Polyfax Ointment

Polymyxin B Sulphate 10,000 IU

Bacitracin zinc 500 IU

Ointment

Topical antibacterial agent. Polyfax Ointment is indicated for the treatment of infected wounds, burns, skin grafts, ulcers, pyoderma, sycosis barbae, impetigo, and in secondarily infected skin lesions of scabies, pediculosis, tinea pedis and contact and allergice dermatitis.

ADULTS

Polyfax Ointment should be applied thinly over the affected area, which is best left exposed. Two or more applications a day may be necessary, depending on the severity of the condition.

CHILDREN

As for adults.

USE IN THE ELDERLY

No specific studies have been carried out in the elderly, however, it may be advisable to monitor renal function in these patients and if there is any impairment then caution should be exercised.

Hypersensitivity to bacitracin, Polymyxins or cross-sensitising substances.

The following statements take into account the possibility that the constituent drugs of Polyfax Ointment may be absorbed to a significant degree after topical application. However, the normal use of Polyfax is unlikely to present any risk of systemic toxicity unless the application were excessive e.g. more than 200 g per day in adults or proportionately less in children and in patients with compromised renal function.

Following significant systemic absorption polymyxin B sulphate and bacitracin zinc have nephrotoxic potential and polymixin B sulphate has neurotoxic potential.

As with all antibacterial preparations prolonged use may result in the overgrowth of non-susceptible organisms including fungi.

Following significant systemic absorption, polymyxin B can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents.

Due to lack of detailed information, the use of Polyfax Ointment during pregnancy and lactation cannot be recommended in circumstances where significant systemic absorption of the active ingredients may occur.

No information is available regarding the excretion of the active ingredients of their metabolites in human milk.

None known.

Allergic reactions following topical application of polymyxin B and bacitracin zinc have rarely been reported.

Anaphylactic reactions have been reported, as rare events, following topical application of zinc bacitracin.

In the unlikely event of significant systemic absorption of the active ingredients of Polyfax Ointment occurring, signs of neurotoxicity and nephrotoxicity may be noted. In such an event, the patient's general status and renal function should be monitored and blood levels of polymyxin B and zinc bacitracin determined.

Polymyxin and Bacitracin zinc are both bactericidal antibiotics. The former exerts its action by binding with the cellular membrane and the latter by inhibiting bacterial cell wall development.

Not applicable.

There are no preclinical data of relevance to the prescriber which are additional to that in other sections of the SmPC.

White soft paraffin, B.P.

None known.

5 years.

Store below 25C.

Lacquered aluminium tubes with polyolefin screw caps.

Pack sizes: 4g, 20g, 90g

No special instructions.

PLIVA Pharma Limited

Vision House

Bedford Road

Petersfield

Hampshire

GU32 3QB

PL 10622/0155

22 April 2003

April 2005