Consumer medicine information

Flucil Oral Solution

Flucloxacillin

BRAND INFORMATION

Brand name

Flucil Oral Liquid

Active ingredient

Flucloxacillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Flucil Oral Solution.

SUMMARY CMI

FLUCIL Oral Solution

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine.

1. Why am I using FLUCIL?

FLUCIL contains the active ingredient flucloxacillin sodium monohydrate. FLUCIL is an antibiotic used to treat some infections in different parts of the body caused by bacteria.

For more information, see Section 1. Why am I using FLUCIL? in the full CMI.

2. What should I know before I use FLUCIL?

Do not use if you have ever had an allergic reaction to FLUCIL, other penicillins or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use FLUCIL? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with FLUCIL and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use FLUCIL?

Your doctor will choose the correct dose for you. Follow all directions given to you by your doctor and pharmacist carefully.

More instructions can be found in Section 4. How do I use FLUCIL? in the full CMI.

5. What should I know while using FLUCIL?

Things you should do
  • If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.
  • If you develop itching with swelling or skin rash or difficulty breathing while you are taking FLUCIL, do not take any more and contact your doctor immediately.
  • If you develop yellow eyes and/or skin (jaundice) while, or soon after taking FLUCIL, contact your doctor immediately.
  • If you get severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs up to several weeks after FLUCIL has been stopped.
  • If you get a sore white mouth or tongue while taking FLUCIL, tell your doctor. Also tell your doctor if you get a vaginal itching or discharge.
  • If you become pregnant while you are receiving FLUCIL, tell your doctor.
  • If you have to have any tests tell your doctor you are taking FLUCIL.
  • Remind any doctor, dentist or pharmacist you visit that you are taking FLUCIL.
Things you should not do
  • Do not take any diarrhoea medicine without first checking with your doctor.
  • Do not give FLUCIL to anyone else, even if they have the same condition as you.
  • Do not take FLUCIL to treat any other complaints unless your doctor tells you to.
Driving or using machines
  • Be careful driving or operating machinery until you know how FLUCIL affects you.
Looking after your medicine
  • Store FLUCIL Oral Solution below 25°C.
  • Reconstituted FLUCIL Oral Solution should be stored between 2-8°C and used within 14 days.

For more information, see Section 5. What should I know while using FLUCIL? in the full CMI.

6. Are there any side effects?

Side effects include mild rash, oral thrush, vaginal thrush, nausea, stomach upsets, mild diarrhoea, constipation, dizziness or headaches. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

WARNING
Flucloxacillin (FLUCIL) can cause jaundice (yellowing of skin and/or eyes) and severe liver disease which may last for a long time. This reaction is more frequent in older patients (particularly those over 55 years of age) and those who receive the drug for more than 14 days.



FULL CMI

FLUCIL Oral Solution

Active ingredient: flucloxacillin sodium monohydrate


Consumer Medicine Information (CMI)

This leaflet provides important information about using FLUCIL. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using FLUCIL.

Where to find information in this leaflet:

1. Why am I using FLUCIL?
2. What should I know before I use FLUCIL?
3. What if I am taking other medicines?
4. How do I use FLUCIL?
5. What should I know while using FLUCIL?
6. Are there any side effects?
7. Product details

1. Why am I using FLUCIL?

FLUCIL contains the active ingredient flucloxacillin (as flucloxacillin sodium monohydrate). FLUCIL is an antibiotic that belongs to a group of medicines called penicillins. These antibiotics work by killing the bacteria that are causing your infection.

FLUCIL is an antibiotic used to treat some infections in different parts of the body caused by bacteria.

FLUCIL will not work against infections caused by viruses, such as colds.

Ask your doctor why FLUCIL has been prescribed for you.

Your doctor may have prescribed it for another reason.

There is no evidence that FLUCIL is additive.

2. What should I know before I use FLUCIL?

Warnings

Do not use FLUCIL if:

  • your skin and/or eyes have turned yellow (Jaundice) while, or soon after taking flucloxacillin (FLUCIL).
  • you are allergic to flucloxacillin, other penicillins or any of the ingredients listed at the end of this leaflet.
    Some of the symptoms of an allergic reaction may include skin rash, itching, difficult breathing or swelling.

Always check the ingredients to make sure you can use this medicine.

  • you have had an allergic reaction to cephalosporins.
  • You may have an increased chance of being allergic to FLUCIL if you are allergic to cephalosporins.
  • the packaging is torn or shows signs of tampering.
  • the expiry date (EXP) printed on the pack has passed.

Check with your doctor if you:

  • have any type of allergic reaction to penicillin, amoxicillin or cephalosporin antibiotics.
    You may have an increased chance of being allergic to FLUCIL if you are allergic to cephalosporins.
  • have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes. This may include medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
  • Have or have ever had any other medical conditions including:
    - asthma, hayfever or hives
    - liver problems
    - kidney problems
    - glandular fever (infectious mononucleosis)
  • your skin and/or eyes have turned yellow (Jaundice) while, or soon after, receiving any antibiotics.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or breastfeeding, intend to become pregnant or breastfeed. Your doctor will discuss with you whether you can take FLUCIL.

3. What if I am taking other medicines?

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

Some medicines may interfere with FLUCIL and affect how it works. These include:

  • probenecid
  • paracetamol
  • aminoglycosides.

Some antibiotics may decrease the effectiveness of some birth control pills. Talk to your doctor about the need for an additional method of contraception whilst receiving FLUCIL.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect FLUCIL.

4. How do I use FLUCIL?

How much to take

  • your doctor will choose the correct dose for you.
  • The usual dose for adults is 250 mg every 6 hours, but this can be increased in severe infections. Children between 2 & 10 years of age should have half the adult dose and infants below 2 years of age should be given a quarter of the adult dose.
  • your pharmacist will explain how many mLs of syrup will be needed to receive the correct dose.
  • follow all directions given to you by your doctor and pharmacist carefully.
    These directions may differ from the information contained in this leaflet.

When to take FLUCIL

  • FLUCIL Oral Solution should be taken 30 minutes to 1 hour before food. If you are too ill to eat, take the medicine when it is due.

How to take FLUCIL

  • FLUCIL Oral Solution is taken orally.

If you forget to use FLUCIL

If it is almost time for 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 FLUCIL as you would normally. If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not take a double dose to make up for the dose you missed.

If you have trouble remembering when to take FLUCIL, ask your pharmacist for some hints.

If you use too much FLUCIL

If you think that you have used too much FLUCIL, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

Symptoms of an overdose may include diarrhoea and nausea.

5. What should I know while using FLUCIL?

Things you should do

Call your doctor straight away if:

  • your symptoms do not improve within a few days, or if they become worse.
  • you develop itching with swelling or skin rash or difficulty breathing soon after taking FLUCIL. Stop taking this medicine immediately and tell your doctor.
  • you develop yellow eyes or skin (jaundice) whilst or soon after taking FLUCIL. Do this even if it occurs several weeks after you have stopped taking FLUCIL. Jaundice may mean that you have a serious condition affecting your liver. You may need urgent medical care.
  • you get severe diarrhoea. Do this even if it occurs up to several weeks after FLUCIL has been stopped. 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 first checking with your doctor.
  • you get a sore white mouth or tongue while taking or soon after stopping FLUCIL. Also tell your doctor if you get a vaginal itching or discharge. This may mean you have a fungal infection called thrush. Sometimes the use of FLUCIL allows fungi to grow and the above symptoms to occur. FLUCIL does not work against fungi.
  • you become pregnant while taking this medicine.

Before starting any new medicine, remind your doctor and pharmacist that you are using FUCIL.

Remind any doctor, dentist or pharmacist you visit that you are taking FLUCIL.

If you have to have any tests, tell your doctor you are taking FLUCIL. FLUCIL may affect the results of some tests.

