Proxymetacaine 0.5% Eye Drops (Minims Proxymetacaine)

VERBATIM UK SPC §4.2 (Minims Proxymetacaine Hydrochloride 0.5% w/v, Eye drops solution): 'Adults (including the elderly) and children: Deep anaesthesia: Instil 1 drop every 5 - 10 minutes for 5 - 7 applications. Removal of sutures: Instil 1 or 2 drops 2 to 3 minutes before removal of stitches. Removal of foreign bodies: Instil 1 or 2 drops prior to operating. Tonometry: Instil 1 or 2 drops immediately before measurement. Do not use if the solution is more than pale yellow in colour. Each Minims unit should be discarded after a single use. A period of at least one minute should be allowed after administration of Minims Proxymetacaine hydrochloride 0.5%, before subsequent administration of other topical agents.' SCOPE: this §4.2 is COMPLETE in the bundle (no truncation marker) and covers every licensed use of the product — all four procedure regimens above are quoted, so nothing licensed has been omitted. NO MAXIMUM DOSE is stated in §4.2, so maxDose is deliberately left unpopulated; the only ceiling the label gives is the '5 - 7 applications' limit inside the deep-anaesthesia regimen, which is stated in the dose text above and must not be applied to the single-instillation regimens. DO NOT USE IF the solution is more than pale yellow in colour. THIS PRODUCT IS NOT INTENDED FOR LONG TERM USE (§4.4): regular and prolonged use of topical ocular anaesthetics, e.g. in conjunction with contact lens insertion, may cause softening and erosion of the corneal epithelium, which could produce corneal opacification with accompanying loss of vision. MISCIBILITY: Minims Proxymetacaine hydrochloride is not miscible with fluorescein; fluorescein can be added to the eye after it has been anaesthetised with proxymetacaine. Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following instillation — the SPC notes this is especially advisable in children. Use with caution in an inflamed eye, as hyperaemia greatly increases the rate of systemic absorption through the conjunctiva. Tonometers soaked in sterilising or detergent solutions should be thoroughly rinsed with sterile distilled water prior to use. §4.5 Interactions: 'None stated.'

THIS IS THE LABEL'S OWN PAEDIATRIC WORDING, not a scaled adult figure — §4.2 gives one regimen for 'Adults (including the elderly) and children'. CONTRAINDICATED IN PREMATURE BABIES, verbatim §4.3: 'In view of the immaturity of the enzyme system which metabolises the ester type local anaesthetics in premature babies, this product should be avoided in these patients.' No dosePerKg or concentration is populated because this is a drop-count topical preparation and the label contains no per-kilogram figure — none has been invented. §4.4 specifically advises compressing the lacrimal sac at the medial canthus for a minute during and after instillation to reduce systemic absorption, noting 'It is especially advisable in children'. Protection of the eye from rubbing, irritating chemicals and foreign bodies during the period of anaesthesia is very important; children should be kept from touching the eye until the anaesthesia has worn off. Verify any paediatric use against a children's formulary.