Consumer medicine information

BACTROBAN™ OINTMENT

Mupirocin

BRAND INFORMATION

Brand name

Bactroban

Active ingredient

Mupirocin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using BACTROBAN™ OINTMENT.

What is in this leaflet?

Please read this leaflet carefully before you use BACTROBAN ointment.

This leaflet answers some common questions about BACTROBAN ointment. It does not contain all of the available information.

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

All medicines have risks and benefits. Your doctor has weighed the expected benefits of you using BACTROBAN ointment against the risks this medicine could have for you.

If you are helping someone else to use BACTROBAN ointment, read this leaflet before applying the first application.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

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

What BACTROBAN ointment is used for

BACTROBAN 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.

BACTROBAN ointment is used for the treatment of mild impetigo (school sores).

BACTROBAN 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 BACTROBAN ointment for another reason.

BACTROBAN ointment is not addictive.

Before you use BACTROBAN ointment

When you must not use it

You must not use BACTROBAN 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 BACTROBAN 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 any allergies to foods, dyes, preservatives or any other medicines.

Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription.

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 BACTROBAN ointment on a cracked nipple, wash the nipple well before breast feeding your baby.

BACTROBAN ointment should not be used to treat infections in or near the eyes, nostrils or mouth. If BACTROBAN ointment is accidentally applied to the eyes, wash the eyes thoroughly with water.

BACTROBAN ointment contains polyethylene glycol. Do not use BACTROBAN ointment on large areas of broken or damaged skin, especially if you suffer from reduced kidney function.

BACTROBAN ointment should not be used to treat areas of skin near tubes inserted into your body for the delivery or removal of fluid (cannulae). BACTROBAN 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 BACTROBAN ointment and tell your doctor.

Medicines like BACTROBAN 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 BACTROBAN ointment.

Taking other medicines

Do not mix BACTROBAN ointment with any other preparation. They may prevent BACTROBAN ointment from working.

How to use BACTROBAN ointment

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

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

How much to use

Use BACTROBAN ointment as directed by your doctor or pharmacist.

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

How to use it

Always wash your hands before and after applying BACTROBAN ointment. With a piece of clean cotton wool or a gauze swab, apply a small quantity of BACTROBAN 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 BACTROBAN ointment for as long as your doctor or pharmacist tells you to. BACTROBAN ointment is usually applied for up to 10 days.

It is important that you take the full course of BACTROBAN 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 BACTROBAN ointment as soon as you can, then continue as before.

Use in children

The use of BACTROBAN ointment in children under two years of age is not recommended.

If you use too much

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, if you think you or anyone else may have swallowed a large quantity of BACTROBAN 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 using BACTROBAN 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 BACTROBAN ointment.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking 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 BACTROBAN ointment to treat any other complaints unless your doctor says to.

Do not stop using BACTROBAN ointment, or change the dose without first checking with your doctor.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using BACTROBAN 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 BACTROBAN ointment, even if the problem is not listed below.

Do not be alarmed by this list of possible 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 BACTROBAN ointment.

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

Tell your doctor immediately if you notice any of the following:

  • Swelling, itching, burning or pain in the area where BACTROBAN 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 using BACTROBAN ointment

Storage

You should keep BACTROBAN ointment in the original pack below 25°C. Do not freeze the ointment.

Do not store BACTROBAN 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 BACTROBAN ointment looks like

BACTROBAN ointment is a white ointment supplied in 15 g tubes.

Ingredients

BACTROBAN ointment contains the active ingredient Mupirocin.

BACTROBAN ointment also contains polyethylene glycol (Macrogol 400 and Macrogol 3350).

Sponsor

GlaxoSmithKline Australia Pty Ltd
Level 4
436 Johnston Street
Abbotsford Victoria 3067
Australia

This leaflet was prepared on 10 October 2013.

The information provided applies only to BACTROBAN® ointment.

BACTROBAN® is a registered trade mark of the GlaxoSmithKline group of companies.

BACTROBAN ointment:
AUST R 11145

©2010 GlaxoSmithKline

Version 4.0

Published by MIMS January 2014

BRAND INFORMATION

Brand name

Bactroban

Active ingredient

Mupirocin

Schedule

S4

 

1 Name of Medicine

Mupirocin calcium.

2 Qualitative and Quantitative Composition

Bactroban cream and Bactroban ointment contain mupirocin calcium 2% w/w equivalent to 20 mg mupirocin as the active ingredient.

List of excipients with known effect.

For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cream or ointment.

