Contains: Proxymetacaine hydrochloride 0.5%w/v.
Main Indications, Dosage and Administration: To be used as a topical ocular anaesthetic. 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.
Contraindications, Precautions and Warnings: Do not use in patients with a known hypersensitivity to any component of the preparation. 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. This product should be used cautiously and sparingly in patients with known allergies, cardiac disease or hyperthyroidism because of the increased risk of sensitivity reactions. This product is not intended for long term use. 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. 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. Protection of the eye from rubbing, irritating chemicals and foreign bodies during the period of anaesthesia is very important. Patients should be advised to avoid touching the eye until the anaesthesia has worn off. Tonometers soaked in sterilising or detergent solutions should be thoroughly rinsed with sterile distilled water prior to use. Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following instillation of the drops. (This blocks the passage of the drops via the naso lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children). Use with caution in an inflamed eye as hyperaemia greatly increases the rates of systemic absorption through the conjunctiva.
Interactions: None stated.
Pregnancy and lactation: Safety for use in pregnancy and lactation has not been established, therefore, use only when considered essential by the physician.
Undesirable effects: May cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery unless vision is clear. Pupillary dilatation or cycloplegic effects have rarely been observed with Proxymetacaine hydrochloride preparations. Irritation of the conjunctiva or other toxic reactions have occurred only rarely. A severe, immediate-type apparently hyperallergic corneal reaction may rarely occur. This includes acute, intense and diffuse epithelial keratitis; a grey ground-glass appearance; sloughing of large areas of necrotic epithelium; corneal filaments and sometimes, iritis with descemetitis.
This Minims Product Requires Refrigerated Storage.
Legal Category: POM
UK PL No: PL 03468/0080 Basic NHS Price: £13.74
Marketing Authorisation Holder: Bausch & Lomb UK Limited, Bausch & Lomb House, 106 London Road, Kingston-Upon-Thames, Surrey, UK, KT2 6TN
Date of Revision: March 2023
Exemption Level: 1
Evocative Code: PROX 0.5
PIP Code: 236-8017
United Kingdom (UK)
