Consumer medicine information

Fucidin Tablets

Sodium fusidate

BRAND INFORMATION

Brand name

Fucidin

Active ingredient

Sodium fusidate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Fucidin Tablets.

SUMMARY CMI

Fucidin® Tablets

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.

1. Why am I using Fucidin® tablets?

Fucidin® tablets contains the active ingredient Sodium fusidate. Fucidin® tablets are used as an antibiotic which kills certain bacteria that can cause serious illness.

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

2. What should I know before I use Fucidin® tablets?

Do not use if you have ever had an allergic reaction to Fucidin® tablets or any of the ingredients listed at the end of the CMI.

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

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

3. What if I am taking other medicines?

Some medicines may interfere with Fucidin® tablets and affect how it works.

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

4. How do I use Fucidin® Tablets?

  • Swallow the tablets whole with a full glass of water, on an empty stomach.
  • The usual dose of Fucidin® Tablets for skin conditions is 1 tablet (250mg) twice daily.
  • For other infections, the adult dose is usually 2 tablets (500 mg) three times daily.
  • The dose for children between 5 and 12 years of age is 1 tablet (250 mg) three times daily.
  • In certain very serious infections, it may be necessary to take other antibiotics in addition to Fucidin® Tablets.

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

5. What should I know while using Fucidin® Tablets?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Fucidin® tablets.
  • Tell your doctor immediately If the symptoms of your infection do not begin to improve within a few days, or if they become worse.
  • Tell your doctor if you become pregnant while you are taking Fucidin® Tablets and if you are about to start taking any new medicine while you are taking Fucidin® Tablets.
Things you should not do
  • Do not give Fucidin® Tablets to anyone else, even if they have the same condition as you.
  • Do not take Fucidin® Tablets to treat any other complaints unless your doctor tells you to.
Driving or using machines
  • Be careful driving or operating machinery until you know how Fucidin® Tablets affect you.
Looking after your medicine
  • Keep Fucidin® Tablets in the blister pack until it is time to take them. Keep your tablets in a cool dry place where the temperature stays below 30°C.

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

6. Are there any side effects?

Fucidin® Tablets 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. Some common side effects include nausea, vomiting, indigestion, diarrhoea, stomach or abdominal pain, wind, tiredness, headache, and skin rash.

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.



FULL CMI

Fucidin® Tablets

Active ingredient(s): Sodium fusidate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Fucidin® Tablets. 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 Fucidin® Tablets.

Where to find information in this leaflet:

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

1. Why am I using Fucidin® Tablets?

Fucidin® Tablets contains the active ingredient Sodium fusidate.

Fucidin® Tablets contain an antibiotic which kills certain bacteria that can cause serious illness. Fucidin® Tablets are active against Staphylococci or “Staph”, which can cause severe infections. Infection may occur in different parts of the body, for example, the lung, bone, blood, heart, joints, eyes, skin and wounds. This medicine may be used with other antibiotics to treat infections. Fucidin® Tablets will not work against infections caused by viruses, such as cold or flu, and certain other bacteria. This medicine is available only with a doctor's prescription. Your doctor may have prescribed Fucidin® Tablets for another reason. Ask your doctor why Fucidin® Tablets have been prescribed for you.

There is no evidence that this medicine is addictive.

2. What should I know before I use Fucidin® Tablets?

Warnings

Do not use Fucidin® Tablets if:

  • you are allergic to Sodium fusidate or fusidic acid, or any of the ingredients listed at the end of this leaflet.
  • Always check the ingredients to make sure you can use this medicine.
  • Do not take this medicine if you are taking certain medicines for cholesterol lowering called statins or HMG-CoA reductase inhibitors. Ask your doctor if you are not sure if you are taking any of these medicines

Check with your doctor if you:

  • have or have ever had any health problems or medical conditions, particularly any illnesses affecting your liver.
  • are taking certain HIV medicines (HIV-protease inhibitors).
  • have a rare birth condition of glucose or lactose intolerance.
  • have biliary disease, such as problems with the transport of bilirubin.