If you are taking FLUCIL for a long time, visit your doctor regularly so that they can check on your progress. You may need to have tests to check your liver and kidney function.

Things you should not do

  • Do not give FLUCIL to anyone else, even if they have the same condition as you.
  • Do not take FLUCIL to treat any other complaints unless your doctor tells you to.
  • 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.
  • Do not take any diarrhoea medicine without first checking with your doctor.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how FLUCIL affects you.

FLUCIL generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, FLUCIL may cause dizziness, drowsiness or tiredness in some people.

If you experience dizziness, do not drive.

If you drink alcohol, dizziness may be worse.

Looking after your medicine

  • Keep the solution in the bottle until it is time to take it.
  • The mixture should be stored between 2-8°C and used within 14 days.

Keep it where young children cannot reach it.

When to discard your medicine

Discard any mixture remaining when the treatment is completed.

Discard any mixture which is not used within 14 days.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Once the pharmacist has made up the solution, it must be used within 14 days.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
  • oral thrush – white, furry, sore tongue and mouth
  • vaginal thrush – sore and itchy vagina and/or discharge
  • nausea or vomiting
  • upset stomach or belching after eating
  • mild diarrhoea or constipation
  • dizziness or headache
  • a mild rash.
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • signs of allergic reaction, e.g. shortness of breath, wheezing, difficulty breathing, swelling of face, lips or tongue or other parts of the body
  • red and/or itchy skin, severe rash or hive on the skin
  • irregular heart beat
  • yellow skin and/or eyes
  • nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching and dark coloured urine (this may be symptoms of hepatitis)
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Other side effects not listed here may occur in some people. An illness consisting of a rash, swollen glands, joint pains and fever may occur about a week after treatment.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What FLUCIL contains

Active ingredient
(main ingredient)
flucloxacillin sodium monohydrate
Other ingredients
(inactive ingredients)
ammonium glycyrrhizinate
disodium edetate
erythrosine
menthol flavour PI (11940)
pineapple flavour PI (12542)
saccharin sodium
sodium benzoate
sodium citrate
sucrose

Each gram of flucloxacillin sodium monohydrate contains 2.2 mmol of sodium.

Do not take this medicine if you are allergic to any of these ingredients.

What FLUCIL looks like

FLUCIL is supplied to the pharmacist as a powder which is made up into 125 mg/5 mL (AUST R 165731) or 250 mg/5 mL (AUST R 165005) pineapple-flavoured solution.

Who distributes FLUCIL

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos Street,
St Leonards NSW 2065
Australia
www.aspenpharmacare.com.au

This leaflet was prepared in June 2023.

Published by MIMS September 2023

BRAND INFORMATION

Brand name

Flucil Oral Liquid

Active ingredient

Flucloxacillin

Schedule

S4

 

1 Name of Medicine

Flucloxacillin (as flucloxacillin sodium).

2 Qualitative and Quantitative Composition

Flucil powder for oral liquid.

125 mg/5 mL.

When dispensed, each 5 mL contains flucloxacillin sodium equivalent to 125 mg of flucloxacillin.

250 mg/5 mL.

When dispensed, each 5 mL contains flucloxacillin sodium equivalent to 250 mg of flucloxacillin.
Each gram of flucloxacillin sodium contains 2.2 mmol of sodium.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Flucil powder for oral liquid 125 mg/5 mL and 250 mg/5 mL are pink coloured dry granular powder which gives a pink coloured solution on reconstitution.

4 Clinical Particulars

4.1 Therapeutic Indications

For the treatment of confirmed or suspected staphylococcal and other Gram positive coccal infections. Indications include pneumonia, osteomyelitis, skin and skin structure and wound infections, infected burns and cellulitis.

4.2 Dose and Method of Administration

The oral dose should be administered ½ to 1 hour before meals.

Usual adult dose.

250 mg 6-hourly.

Usual children's dose.

2 to 10 years.

Half of the adult dose.

Under 2 years.

Quarter of the adult dose.

Note.

In severe infections the dosage may be increased.

