Consumer medicine information

Flucloxacillin Baxter

Flucloxacillin

BRAND INFORMATION

Brand name

Flucloxacillin Baxter

Active ingredient

Flucloxacillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Flucloxacillin Baxter.

SUMMARY CMI

FLUCLOXACILLIN BAXTER

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 taking this medicine.

1. Why am I being given FLUCLOXACILLIN BAXTER?

FLUCLOXACILLIN BAXTER contains the active ingredient flucloxacillin sodium monohydrate. FLUCLOXACILLIN BAXTER 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 being given Flucloxacillin? in the full CMI.

2. What should I know before I am given FLUCLOXACILLIN BAXTER?

Do not take if you have ever had an allergic reaction to flucloxacillin, 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 am given FLUCLOXACILLIN BAXTER? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with FLUCLOXACILLIN BAXTER 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 am I given FLUCLOXACILLIN BAXTER?

FLUCLOXACILLIN BAXTER will be given to you by a doctor or nurse. Your doctor will decide what dose and how long you will receive FLUCLOXACILLIN BAXTER for. This depends on your infection and other factors, such as your weight. For most infections, FLUCLOXACILLIN BAXTER is usually given in divided doses throughout the day.

More instructions can be found in Section 4. How am I given FLUCLOXACILLIN BAXTER? in the full CMI.

5. What should I know after receiving FLUCLOXACILLIN BAXTER?

Things you should do
  • Remind any doctor, dentist, or pharmacist you visit that you are being treated with FLUCLOXACILLIN BAXTER.
  • If 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 receiving FLUCLOXACILLIN BAXTER, do not have any more and tell your doctor immediately.
  • If you develop yellow eyes and/or skin (jaundice) while, or soon after receiving FLUCLOXACILLIN BAXTER, contact your doctor immediately.
  • If you get severe diarrhoea, tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after FLUCLOXACILLIN BAXTER has been stopped.
  • If you get a sore white mouth or tongue while being treated with or soon after stopping FLUCLOXACILLIN BAXTER, tell your doctor. Also tell your doctor if you get vaginal itching or discharge.
  • If you become pregnant while you are taking FLUCLOXACILLIN BAXTER, tell your doctor.
  • If you have to have any tests, tell your doctor you are taking FLUCLOXACILLIN BAXTER.
Things you should not do
  • Do not take any diarrhoea medicine without first checking with your doctor.
Driving or using machines
  • Be careful driving or operating machinery until you know how FLUCLOXACILLIN BAXTER affects you

For more information, see Section 5. What should I know after receiving FLUCLOXACILLIN BAXTER? in the full CMI.

6. Are there any side effects?

Side effects include pain or redness at the site of injection, 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 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

FLUCLOXACILLIN BAXTER

Active ingredient: Flucloxacillin sodium monohydrate (floo-klox-s-SILL-in)

Consumer Medicine Information (CMI)

This leaflet provides important information about using FLUCLOXACILLIN BAXTER.

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 FLUCLOXACILLIN BAXTER.

Where to find information in this leaflet:

1. Why am I being given FLUCLOXACILLIN BAXTER?
2. What should I know before I am given FLUCLOXACILLIN BAXTER?
3. What if I am taking other medicines?
4. How am I given FLUCLOXACILLIN BAXTER?
5. What should I know after receiving FLUCLOXACILLIN BAXTER?
6. Are there any side effects?
7. Product details

1. Why am I being given FLUCLOXACILLIN BAXTER?

FLUCLOXACILLIN BAXTER is an antibiotic that belongs to a group of medicines called penicillins. These antibiotics work by killing the bacteria that are causing your infection.

FLUCLOXACILLIN BAXTER is an antibiotic used to treat some infections in different parts of the body caused by bacteria. FLUCLOXACILLIN BAXTER, like other antibiotics, will not work against infections caused by viruses such as colds or the flu.

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

Your doctor may have prescribed it for another reason. This medicine is not addictive.

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

2. What should I know before I am given FLUCLOXACILLIN BAXTER?

Warnings

Do not use FLUCLOXACILLIN BAXTER if:

  • your skin and/or eyes have turned yellow (Jaundice) while, or soon after receiving flucloxacillin
  • you are allergic to flucloxacillin or other penicillins or any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include skin rash, itching, difficulty breathing or swelling.
  • You have had an allergic reaction to cephalosporin antibiotics.
  • You may have an increased chance of being allergic to FLUCLOXACILLIN BAXTER 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. If you take this medicine after the expiry date has passed, it may not work as well.

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 FLUCLOXACILLIN BAXTER 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 breast-feeding, intend to become pregnant or breastfeed. Your doctor will discuss the possible risks and benefits of being given FLUCLOXACILLIN BAXTER during this time.

3. What if I am taking other medicines?

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

Some medicines may be affected by FLUCLOXACILLIN BAXTER, or they may affect how well it works. These include:

  • Probenecid
  • Aminoglycosides
  • Voriconazole
  • Methotrexate
  • Warfarin
  • Paracetamol

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 FLUCLOXACILLIN BAXTER.

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

4. How am I given FLUCLOXACILLIN BAXTER?

How much is given

Your doctor will decide what dose and how long you will receive FLUCLOXACILLIN BAXTER. This depends on your infection and other factors, such as your weight.

For most infections, FLUCLOXACILLIN BAXTER is usually given in divided doses throughout the day. Sometimes only a single dose of FLUCLOXACILLIN BAXTER is required for the treatment and prevention of certain infections.

How FLUCLOXACILLIN BAXTER is given

FLUCLOXACILLIN BAXTER is available in one strength - 1000mg.

FLUCLOXACILLIN BAXTER 1000mg injection is diluted and then given:

  • as a slow injection into a vein
  • as a deep injection into a large muscle
  • in fluids given into a vein
  • into the space around the lungs

FLUCLOXACILLIN BAXTER must only be given by a doctor or nurse.

If you receive too much

As FLUCLOXACILLIN BAXTER is given to you under the supervision of your doctor, it is very unlikely that you will receive too much.

However, if you experience severe side effects after being given this medicine, 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.

You may need urgent medical attention.

5. What should I know after receiving FLUCLOXACILLIN BAXTER?

Things you must do

Call your doctor straight away if:

  • the symptoms of your infection do not improve within a few days, or if they become worse.
  • you develop itching with swelling or skin rash or difficulty breathing while you are receiving FLUCLOXACILLIN BAXTER.
  • you develop yellow eyes and/or skin (jaundice) while, or soon after receiving FLUCLOXACILLIN BAXTER.
  • you get severe diarrhoea. Do this even if it occurs several weeks after Flucloxacillin 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 being treated with or soon after stopping FLUCLOXACILLIN BAXTER. 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 BAXTER allows fungi to grow and the above symptoms to occur. FLUCLOXACILLIN BAXTER does not work against fungi.

If you become pregnant while you are receiving FLUCLOXACILLIN BAXTER, tell your doctor.

If you are about to start taking any new medicine, tell your doctor and pharmacist that you are receiving FLUCLOXACILLIN BAXTER.

If you have to have any blood or urine tests, tell your doctor you are being given FLUCLOXACILLIN BAXTER. FLUCLOXACILLIN BAXTER may affect the results of some blood or urine tests.

Tell all the doctors, dentists and pharmacists who are treating you that you are being given FLUCLOXACILLIN BAXTER.

Things you should not do

  • 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 flucloxacillin affects you.

This medicine does not generally cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, flucloxacillin 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

FLUCLOXACILLIN BAXTER should be stored in the pharmacy or on the ward. Your doctor, pharmacist or nurse is responsible for storing FLUCLOXACILLIN BAXTER and disposing of any unused product correctly.

The powder for injection is kept in a cool dry place where the temperature stays below 25°C.

