam antibiotic classified within the penicillin class of antimicrobial medicines. This agent is formally grouped as a beta-Lactamase resistant penicillin, reflecting a structural enhancement over earlier, less stable penicillins. Its origin is semi-synthetic, being chemically derived from the core structure of the natural penicillin molecule. Flucloxacillin is categorized as an antibacterial agent for systemic use. This classification is clinically recognized by infectious disease guidelines, indicating the medicine is designed to destroy bacterial organisms throughout the body.

Composition and Available Forms

The substance that provides the therapeutic effect is the active ingredient, Flucloxacillin, usually prepared as the salt Flucloxacillin sodium. This medicine is made available across several high-level dosage forms for different administration needs. These include hard capsules and a powder for oral solution for oral use, and a powder for solution for injection or infusion for parenteral administration. This inherent versatility in formulation allows for the medicine's application across patient groups from adults to children, and is a feature shared by related analogues such as Cloxacillin.

The Purpose and Unique Feature of Flucloxacillin

The primary purpose of Flucloxacillin is to combat bacterial infections caused by susceptible microorganisms, specifically certain Gram-positive organisms. A unique and essential feature of Flucloxacillin is its inherent stability against the deactivating bacterial enzyme beta-lactamase (penicillinase). This resistance is a defining characteristic for its effectiveness against strains of Staphylococcus that would otherwise destroy standard penicillin. This property makes Flucloxacillin a primary agent for managing bacterial infections of the skin or soft tissue, where beta-lactamase-producing organisms are commonly implicated.

Regulatory References

  1. Penicillins (2nd Generation) - LiverTox (NIH)
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What side effects are possible with Flustar (Flucloxacillin)?

Possible Side Effects and Safety Information

Flucloxacillin's officially documented safety profile includes adverse reactions categorized by frequency and the organ system affected. The most common reactions involve minor disturbances, while the medicine carries a specific risk for rare, potentially serious conditions across several body systems, as defined in regulatory documents.

Adverse Reaction Frequency

Classification Examples of Documented Effects
Common Minor gastrointestinal disturbances, such as nausea and mild diarrhoea.
Uncommon Skin reactions, including rash, urticaria (hives), and purpura.
Very Rare Severe reactions, including hepatic disorders (hepatitis, cholestatic jaundice), blood disorders (neutropenia), and serious hypersensitivity responses.

Serious Adverse Reactions

The regulatory profile highlights several serious adverse reactions, including Anaphylactic Shock, which is a potentially fatal systemic reaction, and severe forms of Hepatitis and Cholestatic Jaundice. The medicine is also associated with a risk of Severe Cutaneous Adverse Reactions (SCARs) such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). These are classified as very rare events.

Contextual Safety Patterns

Official documents note specific safety patterns related to patient characteristics and timing. The risk of severe hepatic reactions is documented to be higher in older patients (aged 50 or older) and may exhibit a delayed onset, sometimes occurring up to two months after treatment discontinuation. For patients with severe renal impairment, there is a documented potential for neurological disorders, including convulsions, particularly when high intravenous doses are administered. The medicine is restricted for use in individuals with a known history of hypersensitivity to any penicillin.

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Overdose and Emergency Response

Overdose and When to Seek Help

The officially documented profile for Flucloxacillin overdose focuses on severe manifestations, particularly those affecting the central nervous system (CNS). Seek immediate medical attention or contact emergency services immediately upon known or suspected overdose, as mandated by regulatory authorities.

Overdose presentations documented in official prescribing information include neurological disturbances such as convulsions, seizures, myoclonus, and encephalopathy, potentially progressing to severe CNS toxicity.


Official Regulatory Statements

Overdose Presentation Key Regulatory Actions
Neurological disturbances Seek immediate medical attention and discontinue the medicine.
Hypernatremia/Fluid Imbalance Monitoring of fluid and electrolyte balance is required.

Population-Specific Overdose Notes

The risk of CNS toxicity is significantly increased in patients with impaired renal function, due to the reduced ability to clear the medicine. Furthermore, the high sodium content of the Flucloxacillin salt formulation places infants and children at increased vulnerability to hypernatremia (high blood sodium levels).

