BACTROBAN mupirocin 2% nasal ointment tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mupirocin calcium, Quantity: 21.5 mg/g (Equivalent: mupirocin, Qty 20 mg/g)

Available from:

GlaxoSmithKline Australia Pty Ltd

Pharmaceutical form:

Ointment

Composition:

Excipient Ingredients: white soft paraffin; bis-diglyceryl polyacyladipate-2

Administration route:

Topical

Units in package:

3g tube

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

BACTROBAN (mupirocin) Nasal Ointment is indicated for the elimination of nasal carriage of staphylococci including methicillin resistant Staphylococcus aureus (MRSA).

Product summary:

Visual Identification: White to off-white ointment; Container Type: Tube; Container Material: Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-14

Patient Information leaflet

BACTROBAN
®
_NASAL OINTMENT_
_Mupirocin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you use BACTROBAN nasal
ointment, or before helping someone
else to use BACTROBAN nasal
ointment.
This leaflet answers some common
questions about BACTROBAN nasal
ointment. It does not contain all of
the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the expected benefits of you using
BACTROBAN nasal ointment
against the risks this medicine could
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT BACTROBAN
NASAL OINTMENT IS USED
FOR
BACTROBAN nasal ointment
contains mupirocin (2% w/w) as the
active ingredient.
Mupirocin belongs to a group of
medicines called antibiotics.
Antibiotics work by killing bacteria
which can cause infection.
BACTROBAN nasal ointment is
used to remove bacteria, including
the bacteria called 'Staphylococcus
aureus' (golden staph.) from inside
your nose. BACTROBAN nasal
ointment is for use in your nose only.
Your doctor may have prescribed
BACTROBAN nasal ointment for
another reason.
There is no evidence that
BACTROBAN nasal ointment is
addictive.
BEFORE YOU USE
BACTROBAN NASAL
OINTMENT
_WHEN YOU MUST NOT USE IT:_
DO NOT USE BACTROBAN NASAL
OINTMENT IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
mupirocin
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT USE BACTROBAN NASAL
OINTMENT AFTER THE EXPIRY DATE
(EXP) PRINTED ON THE PACK HAS
PASSED, OR IF THE PACKAGING IS TORN
OR SHOWS SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
IF YOU ARE NOT

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
BACTROBAN (MUPIROCIN CALCIUM) NASAL OINTMENT
1
NAME OF THE MEDICINE
Mupirocin calcium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BACTROBAN nasal ointment contains mupirocin calcium 2% w/w as the
active ingredient.
Each gram of BACTROBAN nasal ointment 2% contains 20 mg mupirocin as
the calcium
salt.
LIST OF EXCIPIENTS WITH KNOWN EFFECT
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Nasal ointment.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BACTROBAN (mupirocin) nasal ointment is indicated for the elimination
of nasal carriage of
staphylococci including methicillin resistant _Staphylococcus aureus
_(MRSA).
4.2
DOSE AND METHOD OF 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 the ointment about the size of a match head is
placed on the little finger
and applied to the inside of each nostril. The nostrils are closed by
pressing the side of the
nose together; this will spread the ointment throughout the nares. A
swab may be used for
application to infants or patients who are very ill.
Nasal carriage should normally clear within 5 - 7 days of commencing
treatment. Treatment
should not continue for more than 10 days.
4.3
CONTRAINDICATIONS
BACTROBAN nasal ointment is contraindicated in patients who have
demonstrated
hypersensitivity to mupirocin calcium or any components of the
formulation.
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If a reaction suggesting sensitivity or chemical irritation should
occur with the use of
BACTROBAN nasal ointment, treatment should be discontinued, the
product should be
wiped off and appropriate alternative therapy for the infection
instituted.
BACTROBAN nasal ointment formulation is not suitable for ophthalmic
use.
Avoid contact with the eyes. If contaminated, the eyes should be
thoroughly irrigated with
water until the ointment residues have been removed.
As with other antibacterial products