Consumer medicine information

DBL Flucloxacillin Sodium for Injection

Flucloxacillin

BRAND INFORMATION

Brand name

DBL Flucloxacillin Sodium Powder for Injection

Active ingredient

Flucloxacillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using DBL Flucloxacillin Sodium for Injection.

What is in this leaflet

This leaflet answers some common questions about DBL Flucloxacillin Sodium for Injection. 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 and benefits. Your doctor has weighed the risks of you being given flucloxacillin against the benefits they expect it will have for you.

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

Keep this leaflet. You may need to read it again.

What DBL Flucloxacillin Sodium for Injection is used for

This medicine is an antibiotic that is used for the treatment of infections in different parts of the body caused by bacteria.

This medicine belongs to a group of medicines known as the penicillins.

It works by killing the bacteria causing your infection or by stopping its growth.

It 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.

Before you are given DBL Flucloxacillin Sodium for Injection

When you must not be given it

You must not be given DBL Flucloxacillin Sodium for Injection if you have an allergy to:

  • flucloxacillin
  • any other penicillins
  • any of the ingredients listed at the end of this leaflet
  • any medicines belonging to another group of antibiotics called the cephalosporins.

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

You must not be given this medicine if you have a history of liver problems that were associated with being treated with flucloxacillin sodium monohydrate in the past.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

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

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

  • kidney disease
  • liver disease.

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

If you have not told your doctor about any of the above, tell him/her before you are given flucloxacillin sodium monohydrate.

Taking other medicines

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

Some medicines and flucloxacillin sodium monohydrate may interfere with each other. These include:

  • paracetamol
  • probenecid, a medicine used to treat gout
  • aminoglycosides; a group of antibiotic medicines used to treat some infections.

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

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while you are being treated with this medicine.

How DBL Flucloxacillin Sodium for Injection is given

How much is given

Your doctor will decide what dose you will receive. This depends on your condition and other factors such as your weight.

How it is given

DBL Flucloxacillin Sodium for Injection is usually injected into a muscle or a vein, or into a lung cavity or joint. It should only be given by a doctor or nurse.

If you receive too much (overdose)

As DBL Flucloxacillin Sodium for Injection 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, tell your doctor immediately.

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

Symptoms of an overdose may include the side effects listed below in the ‘Side Effects’ section, but are usually of a more severe nature.

While you are being given DBL Flucloxacillin Sodium for Injection

Things you must do

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

If you get severe diarrhoea tell your doctor or nurse immediately. Do this even if it occurs several weeks after flucloxacillin sodium monohydrate 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.

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

If you become pregnant while you are being treated with this medicine tell your doctor.

Tell all other doctors, dentists and pharmacists who are treating you that you are being treated flucloxacillin.

Things to be careful of

Be careful driving or operating machinery 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 in some people.

If you experience dizziness, do not drive.

If you drink alcohol, dizziness may be worse.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being treated with flucloxacillin.

This medicine helps treat infections in most people, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

If you are over 65 years of age you may have an increased chance of getting side effects.

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

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

Tell your doctor or nurse if you notice any of the following and they worry you:

  • pain, swelling, or redness around the injection site
  • skin rash
  • itchiness
  • oral thrush - white, furry, sore tongue and mouth
  • vaginal thrush - sore and itchy vagina and/or discharge
  • nausea (feeling sick)
  • mild diarrhoea or constipation
  • dizziness or headache
  • pain or an uncomfortable feeling in the stomach or belching after eating.
  • muscle cramps or weakness, feeling tired, constipation

The above list includes side effects which are usually mild.

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

  • severe blisters and bleeding in the lips, eyes, mouth, nose or genitals
  • itchy spots accompanied by fever and feeling unwell
  • 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; rash, itching or hives on the skin
  • fever
  • severe diarrhoea
  • yellowing of the 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, yellowing of the skin and eyes and dark coloured urine (these may be symptoms of a type of liver disease called hepatitis).
  • tiredness, headaches, being short of breath when exercising, dizziness, looking pale.
  • heart palpitations
  • thirst, together with confusion or muscle twitching

The above list includes very serious side effects. You may need urgent medical attention. Serious side effects are rare.

Tell your doctor or nurse if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some patients.

After finishing treatment with it

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with flucloxacillin sodium monohydrate:

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

These are rare but serious side effects. You may have a serious condition affecting your bowel. Therefore you may need urgent medical attention.

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

After you are given DBL Flucloxacillin Sodium for Injection

Storage

DBL Flucloxacillin Sodium for Injection will generally be stored in the pharmacy or on the ward. It is kept in a cool, dry place where the temperature stays below 25C, and is protected from light.

