Consumer medicine information

1. Why am I using APO-MUPIROCIN?

APO-MUPIROCIN ointment contains the active ingredient mupirocin. APO-MUPIROCIN ointment is used to treat mild impetigo (school sores).
For more information, see Section 1. Why am I using APO-MUPIROCIN? in the full CMI.

2. What should I know before I use APO-MUPIROCIN?

Do not use if you have ever had an allergic reaction to mupirocin 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 APO-MUPIROCIN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-MUPIROCIN 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 APO-MUPIROCIN?

• Always wash your hands before and after applying APO-MUPIROCIN ointment.

• A small amount of APO-MUPIROCIN ointment 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.

• Usually treatment should not continue for more than 10 days.

5. What should I know while using APO-MUPIROCIN?

6. Are there any side effects?

Common side effects include: itching, dryness, redness and stinging.
More serious side effects include: swelling, itching, burning or pain in the area where mupirocin ointment has been applied.
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.
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.

Notes

Distributed by Arrotex Pharmaceuticals

1 Name of Medicine

Mupirocin.

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.

4 Clinical Particulars

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).

5 Pharmacological Properties

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

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMUPIRO.gif 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.
CAS number. CAS registry number: 12650-69-0.
Mupirocin is slightly soluble in water and freely soluble in acetone, methylene chloride, chloroform and methanol.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/APOMUPST.gif