INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo BACTROBAN NASAL (ointment)
SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

BACTROBAN NASAL (ointment)

COMPOSITION:
Bactroban Nasal ointment is a preparation of 2g mupirocin as mupirocin calcium in 100 g of base.

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.6 Topical Antibiotics.

PHARMACOLOGICAL ACTION:
Mupirocin is an antibiotic that inhibits bacterial protein synthesis by binding to bacterial isoleucyl t-RNA synthetase.

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:
Hypersensitivity to any of the constituents of Bactroban Nasal ointment.
Bactroban Nasal ointment is not suitable for ophthalmic use.

DOSAGE AND DIRECTIONS FOR USE:
Adults and Children: Bactroban Nasal ointment should be applied to the anterior nares twice daily for 5 days as follows: Place about a match head size quantity of ointment on the small finger or swab and apply it to the inside of each nostril. Squeeze the nostrils closed from each side to spread the ointment throughout the nares.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Bactroban Nasal ointment has a low potential for sensitisation. Adverse effects localised to the area of application such as burning, stinging and itching have been reported.
Safety during pregnancy has not been established.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects.

IDENTIFICATION:
Bactroban Nasal ointment is a white ointment packed in tubes.

PRESENTATION:
Bactroban Nasal ointment is available in 3 g tubes.

STORAGE INSTRUCTIONS:
Store below 25°C. It is recommended that any ointment remaining at the end of treatment is discarded. Keep out of reach of children.

REGISTRATION NUMBER:
W/20.1.6/218

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Beecham Pharmaceuticals (Pty) Ltd.
6 Carey Street, Wynberg Ext. 6, Johannesburg 2090.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
12.03.1991

Bactroban and the BRL logo are trademarks.
P1627

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