Product description

What it looks like

Flucloxacillin Sodium Monohydrate is a white or almost white powder.

DBL Flucloxacillin Sodium for Injection is available in packs of 5 vials.

Ingredients

Each vial of DBL Flucloxacillin Sodium for Injection (1 g) contains flucloxacillin sodium monohydrate equivalent to 1 gram of flucloxacillin as the active ingredient. DBL Flucloxacillin Sodium for Injection does not contain any other ingredients.

DBL Flucloxacillin Sodium for Injection does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Supplier

DBL Flucloxacillin Sodium for Injection is supplied by:

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au

DBL Flucloxacillin Sodium for Injection is available in the following strengths and packs:

  • Flucloxacillin Sodium Monohydrate equivalent to flucloxacillin 1 g in packs of 5 and 10 - AUST R 50579

This leaflet was updated in May 2020.

™=Trademark

© Copyright

Published by MIMS July 2020

BRAND INFORMATION

Brand name

DBL Flucloxacillin Sodium Powder for Injection

Active ingredient

Flucloxacillin

Schedule

S4

 

1 Name of Medicine

Flucloxacillin sodium monohydrate.

6.7 Physicochemical Properties

Chemical structure.


The chemical formula of flucloxacillin sodium monohydrate is C19H16ClFN3NaO5S,H2O. Its molecular weight is 493.9.

CAS number.

1847-24-1.

2 Qualitative and Quantitative Composition

Each injection contains:
DBL Flucloxacillin Sodium Powder for Injection contains 1 g of flucloxacillin as flucloxacillin sodium monohydrate. DBL Flucloxacillin Sodium Powder for Injection is the sodium salt of flucloxacillin. Flucloxacillin sodium monohydrate is 3-(2'-chloro-6'-fluorophenyl)-5-methyl-4-isoxazolylpenicillin monohydrate. It is a member of the beta-lactamase-stable group of penicillins derived from the penicillin nucleus, 6-amino-penicillanic acid. Flucloxacillin sodium monohydrate is closely related to cloxacillin.
It should be recognised that each 1 gram of flucloxacillin sodium monohydrate contains 2.2 mmol of sodium.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Flucloxacillin sodium monohydrate is a white or almost white, crystalline powder for injection, hygroscopic, freely soluble in water and in methanol, soluble in alcohol.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Flucloxacillin sodium monohydrate is a narrow spectrum antibiotic with considerable activity against the following common Gram-positive organisms: beta-lactamase-producing Staphylococcus aureus, penicillin sensitive Staphylococcus aureus, beta-haemolytic streptococci (Streptococcus pyogenes), Streptococcus pneumoniae (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.

DBL Flucloxacillin Sodium for Injection is well absorbed following intramuscular administration.

Distribution.

Flucloxacillin sodium monohydrate, in common with other isoxazolylpenicillins, is highly bound to serum proteins. The low MICs of flucloxacillin sodium monohydrate against Gram-positive cocci and the free antibiotic levels achieved however ensure that the preparation is fully active against susceptible pathogens.

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.
The concurrent administration of probenecid delays the excretion of DBL Flucloxacillin Sodium for Injection resulting in higher and more prolonged blood levels of the antibiotic.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

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 and skin and skin structure infections, such as wound infections, infected burns and cellulitis.

4.3 Contraindications

Patients with a previous history of flucloxacillin sodium monohydrate associated jaundice or hepatic dysfunction.
DBL Flucloxacillin Sodium Powder for Injection should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. penicillins, cephalosporins).
DBL Flucloxacillin Sodium Powder for Injection should not be used in the eye, either conjunctively or locally.

4.4 Special Warnings and Precautions for Use

Warning.

Liver toxicity.

Flucloxacillin sodium monohydrate 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)).

Anaphylaxis.

Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. 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 an allergic reaction occurs, appropriate therapy should be instituted and flucloxacillin sodium monohydrate 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 sodium monohydrate. 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.
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.
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, DBL Flucloxacillin Sodium Powder for Injection should be discontinued immediately and an alternative treatment should be considered.

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, a close monitoring is recommended in order to detect the appearance of acid-base disorders, namely HAGMA, including the search 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.

Use in hepatic impairment.

During prolonged treatment it is advisable to check periodically for hepatic dysfunction in patients with impaired hepatic function.

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.

Flucloxacillin sodium monohydrate 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)).

Paediatric use.

Animal studies show that high doses of flucloxacillin sodium monohydrate 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 sodium monohydrate. Concurrent use with DBL Flucloxacillin Sodium Powder for Injection may result in increased and prolonged blood levels of flucloxacillin sodium monohydrate. It is recommended that DBL Flucloxacillin Sodium Powder for Injection and aminoglycosides not be mixed together in the same solution for injection due to possible precipitation and the gradual inactivation of the aminoglycosides under these circumstances.
DBL Flucloxacillin Sodium Powder for Injection should not be mixed with blood products or other proteinaceous fluids (e.g. protein hydrolysates).
Caution should be taken when flucloxacillin is used concomitantly with paracetamol as concurrent intake has been associated with high anion gap metabolic acidosis (HAGMA), especially in patients with risk factors.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B1)
Category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals have not shown evidence of an increased occurrence of foetal damage.
Animal studies with flucloxacillin sodium monohydrate 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 DBL Flucloxacillin Sodium Powder for Injection in pregnancy should be reserved for cases considered essential by the clinician.
Flucloxacillin sodium monohydrate is excreted in breast milk in trace amounts. An alternative feeding method is recommended to avoid any possible sensitisation of the newborn.

4.8 Adverse Effects (Undesirable Effects)

The following adverse reactions have been reported as associated with the use of flucloxacillin sodium monohydrate.

Hepatic.

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.

Nausea, vomiting, diarrhoea, dyspepsia, constipation, abdominal pain, heart burn, loss of appetite. As with other antibiotics, pseudomembranous colitis has been reported rarely (see Section 4.4 Special Warnings and Precautions for Use).

Hypersensitivity reactions.

Erythematous maculopapular rashes, urticaria, purpura, eosinophilia, angioneurotic oedema, 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, DBL Flucloxacillin Sodium Powder for Injection should be discontinued. (Note: Urticaria, other skin rashes and serum sickness like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids).

Renal.

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

Pulmonary.

Bronchospasm.

Haemic and lymphatic systems.

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

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.

Metabolism and nutrition disorders.

Post marketing experience: very rare cases of high anion gap metabolic acidosis (HAGMA), when flucloxacillin is used concomitantly with paracetamol, generally in the presence of risk factors.

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.

4.2 Dose and Method of Administration

Dosage.

Usual adult dosage.

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 dosage.

2 to 10 years: ½ adult dose.
Under 2 years: ¼ adult dose.

Note.

In severe infections the dosage may be increased.

Method of administration.

Intramuscular.

Dissolve 1 g vial content in 2.5 mL Water for Injections BP.

Intravenous.

Dissolve 1 g in 15 to 20 mL Water for Injections BP. Administer by slow IV injection (3 to 4 minutes).
DBL Flucloxacillin Sodium Powder for Injection may also be added to infusion fluids or injected, suitably diluted, into the drip tube over a period of 3 to 4 minutes.

Stability in solution.

All injections should be reconstituted from the injection presentations under appropriate aseptic conditions and the solutions prepared should be used as soon as practicable after preparation to reduce microbiological hazards.
Solutions of flucloxacillin sodium monohydrate in water for injections (500 mg/mL), 0.5% lignocaine hydrochloride solution (500 mg/mL), 0.9% sodium chloride solution (1 mg/mL), 2.5% glucose in 0.45% sodium chloride solution (1 mg/mL), 5% glucose in water (1 mg/mL) and 1/6 M sodium lactate solution (1 mg/mL) have been shown to be stable for 24 hours when stored at 2 to 8°C.

Dosage adjustments.

Renal impairment.

As flucloxacillin sodium monohydrate 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 sodium monohydrate is not significantly removed by haemodialysis.

Hepatic impairment.

Adjustment of dosage may not be necessary as flucloxacillin sodium monohydrate is not metabolised in the liver to any appreciable extent. However, during prolonged treatment it is advisable to check periodically for hepatic dysfunction.

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.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia). In New Zealand call 0800 764 766.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

6 Pharmaceutical Particulars

6.1 List of Excipients

This product does not contain excipients.

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.
If storage is necessary, hold at 2 to 8°C for not more than 24 hours. The solutions should be used in one patient on one occasion only and any residue discarded as the solutions do not contain an antimicrobial preservative.

6.4 Special Precautions for Storage

DBL Flucloxacillin Sodium Powder for Injection should be stored in a dry place at less than 25°C. Protect from light and moisture.

6.5 Nature and Contents of Container

Glass vials containing flucloxacillin sodium monohydrate equivalent to 1.0 g of flucloxacillin in cartons of 5 and 10.

6.6 Special Precautions for Disposal

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

Summary Table of Changes