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
  • Pain or redness at the site of injection
  • oral thrush - white, furry, sore tongue and mouth
  • vaginal thrush - sore and itchy vagina and/or discharge
  • nausea or vomiting
  • stomach upsets 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 an allergic reaction, such as shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body
  • red and/or itchy skin, severe rash or hive on the skin
  • irregular heartbeat
  • yellow skin and/or eyes (these may be symptoms of a type of liver disease called jaundice)
  • nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching and dark coloured urine (these may be symptoms of a type of liver disease called hepatitis).
  • a red rash commonly seen on both sides of buttocks, upper inner thighs, armpits, neck.
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.

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

Other side effects not listed here may occur in some people.

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 FLUCLOXACILLIN BAXTER contains

Active ingredient
(main ingredient)		Flucloxacillin sodium monohydrate
Other ingredients
(inactive ingredients)		None
Potential allergensNone

Do not take this medicine if you are allergic to this ingredient.

What FLUCLOXACILLIN BAXTER looks like

FLUCLOXACILLIN BAXTER is white or almost white crystalline powder for injection contained in a vial (AUST R 415551).

Who distributes FLUCLOXACILLIN BAXTER

Baxter Healthcare Pty Ltd
1 Baxter Drive
Old Toongabbie
NSW 2146,
Australia
Toll Free Number: 1800 229 837
www.baxterhealthcare.com.au

This leaflet was prepared in July 2024.

Published by MIMS February 2025

BRAND INFORMATION

Brand name

Flucloxacillin Baxter

Active ingredient

Flucloxacillin

Schedule

S4

 

1 Name of Medicine

Flucloxacillin (as flucloxacillin sodium).

2 Qualitative and Quantitative Composition

Flucloxacillin Baxter powder for injection 1 g vials contain flucloxacillin sodium equivalent to 1 g of flucloxacillin.
Each vial contains 95.0 to 105.0% of the stated amount of flucloxacillin. Each one gram of monograph substance represents 2 mmol of sodium.

3 Pharmaceutical Form

Flucloxacillin Baxter powder for injection is a fine white to off-white homogeneous powder, soluble in water. The injection is prepared by the addition of the appropriate volume of water for injections to give the desired concentration of flucloxacillin.

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

Usual adult dose.

Intramuscular.

250 mg, 6-hourly.

Intravenous.

250 mg to 1 g, 6-hourly.

Intrapleural.

250 mg once daily.

Intra-articular.

250 mg to 500 mg once daily.

Note.

Systemic doses may be doubled where necessary in severe infections.

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.

Preparation of injections.

Intramuscular.

Dissolve the 1 g vial contents in 2.5 mL water for injections.

Intravenous.

Dissolve the 1 g vial contents in 15 mL to 20 mL water for injections. Administer by slow IV injection (3 to 4 minutes). Flucloxacillin Baxter may also be added to infusion fluids or injected, suitably diluted, into the drip tube over a period of 3 to 4 minutes.

Intrapleural.

Dissolve the 1 g vial contents in 20 mL water for injections.

Intra-articular.

Dissolve the 1 g vial contents in up to 10 mL water for injections or in 1 % lidocaine hydrochloride monohydrate solution.
Table 1 may be used as a guide to assist in the preparation of fractional doses of Flucloxacillin Baxter.
When Flucloxacillin Baxter is reconstituted with water for injections, it must be used immediately to reduce microbiological hazard. Flucloxacillin Baxter is for one dose in one patient only. Discard any remaining contents.

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 Flucloxacillin Baxter 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 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.

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).

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 contraindicated.

Use in hepatic impairment.

Flucloxacillin Baxter 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.

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 renal impairment.

The dose or dose interval may need modification in patients with renal failure as the half life in patients with renal failure is increased. As renal function is not fully developed in the neonate the risk/benefit ratio should be considered before administration to such patients.
Very high doses of flucloxacillin can cause hypokalaemia and sometimes hypernatraemia. In patients undergoing high-dose treatment for more than 5 days, electrolyte balance, blood counts, and renal function should be monitored. Additionally, use of a potassium-sparing diuretic may be helpful.

