Minims Proxymetacaine hydrochloride 0.5% w / v & Fluorescein sodium 0.25% w / v

1. Name Of The Medicinal Product

Minims Proxymetacaine Hydrochloride 0.5% w/v & Fluorescein sodium 0.25% w/v

Eye drops, Solution

2. Qualitative And Quantitative Composition

Clear, yellow solution containing 0.5% w/v proxymetacaine hydrochloride Ph.Eur. and 0.25% w/v fluorescein sodium Ph.Eur.

3. Pharmaceutical Form

Single-use, sterile eye drops.

4. Clinical Particulars

4.1 Therapeutic Indications

As a combined topical ocular anaesthetic and diagnostic stain. Uses include tonometry, removal of corneal foreign bodies and other corneal or conjunctival procedures of short duration.

4.2 Posology And Method Of Administration

Adults (including the elderly) and children:

Instil one or two drops into the conjunctival sac prior to the procedure.

Each Minims unit should be discarded after a single use to avoid risk of cross infection.

4.3 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.

4.4 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.

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.)

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

Safety for use in pregnancy and lactation has not been established, therefore, use only when considered essential by the doctor or eye specialist.

4.7 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.

4.8 Undesirable Effects

Transient mild stinging or blurring of vision may occur immediately following the use of this product.

Pupillary dilatation or cycloplegic effects have been observed infrequently with proxymetacaine 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.

ADRs are very rare(<1/10,000),including isolated reports for fluorescein sodium products.

Symptoms of allergic-type reactions and anaphylaxis have been reported following topical ophthalmic administration of Fluorescein sodium and may manifest as:

Eye disorders: allergic conjunctivitis, peri-orbital oedema

Immune system disorders: anaphylactic reaction

Skin and subcutaneous tissue disorders: urticaria, rash

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Proxymetacaine, in common with other local anaesthetics, reversibly blocks the initiation and conduction of nerve impulses by decreasing the permeability of the neuronal membrane to sodium ions.

The time to onset of effect, duration of effect and potency of proxymetacaine are similar to those of amethocaine.

Fluorescein does not stain a normal cornea but conjunctival abrasions are stained yellow or orange, corneal abrasions are stained a bright green and foreign bodies are surrounded by a green ring.

5.2 Pharmacokinetic Properties

Proxymetacaine is readily absorbed into the systemic circulation where, in common with other ester-type local anaesthetics, it is hydrolysed by plasma esterases. Proxymetacaine is also subject to hepatic metabolism.

Fluorescein will resist penetration of a normal cornea and most will therefore be carried with the tear film away from the conjunctival sac. The majority will be lost through the naso-lacrimal ducts and absorbed via the gastro-intestinal tract from where it is converted rapidly to glucuronide and excreted via the urine.

If fluorescein crosses the cornea it will enter the Bowman's membrane, stroma and possibly the anterior chamber. Aqueous flow and diffusion into the blood in the anterior area finally remove fluorescein from the eye and it is excreted unchanged in the urine.

5.3 Preclinical Safety Data

No adverse safety issues were identified during the development of this formulation. The ingredients are well established in clinical ophthalmology.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Purified water

Povidone K30

Hydrochloric acid

Sodium Hydroxide

6.2 Incompatibilities

None known.

6.3 Shelf Life

15 months.

6.4 Special Precautions For Storage

The product should be transported in the original packaging. It should be stored at 2 - 8°C and prevented from freezing.

If necessary, the product may be stored at temperatures not exceeding 25°C for up to 1 month only.

6.5 Nature And Contents Of Container

A sealed conical shaped polypropylene container fitted with a twist and pull-off cap. Each Minims unit contains approximately 0.5ml of solution. Each unit is overwrapped in a polyethylene sachet. 20 units are packed into a suitable carton.

6.6 Special Precautions For Disposal And Other Handling

Each Minims unit should be discarded after a single use.

Excess solution may be washed away with sterile saline solution.

If the product is to be stored unrefrigerated at temperatures not exceeding 25°C, , the adhesive label provided in the carton should be completed and affixed over the bar code, by a pharmacist prior to supply of the product by the pharmacy. An expiry date one month from the supply date, plus the pharmacist's initials, should be written in the spaces provided on this label.

7. Marketing Authorisation Holder

Chauvin Pharmaceuticals Ltd

106 London Road

Kingston-upon-Thames

Surrey

KT2 6TN

8. Marketing Authorisation Number(S)

PL 0033/0152

9. Date Of First Authorisation/Renewal Of The Authorisation

17 February 1997

10. Date Of Revision Of The Text

November 2010

11. LEGAL CATEGORY

POM