Consumer medicine information

APO-Mupirocin

Mupirocin

BRAND INFORMATION

Brand name

APO-Mupirocin Ointment

Active ingredient

Mupirocin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

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

What is in this leaflet

Read this leaflet carefully before taking your medicine.

This leaflet answers some common questions about mupirocin ointment. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

Ask your doctor or pharmacist:

  • if there is anything you do not understand in this leaflet,
  • if you are worried about taking your medicine, or
  • to obtain the most up-to-date information.

You can also download the most up to date leaflet from www.apotex.com.au.

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

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

Keep this leaflet with your medicine. You may want to read it again.

What this medicine is used for

The name of your medicine is APO-Mupirocin. It contains the active ingredient mupirocin.

It is used to treat mild impetigo (school sores).

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

This medicine is available only with a doctor's prescription.

How it works

APO-Mupirocin is for use on your skin only. APO-Mupirocin belongs to a group of medicines called antibiotics. Antibiotics work by killing bacteria which can cause infection.

There is no evidence that this medicine is addictive.

Use in children

This medicine should not be used in children under two years of age.

Before you use this medicine

When you must not use it

Do not use this medicine if:

  • You are hypersensitive to, or have had an allergic reaction to, mupirocin or any of the ingredients listed at the end of this leaflet.

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.

  • The expiry date (EXP) printed on the pack has passed.
  • The packaging is torn, shows signs of tampering or it does not look quite right.

APO-Mupirocin should not be used to treat infections in or near the eyes, nostrils or mouth.

If APO-Mupirocin is accidentally applied to the eyes, wash the eyes thoroughly with water.

APO-Mupirocin should not be used to treat areas of skin near tubes inserted into your body for the delivery or removal of fluid (cannulae). APO-Mupirocin should not be used in combination with cannulae.

APO-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.

Before you start to use it

Before you start taking this medicine, tell your doctor if:

  1. You have allergies to:
  • any other medicines
  • any other substances, such as foods, preservatives or dyes.
  1. You have or have had any medical conditions, especially the following:
  • moderate or severe renal impairment.
  1. You are currently pregnant or you plan to become pregnant. Do not use this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.
  2. You are currently breastfeeding or you plan to breastfeed. Do not use this medicine whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.

If you are using APO-Mupirocin on a cracked nipple, wash the nipple well before breast feeding your baby.

  1. You are planning to have surgery or an anaesthetic.
  2. You are currently receiving or are planning to receive dental treatment.
  3. You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Taking other medicines

Do not mix APO-Mupirocin with any other topical medicines. They may prevent APO-Mupirocin from working.

How to use this medicine

Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.

How much to use

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.

Do not stop taking your medicine or change your dosage without first checking with your doctor.

How to use it

Always wash your hands before and after applying APO-Mupirocin. A small amount of APO-Mupirocin 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.

When to use it

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.

Do not stop using your medicine or change your dosage without first checking with your doctor.

How long to use it for

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 to last over weekends and holidays.

If you forget to use it

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 (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively, go to the Accident and Emergency department at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using this medicine

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.

Go to your doctor regularly for a check-up.

Tell any other doctors, dentists and pharmacists who are treating you that you use this medicine.

Things you must 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.

Possible side effects

Tell your doctor as soon as possible if you do not feel well while you are using APO-Mupirocin or if you have any questions or concerns.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

Tell your doctor if you notice any of the following:

  • itching
  • dryness
  • redness
  • stinging

Tell your doctor as soon as possible if you notice any of the following.

These may be serious side effects and you may need medical attention:

  • swelling, itching, burning or pain in the area where mupirocin has been applied.

If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Other side effects not listed above may occur in some patients.

Allergic reactions

If you think you are having an allergic reaction to APO-Mupirocin, do not use any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction 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.

Storage and disposal

Storage

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 your medicine, 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 this medicine 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.

Disposal

If your doctor tells you to stop using this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What APO-Mupirocin looks like

APO-Mupirocin is a white semi-transparent homogeneous preparation. The tube contains 15 g of ointment.

Ingredients

Each gram of APO-Mupirocin contains 20 mg of mupirocin, as the active ingredient.

It also contains the following inactive ingredients:

  • macrogol 400
  • macrogol 3350.

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

Australian Registration Numbers

APO-Mupirocin 20 mg/g (2% w/w) ointment:
AUST R 276520.

Sponsor

Southern Cross Pharma Pty Ltd
Suite 5/118 Church Street
Hawthorn VIC 3122
Australia

Tel: 1300 881 893

APO and APOTEX are registered trade marks of Apotex Inc.

Distributor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113

This leaflet was last updated in April 2017.

BRAND INFORMATION

Brand name

APO-Mupirocin Ointment

Active ingredient

Mupirocin

Schedule

S4

 

Notes

Distributed by Apotex Pty Ltd

1 Name of Medicine

Mupirocin.

6.7 Physicochemical Properties

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.
Mupirocin is slightly soluble in water and freely soluble in acetone, methylene chloride, chloroform and methanol.

Chemical structure.


CAS number.

12650-69-0.

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.

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.

4 Clinical Particulars

4.1 Therapeutic Indications

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

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.

4.8 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.

4.2 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.

4.7 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.

4.9 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).

7 Medicine Schedule (Poisons Standard)

S4.

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.

Summary Table of Changes