BACTROBAN NASAL OINTMENT 2% ww

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MUPIROCIN

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

R01AX06

Dosage:

2% w/w

Pharmaceutical form:

OINTMENT

Composition:

MUPIROCIN 2% w/w

Administration route:

NASAL

Prescription type:

Prescription Only

Manufactured by:

Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)

Authorization status:

ACTIVE

Authorization date:

1990-09-17

Patient Information leaflet

BACTROBAN
NASAL
MUPIROCIN CALCIUM AS FREE ACID
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mupirocin calcium equivalent to 2% w/w mupirocin free acid in a white
soft paraffin
based ointment.
PHARMACEUTICAL FORM
Nasal ointment.
CLINICAL PARTICULARS
INDICATIONS
Elimination of nasal carriage of staphylococci, including
methicillin-resistant
_Staphylococcus aureus_
(MRSA).
For the treatment of bacterial skin infections
_BACTROBAN_
ointment should be used. See
package leaflet for this
_BACTROBAN_
formulation or contact the manufacturer for details.
DOSAGE AND ADMINISTRATION
POPULATIONS
_Adults and Children:_
_BACTROBAN_
nasal ointment should be applied to the anterior
nostrils 2 to 3 times a day, as follows:
A small amount of ointment, about the size of a match head is squeezed
on the little
finger or a cotton-tipped applicator, if available.
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 nostrils.
Nasal carriage should normally clear within 3 to 5 days of commencing
treatment.
Dosage should not exceed 10 days.
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 ointment.
CONTRAINDICATIONS
_BACTROBAN_
nasal ointment should not be given to patients with a history of
hypersensitivity to mupirocin or any of the constituents of the
preparations.
WARNINGS AND PRECAUTIONS
In the rare event of a possible sensitisation reaction or severe local
irritation occurring
with the use of the product, treatment should be discontinued, the
product should be
wiped 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

Summary of Product characteristics

BACTROBAN
NASAL
MUPIROCIN CALCIUM AS FREE ACID
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mupirocin calcium equivalent to 2% w/w mupirocin free acid in a white
soft paraffin
based ointment.
PHARMACEUTICAL FORM
Nasal ointment.
CLINICAL PARTICULARS
INDICATIONS
Elimination of nasal carriage of staphylococci, including
methicillin-resistant
_Staphylococcus aureus_
(MRSA).
For the treatment of bacterial skin infections
_BACTROBAN_
ointment should be used. See
package leaflet for this
_BACTROBAN_
formulation or contact the manufacturer for details.
DOSAGE AND ADMINISTRATION
POPULATIONS
_Adults and Children:_
_BACTROBAN_
nasal ointment should be applied to the anterior
nostrils 2 to 3 times a day, as follows:
A small amount of ointment, about the size of a match head is squeezed
on the little
finger or a cotton-tipped applicator, if available.
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 nostrils.
Nasal carriage should normally clear within 3 to 5 days of commencing
treatment.
Dosage should not exceed 10 days.
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 ointment.
CONTRAINDICATIONS
_BACTROBAN_
nasal ointment should not be given to patients with a history of
hypersensitivity to mupirocin or any of the constituents of the
preparations.
WARNINGS AND PRECAUTIONS
In the rare event of a possible sensitisation reaction or severe local
irritation occurring
with the use of the product, treatment should be discontinued, the
product should be
wiped 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