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.

What is in this leaflet?

This leaflet answers some common questions about Fucidin® Tablets. 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 taking Fucidin® Tablets against the benefits the medicine is expected to have for you.

If you have any concerns about taking either of these medicines, ask your doctor or pharmacist.

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

What Fucidin® Tablets are used for

Fucidin® Tablets contain an antibiotic which kills certain bacteria which 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 has been prescribed for you.

There is no evidence that this medicine is addictive.

Before you take Fucidin® Tablets

When you must not take it

Do not take this medicine if you have an allergy to:

  • any medicine containing sodium fusidate or fusidic acid
  • any of the ingredients listed at the end of this leaflet (see Product description).

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

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.

Do not take this medicine

  • after the expiry date printed on the pack. If you take it after the expiry date it may have no effect at all, or worse, an unexpected effect.
  • if the packaging is torn, doesn’t look quite right or shows signs of tampering.

If the packaging is damaged or it is past the expiry date, return the medicine to your pharmacist for disposal.

If you are not sure whether you should start taking Fucidin® Tablets, talk to your doctor.

Before you start to take it

Tell your doctor if you

  • have any allergies to any other medicine or any other substances, such as foods, preservatives or dyes. This may include medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
  • have or have ever had any 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.
  • are pregnant or intend to become pregnant. Your doctor can discuss with you the risks and benefits of taking Fucidin® Tablets during pregnancy.
  • are breast-feeding or plan to breast-feed. Your doctor can discuss with you the risks and benefits of taking Fucidin® Tablets when breast-feeding.

If you have not told your doctor about any of the above, tell him/her before you start taking this medicine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may interfere with Fucidin® Tablets.

Some medicines may be affected by Fucidin® Tablets or may affect how well Fucidin® Tablets work. You may need different amounts of your other medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Fucidin® Tablets.

How to take Fucidin® Tablets

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 pack, ask your doctor or pharmacist for help.

How much to take

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.

How to take it

Swallow the tablets whole with a full glass of water.

When to take it

Fucidin® Tablets should be taken without food.

How long to take it

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 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 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 take too much (overdose)

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

If you take too much Fucidin® Tablets you may get stomach pain, heartburn or diarrhoea.

While you are taking Fucidin® Tablets

Things you must do

Tell your doctor immediately

  • 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.

Tell any other doctors, dentists and pharmacists who treat you that you are taking Fucidin® Tablets.

Things you must 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.

Things to be careful of

Be careful driving or operating machinery 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.

Side effects

Like all medicines, 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 side effects may not appear until weeks or months after you have started taking Fucidin® Tablets.

Tell your doctor or pharmacist if you have any unpleasant effects while you are taking Fucidin® Tablets even if you do not think the effect is connected with the medicine or is not listed in this leaflet.

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

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

Antibiotics act by killing bacteria. Your bowel contains bacteria, many of which perform a useful function. When taken by mouth, antibiotics kill some of the normal bacteria in the bowel and can cause nausea, vomiting or diarrhoea. Severe diarrhoea is rare and must be reported to your doctor.

The most common side effects which can sometimes occur after taking Fucidin® Tablets are:

  • nausea
  • vomiting
  • indigestion
  • diarrhoea
  • stomach or abdominal pains
  • wind
  • tiredness
  • headaches
  • skin rash (note that a skin rash may also be a sign of a very serious side effect . Further information and instructions are provided below).

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.

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

  • 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.

These are very serious side effects. You may need urgent medical attention or hospitalisation.

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 using Fucidin® Tablets

Tell your doctor or pharmacist if you have any side effects even if you have stopped taking Fucidin® Tablets.

If you have any queries about any aspect of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor or pharmacist.

Storage

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.

Do not store Fucidin® Tablets, or any other medicine in the bathroom or near a sink. Do not leave them on a window sill or in the car. 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.

Disposal

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.

Product description

What it 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.

Ingredients

Each Fucidin® Tablet contains 250 mg of sodium fusidate as the active ingredient. They also contain:

  • microcrystalline cellulose
  • crospovidone
  • hypromellose
  • lactose monohydrate
  • magnesium stearate
  • dl-alpha-tocopherol
  • colloidal silica anhydrous
  • purified talc
  • titanium dioxide.

They do not contain gluten, tartrazine or any other azo dye.

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

This is not all the information available on Fucidin® Tablets. If you have any more questions or are unsure about anything, ask your doctor or pharmacist.

Supplier

Fucidin® Tablets are supplied in Australia by:

LEO Pharma Pty Ltd
Level 3, Tower 1,
25 Montpelier Road
Bowen Hills, QLD 4006
AUSTRALIA

And manufactured by:
Laboratoires LEO.

This leaflet was prepared in September 2018.

®Fucidin, LEO and LEO/lion device are registered trademarks of LEO Pharma A/S.

Published by MIMS April 2019

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