Management is strictly symptomatic and supportive, and official regulatory texts state that no specific antidote is known. Procedures such as gastric lavage or haemodialysis may be considered in severe cases, as described in official labeling.

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Therapeutic Uses of Flustar (Flucloxacillin)

What Flustar (Flucloxacillin) Treats: Main Uses and Benefits

Flucloxacillin is applied in clinical settings marked by the presence of specific bacterial infections, and is commonly used to help manage symptoms related to infection. This medicine is commonly used in conditions presenting with systemic or localized discomfort, as indicated for infections caused by sensitive Gram-positive organisms, including those that may be difficult to treat due to beta-lactamase production.

Clearing Acute Skin and Soft Tissue Infections

This medicine is commonly used across conditions presenting with systemic or localized discomfort, such as cellulitis, impetigo, and infected wounds, where symptoms cluster into patterns of intense local inflammation, including redness, swelling, and heat. The therapeutic benefit may provide supportive relief in situations involving certain distressing symptoms, which helps ease the overall symptom burden and may assist with easing the impact of local infection symptoms.

Managing Severe and Deep-Seated Bacterial Foci

Flucloxacillin is also relevant in contexts involving a heightened systemic burden, specifically treating deep infections like osteomyelitis (bone infection) or septic arthritis, and is utilized for serious systemic presentations like endocarditis and sepsis. This use may provide supportive relief associated with acute or disruptive episodes, and contributes to easing systemic symptoms like fever, which may assist with maintaining functional stability against significant physiological strain, by assisting with the symptomatic management of deep-seated infection.

Support in High-Risk and Postoperative Scenarios

This medicine is applied in scenarios where additional management of discomfort is required, such as treating infection in chronic leg ulcers or diabetic foot lesions. It is commonly used when short-term symptomatic assistance is needed as a prophylactic agent (preventive use) during major surgical procedures, particularly in orthopaedic or cardiothoracic surgery. This application supports the patient during difficult episodes by easing distress and supports general well-being during symptomatic phases.


Quick Fact: Relief for Inflammatory Symptoms
Flucloxacillin helps address symptom clusters related to local inflammation, such as redness, swelling, and pain, providing supportive relief that assists with maintaining functional stability.

Regulatory References

  1. HPRA Regulatory Summary on Flucloxacillin Indications
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Eligibility and Restrictions for Use

Official Eligibility Rules for Flucloxacillin

Flucloxacillin's eligibility is strictly defined by regulatory documents, focusing on patient history and organ function. Most adults and children are generally eligible for use.

Absolute Contraindications

The medicine is formally contraindicated and must not be used in the following populations:

Contraindicated Group Regulatory Basis
beta-Lactam Hypersensitivity Known allergy to flucloxacillin, any penicillin, or cephalosporin.
Prior Liver Injury History of flucloxacillin-associated jaundice or hepatic dysfunction.

Populations Requiring Conditional Use

Use requires special caution or dose modification in populations where physiological factors may increase risk or alter drug levels:

  • Severe Renal Impairment (creatinine clearance <10 mL/min): Dose reduction or an extension of the dose interval must be considered.
  • Hepatic Dysfunction and Patients ge 50 Years Old: Caution is required due to an increased risk of hepatic reactions.
  • Newborns/Premature Infants: Special caution is essential due to the risk of hyperbilirubinaemia.

Pregnancy and Lactation Eligibility

Use during pregnancy is generally not recommended unless considered essential. Flucloxacillin is excreted in breast milk; administration should be assessed based on whether the potential benefits outweigh the potential risks.

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What should I know about interactions with other medicines?

Official Regulatory Information for Flustar (Flucloxacillin)

The interaction profile for Flucloxacillin is defined by specific regulatory statements regarding co-administration with other substances, detailing pharmacokinetic changes and resulting risks.

Category Summary of Documented Interaction Pattern
Exposure Modification Co-administration with Methotrexate reduces its renal excretion, which formally increases the potential risk of Methotrexate toxicity. Concomitant use with Warfarin is documented to potentially alter the International Normalised Ratio (INR) and requires mandated close laboratory monitoring. Flucloxacillin may also reduce the overall effectiveness of specific therapeutic agents, including the antifungal Voriconazole and the neuromuscular block reversal agent Sugammadex.
Pharmacokinetic Competition Substances such as the uricosuric agents Probenecid and Sulfinpyrazone compete for the same renal tubular secretion pathway. This competition is officially documented to delay Flucloxacillin excretion, resulting in enhanced and more sustained plasma concentrations of the antibiotic.
Pharmacodynamic Risk Caution is advised when Flucloxacillin is co-administered with Paracetamol due to the officially documented risk of high anion gap metabolic acidosis (HAGMA). This risk is specifically noted for patients with pre-existing conditions like severe renal impairment, sepsis, or malnutrition.
Contraindicated/Efficacy Loss Flucloxacillin is formally contraindicated in patients with a history of Flucloxacillin-associated jaundice or hepatic dysfunction. Furthermore, the Oral Typhoid Vaccine (Live attenuated) may be subject to inactivation, leading to loss of its protective effect.

Population-Specific Notes:

Official labeling highlights that high parenteral doses in jaundiced newborns carry a specific risk of kernicterus due to the antibiotic's ability to displace bilirubin from plasma protein binding sites.

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Mechanism of Action

How Flustar (Flucloxacillin) Works: Mechanism of Action

Inhibiting the Bacterial Cell Wall Building Process

Flucloxacillin initiates its action by targeting and irreversibly deactivating a group of bacterial enzymes called Penicillin-Binding Proteins (PBPs), which are essential for constructing the bacterial cell wall structure. This permanent chemical blockade prevents the necessary cross-linking of the peptidoglycan polymer. The resulting failure of the bacterial cell wall structure leads directly to the cell's inability to withstand its own internal pressure, causing it to rupture and die (bactericidal effect).

Structural Resistance to Bacterial Deactivation

A unique structural feature of Flucloxacillin is the bulky isoxazolyl side chain, which confers steric hindrance against the deactivating bacterial enzyme beta-lactamase. This resistance mechanism preserves the beta-lactam ring—the core functional part of the molecule—from enzymatic hydrolysis. This structural stability allows the cell wall inhibition mechanism to function against bacterial strains that produce beta-lactamase enzymes.

Constraints on the Lysis Mechanism

The mechanism is highly selective, meaning its activity is physiologically constrained by bacterial structure. The mechanism is constrained against many Gram-negative bacteria because their outer membrane acts as a barrier, limiting drug access to the PBPs. The mechanism is rendered ineffective against Methicillin-Resistant Staphylococcus aureus (MRSA) because these strains express a modified target enzyme (PBP2a) with extremely low binding affinity for Flucloxacillin.

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Dosage and Administration Information

Official Administration Routes and Forms

Flucloxacillin is designated for use across multiple administration methods, reflecting the spectrum of clinical needs. The medicine is officially approved for oral administration via hard capsules or reconstituted solution, and for parenteral routes, including intravenous (IV) or intramuscular (IM) injection. Specialized local routes such as intra-articular and intrapleural injection are also specified in regulatory labeling.


Dosing Schedule and Timing Constraints

The standard adult dosing for typical infections ranges from 250 mg to 500 mg per dose. This regimen adheres to a divided and frequent dosing schedule, typically requiring administration four times a day (e.g., six-hourly), ensuring a minimum interval of 4 hours between doses. Higher doses, utilizing up to 8 g daily, are documented for deep-seated infections like osteomyelitis.

Crucially, oral administration must occur on an empty stomach to ensure optimal systemic absorption. This instruction mandates taking the dose 60 minutes before a meal or 2 hours after a meal. Furthermore, a formal dose adjustment is specified for severe renal impairment (creatinine clearance <10 mL/min), limiting the maximum dose to 1 g every 8 to 12 hours. This structured administration protocol ensures consistent systemic drug exposure as defined by regulatory standards.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Flustar (Flucloxacillin)

Evidence for Use in Acute Skin and Soft Tissue Infections

Research examining Flucloxacillin's use in conditions like cellulitis and impetigo includes Randomized Controlled Trials (RCTs) and systematic reviews. Studies were primarily conducted on adults, including those with existing conditions like diabetes or lymphoedema. Researchers monitored outcomes related to physical discomfort and the change in local inflammatory states, such as measuring changes in pain, redness, swelling, and heat. Evidence contributes to understanding symptom patterns, as trials described measurements of the change in clinical status. However, the scientific literature has noted a sparsity of high-quality comparative trials and that evidence quality varies across studies.

Evidence for Use in Deep-Seated and Systemic Foci

For deep infections like osteomyelitis and serious presentations such as S. aureus bacteraemia, the research base relies mostly on Retrospective Cohort Studies and Prospective Observational Studies, as large-scale RCTs are lacking. Studies explored outcomes related to systemic or functional imbalance across adults, including the critically ill and those with multiple co-morbidities. Research describes patterns observed, often tracking patients over long-term follow-up durations (sometimes up to 12 months). Comparative evidence is lacking for conditions like osteomyelitis, and the data primarily stem from observational settings.

Evidence for Preventive Use in Surgical Procedures

Flucloxacillin's use as a prophylactic agent during major surgery (e.g., orthopaedic or cardiothoracic) is summarized through Systematic Reviews of Prophylaxis Protocols. The primary outcome monitored was the incidence of a Surgical Site Infection (SSI) following the procedure, typically assessed at 30 or 90 days post-procedure. While evidence synthesis is generally consistent, some analyses may group Flucloxacillin with other similar agents.

What is Still Uncertain About the Research Base

The research base has several limitations documented in the scientific literature. Follow-up durations were limited in acute settings, meaning there is limited information for long-term outcomes or infection recurrence over extended periods. Furthermore, data for certain groups, such as pregnant populations, remain insufficient, and certainty remains low for subgroups where specific research may be limited.

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Frequently Asked Questions (FAQ)

Common questions about Flustar (Flucloxacillin) (FAQ)

Q: Is Flustar considered a broad-spectrum or narrow-spectrum antibiotic?

According to official classifications, Flucloxacillin is considered a narrow-spectrum antibiotic. This means its activity is focused on a more limited range of bacteria, primarily those in the Gram-positive group, including certain strains that produce the beta-lactamase enzyme.

Q: Can Flustar cause a fungal infection like thrush?

It is possible to develop a secondary fungal infection, such as oral or vaginal thrush, while taking antibiotics. Official patient information describes symptoms to be aware of, such as a sore white mouth or vaginal discharge, as this may indicate a fungal infection.

Q: What are the signs of a possible liver problem related to Flustar use?

Official regulatory documents advise watching for signs of liver issues, which can include jaundice. Jaundice is characterized by a yellow coloring of the skin and the whites of the eyes. This is a very rare but serious event often managed through immediate medical consultation.

Q: How should common gastrointestinal side effects from Flustar be generally managed?

If you experience common gastrointestinal effects like mild nausea or diarrhoea, official patient information suggests drinking plenty of fluids to avoid dehydration and sticking to simple, easily digestible meals. It is generally advised not to use over-the-counter anti-diarrhoea medicines without consulting a professional.

Q: Can Flustar cause muscle or joint pain?

Yes, official safety information documents arthralgia (joint pain) and myalgia (muscle pain) as very rare side effects. These effects are sometimes reported to occur more than 48 hours after a patient begins treatment with the medicine.

Q: Is there a risk of Clostridium difficile-associated diarrhea after taking Flustar?

Official safety documents list pseudomembranous colitis as a very rare gastrointestinal side effect. This condition, often linked to the bacteria C. difficile, may be indicated by severe bloody diarrhoea, which often necessitates immediate medical intervention as described in regulatory documents.

Q: Does Flustar cause fatigue or tiredness?

While specific fatigue or tiredness is not commonly listed, official safety documents do include the general disorder malaise. This term describes a general feeling of discomfort, illness, or unease that a person may experience while taking the medicine.

Q: Does Flustar interact with the oral contraceptive pill?

Official patient safety information states that Flucloxacillin is not known to directly stop the oral contraceptive pill from working. However, if the antibiotic causes severe vomiting or diarrhoea, the effectiveness of the contraceptive pill could be reduced, as with any illness that causes malabsorption.

Q: Is it safe to consume alcohol while taking Flustar?

There is no known direct regulatory contraindication that strictly prohibits consuming alcohol with Flucloxacillin. Official advice suggests limiting alcohol intake, as it may worsen common side effects like stomach upset and could potentially increase the risk of liver-related adverse effects when consumed in excess.

Q: What types of over-the-counter medications might have a known interaction with Flustar?

The official product information documents a specific risk when Flucloxacillin is taken with Paracetamol (acetaminophen). Co-administration carries a potential risk of high anion gap metabolic acidosis (HAGMA) in patients who have certain pre-existing conditions.

Q: Does Flustar interact with any common herbal supplements?

Official guidance indicates that patients should inform their doctor or pharmacist of all supplements being taken. This is because insufficient evidence exists to confirm the safety of taking herbal remedies or supplements alongside prescription medicines.

Q: How long does it typically take for a person to start feeling better after beginning Flustar treatment?

Official patient information states that for the most common infections, a person should typically start to feel better within a few days of starting the antibiotic course. The prescribed course should always be completed in full, even if symptoms improve.

Q: What is the general advice for a missed dose of Flustar?

If a dose is missed, official patient instructions advise waiting for the next regularly scheduled dose. Regulatory guidance states that a double dose should not be taken to compensate for a missed dose.

Q: What is the usual duration of a Flustar treatment course for common infections?

The length of the treatment course varies significantly based on the infection being treated. Official patient information often indicates that typical courses for common infections may range from 5 to 7 days, though deep-seated or more severe infections require much longer courses, sometimes weeks or months.

Q: What happens if a person stops taking Flustar before the prescribed course is finished?

Official patient warnings caution against stopping treatment early. Discontinuation before the prescribed course is complete may allow some bacteria to survive, potentially causing the infection to return or leading to the development of antibiotic-resistant bacteria.

Q: Are there any reported steps to reduce throat or esophagus irritation when taking Flustar capsules?

Yes, regulatory documents provide specific administration instructions to reduce irritation. Capsules should be swallowed upright with a full glass of water (250 mL), and patients are advised to avoid lying down immediately after administration.

Q: Have any studies examined the effect of Flucloxacillin on human fertility?

Official patient advice based on regulatory information indicates that there is no evidence available to suggest that taking Flucloxacillin has any effect on fertility in either men or women.

Q: Is yellowing of the skin or eyes a reported side effect of Flustar?

Yes, yellowing of the skin and/or eyes is a documented sign of the very rare but serious adverse effects that can affect the liver, specifically cholestatic jaundice and hepatitis. Consultation with a medical professional is required upon observation of this effect.

Q: What are the symptoms of a serious allergic reaction to Flustar?

Official product information lists symptoms of a serious allergic reaction, which can include swelling of the face, lips, tongue, or throat, difficulty breathing, severe, itchy rash (hives), or wheezing. These symptoms are a recognized reason for seeking immediate medical attention.

Q: Does Flustar have the potential to affect the results of blood tests?

Yes, official regulatory documents advise patients to inform their doctor or lab technician that they are taking Flucloxacillin. This is because the medicine has the potential to affect the results of certain blood tests.

Q: Is Flustar available in pediatric formulations for children?

Yes, to facilitate administration across patient groups, Flucloxacillin is available as a powder for oral solution (a liquid form). The liquid form is commonly used for children, and doses are calculated based on the child's age and weight.

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How should Flustar (Flucloxacillin) be stored and disposed of?

How to Store and Dispose of Flustar (Flucloxacillin)

Official regulatory guidelines define specific requirements for storing and disposing of flucloxacillin to maintain product integrity and safety.

Product Form Storage Temperature Stability/Protection
Capsules/Dry Powder Below 25 C or 30 C Keep in original package; Protect from light and moisture.
Reconstituted Solution Refrigerator (2 C to 8 C) Discard after 7 days, even if refrigerated.

All forms of this medicine must be kept out of the sight and reach of children. Do not use flucloxacillin after the expiry date noted on the packaging.

Disposal instructions mandate that unused or expired medicine not be disposed of via wastewater or general household trash. To help protect the environment, dispose of this medicine in accordance with local requirements, such as a medicine take-back program provided by a pharmacist.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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