Bactroban Ointment

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mupirocin, Quantity: 22 mg/g

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

Mupirocin

Pharmaceutical form:

Ointment

Composition:

Excipient Ingredients: macrogol 3350; macrogol 400

Administration route:

Topical

Units in package:

1g, 15g, 15g(E), 5g, 2g, 30g

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

Therapeutic indications:

BACRTOBAN (mupirocin) ointment is indicated for the topical treatment of mild impetigo.

Product summary:

Visual Identification: A white to off-white ointment; Container Type: Tube; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-14

Patient Information leaflet

BACTROBAN
®
OINTMENT
_Mupirocin (2%w/w)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you use BACTROBAN
ointment.
This leaflet answers some common
questions about BACTROBAN
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 ointment against the
risks this medicine could have for
you.
If you are helping someone else to
use BACTROBAN ointment, read
this leaflet before applying the first
application.
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
OINTMENT IS USED FOR
BACTROBAN 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 ointment is used for
the treatment of mild impetigo
(school sores).
BACTROBAN ointment is for use
on your skin only.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
BACTROBAN ointment for another
reason.
BACTROBAN ointment is not
addictive.
BEFORE YOU USE
BACTROBAN
OINTMENT
_WHEN YOU MUST NOT USE IT_
YOU MUST NOT USE BACTROBAN
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
OINTMENT AFTER THE EXPIRY DATE
PRINTED ON THE PACK, OR THE
OINTMENT SHOWS VISIBLE SIGNS OF
DETERIORATION, OR IF THE PACKAGING IS
TORN OR SHOWS SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharma

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
BACTROBAN (MUPIROCIN CALCIUM) CREAM AND OINTMENT
1
NAME OF THE MEDICINE
Mupirocin calcium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BACTROBAN cream and BACTROBAN ointment contain mupirocin calcium 2%
w/w
equivalent to 20 mg mupirocin as the active ingredient.
LIST OF EXCIPIENTS WITH KNOWN EFFECT
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Cream or ointment.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BACTROBAN (mupirocin) cream is indicated for the topical treatment of
secondarily infected
traumatic skin lesions such as small lacerations, sutured wounds or
abrasions.
BACTROBAN (mupirocin) ointment is indicated for the topical treatment
of mild impetigo.
4.2
DOSE AND METHOD OF ADMINISTRATION
For Dermatologic Use.
A small amount of BACTROBAN should be applied to the affected area
three times daily.
The area treated may be covered with a gauze dressing if desired.
Usually treatment should
not continue for more than 10 days.
RENAL IMPAIRMENT (BACTROBAN OINTMENT)
Refer to Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS.
4.3
CONTRAINDICATIONS
BACTROBAN cream and BACTROBAN ointment are contraindicated in patients
who have
demonstrated hypersensitivity to mupirocin calcium or any components
of the formulations.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If a reaction suggesting sensitivity or chemical irritation should
occur with the use of
BACTROBAN, treatment should be discontinued, the product should be
wiped off and
appropriate alternative therapy for the infection instituted.
2
BACTROBAN is not suitable for ophthalmic use, intranasal use or
application to other
mucosal surfaces.
Avoid contact with eyes. If contaminated, the eyes should be
thoroughly irrigated with water
until the residues have been removed.
BACTROBAN is not suitable for application to the site of cannulation
or for use in
conjunction with cannulae.
Polyethylene glycol (macrogol) can be absorbed from open wounds and
damaged skin and
is excreted by the kidneys. In