Consumer medicine information

Flopen Viatris

Flucloxacillin

BRAND INFORMATION

Brand name

Flopen Viatris

Active ingredient

Flucloxacillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Flopen Viatris.

What is in this leaflet

This leaflet answers some common questions about FLOPEN VIATRIS. It does not contain all of the available information.

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

All medicines have benefits and risks. Your doctor has weighed the risks of you taking FLOPEN VIATRIS against the benefits they expect it will have for you.

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

Keep this leaflet with your medicine. You may need to read it again.

What FLOPEN VIATRIS is used for

FLOPEN VIATRIS contains the active ingredient flucloxacillin.

It is used to treat infections in different parts of the body caused by bacteria.

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

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

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

This medicine is not addictive.

It is available only with a doctor's prescription.

Before you take FLOPEN VIATRIS

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

When you must not take it

Do not take FLOPEN VIATRIS if you have an allergy to:

  • any medicine containing flucloxacillin
  • any other penicillin medicines or cephalosporins
  • beta-lactam antibiotics including imipenem and aztreonam
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

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

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

Do not use this medicine in your eyes.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return to your pharmacist for disposal.

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

Before you start to take it

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

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

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

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.

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

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

Taking other medicines

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

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

Some medicines and FLOPEN VIATRIS may interfere with each other. These include:

  • probenecid (e.g. Pro-Cid), a medicine commonly used to treat gout
  • oral contraceptive pills, medicines used for contraception

You should use other birth control methods while you are taking FLOPEN VIATRIS.

  • These medicines may be affected by FLOPEN VIATRIS 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 taking this medicine.

How to take FLOPEN VIATRIS

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

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

How much to take

Usual Adult Dose

250 mg every 6 hours

Usual Child Dose

2 to 10 years: half of the adult dose

Under 2 years: quarter of the adult dose

How to take it

Swallow the capsules whole with a full glass of water.

When to take it

Take your medicine 30 minutes to 1 hour before food. Food can interfere with the absorption of FLOPEN VIATRIS.

How long to take it

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

It is important to keep taking your medicine even if you feel well.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.

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

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

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

If you take too much (overdose)

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

Symptoms of an overdose may include diarrhoea and nausea.

While you are taking FLOPEN VIATRIS

Things you must do

Before starting any new medicine, tell your doctor or pharmacist that you are taking FLOPEN VIATRIS.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking FLOPEN VIATRIS.

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

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

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

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

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

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

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

Things you must not do

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

Do not use FLOPEN VIATRIS to treat any other conditions unless your doctor tells you to.

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

Do not stop taking your medicine or lower the dosage without checking with your doctor. If you stop taking it suddenly, your condition may worsen.

Things to be careful of

Be careful driving or operating machinery until you know how FLOPEN VIATRIS affects you.

Things to be aware of

FLOPEN VIATRIS can cause jaundice (yellowing of skin and/or eyes) and severe liver damage. This is more frequent in older patients, particularly those over 55 years of age, and those who take the medicine for more than 14 days.

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

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking FLOPEN VIATRIS. FLOPEN VIATRIS treats infections in most people, but it may have unwanted side effects in some people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

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

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

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

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

  • watery and severe diarrhoea, which may also be bloody
  • severe stomach cramps
  • tiredness, headaches, being short of breath when exercising, dizziness and looking pale
  • bleeding or bruising more easily than normal
  • frequent infections such as fever, chills, sore throat or mouth ulcers
  • yellowing of the eyes or skin (jaundice)
  • painful, swollen joints
  • aching muscles, muscle tenderness or weakness, not caused by exercise
  • irregular heart beat
  • dark or cloudy urine, blood in the urine.

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

If any of the following happen, stop taking FLOPEN VIATRIS and tell your doctor immediately, or go to Accident and Emergency at the nearest hospital:

  • any type of skin rash, itching or hives
  • swelling of the face, lips, tongue or other parts of the body
  • shortness of breath, wheezing or troubled breathing.

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

Other side effects not listed above may also occur in some people.

After stopping FLOPEN VIATRIS

Tell your doctor if your skin and/ or eyes have turned yellow (jaundice) whilst or soon after you finish taking FLOPEN VIATRIS.

Tell your doctor immediately if you notice any of the following side effects, even if they occur up to several weeks after finishing treatment with FLOPEN VIATRIS:

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

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

After using FLOPEN VIATRIS

Storage

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

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

Do not keep FLOPEN VIATRIS or any other medicine in the bathroom or near a sink.

