Consumer medicine information

Medsurge Mupirocin Nasal Ointment

Mupirocin

BRAND INFORMATION

Brand name

Medsurge Mupirocin Nasal Ointment

Active ingredient

Mupirocin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

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

SUMMARY CMI

Medsurge MUPIROCIN Nasal 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 Medsurge MUPIROCIN Nasal Ointment?

Medsurge MUPIROCIN Nasal Ointment contains the active ingredient mupirocin calcium 20 mg/g (2% w/w). Medsurge MUPIROCIN Nasal Ointment is used to remove bacteria, including the bacteria called “Staphylococcus aureus (golden staph.)” from inside your nose. It is for use in your nose only.

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

2. What should I know before I use Medsurge MUPIROCIN Nasal Ointment?

Do not use if you have ever had an allergic reaction to Medsurge MUPIROCIN Nasal Ointment 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 Medsurge MUPIROCIN Nasal Ointment? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Medsurge MUPIROCIN Nasal 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 Medsurge MUPIROCIN Nasal Ointment?

  • The usual recommendation is for a small amount, about the size of a match head, to be applied inside the nose two to three times a day.
  • Gently press your nostrils together to help spread the ointment throughout your nose. A swab, such as a cotton bud may be used for application to infants or patients who are very ill.

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

5. What should I know while using Medsurge MUPIROCIN Nasal Ointment?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Medsurge MUPIROCIN Nasal Ointment.
  • It is important that you take the full course of Medsurge MUPIROCIN Nasal Ointment.
Things you should not do
  • Do not stop using this medicine early as the amount of bacteria in your nose may not be reduced.
  • Do not change the dose without first checking with your doctor.
  • Do not use Medsurge MUPIROCIN Nasal Ointment to treat any other complaints unless your doctor says to.
Looking after your medicine
  • Keep Medsurge MUPIROCIN Nasal Ointment in the original pack below 25°C. After first opening of the tube, the contents can be used for up to 7 days.
  • Return any unused or expired medicine to your pharmacist.

For more information, see Section 5. What should I know while using Medsurge MUPIROCIN Nasal 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 - Irritation, Itching, Tingling, Burning, Stinging, Soreness, Facial pain, Post nasal drip, Sinus Pain, Runny or blocked nose, Conjunctivitis etc.

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

Medsurge MUPIROCIN Nasal Ointment

Active ingredient(s): Mupirocin Calcium

Consumer Medicine Information (CMI)

This leaflet provides important information about using Medsurge MUPIROCIN Nasal 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 Medsurge MUPIROCIN Nasal Ointment.

Where to find information in this leaflet:

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

1. Why am I using Medsurge MUPIROCIN Nasal Ointment?

Medsurge MUPIROCIN Nasal Ointment contains the active ingredient mupirocin calcium. Medsurge MUPIROCIN Nasal Ointment belongs to a group of medicines called antibiotics.

Antibiotics work by killing bacteria which can cause infection.

Medsurge MUPIROCIN Nasal Ointment is used to remove bacteria, including the bacteria called “Staphylococcus aureus (golden staph.)” from inside your nose. Medsurge MUPIROCIN Nasal Ointment is for use in your nose only.

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

Your doctor may have prescribed Medsurge MUPIROCIN Nasal Ointment for another reason.

Medsurge MUPIROCIN Nasal Ointment is not addictive.

2. What should I know before I use Medsurge MUPIROCIN Nasal Ointment?

Warnings

Do not use Medsurge MUPIROCIN Nasal Ointment if:

  • you are allergic to mupirocin calcium, 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.
  • 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 Medsurge MUPIROCIN Nasal Ointment.

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

Your doctor will discuss the risks and benefits with you.

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.

Some medicines may interfere with Medsurge MUPIROCIN Nasal Ointment and affect how it works.

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

4. How do I use Medsurge MUPIROCIN Nasal Ointment?

How much to take / use

  • The usual recommendation is for a small amount, about the size of a match head, is to be applied inside the nose two to three times a day.
  • Follow the instructions provided when Medsurge MUPIROCIN Nasal 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 take / use Medsurge MUPIROCIN Nasal Ointment

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

How to use Medsurge MUPIROCIN Nasal Ointment

  • Always wash your hands before and after applying Medsurge MUPIROCIN Nasal Ointment.
  • Squeeze a small quantity of Medsurge MUPIROCIN Nasal Ointment (about the size of a matchstick head) onto the tip of your little finger and apply to the inside surface at the front of each nostril. Gently press your nostrils together to help spread the ointment throughout your nose. A swab, such as a cotton bud may be used for application to infants or patients who are very ill.
  • If you have any questions about Medsurge MUPIROCIN Nasal Ointment and how to use it, please ask your doctor or pharmacist for help.

