Consumer medicine information

APO-Flucloxacillin

Flucloxacillin

BRAND INFORMATION

Brand name

APO-Flucloxacillin

Active ingredient

Flucloxacillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APO-Flucloxacillin.

What is in this leaflet

This leaflet answers some common questions about flucloxacillin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may want to read it again.

What this medicine is used for

Flucloxacillin is used to treat infections in different parts of the body caused by bacteria. It belongs to a group of medicines called penicillins.

How it works

Flucloxacillin is an antibiotic that works by killing the bacteria that are causing your infection.

Flucloxacillin will not work against infections caused by viruses, such as colds or flu.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.

This medicine is available only with a doctor's prescription.

This medicine is not addictive.

There is not enough information to recommend the use of this medicine for children under the age of 2 years

Before you take this medicine

WARNING: Flucloxacillin can cause severe liver damage, particularly in older patients and those who take it for more than 14 days.

When you must not take it

Do not take this medicine if you are allergic to:

  • flucloxacillin
  • penicillin antibiotics
  • cephalosporin antibiotics
  • beta-lactam antibiotics including imipenem and aztreonam
  • any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue, throat or other parts of the body
  • rash, itching or hives on the skin

Do not take this medicine if you have had a reaction affecting your liver while you were taking flucloxacillin or another penicillin antibiotic. Examples of liver reactions include hepatitis and jaundice (yellowing of the eyes or skin).

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

Do not use this medicine in your eyes.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • liver problems or jaundice (yellowing of the skin or eyes)
  • kidney problems
  • asthma, hayfever, eczema or other allergic conditions.

Tell your doctor if you are pregnant or you plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.

The active ingredient Flucloxacillin passes into breast milk and there is a possibility that your baby may be affected.

If you have not told your doctor about any of the above, tell them before you start taking this medicine.

Taking other medicines

Tell your doctor and pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Tell your doctor or pharmacist if you are taking this medicine in combination with paracetamol, particularly if you have impaired kidney function.

Some medicines and flucloxacillin may interfere with each other. This includes:

  • probenecid, a medicine commonly used to treat gout
  • some antibiotics may decrease the effectiveness of some birth control pills, although this has not been shown with flucloxacillin. Talk to your doctor about the need for additional contraception while taking flucloxacillin.

These medicines may be affected by this medicine or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid whilst taking this medicine.

Other medicines not listed above may also interact with flucloxacillin.

How to take this medicine

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

For most infections, the usual dose for adults is 250 mg every 6 hours.

For children 2-10 years: half adult dose.

How to take it

Swallow the capsules whole with a full glass of water.

When to take it

Take this medicine at the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

Take flucloxacillin on an empty stomach, for example, half to one hour before meals and at bedtime. Food can interfere with the absorption of flucloxacillin.

How long to take it for

Continue taking this medicine until you finish the pack, or for as long as your doctor tells you.

Do not stop taking this medicine, even if you feel better after a few days, unless advised by your doctor. Your infection may not clear completely if you stop taking your medicine too soon.

If you forget to take it

If it is almost time to take your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for missed doses. This may increase the chance of you experiencing side effects.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much of this medicine. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much flucloxacillin, you may get diarrhoea and nausea.

While you are taking this medicine

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medication.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately.

Keep all of your doctor's appointments so that your progress can be checked.

Your doctor may occasionally do tests (such as liver function tests) to make sure the medicine is working and to prevent side effects.

If your symptoms do not improve within a few days, or if they become worse, tell your doctor.

If you develop jaundice (yellowing of the eyes or skin), tell your doctor immediately. Do this even if it occurs several weeks after you have stopped taking flucloxacillin. Jaundice may mean that you have a serious condition affecting your liver. You may need urgent medical care.

If you get severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after you have stopped taking flucloxacillin. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without checking with your doctor.

If you get a sore, white mouth or tongue while taking or soon after stopping flucloxacillin, tell your doctor. Also tell your doctor if you get vaginal itching or discharge. This may mean you have a fungal infection called thrush. Sometimes, the use of flucloxacillin allows fungi to grow and the above symptoms to occur. Flucloxacillin does not work against fungi.

If you get severe skin reactions with painful red areas, large blisters, peeling of skin layers; fever, chills, aching muscles, feeling unwell (signs of drug reaction with eosinophiliaand systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome or toxic epidermal necrolysis), stop taking this medicine immediately and tell your doctor.

Things you must not do

Do not take any medicine for diarrhoea without first checking with your doctor or pharmacist.

Do not take this medicine to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor.

If you stop taking it suddenly, your condition may worsen.

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine affects you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking flucloxacillin.

Flucloxacillin treats infections in most people, but it may have unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

IMPORTANT: Flucloxacillin can cause severe liver damage, which can make the skin and whites of the eyes turn yellow in colour. This is more likely to occur in older patients particularly those over 55 years of age and those who take it for more than 14 days.

Immediately contact your doctor if you notice any yellowing of your eyes or skin.

Tell your doctor or pharmacist if you notice any of the following:

  • nausea
  • feeling sick or vomiting
  • stomach upset, diarrhoea
  • a mild rash
  • oral thrush (white, furry sore tongue and mouth)
  • vaginal thrush (sore and itchy vagina and/or vaginal discharge).

The above list includes the more common side effects of your medicine.

Tell your doctor as soon as possible if you notice any of the following:

  • tiredness, headaches, being short of breath when exercising, dizziness and looking pale (possible anaemia).

The above list includes serious side effects that may require medical attention.

If any of the following happen, stop taking your medicine and contact your doctor immediately or go to Accident and Emergency at your nearest hospital, even if they occur several weeks after stopping treatment with flucloxacillin:

  • allergic reaction, symptoms pf which include swelling of the face, lips, tongue or other parts of the body; shortness of breath, wheezing or troubled breathing; skin rash, itching or hives
  • red, scaly rash with bumps under the skin and blisters
  • watery and severe diarrhoea, which may also be bloody
  • severe stomach cramps
  • frequent infections such as fever, chills, sore throat or mouth ulcers
  • convulsions or fits
  • yellowing of the eyes or skin (jaundice)
  • bleeding or bruising more easily than normal
  • painful, swollen joints
  • aching muscles, muscle tenderness or weakness, not caused by exercise
  • irregular heart beat
  • dark or cloudy urine, blood in the urine.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor or pharmacist if notice anything that is making you feel unwell.

Other side effects not listed above may occur in some patients.

After stopping Flucloxacillin

Tell your doctor if your skin and/ or eyes have turned yellow (jaundice) whilst or soon after you finish taking flucloxacillin. Tell your doctor immediately if you notice any of the following side effects, even if they occur up to several weeks after finishing treatment with flucloxacillin:

  • watery and severe diarrhoea, which may also be bloody
  • severe abdominal cramps or stomach cramps
  • fever, in combination with one or both of the above

These are rare but serious side effects. Flucloxacillin can change the bacteria (which are normally present in the bowel and are harmless) to multiply and therefore cause the above symptoms. You may need urgent medical attention.

Storage and

Storage

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 25°C.

Do not store this medicine or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

250 mg capsule (blister pack): Size 2 capsule with blue cap and blue body printed with "F250". AUST R 226382

500 mg capsule (blister pack): Size 0 capsule with blue cap and blue body printed with "F500". AUST R 226374

Pack sizes of 24 and 48 capsules.

* Not all strengths and/or pack sizes may be available.

Ingredients

Each tablet contains 250 mg & 500 mg of flucloxacillin (as sodium) as the active ingredient.

It also contains the following:

  • magnesium stearate
  • titanium dioxide
  • indigo carmine
  • methyl hydroxybenzoate
  • propyl hydroxybenzoate
  • gelatin
  • shellac
  • isopropyl alcohol
  • ethanol

This medicine does not contain gluten, lactose, sucrose, tartrazine and other azo dyes.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113

APO and APOTEX are registered trade marks of Apotex Inc.

This leaflet was prepared in
December 2020.

Published by MIMS February 2021

BRAND INFORMATION

Brand name

APO-Flucloxacillin

Active ingredient

Flucloxacillin

Schedule

S4

 

1 Name of Medicine

Flucloxacillin sodium monohydrate.

2 Qualitative and Quantitative Composition

Each capsule contains 250 mg or 500 mg flucloxacillin (as sodium monohydrate) as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

500 mg capsule.

Size 0 capsule with blue cap and blue body printed with "F500".

250 mg capsule.

Size 2 capsule with blue cap and blue body printed with "F250".

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of confirmed or suspected staphylococcal and other Gram positive coccal infections including pneumonia, osteomyelitis, skin and soft tissue and wound infections, infected burns, cellulitis.

4.2 Dose and Method of Administration

The oral dose should be administered half to one hour before meals.

Usual adult dose.

250 mg, 6 hourly.

Children.

2-10 years.

Half adult dose.

Note.

In severe infections the dosage may be increased.

Impaired hepatic function.

Adjustment of dosage may not be necessary as flucloxacillin is not metabolised in the liver to any appreciable extent. However, during prolonged treatment, it is advisable to check periodically for hepatic dysfunction (see Section 4.4 Special Warnings and Precautions for Use).

Impaired renal function.

As flucloxacillin is excreted to a large extent by the kidney, the dose or dose interval may need modification in patients with renal failure, as the half-life in these patients is increased. Dosage recommendations for various plasma creatinine levels for patients with impaired renal function are not available. Flucloxacillin is not significantly removed by haemodialysis.

4.3 Contraindications

Flucloxacillin is contraindicated for:
Patients who are hypersensitive to beta-lactam antibiotics (e.g. penicillins, cephalosporins).
Patients with a previous history of flucloxacillin-associated jaundice/hepatic dysfunction.
Use in the eye.

4.4 Special Warnings and Precautions for Use

High anion gap metabolic acidosis.

Caution is advised when flucloxacillin sodium monohydrate is administered concomitantly with paracetamol due to the increased risk of high anion gap metabolic acidosis (HAGMA). Patients at high risk for HAGMA are in particular those with severe renal impairment, sepsis or malnutrition especially if the maximum daily doses of paracetamol are used.
After co-administration of flucloxacillin sodium monohydrate and paracetamol, close monitoring is recommended in order to detect the appearance of acid-base disorders, namely HAGMA, including testing for urinary 5-oxoproline.
If flucloxacillin sodium monohydrate is continued after cessation of paracetamol, it is advisable to ensure that there are no signals of HAGMA, as there is a possibility of flucloxacillin sodium monohydrate maintaining the clinical picture of HAGMA. (See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 4.8 Adverse Effects (Undesirable Effects)).

Severe cutaneous adverse reactions.

Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients taking beta-lactam antibiotics. When SCAR is suspected, flucloxacillin sodium monohydrate should be discontinued immediately and an alternative treatment should be considered.

Use in hepatic impairment.

Warning.

Hepatitis, predominantly of cholestatic jaundice, which may be protracted, has been reported with flucloxacillin therapy (see Section 4.8 Adverse Effects (Undesirable Effects)). Reports have been more frequent with increasing age (particularly over 55 years of age) or following prolonged treatment (beyond 14 days). Jaundice may appear several weeks after therapy; in several cases, the course of the reactions has been protracted and lasted for several months. Resolution has occurred with time in most cases. In rare cases, deaths have been reported, nearly always in patients with serious underlying disease or receiving concomitant medication.
Serious, and occasionally fatal, hypersensitivity (anaphylaxis) reactions have been reported in patients receiving beta-lactam antibiotics e.g. penicillins. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral therapy. Before commencing therapy with any beta-lactam antibiotic, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If a hypersensitivity reaction occurs, appropriate therapy should be instituted and flucloxacillin therapy discontinued.
Serious anaphylactoid reactions require emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management including intubation should also be administered as indicated.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including flucloxacillin. A toxin produced with Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases, appropriate therapy with a suitable oral antibacterial agent effective against Clostridium difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated. Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.
Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction, even though this is not a recognised predisposing factor to hepatic reactions to the drug.
Caution should be exercised in the treatment of patients with an allergic diathesis.
The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthematous pustulosis (AGEP). In case of AGEP diagnosis, flucloxacillin should be discontinued and any subsequent administration of flucloxacillin contraindicated.
It should be recognised that each 1 g of flucloxacillin sodium monohydrate contains sodium 2.2 mmol. This should be included in the daily allowance of patients on sodium restricted diets.
During long-term treatments regular monitoring of hepatic and renal function is recommended.

Use in the elderly.

No data available.

Paediatric use.

Animal studies show that high doses of flucloxacillin reduce albumin bound bilirubin to 50-70% of the baseline concentration. The drug should therefore be used with extreme caution in jaundiced neonates or premature infants.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Caution should be taken when flucloxacillin sodium monohydrate is used concomitantly with paracetamol as concurrent intake has been associated with high anion gap metabolic acidosis, especially in patients with risk factors (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).
Probenecid decreases the renal tubular secretion of flucloxacillin. Concurrent use with flucloxacillin may result in increased and prolonged blood levels of flucloxacillin.
In common with other antibiotics, patients should be warned that flucloxacillin may reduce the effectiveness of oral contraceptives.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B1)
The safety of flucloxacillin in the first trimester of pregnancy has not yet been established. Animal studies with flucloxacillin have shown no teratogenic effects. The product has been in clinical use since 1970 and the limited number of reported cases of use in human pregnancy have shown no evidence of untoward effect. Flucloxacillin should not be used in pregnancy unless considered essential by the physician.
 Flucloxacillin is excreted in breast milk in trace amounts. In nursing mothers, an alternative feeding method is recommended because of the risk of allergic sensitisation in the infant.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

As with all penicillins, the possibility of hypersensitivity reactions should always be considered. Reactions are more likely to occur in those with an allergic diathesis. Anaphylactic shock is most likely to occur with injected penicillins (see Section 4.4 Special Warnings and Precautions for Use).
The following adverse reactions have been reported as associated with the use of flucloxacillin.

Metabolism and nutrition disorders.

Post marketing experience: very rare cases of high anion gap metabolic acidosis, when flucloxacillin sodium monohydrate is used concomitantly with paracetamol, generally in the presence of risk factors (see Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Gastrointestinal.

Nausea, vomiting, diarrhoea, dyspepsia. As with other antibiotics, pseudomembranous colitis has rarely been reported.

Hypersensitivity reactions.

Erythematous maculopapular rashes, urticaria, purpura, eosinophilia, angioneurotic oedema. Anaphylaxis and erythema multiforme have been reported rarely. Certain reactions (fever, arthralgia, myalgia) sometimes develop more than 48 hours after the start of treatment. Whenever such reactions occur, flucloxacillin should be discontinued. (Note. Urticaria, other skin rashes and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids).

Renal.

Cases of nephritis, interstitial nephritis and haematuria have been reported.

Hepatic.

Cases of hepatitis and cholestatic jaundice (occasionally severe) have been reported (see Section 4.4 Special Warnings and Precautions for Use). These may be delayed for up to two months post-treatment. A frequency of about 1 in 15,000 exposures have been reported for cholestatic jaundice. Changes in liver function tests may occur, but are reversible when treatment is discontinued.

Haematological.

Haemolytic anaemia has been reported during therapy with flucloxacillin. Reactions such as anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leucopenia, neutropenia and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Central nervous system.

Adverse effects have been reported rarely. They include dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses. As the blood brain barrier becomes more permeable in meningitis, toxic symptoms may be precipitated by lower levels of flucloxacillin in patients with meningitis.

Skin and other subcutaneous tissue disorders.

Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in beta-lactam antibiotics.
A red, scaly rash with bumps under the skin and blisters-AGEP-acute generalised exanthematous pustulosis.

Other.

Vaginal or oral moniliasis may occur following the use of antibiotics.
Amongst the adverse events reported spontaneously to ADRAC, 61% were dermatological effects, 17% were jaundice, 16% were gastrointestinal reactions and 2.5% were CNS related.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

4.9 Overdose

No information is available, but it could be anticipated that overdosage with oral flucloxacillin would cause gastrointestinal and CNS symptoms (see Section 4.8 Adverse Effects (Undesirable Effects)). As the blood brain barrier becomes more permeable in meningitis, toxic symptoms may be precipitated by lower levels of flucloxacillin in patients with meningitis.
Flucloxacillin is not significantly removed from the circulation by haemodialysis. General supportive measures should be instituted and consideration given to the use of activated charcoal to minimise gastrointestinal absorption.
Activated charcoal may reduce absorption of the medicine if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Flucloxacillin is a narrow spectrum antibiotic with considerable activity against the following common Gram positive organisms: penicillinase producing Staphylococcus aureus, penicillin sensitive Staphylococcus aureus, β-haemolytic streptococci (Streptococcus pyogenes), Diplococcus pneumoniae.
It is not active against Gram negative bacilli, methicillin resistant Staphylococcus aureus, nor Streptococcus faecalis.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Flucloxacillin is well absorbed following oral administration, with active levels being reached within half an hour and peak levels within one hour. In the presence of food in the gastrointestinal tract, the absorption of flucloxacillin is delayed resulting in lower peak serum levels.

Distribution.

Flucloxacillin, like other isoxazolyl penicillins, is highly bound to serum proteins (> 92%). The low MICs of flucloxacillin against Gram-positive cocci and the free antibiotic levels achieved, however, ensure that flucloxacillin is fully active against susceptible pathogens.

Metabolism.

No data available.

Excretion.

The major route of excretion is renal (by both glomerular filtration and tubular secretion) and high levels of active antibiotic are produced in the urine. In the first six hours following oral administration, approximately 50% of the dose can be recovered unchanged in the urine. When probenecid is given together with flucloxacillin, the excretion of flucloxacillin is delayed, resulting in higher and more prolonged blood levels of the antibiotic.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Magnesium stearate, titanium dioxide, indigo carmine, methyl hydroxybenzoate, propyl hydroxybenzoate, gelatin, shellac, isopropyl alcohol, ethanol.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Blister pack (PVC/PVDC/Al) of 24 or 48 capsules (AUST R 226382).
Blister pack (PVC/PVDC/Al) of 24 or 48 capsules (AUST R 226374).
*Not all strengths or pack sizes may be available.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Flucloxacillin is a narrow spectrum antibiotic belonging to the isoxazolyl group of semi-synthetic penicillins. It is acid stable and penicillinase resistant and is closely related to cloxacillin. It is a white or almost white powder and is hygroscopic. It is soluble in 1 part of water, in 2 parts of methanol, in 8 parts of ethanol (96%) and in 8 parts of acetone.

Chemical structure.


Chemical name.

Sodium salt of 3-(2'-chloro-6'-fluorophenyl) -5-methyl-4-isoxazolylpenicillin monohydrate.

CAS number.

34214-51-2.

Molecular formula.

C19H16ClFN3NaO5S,H2O.

Molecular weight.

493.9.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes