Active substance(s): BACITRACIN ZINC / POLYMYXIN B SULFATE / BACITRACIN ZINC / POLYMYXIN B SULFATE / BACITRACIN ZINC / POLYMYXIN B SULFATE
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Polymyxin B Sulfate 10,000 IU
Bacitracin zinc 500 IU
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 allergic dermatitis.
Posology and method of administration
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.
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.
Special warnings and precautions for use
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 sulfate and bacitracin
zinc have nephrotoxic potential and polymixin B sulfate has neurotoxic
As with all antibacterial preparations prolonged use may result in the
overgrowth of non-susceptible organisms including fungi.
Interactions with other medicinal products and other forms of interaction
Following significant systemic absorption, polymyxin B can intensify and
prolong the respiratory depressant effects of neuromuscular blocking agents.
Pregnancy and lactation
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.
Effects on ability to drive and use machines
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.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
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
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.
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are
additional to that in other sections of the SmPC.
List of excipients
White soft paraffin, B.P.
Special precautions for storage
Store below 25°C.
Nature and content of container
Lacquered aluminium tubes with polyolefin screw caps.
Pack sizes: 4g, 20g, 90g
Instruction for use and handling
No special instructions.
MARKETING AUTHORISATION HOLDER
Pliva Pharma Ltd
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
22/04/2003 / 21/03/2005
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.