BACTROBAN CREAM 2% ww

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MUPIROCIN CALCIUM EQV MUPIROCIN

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

D06AX09

Dosage:

2% w/w

Pharmaceutical form:

CREAM

Composition:

MUPIROCIN CALCIUM EQV MUPIROCIN 2% w/w

Administration route:

TOPICAL

Prescription type:

Prescription Only

Manufactured by:

SMITHKLINE BEECHAM

Authorization status:

ACTIVE

Authorization date:

1999-10-29

Patient Information leaflet

1
BACTROBAN CREAM
MUPIROCIN CALCIUM
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mupirocin calcium equivalent to 2% w/w mupirocin free acid.
PHARMACEUTICAL FORM
White cream for topical administration in a multi-use tube.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
_BACTROBAN _
Cream
_ _
is indicated for the topical treatment of secondarily infected
traumatic lesions such as small lacerations, sutured wounds or
abrasions due to
susceptible strains of
_Staphylococcus aureus_
and
_Streptococcus pyogenes_
.
POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
_Adults/children/elderly _
3 times a day for up to 10 days, depending on the response.
_Hepatic impairment_
: No dosage adjustment is necessary.
_Renal impairment:_
No dosage adjustment is necessary.
METHOD OF ADMINISTRATION
A small quantity of cream should be applied to the affected area with
a piece of clean
cotton wool or gauze swab.
The treated area may be covered by a dressing.
Do not mix with other preparations as there is a risk of dilution,
resulting in a reduction in
the antibacterial activity and potential loss of stability of the
mupirocin in the cream.
CONTRAINDICATIONS
_BACTROBAN_
Cream
should not be given to patients with a history of hypersensitivity to
any of its constituents.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
_BACTROBAN _
Cream is not formulated for use on mucosal surfaces.
2
In the rare event of a possible sensitisation reaction or severe local
irritation occurring
with the use of
_BACTROBAN _
Cream, treatment should be discontinued, the product
should be washed off and appropriate alternative therapy for the
infection instituted.
As with other antibacterial products, prolonged use may result in
overgrowth of non-
susceptible organisms.
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 m

Summary of Product characteristics

1
BACTROBAN CREAM
MUPIROCIN CALCIUM
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mupirocin calcium equivalent to 2% w/w mupirocin free acid.
PHARMACEUTICAL FORM
White cream for topical administration in a multi-use tube.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
_BACTROBAN _
Cream
_ _
is indicated for the topical treatment of secondarily infected
traumatic lesions such as small lacerations, sutured wounds or
abrasions due to
susceptible strains of
_Staphylococcus aureus_
and
_Streptococcus pyogenes_
.
POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
_Adults/children/elderly _
3 times a day for up to 10 days, depending on the response.
_Hepatic impairment_
: No dosage adjustment is necessary.
_Renal impairment:_
No dosage adjustment is necessary.
METHOD OF ADMINISTRATION
A small quantity of cream should be applied to the affected area with
a piece of clean
cotton wool or gauze swab.
The treated area may be covered by a dressing.
Do not mix with other preparations as there is a risk of dilution,
resulting in a reduction in
the antibacterial activity and potential loss of stability of the
mupirocin in the cream.
CONTRAINDICATIONS
_BACTROBAN_
Cream
should not be given to patients with a history of hypersensitivity to
any of its constituents.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
_BACTROBAN _
Cream is not formulated for use on mucosal surfaces.
2
In the rare event of a possible sensitisation reaction or severe local
irritation occurring
with the use of
_BACTROBAN _
Cream, treatment should be discontinued, the product
should be washed off and appropriate alternative therapy for the
infection instituted.
As with other antibacterial products, prolonged use may result in
overgrowth of non-
susceptible organisms.
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 m