Consumer medicine information

Flucil Injection

Flucloxacillin

BRAND INFORMATION

Brand name

Flucil

Active ingredient

Flucloxacillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Flucil Injection.

What is in this leaflet

This leaflet answers some common questions about FLUCIL.

It does not contain all the available information.

It does not take the place of talking to your doctor and pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you receiving FLUCIL against the benefits this medicine is expected to have for you.

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

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

What FLUCIL is used for

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.

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.

Your doctor may have prescribed FLUCIL for another reason. Ask your doctor why FLUCIL has been prescribed for you.

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

There is no evidence that FLUCIL is addictive.

Before you are given FLUCIL

When you must not be given it

Do not use FLUCIL if:

  • your skin and/or eyes have turned yellow (Jaundice) while, or soon after receiving flucloxacillin (FLUCIL).
  • you have an allergy to FLUCIL or other penicillins.
  • Some of the symptoms of an allergic reaction may include skin rash, itching and difficult breathing.
  • 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.

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

Before you are given it

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.

You must tell your doctor if:

  1. you have an allergy to FLUCIL or other penicillins.
  2. you have had any type of allergic reaction to cephalosporin medicines.
You may have an increased chance of being allergic to FLUCIL if you are allergic to cephalosporins.
  1. you 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.
  2. your skin and/or eyes have turned yellow (Jaundice) while, or soon after, receiving any antibiotics.
  3. you have or have ever had any other health problems/medical conditions, including kidney or liver disease.
  4. you are pregnant or intend to become pregnant.
Your doctor will discuss the risks and benefits of using FLUCIL during pregnancy.
  1. you are breast-feeding or plan to breast-feed.
Your doctor will discuss the risks and benefits of using FLUCIL when breast-feeding.

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

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 may interfere with FLUCIL. These include probenecid (Benemid) and paracetamol.

These medicines may be affected by FLUCIL, 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 or pharmacist has more information on medicines to be careful with or avoid whilst receiving FLUCIL.

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.

How FLUCIL is given

FLUCIL may be given in two ways:

  • as a slow injection into a vein
  • as a deep injection into a large muscle, a joint or the sac surrounding the lung.

FLUCIL must only be given by a doctor or nurse.

Your doctor will decide what the dose is and for how long you will receive FLUCIL. This depends on your infection and other factors, such as your weight. For most infections, FLUCIL is usually given in divided doses throughout the day. Sometimes only a single dose of FLUCIL is required for the treatment and prevention of certain infections.

If you have too much (overdose)

A very large overdose of FLUCIL can cause brain upsets, including fits.

After you have been given FLUCIL

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 develop itching with swelling or skin rash or difficulty breathing after you have been given FLUCIL, contact your doctor immediately.

If you develop yellow eyes and/or skin (jaundice) while, or soon after receiving 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. 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 you have been given FLUCIL, tell your doctor. 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.

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

If you have to have any tests tell your doctor you have been given FLUCIL. FLUCIL may affect the results of some tests.

Tell any doctor, dentist or pharmacist who is treating you that you have been given FLUCIL.

Things to be careful of

Be careful driving or operating machinery 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.

Side Effects

Check with your doctor as soon as possible if you have any problems whilst receiving FLUCIL, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Like other medicines, FLUCIL can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

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

Whilst being given FLUCIL

Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following:

  • a severe rash
  • wheezing
  • irregular heart beat
  • feeling faint
  • yellow skin and/or eyes

Also tell your doctor if you notice:

  • 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
  • a mild rash

Other side effects not listed above may also occur in some patients. These include very rare conditions such as blood, liver and kidney problems or fits.

After finishing FLUCIL

Tell your doctor if your skin and/or eyes have turned yellow (Jaundice) while or soon after receiving flucloxacillin (FLUCIL).

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after finishing treatment with FLUCIL:

  • 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. FLUCIL can change bacteria (which are normally present in the bowel and normally harmless) to multiply and therefore cause the above symptoms. You may need urgent medical attention.

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

An illness consisting of a rash, swollen glands, joint pains and fever may occur about a week after treatment.

Tell your doctor if you notice any side effects.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known. Ask your doctor or pharmacist if you are concerned.

After receiving FLUCIL

Storage

Keep FLUCIL in a cool dry place where the temperature stays below 25°C.

FLUCIL description

What it looks like

FLUCIL Injection is a white to off-white powder which has to be dissolved in water before it is injected.

Ingredients

Flucloxacillin sodium, 500 mg and 1 g.

The Australian Registration Numbers are:

500mg AUST R 90879

1g AUST R 90878

Sponsor

Aspen Pharmacare Australia Pty Limited
34-36 Chandos Street, St Leonards 2065
NSW Australia

Date of revision: November 2019

Published by MIMS January 2020

BRAND INFORMATION

Brand name

Flucil

Active ingredient

Flucloxacillin

Schedule

S4

 

1 Name of Medicine

Flucloxacillin (as flucloxacillin sodium).

2 Qualitative and Quantitative Composition

Flucil powder for injection 500 mg vials contain flucloxacillin sodium equivalent to 500 mg of flucloxacillin.
Flucil 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

Flucil 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 500 mg vial contents in 2.0 mL water for injections, or the 1 g vial contents in 2.5 mL water for injections.

Intravenous.

Dissolve the 500 mg vial contents in 10 mL water for injections, or the 1 g vial contents in 15 mL to 20 mL water for injections. Administer by slow IV injection (3 to 4 minutes).Flucil 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 500 mg vial contents in 10 mL water for injections.

Intra-articular.

Dissolve the 500 mg vial contents in up to 5 mL water for injections or in 0.5% lignocaine hydrochloride solution.
Tables 1 and 2 may be used as a guide to assist in the preparation of fractional doses of Flucil.
When Flucil is reconstituted with water for injections, it must be used immediately to reduce microbiological hazard. Flucil 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 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 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.

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.

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 baseline concentration. The drug should, therefore, be used with extreme caution in jaundiced neonates or premature infants.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

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.
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 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 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 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 micturition 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 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.
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

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

Flucil 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

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

Stability in solution.

Flucil powder for injection 500 mg, after reconstitution in different infusion liquids to a final concentration of 1 mg/mL, retained the flucloxacillin content reported in Table 3. However, to avoid microbiological hazards, Flucil powder for injection should be used immediately following reconstitution. As Flucil 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 Flucil at 2-8°C is required in one of the above intravenous fluids at a concentration of 1 mg/mL, reconstitution should be carried out under appropriate aseptic conditions to avoid microbiological hazards.

6.5 Nature and Contents of Container

Flucil powder for injection, 500 mg and 1 g vials are stored in cartons of 5.

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.

Flucil (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:
C19H16ClFN3NaO5S.H2O.
Flucloxacillin sodium has a molecular weight of 493.9.

CAS number.

1847-24-1.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes