Consumer medicine information

Medicianz Mupirocin Ointment

Mupirocin

BRAND INFORMATION

Brand name

Medicianz Mupirocin Ointment

Active ingredient

Mupirocin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Medicianz Mupirocin Ointment.

SUMMARY CMI

Medicianz Mupirocin Ointment

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 Medicianz MUPIROCIN Ointment?

Medicianz MUPIROCIN Ointment contains the active ingredient mupirocin (2% w/w). Medicianz MUPIROCIN Ointment is used for the treatment of mild impetigo (school sores). It is for use on your skin only.

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

2. What should I know before I use Medicianz MUPIROCIN Ointment?

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 Medicianz MUPIROCIN Ointment? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Medicianz 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 Medicianz MUPIROCIN Ointment?

  • The usual recommendation is for a small amount to be applied to the affected area three times a day.
  • A piece of clean cotton wool or a gauze swab may be used for application to affected area.

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

5. What should I know while using Medicianz MUPIROCIN Ointment?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Medicianz MUPIROCIN Ointment.
  • It is important that you take the full course of Medicianz MUPIROCIN Ointment.
Things you should not do
  • Do not stop using this medicine or change the dose without first checking with your doctor.
  • Do not use Medicianz MUPIROCIN Ointment to treat any other complaints unless your doctor says to.
Looking after your medicine
  • Keep Medicianz MUPIROCIN Ointment in the original pack below 25°C. After first opening of the tube, the contents can be used for up to 10 days.
  • Return any unused or expired medicine to your pharmacist.

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

6. Are there any side effects?

This medicine helps most people, but it may have unwanted side effects in a few people such as - Itching, Dryness, Burning, Redness, Stinging, Pain, Swelling and allergic reactions like wheezing, swelling of the lips/ mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting.

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

Medicianz Mupirocin Ointment

Active ingredient(s): Mupirocin

Consumer Medicine Information (CMI)

This leaflet provides important information about using Medicianz MUPIROCIN Ointment. 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 Medicianz MUPIROCIN Ointment.

Where to find information in this leaflet:

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

1. Why am I using Medicianz MUPIROCIN Ointment?

Medicianz MUPIROCIN Ointment contains the active ingredient mupirocin (2% w/w). Medicianz MUPIROCIN Ointment belongs to a group of medicines called antibiotics.

Antibiotics work by killing bacteria which can cause infection.

Medicianz MUPIROCIN Ointment is used for the treatment of mild impetigo (school sores). Medicianz MUPIROCIN Ointment is for use on your skin only.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed Medicianz MUPIROCIN Ointment for another reason.

Medicianz MUPIROCIN Ointment is not addictive.

2. What should I know before I use Medicianz MUPIROCIN Ointment?

Warnings

Do not use Medicianz MUPIROCIN Ointment 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.
    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 on the skin.
  • Medicianz MUPIROCIN Ointment contains polyethylene glycol. Do not use Medicianz MUPIROCIN Ointment on large areas of broken or damaged skin, especially if you suffer from reduced kidney function.
  • Medicianz MUPIROCIN Ointment should not be used to treat areas of skin near tubes inserted into your body for the delivery or removal of fluid (cannulae). Medicianz MUPIROCIN Ointment should not be used in combination with cannulae.
  • After the expiry date printed on the pack, or if the ointment shows visible signs of deterioration, or if the packaging is torn or shows signs of tampering. disposal.

Check with your doctor if you:

  • have allergies to any other medicines, foods, preservatives or dyes.
  • are not sure whether you should start using this medicine, talk to your doctor.
  • develop an allergic reaction (such as a rash, local pain or swelling), wipe off the ointment, stop using Medicianz MUPIROCIN Ointment.

During treatment, you may be at risk of developing certain side effects. Medicines like Medicianz MUPIROCIN Ointment 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.

It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

If you have not told your doctor about any of the above, tell him/ her before you start using Medicianz MUPIROCIN Ointment.

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.

If you are using Medicianz MUPIROCIN Ointment on a cracked nipple, wash the nipple well before breast feeding your baby.

Your doctor will discuss the risks and benefits with you.

Use in children

The use of Medicianz MUPIROCIN Ointment in children under 4 weeks of age is not recommended.

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 Medicianz MUPIROCIN Ointment with any other preparation. Some medicines may interfere with Medicianz MUPIROCIN Ointment and affect how it works.

4. How do I use Medicianz MUPIROCIN Ointment?

How much to use

  • The usual recommendation is for a small amount to be applied to the affected area three times a day.
  • Follow the instructions provided when Medicianz MUPIROCIN Ointment was prescribed to you by your doctor or pharmacist carefully, including the number of days it should be taken. They may differ from the information contained in this leaflet.

When to use Medicianz MUPIROCIN Ointment

  • Medicianz MUPIROCIN Ointment should be used as prescribed by your doctor.

How to use Medicianz MUPIROCIN Ointment

  • Always wash your hands before and after applying Medicianz MUPIROCIN Ointment.
  • With a piece of clean cotton wool or a gauze swab, apply a small quantity of Medicianz MUPIROCIN Ointment to cover the affected area.
  • After applying the ointment, you may cover the treated area with a sterile bandage or gauze dressing, unless your doctor has told you to leave it uncovered.
  • If you have any questions about Medicianz MUPIROCIN Ointment and how to use it, please ask your doctor or pharmacist for help.

How long to use Medicianz MUPIROCIN Ointment

  • Use Medicianz MUPIROCIN Ointment for as long as your doctor or pharmacist tells you to. Medicianz MUPIROCIN Ointment is usually applied for up to 10 days.
  • It is important that you take the full course of Medicianz MUPIROCIN Ointment. Do not stop early as your symptoms may disappear before the infection is fully cleared.

If you forget to use Medicianz MUPIROCIN Ointment

If you forget an application, apply some Medicianz MUPIROCIN Ointment as soon as you can, then continue as before.

If you use too much Medicianz MUPIROCIN Ointment

If you think that you have used too much Medicianz 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 Medicianz MUPIROCIN Ointment?

Things you should do

Call your doctor straight away if you:

  • for any reason, have not used your medicine exactly as directed. Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.
  • become pregnant while using this medicine, tell your doctor immediately.

Remind any doctor, dentist or pharmacist you visit that you are using Medicianz MUPIROCIN Ointment, if you are about to be started on any new medicine.

Things you should not do

  • Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Do not use Medicianz MUPIROCIN Ointment to treat any other complaints unless your doctor says to.
  • Do not stop using Medicianz MUPIROCIN Ointment or change the dose without first checking with your doctor.
  • Medicianz MUPIROCIN Ointment should not be used to treat infections in or near the eyes, nostrils or mouth. If Medicianz MUPIROCIN Ointment is accidentally applied to the eyes, wash the eyes thoroughly with water.

Looking after your medicine

  • You should keep Medicianz MUPIROCIN Ointment in the original pack below 25°C.

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.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

When to discard your medicine (as relevant)

After first opening of the tube, the contents can be used for up to 10 days.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date or is damaged, 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.

This medicine helps most people, but it may have unwanted side effects in a few people.

Check with your doctor as soon as possible if you think you are experiencing any side effects or allergic reactions due to taking Medicianz MUPIROCIN Ointment, even if the problem is not listed below.

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

Less serious side effects

Less serious side effectsWhat to do
  • Itching
  • Dryness
  • Burning
  • Redness
  • Stinging
  • Pain
  • Swelling
Other symptoms due to allergic reaction-
  • Swelling, itching, burning or pain
  • Wheezing, swelling of the lips/ mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting.
Speak to your doctor if you have any of these commonly reported side effects and they worry you.

If you get a skin reaction, stop using MUPIROCIN ointment. Wipe off any cream and tell your doctor as soon as possible.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

This is not a complete list of all possible side effects. Other side effects not listed here may occur in some people and there may be some side effects not yet known.

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 Medicianz MUPIROCIN Ointment contains

Active ingredient
(main ingredient)		Mupirocin
Other ingredients
(inactive ingredients)		polyethylene glycol (Macrogol 400 and Macrogol 3350).
Potential allergensNone

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

What Medicianz MUPIROCIN Ointment looks like

Medicianz MUPIROCIN Ointment is a white ointment supplied in 15g tubes. (AUST R 279471).

Who distributes Medicianz MUPIROCIN Ointment

Medsurge Healthcare Pty Limited
Telephone: 1300 788 261
Website: www.medsurgehc.com

This leaflet was prepared in October 2024.

Published by MIMS February 2025

BRAND INFORMATION

Brand name

Medicianz Mupirocin Ointment

Active ingredient

Mupirocin

Schedule

S4

 

Notes

Distributed by Medsurge Healthcare Pty Ltd

1 Name of Medicine

Mupirocin.

2 Qualitative and Quantitative Composition

Medicianz Mupirocin Ointment contains mupirocin 2% w/w equivalent to 20 mg/g mupirocin as the active ingredient.
Mupirocin is a naturally occurring antibiotic, produced by fermentation of the organism Pseudomonas fluorescens.
Each gram of Medicianz Mupirocin Ointment contains 20 milligram of mupirocin. Medicianz Mupirocin Ointment also contains polyethylene glycol (macrogol) 400 and polyethylene glycol (macrogol) 3350.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ointment.
Medicianz Mupirocin Ointment is a white, translucent, water-soluble, polyethylene glycol based, homogeneous off-white ointment, which is odourless or nearly odourless.

4 Clinical Particulars

4.1 Therapeutic Indications

Medicianz Mupirocin Ointment is indicated for the topical treatment of mild impetigo.

4.2 Dose and Method of Administration

A small amount of Medicianz Mupirocin Ointment should be applied to the affected area three times daily. The area treated may be covered with a 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.

Renal impairment.

For use in renal impairment, please see Section 4.4 Special Warnings and Precautions for Use.

4.3 Contraindications

Medicianz Mupirocin Ointment is contraindicated in patients who have demonstrated hypersensitivity to mupirocin or any components of the formulations.

4.4 Special Warnings and Precautions for Use

If a reaction suggesting sensitivity or chemical irritation should occur with the use of Medicianz Mupirocin Ointment, treatment should be discontinued, the product should be wiped off and appropriate alternative therapy for the infection instituted.
Medicianz Mupirocin Ointment 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.
Medicianz Mupirocin Ointment is not suitable for application to the site of cannulation or for use in conjunction with cannulae.
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, Medicianz Mupirocin Ointment 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.
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 the elderly.

No data available.

Paediatric use.

Medicianz Mupirocin Ointment has not been studied in term and preterm newborn infants under 4 weeks of age and therefore it should not be used in these patients.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No drug interactions have been studied with mupirocin. Medicianz Mupirocin Ointment 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, this drug 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 Medicianz 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 including anaphylaxis, generalised rash, urticaria and angioedema have been reported with Medicianz 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 ointments so far.
Medicianz Mupirocin Ointment did not demonstrate any delayed hypersensitivity, cutaneous sensitization, phototoxicity or photo-contact sensitisation in studies on normal subjects.
Cutaneous sensitisation has been reported rarely in post marketing surveillance of mupirocin ointments.

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

4.9 Overdose

The toxicity of mupirocin is very low. In the event of accidental ingestion of the ointment symptomatic treatment should be given.
In case of erroneous oral intake of large quantities of the ointment, renal function should be closely monitored in patients with renal insufficiency because of the possible side effects of polyethylene glycol.
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.

Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA 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 MRSA positive strains), Staphylococcus saprophyticus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus viridans, Streptococcus agalactiae, and Streptococcus pneumoniae.
Group D Streptococci (including S. faecalis and S. faecium), are much less sensitive to mupirocin. Most Gram negative organisms (except for H. 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 S. aureus and coagulase-negative staphylococci.

Clinical trials.

Comparability of Medicianz Mupirocin Ointment and Bactroban Ointment.

The efficacy and safety of Medicianz Mupirocin Ointment for the treatment of impetigo were assessed in a multicentre, randomised, double-blind clinical trial with the originator (Bactroban 2% Ointment) as the active comparator. Both ointments were administered topically three times a day for 7 days. Patients of either gender, aged 28 days to 15 years, were eligible for study participation, if their SIRS (Skin Infection Rating Scale) score was 4 or higher and at least 3 SIRS categories were present. A baseline swab from the affected skin area had to be positive for Staphylococcus aureus and/or Streptococcus pyogenes. Clinical cure was assessed as the primary efficacy parameter on day 14 ± 4, i.e. 7 days after the end of treatment.
A total of 120 patients with a positive baseline bacteriological finding were treated in this study (57 with Medicianz Mupirocin Ointment, 63 with Bactroban 2% Ointment). The mITT (modified intention-to-treat) population consisted of 119 patients (56/63), the per-protocol population consisted of 115 patients (55/60). The clinical cure rates in the per-protocol population were 100.0% for Medicianz Mupirocin Ointment and 95.0% for the comparator. The treatment difference was 0.050 with a 90% CI of -0.01 to +0.11 which was entirely within the predefined equivalence margin of -0.20 to +0.20, indicating a statistical equivalence of both medications. This was confirmed in a corresponding analysis in the mITT population. The microbiological cure rates at day 14 (absence of Staphylococcus aureus and Streptococcus pyogenes) were 100.0% for Medicianz Mupirocin Ointment and 98.3% for the comparator in the PP population and 100.0% versus 98.4% in the mITT population.

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 minutes and 77 minutes, respectively.

Excretion.

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

Special patient populations.

Elderly patients.

No restrictions unless there is evidence of moderate or severe renal impairment (see Section 4.4 Special Warnings and Precautions for Use).

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

Macrogol 400, 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.
After first opening of the tube, the contents can be used for up to 10 days.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Medicianz Mupirocin Ointment is supplied in aluminium tube with polypropylene cap in the following presentations. See Table 1.
Not all pack sizes may be 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

The chemical name is: 9-[4-[5S-[2S,3S-epoxy-5S-hydroxy-4S-methylhexyl]-3R,4R- dihydroxytetrahydropyran-2S-yl]-3-methylbut-2-(E)-enoyloxy]nonanoic acid.

Chemical structure.

The chemical structure of mupirocin is shown below:
Molecular formula: C26H44O9.
Molecular mass: 500.63.

CAS number.

12650-69-0.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes