BACTROBAN CREAM GlaxoSmithKline

BACTROBANTM CREAM
GlaxoSmithKline
Mupirocin calcium
Warnings and Precautions
For intranasal use, a separate presentation,
QUALITATIVE AND QUANTITATIVE
BACTROBAN nasal ointment, is available.
COMPOSITION
Mupirocin calcium equivalent to 2% w/w mupirocin Avoid contact with the eyes.
In the rare event of a possible sensitisation reaction
free acid.
or severe local irritation occurring with the use of
PHARMACEUTICAL FORM
BACTROBAN cream, treatment should be discontinWhite cream for topical administration in a multi-use ued, the product should be washed off and appropritube.
ate alternative therapy for the infection instituted.
As with other antibacterial products, prolonged use
CLINICAL PARTICULARS
may result in overgrowth of non-susceptible organisms.
Indications
BACTROBAN cream is indicated for the topical Interactions
treatment of secondarily infected traumatic lesions No drug interactions have been identified.
such as small lacerations, sutured wounds or abraPregnancy and Lactation
sions.
Use in pregnancy:
Dosage and Administration
Adequate human data on use during pregnancy
Dosage
are not available. However, animal studies have not
Adults/children/elderly
identified any risk to pregnancy or embryo-foetal
Three times a day for up to 10 days, depending on development.
the response.
Mupirocin should only be used in pregnancy when
Hepatic impairment: No dosage adjustment is nec- the potential benefits outweigh the potential risks
essary.
associated with treatment.
Renal impairment: No dosage adjustment is necesUse in lactation:
sary.
Adequate human and animal data on use during lacMethod of administration
tation are not available.
A small quantity of cream should be applied to the If a cracked nipple is to be treated, it should be thoraffected area with a piece of clean cotton wool or oughly washed prior to breast feeding.
gauze swab.
Effects on Ability to Drive and Use Machines
The treated area may be covered by a dressing.
No adverse effects on the ability to drive or operate
Do not mix with other preparations as there is a risk
machinery have been identified.
of dilution, resulting in a reduction in the antibacterial activity and potential loss of stability of the mupi- Adverse Reactions
rocin in the cream.
The following convention has been used for the
classification of frequency:
Contraindications
BACTROBAN cream should not be given to patients common: >1/100 and <1/10
with a history of hypersensitivity to any of its constit- Skin and subcutaneous tissue disorders:
uents.
Common: Cutaneous hypersensitivity reactions
Overdose
Not applicable.
broken/diseased skin. However, clinical trials have
shown that when given systemically, it is metabolised to the microbiologically inactive metabolite
PHARMACOLOGICAL PROPERTIES
monic acid and rapidly excreted.
Pharmacodynamics
Mupirocin is rapidly eliminated from the body by
Pharmacodynamic properties
metabolism to its inactive metabolite monic acid
Mupirocin is a novel antibiotic produced through ferwhich is rapidly excreted by the kidney.
mentation by Pseudomonas fluorescens. Mupirocin
inhibits isoleucyl transfer-RNA synthetase, thereby Pre-clinical Safety Data
arresting bacterial protein synthesis. Due to this par- No further information of relevance.
ticular mode of action and its unique chemical strucPHARMACEUTICAL PARTICULARS
ture, mupirocin does not show any cross-resistance
List of Excipients
with other clinically available antibiotics.
Xanthan gum
Mupirocin shows little risk of selection of bacterial
Liquid paraffin
resistance if used as prescribed.
Cetomacrogol 1000
Mupirocin has bacteriostatic properties at minimum
Stearyl alcohol
inhibitory concentrations and bactericidal properties
Cetyl alcohol
at the higher concentrations reached when applied
Phenoxyethanol
locally.
Benzyl alcohol
Mupirocin is a topical antibacterial agent showing in
Purified water
vivo activity against Staphylococcus aureus (including methicillin-resistant strains), S. epidermidis and Incompatibilities
beta-haemolytic Streptococcus species.
None identified.
The in vitro spectrum of activity includes the follow- Shelf Life
ing bacteria:
The expiry date is indicated on the packaging.
Aerobic Gram-positive:
Staphylococcus aureus (including beta-lactamaseproducing strains and methicillin resistant strains).
Staphylococcus epidermidis (including beta-lactamase-producing and methicillin-resistant strains)
Other coagulase-negative staphylococci (including
methicillin-resistant strains).
Streptococcus species
Special Precautions for Storage
BACTROBAN cream may be stored at room temperature (below 25oC) up to the expiry date.
Do not freeze.
Nature and Contents of Container
Squeezable aluminium tubes with a screw cap containing 15 g.
Instructions for Use/Handling
No special instructions.
Any product remaining at the end of treatment
should be discarded.
Not all presentations are available in every country.
Version number: MDS03/IPI02
Date of issue: 02 June 2004
Pharmacokinetics
Systemic absorption of mupirocin through intact BACTROBAN is a trademark of:
human skin is low although it may occur through the GlaxoSmithKline group of companies
Aerobic Gram-negative:
Haemophilus influenzae
Neisseria gonorrhoeae
Neisseria meningitidis
Moraxella catarrhalis
Pasteurella multocida
BACTROBAN OINTMENT
GlaxoSmithKline
Mupirocin free acid
not available. There is, therefore, inadequate evidence
of safety to recommend the use of BACTROBAN durQUALITATIVE AND QUANTITATIVE
ing pregnancy.