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 intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

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

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

4. How do I use Fucidin® Tablets?

How to take it

Swallow the tablets whole with a full glass of water

How much to take / use

  • The usual dose of Fucidin® Tablets for skin conditions is 1 tablet (250 mg) twice daily.
  • For other infections, the adult dose is usually 2 tablets (500 mg) three times daily.
  • The dose for children between 5 and 12 years of age is 1 tablet (250 mg) three times daily.
  • In certain very serious infections, it may be necessary to take other antibiotics in addition to Fucidin® Tablets.
  • Follow the instructions provided and use Fucidin® Tablets until your doctor tells you to stop.

When to take / use Fucidin® Tablets

  • Fucidin® Tablets should be taken without food.

How long to use Fucidin® Tablets

  • It is usually necessary to take a course of Fucidin® Tablets for between 5 and 10 days.
  • Continue taking Fucidin® Tablets until you finish the pack unless your doctor recommends otherwise.
  • Do not stop taking Fucidin® Tablets because you are feeling better.
  • If you do not complete the full course prescribed by your doctor, all of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not clear completely or it may return.

If you forget to use Fucidin® Tablets

Fucidin® Tablets should be used regularly at the same time each day. If you miss your dose at the usual time and it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking Fucidin® Tablets as you would normally. If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you have trouble remembering to take Fucidin® Tablets, ask your doctor or pharmacist for some hints.

If you use too much Fucidin® Tablets

If you think that you have taken too many Fucidin® Tablets, you may need urgent medical attention.

You should immediately:

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

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

5. What should I know while using Fucidin® Tablets?

Things you should do

Call your doctor straight away if you:

  • if the symptoms of your infection do not begin to improve within a few days, or if they become worse.
  • if you get severe diarrhoea whilst taking Fucidin® Tablets. Do this even if the diarrhoea occurs several weeks after Fucidin® Tablets has been stopped.
  • if your urine becomes very dark, your bowel motions become very pale or your eyes or skin look yellow.
  • if you become pregnant while you are taking Fucidin® Tablets.
  • if you are about to start taking any new medicine while you are taking Fucidin® Tablets.

Remind any doctor, dentist or pharmacist you visit that you are using Fucidin® Tablets.

Things you should not do

  • Do not give Fucidin® Tablets to anyone else, even if they have the same condition as you.
  • Do not take Fucidin® Tablets to treat any other complaints unless your doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Fucidin® Tablets affects you.

Fucidin® Tablets generally do not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, Fucidin® Tablets may cause drowsiness or tiredness in some people. If you have any of these symptoms, do not drive or operate machinery.

Looking after your medicine

  • Keep Fucidin® Tablets in the blister pack until it is time to take them. Keep your tablets in a cool dry place where the temperature stays below 30°C.
  • Heat and dampness can destroy some medicines.
  • Keep Fucidin® Tablets where children cannot reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
  • Do not use Fucidin® Tablets after the expiry date on the package.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

When to discard your medicine

If your doctor tells you to stop taking Fucidin® Tablets or the expiry date has passed, ask your pharmacist what to do with any Fucidin® Tablets that are left over.

Getting rid of any unwanted medicine

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

Do not use this medicine after the expiry date.

6. Are there any side effects?

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

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

Less serious side effects

Less serious side effectsWhat to do
  • Nausea
  • Vomiting
  • Indigestion
  • Diarrhoea
  • Stomach or abdominal pains
  • Wind
  • Tiredness
  • Headaches
  • Skin 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
  • Temporary paralysis or weakness of muscles
  • Muscle swelling or pain
  • Itching with swelling or skin
  • Rash
  • Swelling of the face, lips, mouth or throat, difficulty in swallowing or breathing
  • Skin rash, redness, or a widespread rash with blisters
  • Peeling skin particularly around the mouth, throat, nose, eyes and/or genitals
  • Flu-like symptoms (fever, headache, body ache) that are followed by a rash
  • Stinging eyes
  • Discomfort when swallowing.
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.

Fucidin® Tablets can occasionally cause liver upsets which can produce jaundice (yellow skin).

This condition will almost always get better after you finish taking Fucidin® Tablets.

Tell your doctor if you notice any of the following:

  • very dark urine
  • very pale bowel motions
  • yellowing of the whites of your eyes
  • yellow skin.

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 Fucidin® Tablets contains

Active ingredient
(main ingredient)		Sodium Fusidate (250 mg)
Other ingredients
(inactive ingredients)
  • Microcrystalline cellulose
  • Crospovidone
  • Hypromellose
  • Lactose monohydrate
  • Magnesium stearate
  • dl-alpha-tocopherol
  • Colloidal silica anhydrous
  • Purified talc
  • Titanium dioxide

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

Fucidin® Tablets do not contain gluten, tartrazine or any other azo dye.

What Fucidin® Tablets looks like

Fucidin® Tablets are white in colour and oval in shape. Available in a box of 36 tablets, supplied in blister strips, each of which contains 9 tablets.

The Australian Registration Number for Fucidin® Tablets is AUST R 125822.

Who distributes Fucidin® Tablets

Fucidin® Tablets is supplied in Australia by:

LEO Pharma Pty Ltd
Brisbane, QLD Australia
Toll free no: 1800 991 778
Web: www.leo-pharma.com.au

Fucidin® is a registered trademarks of LEO Pharma A/S.

This leaflet was prepared in May 2022.

Published by MIMS April 2023

BRAND INFORMATION

Brand name

Fucidin

Active ingredient

Sodium fusidate

Schedule

S4

 

1 Name of Medicine

Sodium fusidate.

2 Qualitative and Quantitative Composition

Fucidin Tablets contain sodium fusidate 250 mg.

Excipients with known effect.

Lactose monohydrate, sugars, galactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Fucidin Tablets are approximately 7.8 x 16.0 mm white to off-white greyish marble film coated oval biconvex tablets without embossing.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of localised, as well as generalised, staphylococcal infections caused by susceptible organisms.
In severe infections, deep-seated infections, infections due to methicillin-resistant Staphylococci or when prolonged therapy may be required, Fucidin must be given concurrently with other anti-staphylococcal antibiotic therapy.

4.2 Dose and Method of Administration

Fucidin tablets should be taken without a meal to avoid a reduction in the extent and rate of absorption of Fucidin by a concomitant meal.
In severe infections, deep-seated infections, infections due to methicillin-resistant Staphylococci or when prolonged therapy may be required, Fucidin must be given concurrently with other anti-staphylococcal antibiotic therapy. Such combinations may produce enhanced activity, broaden the antibacterial spectrum and minimise the risk of the development of resistance to fusidic acid and its salt. In general, full dosage of each antibiotic should be used and in very severe cases, the dosage of Fucidin may also be doubled.
The average duration of treatment is 5-10 days although more severe infection may require a longer treatment period.

Dosage in hepatic insufficiency.

Dosage reduction may be necessary in patients with hepatic impairment, since the active ingredient is cleared from the blood via hepatic metabolism.
For community-acquired mild to moderate acute skin and skin-structure infections likely to be caused by methicillin-sensitive Staphylococci, e.g. boils, carbuncles, furuncles, superficial abscesses, paronychia, superficial wound infections and impetigo.
Adults: 250 mg twice daily.
For all other infections caused by Staphylococcus aureus.
Adults: 2 x 250 mg three times daily.
Children. 5 to 12 years: 250 mg three times daily.
Over 12 years: as for adults.

4.3 Contraindications

Concomitant treatment with statins, see Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.
Hypersensitivity to fusidic acid hemihydrate or its salts or any excipient ingredient in the formulation of Fucidin.

4.4 Special Warnings and Precautions for Use

The medicinal product contains 0.45 mmol (11 mg) sodium per tablet, equivalent to 0.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Fucidin must not be co-administered with statins. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). In patients where the use of systemic Fucidin is considered essential, statin treatment should be discontinued throughout the duration of Fucidin treatment. The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be re-introduced seven days after the last dose of Fucidin.
Fucidin is metabolised by the liver and excreted in the bile. Elevated liver enzymes and jaundice have occurred during systemic Fucidin therapy but are usually reversible on discontinuation of the drug. Liver function tests should be performed regularly in patients taking high doses, in patients taking the drug for prolonged periods and in patients with abnormal liver function.
In a few cases, serious cutaneous reactions putting life at risk such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, toxic epidermal necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome have been reported with systemic Fucidin. Patients should be advised to monitor cutaneous reactions as well as signs and symptoms suggestive of these reactions which usually appear in the first weeks of therapy. If such reactions are suspected to be due to systemic Fucidin, treatment with systemic Fucidin should be stopped and it is recommended not to reintroduce the therapy.
Sodium fusidate competitively inhibits binding of bilirubin to albumin. Caution is necessary if systemic Fucidin is administered to patients with impaired transport and metabolism of bilirubin. Particular care is advised in neonates due to the theoretical risk of kernicterus (see Section 4.4, Paediatric use).
Resistance has developed both in vitro and in vivo and physicians should be alert to this possibility. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine due to the content of lactose.
Risk-benefit should be considered when the following medical problems exist.
Caution is required in patients with biliary disease and biliary tract obstruction.
Caution is required in patients treated with HIV-protease inhibitors (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Use in hepatic impairment.

Hepatic function impairment.

Fucidin is metabolised in the liver; patients with impaired or immature hepatic function, especially neonates and infants or adults with impaired hepatic function, may require a reduction in dose or an alternative antibiotic should be considered.

Use in the elderly.

No data available.

Paediatric use.

Use in neonates.

Due to the high degree of protein binding, sodium fusidate may cause kernicterus in babies during the first month of life by displacing bilirubin from plasma albumin.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic Fucidin with statins. The mechanism of this interaction (whether it is pharmacodynamics or pharmacokinetic, or both) is yet unknown. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination. If treatment with Fucidin is necessary, statin treatment should be discontinued throughout the duration of the Fucidin treatment. Also see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use.
Fusidic acid and its salts, when administered systemically, and concomitantly with oral anticoagulants such as warfarin, other coumarin derivatives or anticoagulants with similar action, may increase the plasma concentration of these anticoagulant agents, enhancing the anticoagulant effect. Downward adjustment of the oral anticoagulant dose, monitored by laboratory coagulation testing and clinical status, may be necessary in order not to exceed the desired level of anticoagulation. The mechanism of this suspected interaction remains unknown.
Specific pathways of Fucidin metabolism in the liver are not known, however, an interaction between Fucidin and drugs biotransformed via CYP3A4 is suspected. It is recommended that patients concomitantly treated with CYP3A4 biotransformed drugs and systemic Fucidin are monitored as there is conflicting evidence that suggests Fucidin may inhibit or induce CYP3A4.
Co-administration of systemic Fucidin and HIV protease inhibitors, such as ritonavir and saquinavir, causes increased plasma concentrations of both agents, which may result in hepatotoxicity. Concomitant use is not recommended.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There are no clinical studies with systemic Fucidin regarding fertility. Pre-clinical studies did not show any effect of sodium fusidate on the fertility in rats. A study in male rats at oral doses up to 400 mg/kg/day showed no effects on fertility.
(Category C)
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of Fucidin in pregnant women. Limited animal studies do not indicate direct or indirect harmful effect with respect to reproductive toxicity. There is, however, evidence that the drug can penetrate the placental barrier and safety in pregnancy has not been established. Due to the high degree of protein binding, Fucidin may cause neonatal kernicterus if given during the last month of pregnancy. As a precautionary measure, it is preferable to avoid the use of systemic Fucidin during pregnancy.
 Safety in lactation has not been established. The drug has been shown to be present in human milk. Caution is required when fusidic acid or its salt are used in mothers who wish to breast feed.

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)

The most frequently reported undesirable effects of Fucidin administered orally are gastrointestinal disorders like abdominal discomfort and pain, diarrhoea, dyspepsia, nausea and vomiting. Anaphylactic shock has been reported.

Clinical trials experience.

Adverse events reported amongst patients treated with sodium fusidate for staphylococcal skin infections at different dosage regimes during controlled clinical trials (see Section 5.1, Clinical trials) are shown in Table 1. A dash represents an incidence of less than 1%.

Post-marketing experience.

The estimation of the frequency of undesirable effects is based on a pooled analysis of data from spontaneous reporting and clinical trials.
Undesirable effects are listed by MedDRA System of classification (SOC) and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency group, adverse reactions are presented in the order of decreasing seriousness.
Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from available data).

Blood and lymphatic system disorders.

Uncommon: Pancytopenia, leukopenia1, thrombocytopenia, anaemia.

Immune system disorders.

Uncommon: Anaphylactic shock/anaphylactic reaction.
Rare: Hypersensitivity.

Nervous system disorders.

Uncommon: Somnolence, headache.

Gastrointestinal disorders.

Common: Vomiting, diarrhoea, abdominal pain, dyspepsia, nausea, abdominal discomfort.

Hepatobiliary disorders.

Uncommon: Hepatic failure, cholestasis, hepatitis2, jaundice3, hyperbilirubinaemia, liver function test abnormal4.
Rare: Hepatic function abnormal.

Skin and subcutaneous tissue disorders.

Uncommon: Acute generalized exanthematous pustulosis, urticaria, pruritus, rash5, erythema.
Rare: Angioedema.
Not known: Toxic epidermal necrolysis (Lyell's syndrome)6, Stevens-Johnson syndrome6, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome6.

Musculoskeletal and connective tissue disorders.

Uncommon: Rhabdomyolysis (examples of signs and symptoms are muscle weakness, muscle swelling and muscle pain; dark urine, myoglobinuria, elevated serum creatine kinase, acute renal failure, cardiac arrhythmia). Rhabdomyolysis may be fatal. See Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

Renal and urinary disorders.

Uncommon: Renal failure7.

General disorders and administration site conditions.

Common: Lethargy/Fatigue/Asthenia.
1 Haematological disorders affecting the white cell line (neutropenia, granulocytopenia and agranulocytosis) and more rarely disorders affecting the other two cell lines have been reported, either as isolated or associated events. This has been observed especially in cases of treatment duration of more than 15 days and is reversible upon drug withdrawal.
2 Hepatitis also includes Hepatitis cholestatic/ Cytolytic hepatitis.
3 Jaundice also includes Jaundice cholestatic.
4 Including alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased and gamma-glutamyltransferase increased.
5 Rash includes various types of rash reactions such as drug eruption, erythematous and maculo-papular rash.
6 These adverse reactions were identified through post-marketing surveillance. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (see Section 4.4 Special Warnings and Precautions for Use).
7 Renal failure also includes renal failure acute.

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: https://www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms.

Acute symptoms of overdose include gastrointestinal disturbances. An overdose of 4 g/day for a duration of ten days in an adult has been reported without any adverse events. An overdose of 1,250 mg/day for a duration of seven days in a child (three years old) has been reported without any adverse events.

Treatment.

There are no published reports of the treatment of accidental massive overdosage with Fucidin and there has been no experience with any specific treatment.
Management should be directed towards alleviation of symptoms. Dialysis will not increase the clearance of sodium fusidate.
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Sodium fusidate is an antibiotic derived from the fungus Fusidium coccineum.

Mechanism of action.

The mode of action is by inhibition of protein synthesis by the prevention of translocation on the ribosome. Concentrations adequate for bactericidal activity against Staphylococci after oral or parenteral administration have been demonstrated in the following: pus, exudate, soft tissue, bone tissue, synovial fluid, aqueous humour, vitreous body, burn crusts, intracranial abscess, sputum and serum.
Fucidin exerts antibacterial activity against most Gram-positive organisms; in particular, it is effective against pathogenic Staphylococci, including penicillinase-producing and methicillin-resistant strains. 50% of methicillin-resistant Staphylococcus aureus strains are inhibited by sodium fusidate, with an MIC of ≥ 0.19 microgram/mL. It has slight or no activity against Gram-negative organisms and fungi.
Oral Fucidin have been given in combination with other antibiotics. Use in combination with an anti-staphylococcal penicillin may prevent the development of Fucidin resistant strains. No cross resistance occurs between Fucidin and any other antibiotic in clinical use. Because it is predominantly effective against Gram-positive organisms, disturbance of the normal gastrointestinal flora is unlikely.

Clinical trials.

Two large scale randomised double-blind studies were conducted over 10 days in Europe between 1987 and 1991 in which Fucidin 250 mg tablets twice daily was compared with Fucidin 500 mg twice daily in one study and also with 500 mg three times daily in the other study. The patients had a range of skin and soft tissue infections. Patients with isolates resistant to sodium fusidate were excluded. In one study 148/617 patients were assessed for bacteriological efficacy by way of follow-up cultures. In those patients tested, the eradication of S. aureus at day 5 was 62%, 77% and 52% for the 250 mg twice daily, 500 mg twice daily and 500 mg three times daily doses respectively. The clinical results obtained by combining the results of the 2 trials are found in Table 2.

5.2 Pharmacokinetic Properties

Absorption.

Oral fusidic acid and its salt are absorbed from the gastrointestinal tract, producing maximum serum concentrations in 2 to 4 hours. Maximum serum levels (Cmax), time to maximum serum concentration (Tmax) and t1/2 after an oral dose of 500 mg sodium fusidate tablet are:

Under fed conditions.

Cmax of 31.76 microgram/mL and Tmax of 3.37 hours and t1/2 10.53 hours.

Under fasting conditions.

Cmax of 38.79 microgram/mL and Tmax 2.21 hours and t1/2 8.89 hours.
Following a single 250 mg sodium fusidate tablet oral dose in fasting subjects, the mean Cmax sodium fusidate was 11.6 microgram/mL and the mean t1/2 was reported to be 8.7 hours.

Distribution.

Fusidic acid and its salt are distributed into tissues and body fluids, including bone, pus and synovial fluid, but penetrate poorly to CSF.

Metabolism.

Fusidic acid and its salt are bound to plasma protein to a high degree (95%).

Excretion.

Only small amounts (on average only 0.15%) of fusidic acid and its salt are excreted in the urine; it is mainly excreted and concentrated in bile. Approximately 2% is excreted in the faeces as the unchanged drug.

5.3 Preclinical Safety Data

No data available.

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Fucidin Tablets contain lactose monohydrate, magnesium stearate, colloidal silica anhydrous, purified talc, crospovidone, microcrystalline cellulose, dl-alpha-tocopherol, hypromellose and titanium dioxide.

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 30°C.

6.5 Nature and Contents of Container

Pack Sizes 12*, 24* or 36 tablets per box. The 36 tablet box is supplied in either PVC/Aluminium or Aluminium/Aluminium blister strips, each of which contains 9 tablets.
* Not currently distributed in Australia.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Sodium fusidate is Sodium ent-(17Z)-16α-(acetyloxy)-3β,11β-dihydroxy-4β,8,14-trimethyl-18-nor-5β,10α-cholesta-17(20), 24-dien-21-oate; C31H47NaO6.
Sodium fusidate is a white or almost white crystalline powder, slightly hygroscopic, and freely soluble in water and ethanol (96 percent). pH is 7.5-9.0 with a partition coefficient of 2.6 and pKa of 4.9.
Sodium fusidate is an antimicrobial substance produced by the growth of certain strains of Fusidium coccineum.

Chemical structure.

Sodium fusidate has the following structure:
C31H47NaO6. Mw 538.7.

CAS number.

751-94-0.

7 Medicine Schedule (Poisons Standard)

Schedule 4.

Summary Table of Changes