4 Clinical Particulars

4.1 Therapeutic Indications

Bactroban (mupirocin) cream is indicated for the topical treatment of secondarily infected traumatic skin lesions such as small lacerations, sutured wounds or abrasions.
Bactroban (mupirocin) ointment is indicated for the topical treatment of mild impetigo.

4.2 Dose and Method of Administration

For dermatologic use.
A small amount of Bactroban 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.

Renal impairment (Bactroban ointment).

See Section 4.4 Special Warnings and Precautions for Use.

4.3 Contraindications

Bactroban cream and Bactroban ointment are contraindicated in patients who have demonstrated hypersensitivity to mupirocin calcium 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 Bactroban, treatment should be discontinued, the product should be wiped off and appropriate alternative therapy for the infection instituted.
Bactroban 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.
Bactroban 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, Bactroban 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.

Elderly patients.

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

Paediatric use.

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

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.
Bactroban cream or 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 Bactroban is administered to a nursing woman. If a cracked nipple is being treated, the nipple should be thoroughly washed prior to breast feeding.

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 Bactroban cream or ointment.

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 Bactroban ointment so far.
Bactroban 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 postmarketing surveillance of Bactroban ointment.

Cream.

Skin and subcutaneous tissue disorders.

Common: Cutaneous hypersensitivity reactions.
Generally, Bactroban cream was well tolerated. Adverse events from the two pivotal clinical trials, thought to be at least possibly drug-related, are listed in Table 1.
In the two pivotal clinical trials, application site reactions were reported in 0.8% patients treated with either Bactroban cream or placebo. In a supportive safety study, where Bactroban cream was used in the treatment of secondarily infected eczema, application site reactions were reported in 2.4% of patients.

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

4.9 Overdose

There is currently limited experience with overdosage of Bactroban.
There is no specific treatment for an overdose of Bactroban. 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.
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.

The efficacy of topical Bactroban cream for the treatment of secondarily infected traumatic skin lesions (e.g. small lacerations, sutured wounds, and abrasions) was compared to that of oral cephalexin in two randomized, double-blind, double-dummy clinical trials. Bactroban cream was administered topically three times a day for 10 days; cephalexin 250 mg was given orally four times a day for 10 days. Patients weighing less than 40 kg were given 25 mg/kg/day oral cephalexin in four divided doses. Patients of either gender of any age were eligible for the study. Lacerations or sutured wounds were up to 10 cm in length and erythema surrounding abrasions did not exceed 2 cm from the edge of the abrasion.
In a combined analysis of the two pivotal clinical trials, the clinical and bacteriological efficacy rates of mupirocin at follow-up (7-12 days post-therapy) were shown to be equivalent to those of oral cephalexin. A total of 245 patients treated with Bactroban cream and 233 patients treated with oral cephalexin were evaluable for per-protocol clinical efficacy at follow-up. The per-protocol clinical efficacy rate was 95.1% for Bactroban cream and 95.3% for oral cephalexin (95% Confidence Interval for difference between treatment groups -4.04, 3.64). Ninety eight patients given Bactroban cream and 92 patients given cephalexin were evaluable for per-protocol bacteriological efficacy at follow-up. The per-protocol bacteriological success rate was 96.9% for Bactroban cream and 98.9% for oral cephalexin (95% Confidence Interval -6.04, 2.04).
The safety and efficacy of Bactroban cream has not been established in the topical treatment of burns.

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

5.3 Preclinical Safety Data

Genotoxicity.

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

Carcinogenicity.

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

6 Pharmaceutical Particulars

6.1 List of Excipients

Bactroban cream also contains xanthan gum, liquid paraffin, cetomacrogol 1000, stearyl alcohol, cetyl alcohol, phenoxyethanol, benzyl alcohol and purified water.
Bactroban ointment also contains macrogol 400 and macrogol 3350.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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. Do not freeze.

6.5 Nature and Contents of Container

Bactroban ointment 2% is supplied in 1 g, 2 g, 5 g, 15 g and 30 g tubes.
Bactroban cream 2% is supplied in 15 g tubes.
Not all dose forms and pack sizes may be distributed in Australia.

6.6 Special Precautions for Disposal

Any product remaining at the end of treatment should be discarded.
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Mupirocin is a naturally occurring antibiotic, produced by fermentation of the organism Pseudomonas fluorescens.
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. The chemical structure of mupirocin is shown below:

Chemical structure.


CAS number.

The CAS number for mupirocin is 12550-69-0.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes