Proxymetacaine hydrochloride

SOURCE IDENTITY — EXACT MATCH. The fetched product is 'Minims Proxymetacaine Hydrochloride 0.5% w/v, Eye drops solution' (UK SPC via eMC, product 3745). || VERBATIM UK SPC 4.2: '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 anywhere in this bundle) and lists every licensed procedure regimen the product carries — all four are quoted above, so nothing licensed has been omitted. || WHY maxDose IS DELIBERATELY UNPOPULATED: 4.2 states no maximum dose. The only ceiling the label gives is the '5 - 7 applications' limit that belongs INSIDE the deep-anaesthesia regimen, which is stated in the dose text above; it is not a ceiling for the single-instillation procedures and must not be applied to them, so it has not been promoted to a page-level maximum. || NOT 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 (4.4): 'Minims Proxymetacaine hydrochloride is not miscible with fluorescein, however, fluorescein can be added to the eye after it has been anaesthetised with Minims Proxymetacaine hydrochloride.' || Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following instillation. 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, verbatim and in full: 'None stated.'

THIS IS THE LABEL'S OWN PAEDIATRIC WORDING, NOT A SCALED ADULT FIGURE — section 4.2 addresses 'Adults (including the elderly) and children' together in one regimen and gives no separate paediatric figure: tonometry 1 or 2 drops immediately before measurement; foreign-body removal 1 or 2 drops prior to operating; suture removal 1 or 2 drops 2 to 3 minutes before removal; deep anaesthesia 1 drop every 5 to 10 minutes for 5 to 7 applications. || ⚠️ 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.' || dosePerKg and concentration are deliberately left unpopulated: this is a drop-count topical preparation and the label contains no per-kilogram figure and no dosing concentration — neither has been invented. || 4.4 advises compressing the lacrimal sac at the medial canthus for a minute during and following instillation to reduce systemic absorption, noting 'It is especially advisable in children.' Protect the eye from rubbing, irritating chemicals and foreign bodies during the period of anaesthesia; children should be kept from touching the eye until the anaesthesia has worn off. Verify any paediatric use against a children's formulary.