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Drug Details

BACTROBAN CREAM

• Drug Class Description
  Broad-spectrum antibiotics.
• Generic Name
  Mupirocin
• Presentation
  Cream. Bactroban Cream is presented as a white cream of homogeneous appearance.
• Description
  1g Cream contains: 21.5mg Mupirocin calcium equivalent to 20.0mg mupirocin.
• Indications
  Bactroban Cream is indicated for the topical treatment of secondarily infected traumatic lesions such as small lacerations, sutured wounds or abrasions (up to 10cm in length or 100cm2 in area), due to susceptible strains of Staphylococcus aureus and Streptococcus pyogenes.
• Adult Dosage
  

  Three times a day for up to 10 days, depending on the response.

  Patients not showing a clinical response within 3 to 5 days should be re-evaluated.

  The duration of treatment should not exceed 10 days.

  Hepatic impairment: No dosage adjustment is necessary.

  Renal impairment: No dosage adjustment is necessary.

  Method of administration

  A thin layer of cream should be applied to the affected area with a piece of 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 of dilution, resulting in a reduction in the antibacterial activity and potential loss of stability of the mupirocin in the cream.

• Child Dosage
  Under 1 year, not recommended; over 1 year, as for adults.
• Contra Indications
  History of hypersensitivity to mupirocin or any of the excipients.
• Special Precautions
  

  Avoid contact with the eyes.

  Should a possible sensitisation reaction or severe local irritation occur with the use of Bactroban Cream, treatment should be discontinued, the product should be washed off and appropriate alternative therapy for the infection instituted.

  As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms.

  Bactroban Cream has not been studied in infants under 1 year old and therefore it should not be used in these patients until further data become available.

  Bactroban Cream contains cetyl alcohol and stearyl alcohol. These inactive ingredients may cause local skin reactions (e.g. contact dermatitis).

• Interactions
  No drug interactions have been identified.
• Adverse Drug Reactions
  

  Data from clinical trials was used to determine the frequency of very common to rare undesirable effects.

  The following convention has been used for the classification of frequency:-

  very common >1/10, common >1/100 and <1/10 , uncommon >1/1000 and <1/100, rare >1/10,000 and <1/1000 , very rare <1/10,000.

  Skin and subcutaneous tissue disorders:

  Common: Application site hypersensitivity reactions including urticaria, pruritus, erythema, burning sensation, contact dermatitis, rash

  Skin dryness and erythema have been reported in irritancy studies in volunteers.