Bactroban Ointment *

  • Company:

    GlaxoSmithKline (Ireland) Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 01 September 2021

File name

ie-pl-bactroban-oint-issue7draft1-clean-meds_1630495123.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 12 February 2021

File name

ie-pl-bactroban-oint-issue6draft1-clean-medsie_1613128352.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 19 March 2019

File name

ie-pl-bactroban-oint-issue5draft1 for meds.ie_1553003438.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 27 August 2015

File name

PIL_8128_140.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 August 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 27 August 2015

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 2 – active substance correction
Section 10 – date of revision updated

Updated on 27 August 2015

Reasons for updating

  • Change of trade or active ingredient name
  • Change to date of revision

Updated on 17 July 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to address of the MA Holder

Updated on 17 July 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 02 July 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



·         Section 2 – Update to qualitative and quantitative composition statement

·         Section 3 – Editorial update

·         Section 4.2 – Minor QRD update

 

·         Section 4.4 - Editorial updates and re-structuring to keep the renal impairment issues together with a consequential update to section 5.2. The reposition of the warning statements is amended as follows:

- Text relating to polyethylene glycol absorption has been moved directly below the “Renal impairment” title.

- Statement regarding elderly patients has been removed from the section 4.4 and placed in the within section 5.2 Pharmacokinetics section.

·         Section 4.6 – Minor QRD update

·         Section 4.8 – Addition of the term ‘anaphylaxis’; Updated HPRA details; QRD and minor editorial updates

·         Section 4.9 - Updated statements and management of overdose

·         Section 5.2 – Elderly patients statement removed from section 4.4 and placed within section 5.2

·         Section 6.3 – Editorial update

·         Section 6.5 – Editorial update

·         Section 6.6 – QRD update concerning disposal

·         Section 9 – Minor editorial

·         Section 10 – Date of revision update

 

 

 

 

 

 

 

 

 

 

 

 

Updated on 02 July 2015

Reasons for updating

  • Change of trade or active ingredient name
  • Change to, or new use for medicine
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 07 April 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes to:

Section 4.4 - Special warnings and precautions for use,
Section 4.6 - Pregnancy and lactation,
Section 4.7 - Effects on ability to drive and use machines,
Section 4.8 - Undesirable effects,
Section 5.3 - Preclinical safety data,
Section 6.6 - Special precautions for disposal

 

Updated on 04 April 2014

Reasons for updating

  • Change to side-effects

Updated on 09 September 2013

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery

Updated on 19 June 2013

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes to:

Section 4.1 -Therapeutic indications,
Section 5.1 - Pharmacodynamic properties

Updated on 17 September 2012

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

4.2       Posology and Method of Administration

 

            Dosage:

 

            Adults (including elderly) and children:

 

            Bactroban Ointment should be applied to the affected area up to three times a day for up to 10 days, depending on the response. Dosage should not exceed ten days.

Updated on 30 August 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 06 May 2010

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

1.         Name of the Medicinal Product

 

            ‘Bactroban’ 2% w/w Ointment

 

4.3       Contraindications

 

            Hypersensitivity to mupirocin or any of the excipients (see section 6.1).

 

            ‘Bactroban’ ointment should not be given to patients with a history of hypersensitivity to any of its constituents.

 

            This ‘Bactroban’ Ointment formulation is not suitable for ophthalmic or intranasal use.

 

4.4       Special Warnings and Special Precautions for Use

 

            When ‘Bactroban’ Ointment is used on the face, care should be taken to avoid the eyes.

 

            Since absorption of mupirocin from areas of denuded skin has not yet been quantified, it is not recommended that the product be used in patients with skin ulcers, burns or with areas of traumatised skin.

 

            Polyethylene glycol 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 be used with caution if there is evidence of moderate or severe renal impairment.

 

            In the rare event of a possible sensitisation reaction or severe local irritation occurring with the use of ‘Bactroban’ ointment, treatment should be discontinued, the product should be rinsed off and appropriate alternative therapy for the infection instituted.

 

Should a possible sensitisation reaction or severe local irritation occur with the use of Mupirocin Ointment, treatment should be discontinued, the product should be washed off and appropriate therapy instituted.

 

As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms.

 

Renal impairment
Elderly patients: No restrictions unless the condition being treated could lead to absorption of polyethylene glycol and there is evidence of moderate or severe renal impairment.

 

Mupirocin ointment is not suitable for:

-           ophthalmic use

-           intranasal use

-           use in conjunction with cannulae

-           at the site of central venous cannulation.

 

For intranasal use, a separate presentation, Mupirocin nasal ointment, is available.

 

Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until the ointment residues have been removed.

 

Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol based ointments, 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.

 

4.5       Interaction with Other Medicinal Products and Other Forms of Interaction

 

            None stated.

 

            No drug interactions have been identified.

 

4.6       Pregnancy and Lactation

 

            This product should not be used during pregnancy and lactation unless considered essential by the physician. 

 

            Pregnancy: Adequate human data on use during pregnancy are not available.  However animal studies have not identified any risk to pregnancy or embryo-foetal development.

           

            Lactation: Adequate human and animal data on use during lactation are not available.

 

Use in pregnancy:

Reproduction studies on mupirocin in animals have revealed no evidence of harm to the foetus. As there is no clinical experience on its use during pregnancy, mupirocin should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.

 

Use in lactation:

There is no information on the excretion of mupirocin in milk. If a cracked nipple is to be treated, it should be thoroughly washed prior to breast feeding.

 

4.7       Effects on Ability to Drive and Use Machines

 

            None stated.

 

No adverse effects on the ability to drive or operate machinery have been identified.

 

4.9       Overdose

 

            The toxicity of mupirocin is very low.  In the event of overdose accidental ingestion, symptomatic treatment should be given.

 

Updated on 07 April 2009

Reasons for updating

  • Change to name of manufacturer

Updated on 26 August 2008

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 10:
 
should read December 2006

Updated on 09 May 2008

Reasons for updating

  • Change to name of manufacturer

Updated on 26 April 2007

Reasons for updating

  • Change of manufacturer

Updated on 09 March 2007

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 14 December 2006

Reasons for updating

  • Improved electronic presentation

Updated on 10 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 03 July 2003

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 19 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)