Consumer medicine information

APO-Mupirocin

Mupirocin

BRAND INFORMATION

Brand name

APO-Mupirocin

Active ingredient

Mupirocin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APO-Mupirocin.

SUMMARY CMI

APO-MUPIROCIN

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 APO-MUPIROCIN?

APO-MUPIROCIN ointment contains the active ingredient mupirocin. APO-MUPIROCIN ointment is used to treat mild impetigo (school sores).

For more information, see Section 1. Why am I using APO-MUPIROCIN? in the full CMI.

2. What should I know before I use APO-MUPIROCIN?

Do not use if you have ever had an allergic reaction to mupirocin 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 APO-MUPIROCIN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-MUPIROCIN ointment 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 APO-MUPIROCIN?

  • Always wash your hands before and after applying APO-MUPIROCIN ointment.
  • A small amount of APO-MUPIROCIN ointment should be applied to the affected area three times daily. The area treated may be covered with gauze dressing if desired, unless your doctor has told you to leave it uncovered.
  • Usually treatment should not continue for more than 10 days.

More instructions can be found in Section 4. How do I use APO-MUPIROCIN? in the full CMI.

5. What should I know while using APO-MUPIROCIN?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using APO-MUPIROCIN ointment.
  • Tell your doctor if you are pregnant or are planning to become pregnant.
  • Tell your doctor if you are breastfeeding or are planning to breastfeed.
  • Tell your doctor if you are about to have any blood tests or are going to have surgery, an anaesthetic or are going into hospital.
  • Do not use this medicine to treat infections in or near the eyes, nostrils or mouth or near tubes inserted into your body for the delivery or removal of fluid (cannulae).
Things you should not do
  • Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Do not use your medicine to treat any other condition unless your doctor tells you to.
  • Do not stop using your medicine, or change the dosage, without first checking with your doctor.
  • Do not mix this medicine with any other topical medicines.
Looking after your medicine
  • Keep your medicine in its original packaging until it is time to take it.
  • Keep your medicine in a cool dry place where the temperature will stay below 25°C.

For more information, see Section 5. What should I know while using APO-MUPIROCIN? in the full CMI.

6. Are there any side effects?

Common side effects include: itching, dryness, redness and stinging.

More serious side effects include: swelling, itching, burning or pain in the area where mupirocin ointment has been applied.

Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting or hay fever-like symptoms.

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

APO-MUPIROCIN

Active ingredient: mupirocin

Consumer Medicine Information (CMI)

This leaflet provides important information about using APO-MUPIROCIN. 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 APO-MUPIROCIN.

Where to find information in this leaflet:

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

1. Why am I using APO-MUPIROCIN?

APO-MUPIROCIN contains the active ingredient mupirocin. APO-MUPIROCIN is an antibiotic. Antibiotics work by killing bacteria which can cause infection.

APO-MUPIROCIN ointment is used to treat mild impetigo, also known as school sores.

2. What should I know before I use APO MUPIROCIN?

Warnings

Do not use APO-MUPIROCIN:

  • If you are allergic to mupirocin, or any of the ingredients listed at the end of this leaflet.
    Always check the ingredients to make sure you can use this medicine.
    Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.
    If you think you are having an allergic reaction, do not use any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
  • to treat infections in or near the eyes, nostrils or mouth. If this medicine is accidentally applied to the eyes, wash the eyes thoroughly with water.
  • to treat areas of skin near tubes inserted into your body for the delivery or removal of fluid (cannulae). This medicine should not be used in combination with cannulae.
    Mupirocin can cause inflammation of the colon (large intestine), causing diarrhoea, usually with blood and mucus, stomach pain, fever (pseudomembranous colitis).
    Tell your doctor as soon as possible if you get any of these symptoms.

This medicine should not be used for children under 2 years of age.

Check with your doctor if you:

  • have any other medical conditions, especially moderate or severe renal impairment;
  • are planning to have surgery or an anaesthetic
  • are currently receiving or are planning to receive dental treatment.
  • have any allergies to medicine, foods or other substances
  • take any medicines for any other condition.

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.

Your doctor will discuss the risks and benefits involved.

If you are using this medicine on a cracked nipple, wash the nipple well before breast feeding your baby.

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.

Do not mix this medicine with any other topical medicines. They may prevent APO-MUPIROCIN ointment from working.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect APO-MUPIROCIN.

4. How do I use APO-MUPIROCIN?

How much to use

  • Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.
  • Your doctor will tell you how much of this medicine you should use. This will depend on your condition and whether you are taking any other medicines.
  • Always wash your hands before and after applying APO-MUPIROCIN ointment.
  • A small amount of APO-MUPIROCIN ointment should be applied to the affected area three times daily.
  • The area treated may be covered with gauze dressing if desired, unless your doctor has told you to leave it uncovered.
  • Do not stop using your medicine or change your dosage without first checking with your doctor.
  • Continue using your medicine for as long as your doctor tells you. Usually treatment should not continue for more than 10 days.
  • Make sure you have enough of this medicine to last over weekends and holidays.

When to use APO-MUPIROCIN

  • Use this medicine at the same time each day. Applying it at the same time each day will have the best effect and will also help you remember when to use it.

If you forget to use APO-MUPIROCIN

If it is almost time to use your ointment, skip the missed application and use it at the usual time.

Otherwise, apply it as soon as you remember and then go back to taking your medicine as you would normally.

If you have trouble remembering to apply your medicine, ask your pharmacist for some hints to help you remember.

If you use too much APO-MUPIROCIN

If you think that you have used too much APO-MUPIROCIN ointment, 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 APO-MUPIROCIN?

Things you must do

Tell your doctor that you are using this medicine if:

  • you are about to be started on any new medicine
  • you are pregnant or are planning to become pregnant
  • you are breastfeeding or are planning to breastfeed
  • you are about to have any blood tests
  • you are going to have surgery or an anaesthetic or are going into hospital.

Remind any doctor, dentist or pharmacist you visit that you are using APO-MUPIROCIN ointment.

Go to your doctor regularly for a check-up while using this medicine.

Things you should not do

Do not:

  • give this medicine to anyone else, even if their symptoms seem similar to yours.
  • use your medicine to treat any other condition unless your doctor tells you to.
  • stop using your medicine, or change the dosage, without first checking with your doctor.

Looking after your medicine

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

Keep your medicine in its original packaging until it is time to take it. If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 25°C.

Do not store it in the bathroom or near a sink; or in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

Any product remaining at the end of treatment should be discarded.

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
  • itching
  • dryness
  • redness
  • stinging
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
  • swelling, itching, burning or pain in the area where the ointment has been applied
  • allergic reaction. Symptoms of may include some or all of the following:
    - cough, shortness of breath, wheezing or difficulty breathing
    - swelling of the face, lips, tongue, throat or other parts of the body
    - rash, itching or hives on the skin
    - fainting
    - hay fever-like symptoms
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.

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.

There is no evidence that this medicine is addictive.

What APO-MUPIROCIN contains

Active ingredient
(main ingredient)		mupirocin
Other ingredients
(inactive ingredients)		macrogol 400
macrogol 3350

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

This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.

What APO-MUPIROCIN looks like

APO-MUPIROCIN is a white semi-transparent homogeneous preparation. The tube contains 15 g of ointment with 20 mg/g (2% w/w) mupirocin.

(AUST R 276520)

Sponsor

Southern Cross Pharma Pty Limited,
Suite 2, Level 2, 19-23 Prospect Street
VIC 3128.

Who distributes APO-MUPIROCIN

Arrotex Pharmaceuticals Pty Limited
15-17 Chapel Street, Cremorne VIC 3121
www.arrotex.com.au

This leaflet was prepared in December 2024

Published by MIMS March 2025

BRAND INFORMATION

Brand name

APO-Mupirocin

Active ingredient

Mupirocin

Schedule

S4

 

Notes

Distributed by Arrotex Pharmaceuticals

1 Name of Medicine

Mupirocin.

2 Qualitative and Quantitative Composition

Each gram of mupirocin ointment contains 20 mg of mupirocin (2% w/w) as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

APO-Mupirocin ointment is a white, semi-transparent, homogeneous ointment.

4 Clinical Particulars

4.1 Therapeutic Indications

APO-Mupirocin is indicated for the topical treatment of mild impetigo.

4.2 Dose and Method of Administration

APO-Mupirocin is intended for topical application only.
A small amount of mupirocin ointment should be applied to the affected area three times daily. The area treated may be covered with gauze dressing if desired. Usually treatment should not continue for more than 10 days.
Any product remaining at the end of treatment should be discarded.

4.3 Contraindications

APO-Mupirocin is contraindicated in patients who have demonstrated hypersensitivity to mupirocin, mupirocin calcium, or any components of the formulation.

4.4 Special Warnings and Precautions for Use

If a reaction suggesting sensitivity or chemical irritation should occur with the use of APO-Mupirocin, treatment should be discontinued, the product should be wiped off and appropriate alternative therapy for the infection instituted.
APO-Mupirocin is not suitable for ophthalmic use, intranasal use or application to other mucosal surfaces.
Avoid contact with eyes. If contaminated, the eyes should be thoroughly irrigated with water until the residues have been removed.
APO-Mupirocin is not suitable for application to the site of cannulation or for use in conjunction with cannulae.
As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.
Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. Although this is less likely to occur with topically applied mupirocin, if prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.

Use in renal impairment.

Polyethylene glycol (macrogol) can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol based ointments, APO-Mupirocin should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment.

Use in the elderly.

No restrictions unless there is evidence of moderate or severe renal impairment.

Paediatric use.

The safety and efficacy of mupirocin ointment has not been established in children less than two years of age.

Effects on laboratory tests.

Interactions with laboratory tests have not been established.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No drug interactions have been studied with mupirocin.
APO-Mupirocin should not be combined with other topical preparations as there is a risk of dilution, resulting in a reduction in the antibacterial activity and potential loss of stability of the mupirocin.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Fertility of male and female rats was not affected by mupirocin at subcutaneous doses up to 100 mg/kg/day.
(Category B1)
Reproduction studies have been performed in rats and rabbits at systemic doses up to 160 mg/kg and have revealed no evidence of harm to the foetus due to mupirocin.
There are, however, no adequate and well controlled studies in pregnant women. Because animal studies are not always predictive of human response, mupirocin ointment should be used during pregnancy only if clearly needed.
 Adequate human and animal data on use during lactation are not available.
Caution should be exercised when mupirocin ointment is administered to a nursing woman. If a cracked nipple is being treated, the nipple should be thoroughly washed prior to breastfeeding.

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)

Systemic allergic reactions such as generalised rash, urticaria and angioedema have been reported with mupirocin ointment.

Local reactions.

Common (approximately 2%): itching, burning, erythema, stinging, pain/ swelling at site of application and dryness. Less than 1% of patients discontinued therapy because of these local reactions.
Uncommon: cutaneous sensitisation reactions to mupirocin or the ointment base.

Gastrointestinal.

One case of nausea has been reported in studies of mupirocin ointment so far.
Mupirocin ointment did not demonstrate any delayed hypersensitivity, cutaneous sensitisation, phototoxicity or photo-contact sensitisation in studies on normal subjects.
Cutaneous sensitisation has been reported rarely in postmarketing surveillance of mupirocin ointment.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medical 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 http://www.tga.gov.au/reporting-problems.

4.9 Overdose

There is currently limited experience with overdosage of mupirocin ointment.
There is no specific treatment for an overdose of mupirocin. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Microbiology.

Mupirocin is a naturally occurring antibiotic, produced by fermentation of the organism Pseudomonas fluorescens.
Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer RNA (tRNA) synthetase. It shows no cross resistance with other commonly used and clinically important antibiotics.
In vitro mupirocin is active mainly against Gram positive aerobes including Staphylococcus aureus (including methicillin resistant Staph. aureus (MRSA) positive strains), Staph. saprophyticus, Staph. epidermidis, Streptococcus pyogenes, Strep. viridans, Strep. agalactiae and Strep. pneumoniae.
Group D Streptococci (including Strep. faecalis and Strep. faecium) are much less sensitive to mupirocin. Most Gram negative organisms (except for Haemophilus influenzae, Neisseria and Branhamella) and anaerobes (including Propionibacterium acnes) are not sensitive to mupirocin.
When mupirocin resistance does occur, it appears to result from the production of a modified isoleucyl tRNA synthetase. High level plasmid mediated resistance (MIC > 1024 microgram/mL) has been reported in some strains of Staph. aureus and coagulase negative staphylococci.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Mupirocin is poorly absorbed through intact human skin; less than 0.24% of a 0.5 g dose being available systemically following the topical application of mupirocin in the ointment base.

Distribution.

Application of 14C-labelled mupirocin ointment to the lower arm of normal male subjects followed by occlusion for 24 hours showed no measurable systemic absorption. Measurable radioactivity was present in the stratum corneum of these subjects 72 hours after application.

Metabolism.

If mupirocin is absorbed through broken skin or is given systemically, it is metabolised to the inactive metabolite, monic acid. The mean plasma half-lives of mupirocin and monic acid are 19 and 77 minutes, respectively.

Excretion.

The major elimination pathway is via the kidney (90%).

5.3 Preclinical Safety Data

Genotoxicity.

Results of the following studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not indicate a potential for mutagenicity: rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, metaphase analysis of human lymphocytes, mouse lymphoma assay and bone marrow micronuclei assay in mice.

Carcinogenicity.

The carcinogenic potential of mupirocin has not been assessed in long-term animal studies.

6 Pharmaceutical Particulars

6.1 List of Excipients

The ointment contains the following inactive ingredients: macrogol 400 and macrogol 3350.

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.

6.5 Nature and Contents of Container

Aluminium tube with polyethylene cap containing 15 g of ointment (AUST R 276520).

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

Chemical structure.


Chemical Name: 9-[[(2E)-4-[(2S,3R,4R,5S)-3,4-Dihydroxy-5-[[(2S,3S)-3-[(1S,2S)-2-hydroxyl-1-methylpropyl]oxiranyl]methyl]tetrahydro-2H-pyran-2-yl]-3-methylbut-2-enoyl]oxy]nonanoic acid.
Molecular Formula: C26H44O9.
Molecular Weight: 500.622 g/mol.

CAS number.

CAS registry number: 12650-69-0.
Mupirocin is slightly soluble in water and freely soluble in acetone, methylene chloride, chloroform and methanol.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes