QUAliTATIVE AND QUANTITATIVE COMPOSITION (active ingredient only) :
Mupirocin calcium eqUNalent to 2% wlw mu~rocin free acid.
PHARMACEUTICAL FORM :
white cream 0f homogeneous appearance.
CLINICAL PARTICULARS :
Therapeutic indications: Bactroban CREAM is indicated for the topical treatment 0f secondarily infected traumatic lesions such as small lacerations, Sutured wounds or abrasions (up to 10 cm in length or 100 cm> in area), due to susceptible
strains 0f Staphylococrus aureus and streptococcus pyogenes
Posology and method of administration
three times a day for up to 10 days, deperdi1g 0n the response. Patients not showing a clinical response within 3 to 5 days should be re evaluated.
The duration 0f treatment should not exceed 10 days
Heparic impairment No d0sage adjustment is necessary.
Renal impairment No d0sage adjustment is necessary.
Method of administration :
A thin layer 0f cream should be applied to the affeaed area with a piece 0f clean Cotton wool or gauze swab. The treated area may be Covered by a dressing. Do not mix with other preparations as there is a risk 0f dilution, resulting in a reduction in the antilacterial activity and potential loss of stability of the mupirocin in the cream.
Bactroban CREAM should not be given to patients with ahistay of hypersensitivity to any of its constituents
Special warnings and special precautions for use
For intranasal use, a separate presentation, Bactroban Nasal Ointment, is available.
Avoid contact with the eyes In the rare event of a possible sensitisation reaction or severe local mtation occurring v.ith the use of Bactroban CREAM, treatment should be discootinued, the product shoud be washed off and awopriate anemJtM> therapy for the infeaion instiMed. As v.ith othe< antibacterial productl, prolonged use may resun in overgn:r.Yth of norKUSCeptible organilms. Bactroban Cream has not been studied in infants under 1 yeare old and therefore it shoud not be used in these until hrther data bealme available.
Bactroban Cream contains cetly alcohol and steary alcohol These illil<tM! ingredieflt5 may cause local skin reaaions (e.g. cootact dermatitisl.
Interaction with other medicaments and other forms of interaction :
No <lug ilteraaions haw! been identified.
Pregnancy and lactation :
Use in pregnancy .
Adequate Iunan data on use during pregnancy are not avaliable, animal studies have not identified any risk to pregency or embryo foetal development Mupirocin shoud only be used in pregenancy when the poIfntiii benefits outweigh the potential risks associated with treatment.
Use in lactation:
Adequate human and animaI data on use during lactation are not available. if a cracked nipple is to be treated, it shoud be thoroughly washed prior to breast feeding
Effeds on ability to drive and use machines :
No adverse on the ability to drive or operate machinery haw! been identified.
Undesirable effects :
The following convention has been used for the classification of frequency common 1/100 and 1/10
skin and Subcutaneous tissue disorders:
Common: Cutaneous hypersensitivity reactions
The toxicity of mupirodn is very low in the event of accidental i1gestion of the cream symptomatic treatment shoud be given
PHARMACOlOGiCAl PROPERTIES :
Mupirocin is a novel antibiotic produced throogh fermentation by pseudomonas fluorescens mupirocin inhibits isoleucyl transfer·RNA synthetase, thereby arresting bacterial protein synthesis. due to this particular mode of action and its unique chemical structure, Mupirocin does not shaw any cross-resistance with other clinically available antibiotics.
Mupirocin has bacteriostatic properties at minimum inhibitory concentrations and bactericidal properties at the higler concentrations reached when applied locally
Mupirorin is a topical antibacterial agent showing in vivo activity against staphylococcus aureus (including methicillin resistant strains) 5. epidem1idis and beta-haemolytic streptococcusspedes. The in vitro spectrum of activity irdudes the following bacteria
– staphlococcus aureus (including beta lactamase producing strains and methicillin resistant strains)
– staphlococcus epidemidis (including beta lactamase producing and methicillin resistant strains)
– Other coagulase negative staphylococci (including methicillin resistant strains)
– streptococcus species
Aerobic Gram-negative :
– haemophilus influenzae
– neisserie gonorrhoeae
– moraxella catarrhalis
– Pasteurella multocida
Pharmacokintic properties :
Systemic absorption of Mupirocin through intact human skin is low although it may occur through broken diseased skin however clinical trials have shown that when given systemically it is metabolised to the microbiologically inactive metabolite monic acid and rapidIy excreted by the kidney.
Predinical safety data :
No further information of relevance.
Nature and contents of container :
squeezable aluminium tubes with ascrew cap containing 15 g.
Instructions for use/handling :
any product remaining at the end of treatment should be discarded.
manufactured by :
Glaxo operations UK limited’
‘Member of the GIaxosmithKline group of companies.