Consumer medicine information

Supirocin Cream

Mupirocin

BRAND INFORMATION

Brand name

Supirocin

Active ingredient

Mupirocin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Supirocin Cream.

FULL CMI

SUPIROCIN CREAM

Active ingredient: mupirocin (as calcium)

Consumer Medicine Information (CMI)

This leaflet provides important information about using SUPIROCIN cream. 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 SUPIROCIN cream.

Where to find information in this leaflet:

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

1. Why am I using SUPIROCIN cream?

SUPIROCIN cream contains the active ingredient mupirocin (as calcium).

Mupirocin belongs to a group of medicines called Antibiotics.

Antibiotics work by killing bacteria which can cause infection.

SUPIROCIN cream is used to treat small wounds which have become infected. These wounds may include small cuts and abrasions or stitches.

SUPIROCIN cream is for use on your skin only.

2. What should I know before I use SUPIROCIN cream?

Warnings

Do not use SUPIROCIN cream if:

  • you are allergic to mupirocin calcium or mupirocin, or any of the ingredients listed at the end of this leaflet.

Always check the ingredients to make sure you can use this medicine.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

Check with your doctor if you:

  • have any other medical conditions
  • take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

If you are using SUPIROCIN cream on a cracked nipple, wash the nipple well before breast feeding your baby.

3. What if I am taking other medicines?

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

Do not mix SUPIROCIN cream with any other preparation. They may prevent SUPIROCIN cream from working.

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

4. How do I use SUPIROCIN cream?

How much to take / use

  • The usual recommendation is for a small amount to be applied to the affected area three times daily.
  • Follow the instructions provided and use SUPIROCIN until your doctor tells you to stop.

Use SUPIROCIN cream for as long as your doctor or pharmacist tells you to. SUPIROCIN cream treatment is usually for up to 10 days.

It is important that you take the full courses of SUPIROCIN cream. Do not stop early as your symptoms may disappear before the infection is fully cleared.

Do not apply SUPIROCIN cream to children under 2 years of age unless instructed by your doctor.

How to use SUPIROCIN cream

Always wash your hands before and after applying SUPIROCIN cream.

With a piece of clean cotton wool or a gauze swab, apply a small quantity of SUPIROCIN cream to cover the affected area.

After applying the cream, you may cover the treated area with a sterile bandage or gauze dressing, unless a doctor has told you to leave it uncovered.

If you forget to use SUPIROCIN cream

SUPIROCIN cream should be used regularly at the same time each day. If you forget an application, apply some SUPIROCIN cream as soon as you can, then continue as before.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you use too much SUPIROCIN cream

If you think that you have used too much SUPIROCIN cream or accidentally swallowed SUPIROCIN cream, 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 SUPIROCIN cream?

Things you should do

If SUPIROCIN cream is accidentally applied to the eyes, wash the eyes thoroughly with water.

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

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.

Call your doctor straight away if you:

  • Medicines like SUPIROCIN cream 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.

Remind any doctor, dentist or pharmacist you visit that you are using SUPIROCIN cream.

Things you should not do

  • Do not stop using this medicine suddenly.
  • Do not use SUPIROCIN cream to treat any other complaints unless your doctor says to.
  • Do not stop using SUPIROCIN cream, or change the dose without first checking with your doctor.
  • SUPIROCIN cream should not be used to treat infections in or near the eyes, nostrils or mouth
  • SUPIROCIN cream should not be used to treat areas of skin near tubes inserted into your body for the delivery or removal of fluid (cannulae). SUPIROCIN cream should not be used in combination with cannulae.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how SUPIROCIN cream affects you.

This medicine does not affect your ability to drive or operate machinery.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly. Store below 25°C. Do not freeze.

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.

Getting rid of any unwanted medicine

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

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

Less serious side effects

Less serious side effectsWhat to do
Skin:
Application site reactions
  • Itching
  • Redness
  • Stinging of the skin
General:
  • Headache
  • Nausea
  • Diarrhoea
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
Allergic Reactions:
  • Rash
  • Hives
  • Swelling
  • Wheezing
  • Swelling of the lips/mouth
  • Difficulty in breathing
  • Fainting
Site of Application:
  • Swelling
  • Itching
  • Burning or pain in the area where SUPIROCIN cream is applied
If you get a skin reaction, stop using SUPIROCIN cream. Wipe off any cream and 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.

Other side effects not listed here may occur in some people.

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 SUPIROCIN cream contains

Active ingredient
(main ingredient)		Mupirocin (as calcium)
Other ingredients
(inactive ingredients)		xanthan gum, liquid paraffin, cetomacrogol 1000, glyceryl monostearate 40-55%, phenoxyethanol, benzyl alcohol and purified water

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

What SUPIROCIN cream looks like

SUPIROCIN cream is white soft homogeneous cream supplied in 15 g tubes.

Australian Registration Number

AUST R 385530

Who distributes SUPIROCIN cream

Glenmark Pharmaceuticals Australia Pty Ltd
Suite 1503, Level 15
14 Martin Place
Sydney, NSW 2000
Email: [email protected]
Phone: 1800 371 274

This leaflet was prepared in April 2024

Published by MIMS June 2024

BRAND INFORMATION

Brand name

Supirocin

Active ingredient

Mupirocin

Schedule

S4

 

1 Name of Medicine

Mupirocin calcium.

2 Qualitative and Quantitative Composition

Supirocin cream contains 20 mg (2% w/w) of mupirocin per gram equivalent to 21.5 mg (2.15% w/w) of mupirocin calcium in an oil and water based emulsion.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cream.

4 Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Dose and Method of Administration

For dermatologic use.
A small amount of Supirocin 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.

4.3 Contraindications

Supirocin cream is 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 Supirocin, treatment should be discontinued, the product should be wiped off and appropriate alternative therapy for the infection instituted.
Supirocin 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.
Supirocin 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 the elderly.

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

Paediatric use.

The safety and efficacy of mupirocin 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.
Supirocin cream 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 mupirocin cream 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 mupirocin cream.

Skin and subcutaneous tissue disorders.

Common: cutaneous hypersensitivity reactions.
Generally, mupirocin 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 mupirocin cream or placebo. In a supportive safety study, where mupirocin 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 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.
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 mupirocin 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. Mupirocin 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 mupirocin 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 mupirocin cream and 95.3% for oral cephalexin (95% Confidence Interval for difference between treatment groups -4.04, 3.64). Ninety eight patients given mupirocin 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 mupirocin cream and 98.9% for oral cephalexin (95% Confidence Interval -6.04, 2.04).
The safety and efficacy of mupirocin 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

Supirocin cream also contains xanthan gum, liquid paraffin, cetomacrogol 1000, glyceryl monostearate 40-55%, phenoxyethanol, benzyl alcohol and purified water.

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

Supirocin cream 2% is packed in 15 g lacquered, latex aluminium tube, with white polypropylene (PP) cap having a piercing point.

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.
Chemical name: Calcium bis[9-[[(2E)-4-[(2S,3R,4R,5S)-3,4-dihydroxy-5-[[(2S,3S)-3-[1S,2S)-2-hydroxy-1 methylpropyl]oxiranyl]methyl]tetrahydro-2H-pyran-2-yl]-3-methylbut-2-enoyl]oxy]nonanoate] dihydrate.

Chemical structure.


CAS number.

115074-43-6.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes