BACTOPIC OINTMENT 2%
Pharmacotherapeutic group: Antibiotic and chemotherapeutic for dermatological use
Mode of action
Mupirocin is a novel antibiotic produced through fermentation by Pseudomonas fluorescens. 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.
After topical application of Bactopic ointment, mupirocin is only very minimally absorbed systemically and that which is absorbed is rapidly metabolised to the antimicrobially inactive metabolite, monic acid. Penetration of mupirocin into the deeper epidermal and dermal layers of the skin is enhanced in traumatised skin under occlusive dressings.
Bactopic is a topical antibacterial agent, active against those organisms responsible for the majority of skin infections, e.g. Staphylococcus aureus, including methicillin-resistant strains, other staphylococci, streptococci. It is also active against Gram-negative organisms such as Escherichia coli and Haemophilus influenzae. Bactopic ointment is used for skin infections, e.g. impetigo, folliculitis, furunculosis.
Hypersensitivity to the active substances or to any of the excipients. This Bactopic Ointment formulation is not suitable for ophthalmic or intranasal use.
Administration and dosage
Posology: Two or three times a day for up to ten days, depending on the response.
Method of administration
For topical administration
A small quantity of Bactopic ointment should be applied to cover the affected area. The treated area may be covered by a dressing.
Any product remaining at the end of treatment should be discarded .
Do not mix with other preparations as there is a risk of dilution, resulting in a reduction of the antibacterial activity and potential loss of stability of the mupirocin in the ointment.
- Burning localised to the area of application
- itching, erythema, stinging and dryness localized to the area of application.
Pregnancy and lactation
Pregnancy: Reproduction studies on mupirocin in animals have revealed no evidence of harm to the foetus. As there is no clinical experience on its use during pregnancy, Bactopic 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 mupirocin in milk. If cracked nipple is to be treated, it should be thoroughly washed prior to breast feeding.
There are no data on the effects of mupirocin on human fertility. Studies in rats showed no effects on fertility
Special warnings and precautions
Should a possible sensitisation reaction or severe local irritation occur with the use of Bactopic ointment, treatment should be discontinued, the product should be washed off and appropriate therapy instituted.
As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms.
Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. Although this is less likely to occur with topically applied mupirocin, if prolonged or significant diarrhea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.