Bactroban 2% Nasal Ointment
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bactroban® 2% Nasal Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of nasal ointment contains 20 mg mupirocin.
3 PHARMACEUTICAL FORM
White soft paraffin ointment containing a glycerin ester.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The elimination of nasal carriage of staphylococci, including methicillin resistant Staphylococcus aureus (MRSA)
4.2 Posology and method of administration
Dosage: Adults (including the elderly/renally impaired/hepatically impaired) and children:
Apply a small quantity of Mupirocin nasal ointment, about the size of a match head (approximately 30 mg of ointment) to each nostril two to three times a day for at least 5 days.
Method of Administration:
Use a cotton tipped applicator. After application, the nostrils should be closed by pressing the sides of the nose together several times.
Nasal carriage should normally be clear within three to five days of treatment.
Dosage should not exceed ten days.
Do not mix with other preparations as there is a risk of dilution, resulting in a reduction in the antibacterial activity and potential loss of stability of the mupirocin in the ointment.
Contraindications
4.3
Hypersensitivity to mupirocin or any of the excipients (see section 6.1).
4.4 Special warnings and precautions for use
Should a possible sensitisation reaction or severe local irritation occur with the use of Bactroban Nasal Ointment, treatment should be discontinued, the product should be wiped away and appropriate therapy instituted.
As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms.
Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until the ointment residues have been removed.
4.5 Interaction with other medicinal products and other forms of interaction
No drug interactions have been identified.
4.6 Fertility, pregnancy and lactation
Fertility: There are no data on the effects of mupirocin on human fertility. Studies in rats showed no effects on fertility (see section 5.3).
Pregnancy: Reproduction studies on Bactroban in animals have revealed no evidence of harm to the foetus (see section 5.3). As there is no clinical experience on its use during pregnancy, Bactroban should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.
Breast-feeding: There is no information on the excretion of Bactroban in milk.
4.7 Effects on ability to drive and use machines
No adverse effects on the ability to drive or operate machinery have been identified.
4.8 Undesirable effects
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as : very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000), including isolated reports.
Uncommon adverse reactions were determined from pooled safety data from a clinical trial population of 422 treated patients encompassing 12 clinical studies.
Very rare adverse reactions were primarily determined from post-marketing experience data and therefore refer to reporting rate rather than true frequency.
Immune system disorders
Very rare: Cutaneous hypersensitivity reactions.
Respiratory, thoracic and mediastinal disorders Uncommon: Nasal mucosa reactions.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report andy suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
The toxicity of mupirocin is very low. In the event of accidental ingestion of the nasal ointment, symptomatic treatment should be given.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Dermatologicals
ATC code: D06AX09, Antibiotics and chemotherapeutics for dermatological use.
Mode of Action
Mupirocin is a novel antibiotic produced through fermentation by Pseudomonasfluorescens. Mupirocin inhibits isoleucyl transfer-RNA synthetase, thereby arresting bacterial protein synthesis.
Mupirocin has bacteriostatic properties at minimum inhibitory concentrations and bactericidal properties at the higher concentrations reached when applied locally.
Mechanism of Resistance
Low-level resistance in staphylococci is thought to result from point mutations within the usual staphylococcal chromosomal gene (ileS) for the target
isoleucyl tRNA synthetase enzyme. High-level resistance in staphylococci has been shown to be due to a distinct, plasmid encoded isoleucyl tRNA synthetase enzyme.
Intrinsic resistance in Gram negative organisms such as the Enterobacteriaceae could be due to poor penetration of the outer membrane of the Gram-negative bacterial cell wall.
Due to its particular mode of action, and its unique chemical structure, mupirocin does not show any cross-resistance with other clinically available antibiotics.
Microbiological Susceptibility
The prevalence of acquired resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infection is questionable.
Staphylococcus aureus*
Streptococcus pyogenes*
Streptococcus spp. (P-haemolytic, other than S. pyogenes)
Staphylococcus spp., coagulase negative Inherently resistant organisms
Corynebacterium spp. Micrococcus spp.
* Activity has been satisfactorily demonstrated in clinical studies
5.2 Pharmacokinetic properties
Studies have shown that following topical application of mupirocin there is very little systemic absorption of drug-related material. To mimic possible enhanced systemic penetration of mupirocin by application to damaged skin or a vascular site such as the mucous membrane, intravenous studies have been performed. Mupirocin was rapidly eliminated from the plasma by metabolism to monic acid, which in turn was excreted mainly in the urine.
5.3 Preclinical safety data
Pre-clinical effects were seen only at exposures which are extremely unlikely to cause concern for humans under normal conditions of clinical use. Mutagenicity studies revealed no risks to man.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
White soft paraffin and Softisan 649
6.2 Incompatibilities
None known
6.3 Shelf life
Bactroban Nasal Ointment has a shelf-life of three years.
6.4 Special precautions for storage
Store at room temperature (below 25°C)
6.5 Nature and contents of container
Lacquered aluminium tube fitted with a nozzle and screw cap - 3g ointment.
6.6 Special precautions for disposal
Any product remaining at the end of treatment should be discarded.
7 MARKETING AUTHORISATION HOLDER
Beecham Group plc
Great West Road, Brentford, Middlesex TW8 9GS Trading as:
GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex,
UB11 1BT Or
Beecham Research; Bencard; Bridge Pharmaceuticals; SmithKline & French Laboratories; SmithKline Beecham Pharmaceuticals, all at: Mundells
Welwyn Garden City Herts AL7 1EY
8 MARKETING AUTHORISATION NUMBER(S)
PL 00038/0347
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
7 March 1988 / 22 June 2005
10 DATE OF REVISION OF THE TEXT
27/01/2014