Use in the elderly.

See Hepatitis.

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 Flucloxacillin Baxter may result in increased and prolonged blood levels of flucloxacillin.
In common with other antibiotics, patients should be warned that Flucloxacillin Baxter may reduce the effectiveness of oral contraceptives.
Flucloxacillin may require dose adjustment when used in combination with methotrexate and warfarin. Cases have been reported, in which the efficacy of warfarin decreased during concomitant oral treatment with flucloxacillin.
Flucloxacillin has been reported to significantly decrease plasma voriconazole concentrations. If concomitant administration of flucloxacillin and voriconazole cannot be avoided, monitor patient for potential loss of voriconazole effectiveness. An increased dose of voriconazole may be required.
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 Flucloxacillin Baxter 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 and abdominal pain. 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 Flucloxacillin Baxter 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. 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), and symmetrical drug-related intertriginous and flexural exanthema (SDRIFE) (baboon syndrome) have been reported in beta-lactam antibiotics. Adverse reaction of pruritus has been reported very rarely.

Metabolism and nutrition disorders.

Post marketing 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.

General disorders and administration site conditions.

Pain may be experienced at the site of intramuscular injection and phlebitis at the site of intravenous injection.
Amongst the adverse events spontaneously reported to the Therapeutic Goods Administration (TGA), 61% were dermatological effects, 17% were jaundice, 16% were gastrointestinal reactions and 2.5% were CNS related.

Other.

Malaise, bad taste, sore throat, sore tongue, pruritus vulvae, arthralgia, dizziness, depression and headache.

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 Flucloxacillin Baxter 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.
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. Flucloxacillin Baxter 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

Flucloxacillin is well absorbed following intramuscular injection.
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. 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

Flucloxacillin Baxter powder for injection contains no antiseptics or buffering agents nor are there any excipients.

6.2 Incompatibilities

It is recommended that flucloxacillin sodium for injection and aminoglycosides are not to be mixed together in the same solution for injection, due to possible precipitation and the gradual inactivation of the aminoglycosides under these circumstances.
Flucloxacillin sodium for injections should not be mixed with blood products or other proteinases fluids (e.g. protein hydrolysates).
Flucloxacillin sodium for injection is incompatible with aminoglycosides, amiodarone, atropine, buprenorphine, calcium gluconate, chlorpromazine, ciprofloxacin, diazepam, dobutamine, erythromycin lactobionate, metoclopramide, morphine sulphate, pefloxacin, pethidine, prochlorperazine edisylate and verapamil.

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

Flucloxacillin Baxter powder for injection should be stored in a dry place, protected from light, at less than 25°C.
Flucloxacillin Baxter powder for injection should be used immediately following reconstitution.

Stability in solution.

Flucloxacillin Baxter powder for injection 1 g after reconstitution in different infusion liquids to a final concentration of 10 mg/mL, retained the flucloxacillin content reported in Table 2. However, to avoid microbiological hazards, Flucloxacillin Baxter powder for injection should be used immediately following reconstitution. As Flucloxacillin Baxter powder for injection does not contain an antimicrobial preservative, the reconstituted injection solution should be used only once and any residue discarded.
If up to 24 hour storage of Flucloxacillin Baxter at 2-8°C is required in one of the above intravenous fluids at a concentration of 10 mg/mL, reconstitution should be carried out under appropriate aseptic conditions to avoid microbiological hazards.

6.5 Nature and Contents of Container

Flucloxacillin Baxter powder for injection 1 g vials are stored in cartons of 10.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

Flucloxacillin Baxter (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. It is a member of the beta-lactamase-stable group of penicillins derived from the penicillin nucleus, 6-amino-penicillanic acid. Flucloxacillin sodium has the following structure:
C19H16CIFN3NaO5S.H20.
Flucloxacillin sodium has a molecular weight of 493.9.

CAS number.

1847-24-1.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes