Polyfax Ophthalmic Ointment
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Polyfax Ophthalmic Ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
10,000 IU Polymyxin B Sulphate EP per gram of ointment 500 IU Bacitracin Zinc EP per gram of ointment
3. PHARMACEUTICAL FORM
Ointment
4. Clinical Particulars
4.1 Therapeutic indications
Polyfax Ophthalmic Ointment is indicated for the treatment of bacterial infections of the eye and its adnexa, including conjunctivitis, keratitis, corneal ulceration and ulcerative blepharitis.
Polyfax Ophthalmic Ointment may be applied both pre- and post-operatively to prevent ocular infection following surgical procedures, including the removal of foreign bodies from the eye.
The use of Polyfax does not exclude concomitant systemic therapy or other forms of local therapy where appropriate.
4.2 Posology and method of administration
ADULTS
A thin film of ointment should be applied to the affected part or inside of the lower eyelid two or more times a day depending on the severity of the condition.
Treatment should be continued until at least two days after the eye has apparently recovered.
CHILDREN
As for adults.
USE IN THE ELDERLY
No special comment.
4.3 Contraindications
Hypersensitivity to bacitracin, Polymixin B Sulphate or cross-sensitising substances.
4.4 Special warnings and precautions for use
Following significant systemic absorption polymixin 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.
4.5 Interactions with other medicinal products and other forms of interaction
Following significant systemic absorption, polymixin B sulphate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents.
4.6 Pregnancy and lactation
Polyfax has been used for several years without any untoward effect in pregnancy. The clinical benefit of the treatment to the patient must be balanced against any possible but unknown hazards to the developing foetus. No information is available regarding the excretion of the active ingredients or their metabolites in human milk.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Allergic reactions following topical (dermatological) application of polymyxin B and bacitracin zinc is rare but has been reported.
As with other antibacterial preparations, prolonged use may result in the overgrowth of non-susceptible organisms, including fungi.
4.9 Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Polymyxin B sulphate 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.
It has been shown in animal studies that both Polymyxin B Sulphate and Bacitracin zinc may be absorbed into the aqueous humour following topical application to the eye, especially in circumstances where the cornea is either abraded or inflamed.
In vitro activity: Gram positive: Species of staphylococcus; streptococcus, including
S. Pyogenes (B haemolytic streptococcus) and S. Pneumoniae (Pneumococcus); and corynebacterium.
Gram negative: Species of pseudomonas (including P. Aeruginosa), haemophilus, klebsiella, enterobacter, escherichia and neisseria.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that in other sections of the SmPC.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
White Petrolatum USP.
6.2 Incompatibilities
None known.
6.3 Shelf life
5 years.
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
Pack size 4g
Lacquered ophthalmic ointment tubes with polyolefin screw caps.
6.6 Instructions for use and handling
No special instructions.
MARKETING AUTHORISATION HOLDER
7
Pliva Pharma Ltd Ridings Point Whistler Drive Castleford West Yorkshire WF10 5HX UK
8. MARKETING AUTHORISATION NUMBER
PL 10622/0156
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22 04/2003 / 21/03/2005
10 DATE OF REVISION OF THE TEXT
03/05/2011