How long to use Medsurge MUPIROCIN Nasal Ointment

  • Use Medsurge MUPIROCIN Nasal Ointment for as long as your doctor or pharmacist tells you to. Medsurge MUPIROCIN Nasal Ointment is usually applied for up to 7 days. Do not use for more than 10 days.
  • It is important that you take the full course of Medsurge MUPIROCIN Nasal Ointment. Do not stop early as your symptoms may disappear before the infection is fully cleared.

If you forget to use Medsurge MUPIROCIN Nasal Ointment

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

If you use too much Medsurge MUPIROCIN Nasal Ointment

If you think that you have used too much Medsurge MUPIROCIN Nasal 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 Medsurge MUPIROCIN Nasal Ointment?

Things you should do

Call your doctor straight away if you:

  • for any reason, you 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.

Remind any doctor, dentist or pharmacist you visit that you are using Medsurge MUPIROCIN Nasal Ointment.

Things you should not do

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

Looking after your medicine

  • You should keep Medsurge MUPIROCIN Nasal 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 7 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.

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

Check with your doctor as soon as possible if you think you are experiencing any side effects or allergic reactions due to taking Medsurge MUPIROCIN Nasal 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
  • Irritation
  • Itching
  • Tingling
  • Burning
  • Stinging
  • Soreness
  • Facial pain
  • Post nasal drip
  • Sinus Pain
  • Runny or blocked nose
  • Conjunctivitis
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
  • Wheezing,
  • swelling of the lips/ mouth,
  • difficulty in breathing,
  • hayfever,
  • lumpy rash (hives) or fainting.
    These could be symptoms of an allergic reaction.
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.

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 Medsurge MUPIROCIN Nasal Ointment contains

Active ingredient
(main ingredient)		Mupirocin as the calcium salt
Other ingredients
(inactive ingredients)		white soft paraffin and bis-diglyceryl polyacyladipate-2.
Potential allergensNone

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

What Medsurge MUPIROCIN Nasal Ointment looks like

Medsurge MUPIROCIN Nasal Ointment is an off-white smooth ointment supplied in 3g and 5g tubes. Not all pack sizes may be marketed. (Aust R 300228).

Who distributes Medsurge MUPIROCIN Nasal Ointment

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

This leaflet was prepared in September 2024.

Published by MIMS February 2025

BRAND INFORMATION

Brand name

Medsurge Mupirocin Nasal Ointment

Active ingredient

Mupirocin

Schedule

S4

 

Notes

Marketed and distributed by Medsurge Healthcare Pty Ltd.

1 Name of Medicine

Mupirocin Nasal Ointment contains mupirocin 2% w/w, as calcium salt, as the active ingredient.

2 Qualitative and Quantitative Composition

Mupirocin 20 mg/g (2% w/w), as mupirocin calcium.
Mupirocin is a naturally occurring antibiotic, produced by fermentation of the organism Pseudomonas fluorescens.
Each gram of Mupirocin Nasal Ointment contains 20 milligrams of mupirocin as the calcium salt in a white soft paraffin based ointment containing a glycerin ester (bis-diglyceryl polyacyladipate-2).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Nasal Ointment.
Mupirocin Nasal Ointment is an off-white smooth nasal ointment.

4 Clinical Particulars

4.1 Therapeutic Indications

Mupirocin Nasal Ointment is indicated for the elimination of nasal carriage of staphylococci, including methicillin resistant Staphylococcus aureus (MRSA).

4.2 Dose and Method of Administration

Adults and children.

Mupirocin Nasal Ointment should be applied to the anterior nares two to three times a day as follows:
A small amount of the ointment about the size of a match head is placed on the little finger and applied to the inside of each nostril. The nostrils are closed by pressing the sides of the nose together; this will spread the ointment throughout the nares. A swab may be used for application to infants or patients who are very ill.
Nasal carriage should normally clear within 5-7 days of commencing treatment. Treatment should not continue for more than 10 days.
Any product remaining at the end of treatment should be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Wash your hands after application.

4.3 Contraindications

Mupirocin Nasal Ointment is contraindicated in patients who have demonstrated hypersensitivity to 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 Mupirocin Nasal Ointment, treatment should be discontinued, the product should be wiped off and appropriate alternative therapy for the infection instituted.
Mupirocin Nasal Ointment is not suitable for ophthalmic use.
Avoid contact with eyes. If contaminated, the eyes should be thoroughly irrigated with water until the ointment residues have been removed.
As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.
The occurrence of resistance to topical mupirocin has occasionally been reported. The possibility of the development of resistance following intranasal use should therefore be borne in mind, particularly in treatment courses lasting longer than 5-7 days. Long term, continuous use of Mupirocin Nasal Ointment should be avoided to minimise this possibility, particularly in the hospital environment.
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.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Mupirocin Nasal Ointment should not be mixed with other preparations as there is a risk of dilution, resulting in a reduction in the antibacterial activity and potential loss of stability of the mupirocin in the ointment.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Reproduction studies have been performed in rats and rabbits at systemic doses up to 160 mg/kg and have revealed no evidence of impaired fertility or harm to the foetus due to mupirocin.
(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.
Adequate human data on use during pregnancy are not available. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
 Adequate human data on use during lactation are not available. Caution should be exercised when Mupirocin Nasal Ointment is administered to a nursing woman.

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 following local adverse reactions with an overall incidence of approximately 2%, have been reported in connection with the use of this product: irritation, itching, tingling, burning, stinging, soreness, facial pain over maxillae, post nasal drip, sinusitis, rhinitis and conjunctivitis. However, less than 0.2% of patients withdrew due to adverse experiences.
Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema have been reported very rarely.
No evidence of contact sensitization has been demonstrated with the white soft paraffin ointment formulation of mupirocin (Mupirocin Nasal Ointment).

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

There is currently limited experience with overdosage of mupirocin.
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 Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

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.

Clinical trials.

Comparability of Mupirocin Nasal Ointment and Bactroban Nasal Ointment 2%.

The efficacy and safety of intranasal treatment with Mupirocin Nasal Ointment in the eradication of Staphylococcus aureus were assessed in a monocentric, randomised, double-blind, three-armed, vehicle-controlled clinical trial with the originator (Bactroban Nasal Ointment 2%) as the active comparator and a vehicle arm to demonstrate sufficient study sensitivity. All ointments were administered intranasally three times a day for 5 days. Healthy volunteers of either gender, aged ≥ 18 years, with stable nasal colonisation with Staphylococcus aureus were eligible for study participation. Stable colonisation was ensured by ≥ 2 positive baseline nasal cultures (at least 24 hours apart) for Staphylococcus aureus within 5 days before starting treatment. Treatment success was assessed as the primary efficacy parameter on day 8 ± 1, i.e. 48-96 hours after the end of treatment, and was defined as complete eradication of Staphylococcus aureus, i.e. a negative nasal culture for all Staphylococcus aureus strains.
A total of 245 subjects with stable nasal colonisation with Staphylococcus aureus were treated in this study (104 with Mupirocin Nasal Ointment, 105 with Bactroban Nasal Ointment 2%, 36 with vehicle ointment). The FA (full-analysis) population consisted of all 245 subjects, the PP (per-protocol) population consisted of 238 subjects (101/103/34). The treatment success rates in the PP population were 81.2% for Mupirocin Nasal Ointment, 81.6% for Bactroban Nasal Ointment 2%, and 8.8% for vehicle. The difference in treatment success between Mupirocin Nasal Ointment and Bactroban Nasal Ointment 2% was -0.004 with a 95% CI of -0.120 to +0.113, which was entirely within the predefined equivalence margin (delta) of -0.20 to +0.20, indicating a statistical equivalence of both medications. Corresponding results were found in the FA population (95% CI of -0.116 to +0.112). Study sensitivity with regard to the chosen delta of 0.20 was proven because the delta did not exceed the predefined limit of 50% of the difference (0.5 * 0.727 = 0.3635) between the treatment success rate in the Bactroban Nasal Ointment 2% group (comparator) and in the vehicle group for the PP population.
Whilst mupirocin successfully eradicates S. aureus colonisation of the nasal mucosa there are currently insufficient data to determine the frequency of, and time to, recolonisation.

5.2 Pharmacokinetic Properties

This formulation has been designed as appropriate for use in the interior nares. Limited data are available on the absorption of mupirocin following intranasal application in adults. Adverse effects from continued absorption from the nose cannot be ruled out.
Mupirocin is absorbed in neonates and premature infants following intranasal administration of mupirocin ointment. In clinical studies of neonates, intranasal administration of mupirocin for up to 5 days was well tolerated. The safety of courses lasting longer than 5 days in neonates and infants has not been studied.
If absorption occurs, mupirocin will be quickly hydrolysed to the antimicrobially inactive metabolite monic acid which is rapidly cleared from the body.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

White soft paraffin, Glycerin ester (bis-diglyceryl polyacyladipate-2).

6.2 Incompatibilities

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

6.3 Shelf Life

3 years.
After first opening of the tube, the contents can be used for up to 7 days.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Mupirocin Nasal Ointment is supplied in lacquered aluminium tubes fitted with a nozzle and screw 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.


Molecular Formula: C26H44O9 (mupirocin) and C52H90CaO20 (mupirocin calcium dihydrate).
Molecular Mass: 500.63 (mupirocin) and 1075.35 g/mol (mupirocin calcium dihydrate).

CAS number.

12650-69-0 (mupirocin) and 115074-43-6 (mupirocin calcium dihydrate).

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes