Prescribing Details
Description
Systop® is the preparation of Mupirocin which is a naturally occurring antibiotic, produced by fermentation of the organism Pseudomonas fluorescens. Mupirocin inhibits bacterial protein sysnthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase. Due to its unique mode of action it shows no cross resistance with other commonly used and clinically important antibiotics. It is active against a wide range of gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA). It is also active against certain gram-negative bacteria. Mupirocin is bactericidal at concentrations achieved by topical administration. However, the minimum bactericidal concentration (MBC) against relevant pathogens is generally eight-fold to thirty-fold higher than the minimum inhibitory concentration (MIC).
Uses
No Data
Indications
Systop® ointment is indicated for the topical treatment of secondarily infected traumatic skin lesions such as small lacerations, sutured wounds or abrasions and Systop® ointment is indicated for the topical treatment of mild impetigo due to susceptible strains of Staphylococcus aureus and Streptococcus pyogenes.
Dosage and administration
For Adults: A small amount of Systop® ointment should be applied to the affected area up to 3 times a day. The area treated may be covered with gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated. Usually treatment should not continue for more than 10 days.
For children (2 months to 16 years): Same as adult dose.
Use in pregnancy & lactation
Pregnancy Category B. Since there are no adequate and well-controlled studies in pregnant women and as animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mupirocin is administered to a nursing woman.
Precautions
Mupirocin ointment is for external use only. It is not for ophthalmic use, intranasal use or application to other mucosal surfaces. Avoid contact with eyes when Mupirocin is used on the face. Mupirocin is not suitable for application to the site of cannulation. If a reaction suggesting sensitivity or chemical irritation should occur with the use of Mupirocin, treatment should be discontinued and appropriate therapy for the infection instituted. As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.
Side effects
Side effects reported with the use of Mupirocin ointment are burning, stinging, pain, itching, rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudates. Systemic reactions to Mupirocin have occurred rarely.
Contraindications
Mupirocin is contraindicated in patients with a history of known hypersensitivity reactions to any of its components.
Drug interactions
No drug interactions have been studied with Mupirocin. This product should not be combined with other topical preparations as there is a risk of dilution, resulting in a reduction in the antibacterial activity and potential loss of stability of the Mupirocin.
Overdose
No Data
Preparation
No Data
Pharmaceutical precautions
Store in a cool and dry place protected from light.
Presentation
No Data
Package quantities
Systop® Ointment : Tube of 10 g.
® Registered Trade Mark
