MINIMS PROXYMETACAINE Eye drops, solution Ref.[7055] Active ingredients: Proparacaine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Bausch & Lomb UK Limited, Bausch & Lomb House, 106 London Road, Kingston-Upon-Thames, Surrey, UK, KT2 6TN

Contraindications

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.

Special warnings and precautions for use

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.

Interaction with other medicinal products and other forms of interaction

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.

Effects on ability to drive and use machines

May cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery unless vision is clear.

Undesirable effects

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.

Incompatibilities

None known.

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