COMPOSITION
2% w/w mupirocin free acid in a white, translucent, However, studies in experimental animals have
shown mupirocin to be without teratogenic effects.
water soluble, polyethylene glycol base.
Adequate human and animal data on use during lacPHARMACEUTICAL FORM
tation are not available.
Ointment.
Effects on Ability to Drive and Use Machines
CLINICAL PARTICULARS
No adverse effects on the ability to drive and use
Indications
machines have been observed.
Bacterial skin infections, e.g. impetigo, folliculitis and
Adverse Reactions
furunculosis.
Clinical trials data
Dosage and Administration
Skin and subcutaneous tissue disorders:
Adults and Children:
Burning localised to the area of application.
BACTROBAN should be applied to the affected
Itching, erythema, stinging and dryness localised to
area up to three times daily, for up to 10 days. The
the area of application.
area may be covered with a dressing or occluded if
Cutaneous sensitisation reactions to mupirocin or
desired.
the ointment base.
Contraindications
Post-marketing experience
Hypersensitivity to BACTROBAN or other ointments
containing polyethylene glycol and any of its constit- Immune system disorders:
Systemic allergic reactions have been reported with
uents.
BACTROBAN ointment.
Warnings and Precautions
This BACTROBAN formulation is not suitable for Overdose
ophthalmic or intra-nasal use. When BACTROBAN Not applicable.
is used on the face care should be taken to avoid PHARMACOLOGICAL PROPERTIES
the eyes. Polyethylene glycol can be absorbed from Pharmacodynamics
open wounds and damaged skin and is excreted by BACTROBAN is a topical antibacterial agent, active
the kidneys.
against those organisms responsible for the majority
In common with other polyethylene glycol-based of skin infections, e.g. Staphylococcus aureus, includointments, BACTROBAN should be used with cau- ing methicillin-resistant strains, other staphylococci
tion if there is evidence of moderate or severe renal and streptococci. It is also active against certain Gramimpairment.
negative pathogens, such as Haemophilus influenzae.
Interactions
Pharmacokinetics
None reported.
Absorption
Pregnancy and Lactation
BACTROBAN penetrates intact human skin but the
Adequate human data on use during pregnancy are rate of systemic absorption appears to be low.
Excretion
Systemically absorbed BACTROBAN is rapidly
metabolised to the inactive metabolite monic acid
and quickly excreted by the kidneys.
PHARMACEUTICAL PARTICULARS
List of Excipients
Polyethylene glycol
Incompatibilities
None reported.
Shelf Life
The expiry date is indicated on the packaging.
Special Precautions for Storage
Store below 25oC.
Nature and Contents of Container
As registered locally.
Instructions for Use/Handling
Any ointment remaining at the end of the treatment
should be discarded.
Version number: MDS006/IPI02
Date of issue: 26 February 2004
BACTROBAN is a trademark of:
the GlaxoSmithKline group of companies.
BACTROBAN NASAL
GlaxoSmithKline
Mupirocin calcium
Interactions
None reported.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Pregnancy and Lactation
Mupirocin calcium equivalent to 2% w/w mupirocin Adequate human data on use during pregnancy
free acid in a white soft paraffin based ointment.
are not available. However, animal studies have not
identified any risk to pregnancy or embryo-foetal
PHARMACEUTICAL FORM
development.
Nasal ointment:
Adequate human and animal data on use during lacCLINICAL PARTICULARS
tation are not available
Indications
Effects on Ability to Drive and Use Machines
Elimination of nasal carriage of staphylococci,
No adverse effects on the ability to drive or use
including methicillin resistant Staphylococcus auremachinery have been observed.
us (MRSA).
For the treatment of bacterial skin infections Adverse Reactions
Clinical trials data
BACTROBAN ointment should be used.
See package leaflet for this BACTROBAN formula- Nasal mucosa reactions have been reported
tion or contact the manufacturer for details.
Post marketing data
Dosage and Administration
Adults and Children: BACTROBAN nasal ointment
should be applied to the anterior nares two to three
times a day, as follows:
A small amount of ointment, about the size of a
match head is squeezed on the little finger.
The ointment is applied to the inside of one nostril.
This is repeated for the other nostril.
The nostrils are closed by pressing the sides of the
nose together. This spreads the ointment throughout
the nares.
A swab may be used to carefully apply the ointment
to infants or patients who are very ill.
Nasal carriage should normally clear within 3-5 days
of commencing treatment.
Contraindications
Hypersensitivity to any of its constituents.
Cutaneous hypersensitivity reactions
Overdose
Not applicable.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
BACTROBAN is a novel antibiotic, both in chemical
structure and mode of action, available only for topical use.
BACTROBAN is active against those organisms
responsible for the majority of skin infections, e.g.
Staphylococcus aureus, including methicillin-resistant strains, other staphylococci and streptococci. It
is also active against certain Gram-negative pathogens, such as Haemophilus influenzae.
PHARMACEUTICAL PARTICULARS
List of Excipients
White soft paraffin
Softisan
Warnings and Precautions
As with all topical preparations care should be taken Incompatibilities
to avoid contact with the eyes.
None reported.
Shelf Life
The expiry date is indicated on the packaging.
Special Precautions for Storage
Store below 25oC.
Nature and Contents of Container
As registered locally.
Instructions for Use/Handling
Any ointment remaining at the end of the treatment
should be discarded.
Version number: GDS012/IPI03
Date of issue: 09 February 2006
BACTROBAN is a trademark of:
the GlaxoSmithKline group of companies