BACTROBAN NASAL OINTMENT

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

GlaxoSmithKline South Africa (Pty) Limited

Dosage:

See ingredients

Pharmaceutical form:

OINTMENT

Composition:

EACH 100 g OINTMENT CONTAINS MUPIROCIN 2 g

Authorization status:

Registered

Authorization date:

1990-02-04

Patient Information leaflet

Page 1 of 4
PATIENT INFORMATION LEAFLET
BACTROBAN
® NASAL
SCHEDULING STATUS:
S2
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:
BACTROBAN
® NASAL Ointment
Mupirocin 2 % (_m/m)_
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
BACTROBAN NASAL is available without a doctor’s prescription, for
you to treat a mild
illness. Nevertheless you still need to use BACTROBAN NASAL carefully
to get the best
results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share BACTROBAN NASAL with any other person.
•
Ask your pharmacist if you need more information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
10 days.
WHAT BACTROBAN NASAL CONTAINS:
Each gram of BACTROBAN NASAL contains 20 mg of mupirocin.
The other ingredients are: Softisan 649 and White soft paraffin.
WHAT BACTROBAN NASAL IS USED FOR:
BACTROBAN NASAL is an antibiotic. It is used to reduce the amount of
some bacteria
in your nose.
Page 2 of 4
BEFORE YOU USE BACTROBAN NASAL:
Do not use BACTROBAN NASAL:
•
If you have previously had an allergic reaction to BACTROBAN NASAL, or
any of
its ingredients.
TAKE SPECIAL CARE WITH BACTROBAN NASAL:
BACTROBAN NASAL can cause skin irritation and allergic reactions (see
Possible Side
Effects).
Keep the ointment away from your eyes. If the ointment gets into your
eyes accidentally,
rinse your eyes thoroughly with water.
PREGNANCY AND BREASTFEEDING:
If you are pregnant or breastfeeding your baby, please consult your
doctor, pharmacist
or other health care professional for advice before using BACTROBAN
NASAL. Your
doctor will discuss with you the possible risks and benefits of using
BACTROBAN
NASAL during pregnancy.
TAKING OTHER MEDICINES WITH BACTROBAN NASAL:
Always tell your health care professional if you are taking any other
medicine. (This
includes complementary or traditional medicines).
HOW TO USE BACTROBAN NASAL:
Do not share medicines prescribed for you with any other person.
Always use BACTROBAN NASAL exactly as y

Summary of Product characteristics

1.3.1.1 Package insert_ _
Page 1 of 4
BACTROBAN
 NASAL
SCHEDULING STATUS:
S2
PROPRIETARY NAME AND DOSAGE FORM:
BACTROBAN
 NASAL Ointment
COMPOSITION:
BACTROBAN NASAL ointment is a preparation of 2 g mupirocin as
mupirocin calcium in
100 grams of base.
Excipients: Softisan 649 and White soft paraffin.
PHARMACOLOGICAL CLASSIFICATION:
A 20.1.6 Topical antibiotics
PHARMACOLOGICAL ACTION:
PHARMACODYNAMIC PROPERTIES:
Mupirocin is an antibiotic produced through fermentation of
_Pseudomonas fluorescens_
and inhibits bacterial protein synthesis by binding to bacterial
isoleucyl t-RNA
synthetase.
PHARMACOKINETIC PROPERTIES:
Mupirocin is suitable only for topical application. Following
intravenous or oral
administration, mupirocin is metabolised to inactive monic acid.
1.3.1.1 Package insert_ _
Page 2 of 4
INDICATIONS:
BACTROBAN NASAL ointment is indicated for the intranasal treatment of
colonisation of
the nasal passages by Staphylococcus strains including
methicillin-resistant
_Staphylococcus aureus_ strains.
CONTRA-INDICATIONS:
BACTROBAN NASAL should not be given to patients with a history of
hypersensitivity to
any of its constituents.
BACTROBAN NASAL formulation is not suitable for ophthalmic use.
WARNINGS AND SPECIAL PRECAUTIONS:
In cases of sensitisation reaction or severe local irritation
occurring with the use of
BACTROBAN NASAL, treatment should be discontinued, the product should
be wiped
off and appropriate alternative therapy for the infection instituted.
Prolonged and intermittent use may result in overgrowth of
non-susceptible _S. aureus_
organisms.
PREGNANCY AND LACTATION:
The safety during pregnancy and lactation has not been established.
DOSAGE AND DIRECTIONS FOR USE:
Apply a small quantity of BACTROBAN NASAL, about the size of a match
head
(approximately 30 mg of ointment) to each nostril twice a day for at
least 5 days.
Dosage should not exceed 10 days.
METHOD OF ADMINISTRATION:
Use a cotton tipped applicator.
After application, the nostrils should be closed by pressing the sides
of the nose togeth