Dosage in patients with impaired liver 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).

Dosage in patients with 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 patients with renal failure is increased. However, dosage recommendations for various plasma creatinine levels for patients with impaired renal function are not available. Flucloxacillin is not significantly removed by haemodialysis.

Directions for mixing syrup.

Reconstitute with 58 mL of water at time of dispensing as follows: tap bottle until all powder flows freely; add approximately half the total volume of water for reconstitution and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.

4.3 Contraindications

History of flucloxacillin associated jaundice or hepatic dysfunction.
History of a hypersensitivity reaction to beta-lactam antibiotics, e.g. penicillins.
Use in the eye.

4.4 Special Warnings and Precautions for Use

Hepatic toxicity.

Flucloxacillin can cause severe hepatitis and cholestatic jaundice, which may be protracted. This reaction is more frequent in older patients and those who take the drug for prolonged periods (see Section 4.8 Adverse Effects (Undesirable Effects)).
Serious, and occasionally fatal, hypersensitivity reactions (anaphylaxis) 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 Flucil 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.

Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including flucloxacillin. A toxin produced by 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.
Caution should be exercised in the treatment of patients with an allergic diathesis.

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 should be discontinued immediately and an alternative treatment should be considered.
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 contra-indicated.

Use in hepatic impairment.

Flucil should be used with caution in patients with evidence of hepatic dysfunction even though the latter is not a recognised predisposing factor to hepatic reactions to the drug.

High anion gap metabolic acidosis.

Caution is advised when flucloxacillin 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 and paracetamol, close monitoring is recommended in order to detect the appearance of acid-base disorders, namely HAGMA, including the testing of urinary 5-oxoproline.
If flucloxacillin 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 maintaining the clinical picture of HAGMA (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Hepatitis.

Hepatitis, predominantly of a cholestatic type, has been reported (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 (more than 14 days). Jaundice may appear several weeks after therapy: in some 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.

Use in the elderly.

See Hepatitis.

Use in renal impairment.

During long-term treatments, regular monitoring of renal function is recommended. Also see Section 4.2 Dose and Method of Administration, Dosage in patients with impaired renal function.

Paediatric use.

Animal studies show that high doses of flucloxacillin reduce albumin-bound bilirubin to 50 to 70% of the base line 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

Probenecid decreases the renal tubular secretion of flucloxacillin. Concurrent use with Flucil may result in increased and prolonged blood levels of flucloxacillin.
In common with other antibiotics, patients should be warned that Flucil may reduce the effectiveness of oral contraceptives.
Caution should be taken when flucloxacillin 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).

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. The use of flucloxacillin in pregnancy should be reserved for cases considered essential by the clinician.
Flucloxacillin is excreted in breast milk in trace amounts. An alternative feeding method is recommended to avoid any possible sensitisation of the newborn.

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. However, adverse effects of Flucil include dizziness which could affect the ability to drive or use machines (see Section 4.8 Adverse Effects (Undesirable Effects)).

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.

Hepatobiliary disorders.

Hepatitis and cholestatic jaundice (occasionally severe) have been reported with a frequency of about 1 in 15,000 exposures (see Section 4.4 Special Warnings and Precautions for Use).

Gastrointestinal disorders.

Nausea, vomiting, diarrhoea, dyspepsia. As with other antibiotics, pseudomembranous colitis has been reported rarely (see Section 4.4 Special Warnings and Precautions for Use).

Immune system disorders.

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

Renal and urinary disorders.

Isolated cases of nephritis, interstitial nephritis, frequency of micturation and haematuria have been reported.

Blood and lymphatic disorders.

Haemolytic anaemia has been reported during therapy with flucloxacillin sodium monohydrate. Reactions such as anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leucopenia 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.

Nervous system disorders.

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 subcutaneous tissue disorders.

A red, scaly rash with bumps under the skin and blisters - AGEP - acute generalized exanthematous pustulosis.
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.

Metabolism and nutrition disorders.

Postmarketing experience: very rare cases of high anion gap metabolic acidosis, when flucloxacillin is used concomitantly with paracetamol, generally in the presence of risk factors (see Section 4.4 Special Warnings and Precautions for Use).

Infections and infestations.

Vaginal or oral moniliasis may occur following the use of antibiotics.

Other.

Malaise, bad taste, sore throat, sore tongue, pruritus vulvae, arthralgia, dizziness, depression and headache.
Amongst the adverse events reported spontaneously to the Therapeutic Goods Administration (TGA), 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 www.tga.gov.au/reporting-problems.

4.9 Overdose

No information is available, but it could be anticipated that overdosage with oral Flucil 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.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Microbiology. Flucil is a narrow spectrum antibiotic with considerable activity against the following Gram-positive organisms: beta-lactamase producing Staphylococcus aureus, penicillin sensitive Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae.
It is less active than benzylpenicillin against organisms which are sensitive to benzylpenicillin.
It is not active against Gram-negative bacilli, methicillin resistant Staphylococcus aureus (MRSA), nor Streptococcus faecalis.

Susceptibility tests.

Dilution or diffusion techniques, either quantitative (MIC) or breakpoint, should be used following a regularly updated, recognised and standardised method (e.g. NCCLS). Standardised susceptibility test procedures require the use of laboratory control microorganisms to control the technique aspects of the laboratory procedures.
A report of "Susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations achievable. A report of "Intermediate" indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone, which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.
Note: The prevalence of resistance may vary geographically for selected species and local information on resistance is desirable, particularly when treating severe infections.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Blood level studies in fasting subjects show that flucloxacillin is well absorbed following oral administration with peak levels being achieved within one hour. The presence of food in the gastrointestinal tract delays the absorption of flucloxacillin resulting in lower peak serum levels.
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. Following oral administration approximately 50% of the oral dose can be recovered unchanged in the urine in the first six hours. At least 10% of the dose is excreted as an active metabolite which can rise to as high as 50% in renal failure.
The concurrent administration of probenecid delays the excretion of flucloxacillin resulting in higher and more prolonged blood levels of the antibiotic.
Flucloxacillin, in common with other isoxazolylpenicillins, is highly bound to serum proteins. However, the low minimum inhibitory concentrations of flucloxacillin against Gram positive cocci and the free antibiotic levels achieved ensure that the preparation is fully active against susceptible pathogens.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Flucil 125 mg/5 mL and 250 mg/5 mL powders for oral liquid contain flucloxacillin as the sodium salt, saccharin sodium, sodium benzoate, sucrose, sodium citrate, disodium edetate, ammonium glycyrrhizinate, pineapple flavour PI (12542) and menthol flavour PI (11940) and erythrosine as the colouring agent.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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

All presentations should be stored in dry place, protected from light, at less than 25°C.
Flucil powder for oral liquid, when reconstituted as syrup, should be stored at 2 to 8°C (Refrigerate. Do not freeze) and discarded after 14 days.

6.5 Nature and Contents of Container

Flucil 125 mg/5 mL and 250 mg/5 mL powders for oral liquid are presented in bottles with a pack size of 1.

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

Chemical structure.

Flucil (as flucloxacillin sodium) is a member of the beta-lactamase stable group of penicillins derived from the penicillin nucleus, 6-amino-penicillanic acid. Flucloxacillin sodium is the sodium salt of (2S,5R,6R)-6- [3-(2-chloro-6-fluorophenyl)- 5-methylisoxazole- 4-carboxamido]- 3,3-dimethyl-7-oxo-4- thia-1-azabicyclo [3.2.0]heptane- 2-carboxylic acid. Flucloxacillin sodium has the following structure:
Flucloxacillin sodium has a molecular weight of 493.9.
Chemical formula: C19H16ClFN3NaO5S.H2O.
Flucloxacillin sodium is a white or almost white, crystalline powder, hygroscopic, freely soluble in water and in methanol, soluble in alcohol.

CAS number.

1847-24-1.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes