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.

What is in this leaflet

Please read this leaflet carefully before you use Medicianz Medicianz MUPIROCIN Ointment.

This leaflet answers some common questions about Medicianz MUPIROCIN Ointment. It does not contain all the available information

It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you using the Medicianz MUPIROCIN Ointment against the benefits they expect it will have for you.

If you are helping someone else to use Medicianz MUPIROCIN Ointment, read this leaflet before applying the first application.

If you have any concerns about being treated with Medicianz MUPIROCIN Ointment, ask your doctor or pharmacist.

This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor, or from www.tga.gov.au and may contain important information about the medicine and its use of which you should be aware.

Keep this leaflet with the medicine. You may need to read it again.

What Medicianz MUPIROCIN Ointment is used for

Medicianz MUPIROCIN Ointment contains mupirocin (2% w/w) as the active ingredient.

MUPIROCIN 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.

Before you use Medicianz MUPIROCIN Ointment

When you should not be given it

You must not be given Medicianz MUPIROCIN Ointment if you have an allergy to:

  • any medicine containing mupirocin.
  • any of the ingredients listed at the end of this leaflet.

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.

Do not use Medicianz MUPIROCIN Ointment after the expiry date printed on the pack, or the ointment shows visible signs of deterioration, or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start using this medicine, talk to your doctor.

Before you start to use it:

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you are breastfeeding, pregnant or trying to become pregnant. Your doctor will discuss the risks and benefits with you.

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

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.

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.

If you develop an allergic reaction (such as a rash, local pain or swelling), wipe off the ointment, stop using Medicianz MUPIROCIN Ointment and tell your doctor.

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.

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

Taking other medicines

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

Do not mix Medicianz MUPIROCIN Ointment with any other preparation. They may prevent Medicianz MUPIROCIN Ointment from working.

Taking Medicianz MUPIROCIN Ointment

How much to use

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

The usual recommendation is for a small amount to be applied to the affected area three times a daily.

If you have any questions about Medicianz MUPIROCIN Ointment and how to use it, please ask your doctor or pharmacist for help.

How to use it

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.

How long to use it

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 it

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

Use in children

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

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 131126) for advice, if you think you or anyone else may have swallowed a large quantity of Medicianz MUPIROCIN Ointment, even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you are not sure what to do, contact your doctor, pharmacist or nearest hospital.

While you are taking Medicianz MUPIROCIN Ointment

Things you must do:

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Medicianz MUPIROCIN Ointment.

Tell any other doctors, dentists, and pharmacists who treat you that you have been given this medicine.

If you become pregnant while using this medicine, tell your doctor immediately.

Tell your doctor if, 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.

Things you must 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.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Medicianz MUPIROCIN Ointment.

This medicine helps most people, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the 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 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.

The most commonly reported side- effects are:

  • Itching
  • Dryness
  • Burning
  • Redness
  • Stinging
  • Pain
  • Swelling

Allergic reactions such as a rash, hives or swelling can occur with the use of Medicianz MUPIROCIN Ointment.

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

Tell your doctor if you notice any of the following:

  • Swelling, itching, burning or pain in the area where Medicianz MUPIROCIN Ointment is applied.
  • Wheezing, swelling of the lips/ mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting. These could be symptoms of an allergic reaction.

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

Tell your doctor or pharmacist if you notice any side effects from your medicine which are not mentioned here.

After being given Medicianz MUPIROCIN Ointment

You should 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.

Do not store Medicianz MUPIROCIN Ointment or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and- a-half metres above the ground is a good place to store medicines.

Return any unused or expired medicine to your pharmacist.

Product description

What it looks like:

Medicianz MUPIROCIN Ointment is a white ointment supplied in 15g tubes.

Ingredients

Medicianz MUPIROCIN Ointment contains the active ingredient Mupirocin.

Medicianz MUPIROCIN Ointment also contains polyethylene glycol (Macrogol 400 and Macrogol 3350).

Sponsor

Medicianz Healthcare Pty Limited
Unit 2, 6-7 Gilda Court
Mulgrave Victoria
Australia 3170

Marketed and distributed by:

Medsurge Healthcare Pty Ltd

Australian Registration Numbers

AUST R 279471

This leaflet was prepared in July 2017

Published by MIMS June 2018

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