BACTROBAN mupirocin (as calcium) 20mg/g cream tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mupirocin calcium, Quantity: 20.7683 mg/g

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

Mupirocin

Pharmaceutical form:

Cream

Composition:

Excipient Ingredients: cetyl alcohol; benzyl alcohol; purified water; cetomacrogol 1000; stearyl alcohol; liquid paraffin; xanthan gum; phenoxyethanol

Administration route:

Topical

Units in package:

15g

Prescription type:

(S4) Prescription Only Medicine

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.

Product summary:

Visual Identification: A white cream of homogenous appearance.; Container Type: Tube; Container Material: Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1998-04-23

Patient Information leaflet

BACTROBAN
® CREAM
_Mupirocin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start using BACTROBAN
cream, or before helping someone
else to use BACTROBAN cream.
This leaflet answers some common
questions about BACTROBAN
cream. 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 cream 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
CREAM IS USED FOR
BACTROBAN cream 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 cream can be used to
treat small wounds which have
become infected. These wounds may
include small cuts and abrasions or
stitches.
BACTROBAN cream 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 cream for another
reason.
There is no evidence that
BACTROBAN cream is addictive.
BEFORE YOU USE
BACTROBAN CREAM
_WHEN YOU MUST NOT USE IT_
YOU MUST NOT USE BACTROBAN
CREAM 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 CREAM
AFTER THE EXPIRY DATE PRINTED ON THE
PACK 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 SURE WHETHER YOU
SHOULD START USI

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