Do not leave FLOPEN VIATRIS in the car or on window sills. Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking FLOPEN VIATRIS, or your capsules have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

FLOPEN VIATRIS 250 mg is a Size 2 capsule with yellow body and black cap.

FLOPEN VIATRIS 500 mg is a Size 0 capsule with yellow body and black cap.

Ingredients

The active ingredient in FLOPEN VIATRIS is flucloxacillin (as flucloxacillin sodium monohydrate).

  • FLOPEN VIATRIS 250 mg capsule contains 250 mg of flucloxacillin (as sodium monohydrate)
  • FLOPEN VIATRIS 500 mg capsule contains 500 mg of flucloxacillin (as sodium monohydrate).

The capsules also contain:

  • povidone
  • purified talc
  • sodium starch glycollate
  • microcrystalline cellulose
  • magnesium stearate
  • iron oxide red
  • iron oxide yellow
  • titanium dioxide
  • brilliant blue FCF
  • gelatin

The capsules also contain trace amounts of sulfites.

Sponsor

FLOPEN VIATRIS is sponsored by:

Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

Australian Registration Numbers:

AUST R: 387418 FLOPEN VIATRIS 250

AUST R: 387419 FLOPEN VIATRIS 500

FLOPEN® is a Viatris company trade mark

This leaflet was prepared in January 2024.

FLOPEN VIATRIS_cmi\Jan24/00

Published by MIMS March 2024

BRAND INFORMATION

Brand name

Flopen Viatris

Active ingredient

Flucloxacillin

Schedule

S4

 

1 Name of Medicine

Flucloxacillin sodium monohydrate.

2 Qualitative and Quantitative Composition

Each Flopen Viatris 250 mg and 500 mg capsule contains 250 mg or 500 mg of flucloxacillin (as sodium monohydrate) as the active ingredient.

Excipients with known effect.

Trace amounts of sulfites.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Flopen Viatris 250 mg.

Size 2 capsule with yellow body and black cap.

Flopen Viatris 500 mg.

Size 0 capsule with yellow body and black cap.

4 Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Dose and Method of Administration

Dosage (dose and interval).

Usual adult dose. 250 mg, 6 hourly.
Children 2 to 10 years. half adult dose.

Note.

In severe infections the dosage may be increased.

Method of administration.

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

Dosage adjustment.

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 these patients is increased. 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 (see Section 4.4 Special Warnings and Precautions for Use).

4.3 Contraindications

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

4.4 Special Warnings and Precautions for Use

High anion gap metabolic acidosis.

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

Severe cutaneous adverse reactions.

Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients taking beta-lactam antibiotics. When SCAR is suspected, flucloxacillin sodium monohydrate should be discontinued immediately and an alternative treatment should be considered.
The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of AGEP. In case of AGEP diagnosis, flucloxacillin sodium monohydrate should be discontinued and any subsequent administration of flucloxacillin sodium monohydrate contraindicated.
It should be recognised that each 1 g of flucloxacillin sodium monohydrate contains sodium 2.2 mmol. This should be included in the daily allowance of patients on sodium restricted diets.

Hypersensitivity and anaphylaxis.

Serious, and occasionally fatal, hypersensitivity (anaphylaxis) reactions have been reported in patients receiving beta-lactam antibiotics e.g. penicillins. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral therapy. Before commencing therapy with any beta-lactam antibiotic, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If a hypersensitivity reaction occurs, appropriate therapy should be instituted and Flopen Viatris therapy discontinued.
Serious anaphylactoid reactions require emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management including intubation should also be administered as indicated.

Antibiotic associated pseudomembranous colitis.

Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including flucloxacillin 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 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.

Use in hepatic impairment.

Hepatitis.

Warning.

Hepatitis, predominantly of cholestatic jaundice, which may be protracted, has been reported with flucloxacillin sodium monohydrate therapy (see Section 4.8 Adverse Effects (Undesirable Effects)). Reports have been more frequent with increasing age (particularly over 55 years of age) or following prolonged treatment (beyond 14 days). Jaundice may appear several weeks after therapy; in several cases, the course of the reactions has been protracted and lasted for several months. Resolution has occurred with time in most cases. In rare cases, deaths have been reported, nearly always in patients with serious underlying disease or receiving concomitant medication.
During long-term treatments regular monitoring of hepatic function is recommended.
Flucloxacillin sodium monohydrate should be used with caution in patients with evidence of hepatic dysfunction, even though this is not a recognised predisposing factor to hepatic reactions to the drug.

Use in renal impairment.

During long-term treatments, regular monitoring of renal function is recommended. Also see Section 4.2 Dose and Method of Administration, Dosage adjustment, Renal impairment.

Use in the elderly.

No data available.

Paediatric use.

Use in neonates.

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

Paracetamol.

Caution should be taken when flucloxacillin sodium monohydrate is used concomitantly with paracetamol as concurrent intake has been associated with high anion gap metabolic acidosis, especially in patients with risk factors (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).

Probenacid.

Probenecid decreases the renal tubular secretion of flucloxacillin sodium monohydrate. Concurrent use with Flopen Viatris may result in increased and prolonged blood levels of flucloxacillin sodium monohydrate.

Oral contraceptives.

In common with other antibiotics, patients should be warned that Flopen Viatris may reduce the effectiveness of oral contraceptives.

Methotrexate and warfarin.

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.

Voriconazole.

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.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B1)
The safety of Flopen Viatris in the first trimester of pregnancy has not yet been established. 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. Flucloxacillin sodium monohydrate should not be used in pregnancy unless considered essential by the physician.
 Flucloxacillin sodium monohydrate is excreted in breast milk in trace amounts. In nursing mothers, an alternative feeding method is recommended because of the risk of allergic sensitisation in the infant.

4.7 Effects on Ability to Drive and Use Machines

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

4.8 Adverse Effects (Undesirable Effects)

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

Metabolism and nutrition disorders.

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

Skin and other subcutaneous tissue disorders.

Severe cutaneous adverse reactions, including SJS, TEN, DRESS, and AGEP (red, scaly rash with bumps under the skin and blisters) have been reported in beta-lactam antibiotics. Adverse reaction of pruritus is very rare.

Central nervous system.

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

Gastrointestinal.

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

Haematological.

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

Hepatic.

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

Hypersensitivity reactions.

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

Renal.

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

Other.

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

Reporting suspected adverse effects.

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

4.9 Overdose

No information is available, but it could be anticipated that overdosage with oral flucloxacillin sodium monohydrate 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 sodium monohydrate in patients with meningitis.
Flucloxacillin sodium monohydrate is not significantly removed from the circulation by haemodialysis. General supportive measures should be instituted, and consideration given to the use of activated charcoal to minimise gastro-intestinal absorption.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Microbiology.

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

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

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

Distribution.

Flopen Viatris, like other isoxazolyl penicillins, is highly bound to serum proteins (> 92%). The low MICs of flucloxacillin sodium monohydrate against Gram positive cocci and the free antibiotic levels achieved, however, ensure that Flopen Viatris 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. In the first six hours following oral administration, approximately 50% of the dose can be recovered unchanged in the urine. When probenecid is given together with flucloxacillin sodium monohydrate, the excretion of flucloxacillin sodium monohydrate is delayed, resulting in higher and more prolonged blood levels of the antibiotic.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Povidone, purified talc, sodium starch glycolate, microcrystalline cellulose, magnesium stearate, iron oxide yellow, iron oxide red, brilliant blue FCF, titanium dioxide, and gelatin.

6.2 Incompatibilities

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

6.3 Shelf Life

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

6.4 Special Precautions for Storage

Store below 25°C.
Flopen Viatris capsules should be kept in a well closed container and stored in a dry place.

6.5 Nature and Contents of Container

Container type: PVC/PE/PVDC/Al blister packs.
Pack sizes: 24 or 30.
Some strengths, pack sizes and/or pack types may not be marketed.

Australian register of therapeutic goods (AUST R).

AUST R: 387418 Flopen Viatris 250 Flucloxacillin 250 mg (as sodium) capsule blister pack.
AUST R: 387419 Flopen Viatris 500 Flucloxacillin 500 mg (as sodium) capsule blister pack.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

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

Chemical structure.


Chemical name: 3 (2' chloro 6' fluorophenyl)-5 methyl 4 isoxazolylpenicillin monohydrate.
Molecular formula: C19H16ClFN3NaO5S,H2O.
Molecular weight: 493.9.

CAS number.

1847-24-1.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes