Consumer medicine information

Minims Amethocaine (Tetracaine) Eye Drops

Tetracaine (amethocaine) hydrochloride

BRAND INFORMATION

Brand name

Minims Amethocaine Eye Drops

Active ingredient

Tetracaine (amethocaine) hydrochloride

Schedule

What is in this leaflet

This leaflet answers some common questions about Minims Amethocaine Eye Drops.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of your using Minims Amethocaine Eye Drops against the benefits they expect it will have for you.

If you have any concerns about this medicine, ask your doctor.

Keep this leaflet in a safe place. You may need to read it again.

What Minims Amethocaine Eye Drops is used for

Minims Amethocaine Eye Drops belongs to a group of medicines called local anaesthetics.

It is used to numb or block the feeling of pain in your eye(s) during short term medical procedures. These procedures may include, measuring the pressure in your eye, inserting contact lenses, removing foreign bodies from your eye(s) and other minor operations on your eye(s).

Ask your doctor if you have any questions about why this medicine has been prescribed to you. Your doctor may have prescribed it for another reason.

Before you are given Minims Amethocaine Eye Drops

When you must not be given it

Do not use Minims Amethocaine Eye Drops if you have an allergy to:

Any medicine containing tetracaine
Any other local anaesthetic
Any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

Shortness of breath
Wheezing or difficulty breathing
Swelling of the face, lips, tongue or other parts of the body
Rash, itching or hives on the skin

Do not use this medicine if you are being treated with a group of medicines called sulphonamides.

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

This medicine has been developed for use in the eye only. It should not be swallowed or injected.

This medicine should not be given to premature babies.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have had an allergy to any other medicines, foods, preservatives or dyes.

Tell your doctor if you are pregnant or breast-feeding. Your doctor will discuss the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start using Minims Amethocaine Eye Drops.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Minims Amethocaine Eye Drops may interfere with each other. These include a group of medicines called sulphonamides.

These medicines may be affected by Minims Amethocaine Eye Drops or may affect how well it works. You may need different amounts of your medicines, or you may need to use different medicines.

Your doctor will advise you and decide whether or not to give you Minims Amethocaine Eye Drops.

How Minims Amethocaine Eye Drops is given

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

How much to use

Your doctor will put the correct number of drops of Minims Amethocaine Eye Drops into your eye(s) before starting the procedure on your eye(s). Your doctor will not give you a prescription for your own use. This medicine has been specifically developed for use by your doctor to numb the feeling in your eye(s) while he/she is attending to your eye(s), and not for long-term use.

The usual dose is one drop into your eye(s) before starting the procedure on your eye(s). The number of times your doctor will put drops in your eye(s) will depend on the type and length of the procedure to be performed.

Local anaesthetic drops can damage the surface of the eye if they are used too much or too often.

If you are wearing contact lenses, you will be asked to remove them before putting in the eye drops. You may put your contact lenses back into your eye after the numbness has worn off or when you doctor tells you to.

Your eye(s) may remain numb for up to one hour after the last drop is put in.

Do not touch or rub your eye while your eye is numb. You may scratch the surface of the eye and damage it. Your doctor will put a patch over your eye after finishing the procedure to protect your eye and stop you from touching it.

If you use too much (overdose)

The doctor giving you Minims Amethocaine Eye Drops will be experienced in its use, so it is unlikely that you will be given an overdose.

If too many drops have accidentally been put into your eye(s), immediately rinse your eye(s) with plenty of warm water or saline and continue rinsing for 15 minutes. A further examination should be performed if irritation, pain or swelling continue beyond 15 minutes.

Accidental swallowing of the solution is unlikely to cause any bad side effects due to the low content of tetracaine. If you think that you or anyone else may have swallowed any or all of the contents of the container of Minims Amethocaine Eye Drops, immediately telephone your doctor or Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) for advice.

After being given Minims Amethocaine Eye Drops

Things you must do

Protect your eyes from dust. You should protect your anesthetised eye from dust particles, which could cause infections.

Things you must not do

Things to be careful of

Be careful driving or operating machinery until you know how Minims Amethocaine Eye Drops affects you.

Keep the patch that your doctor puts on your eye until normal feeling returns. Sufficient time should be allowed to regain clear vision before driving or operating hazardous machinery.

Side effects

Tell your doctor or pharmacist if you do not feel well while you are using Minims Amethocaine Eye Drops.

This medicine helps most people to numb the eye, but it may have unwanted effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

Stinging or burning sensation.
Prolonged blurred vision, watery eyes.

The above list includes the more common side effects of your medicine. They are usually mild and short lived.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

After using Minims Amethocaine Eye Drops

Storage

Minims Amethocaine Eye Drops will be stored by your doctor in a refrigerator (2-8°C). The eye drops should not be frozen or exposed to strong light.

Discard each single dose unit and any remaining solution in it immediately after use. Do not save unused contents.

Product description

What it looks like

Minims Amethocaine Eye Drops come in single dose units containing 0.5mL of a clear, colourless solution.

Each carton contains 20 single dose units.

Ingredients

Minims Amethocaine Eye Drops contains 0.5%w/v or 1.0%w/v of tetracaine (amethocaine) hydrochloride as the active ingredient.

They also contain:

Water - Purified

Hydrochloric acid

The eye drops do not contain any preservatives.

Manufacturer/Supplier

In Australia, Minims Amethocaine Eye Drops is supplied by:

Bausch & Lomb (Australia) Pty Ltd
Chatswood, NSW 2067
Phone: 1800 251 150

Minims Amethocaine Eye Drops 0.5%
AUST R 32252

Minims Amethocaine Eye Drops 1%
AUST R 32254

In New Zealand, Minims Amethocaine Eye Drops is supplied by:

Bausch & Lomb (NZ) Ltd
c/- Bell Gully
Auckland Vero Centre
48 Shortland Street
Auckland 1140
New Zealand
Toll free number: 0508375394

Date of preparation

This leaflet was prepared in April 2020.

Published by MIMS June 2020

BRAND INFORMATION

Brand name

Minims Amethocaine Eye Drops

Active ingredient

Tetracaine (amethocaine) hydrochloride

Schedule

1 Name of Medicine

Tetracaine (amethocaine) hydrochloride.

2 Qualitative and Quantitative Composition

Minims Amethocaine Eye Drops contain tetracaine hydrochloride 0.5% or 1% w/v. No preservatives are contained in the formulation.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

A single-use eye drops, solution.
Minims Amethocaine Eye Drops are clear, colourless sterile eye drops reasonably free from visible particulate matter. No preservatives are contained in the formulation.

4 Clinical Particulars

4.1 Therapeutic Indications

Minims Amethocaine Eye Drops are indicated to produce local anaesthesia in the eye.

4.2 Dose and Method of Administration

Adults and children.

One drop as required.
Further drops may be needed to achieve a complete anaesthetic effect; if this is required, instillation must be strictly as recommended and supervised by the treating physician.
Normal corneal sensitivity can be expected after approximately 1 hour. Although unlikely, due to the small volume in each unit dose, systemic absorption of local anaesthetics is rapid from mucosal membranes (see Section 4.9 Overdose). Systemic absorption of tetracaine may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the nasolacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)
Each Minims Amethocaine Eye Drop unit should be discarded after a single use.

4.3 Contraindications

Minims Amethocaine Eye Drops are contraindicated in patients with hypersensitivity to any of the components of the preparation.
Tetracaine is hydrolysed in the body to p-amino benzoic acid and should therefore not be used in patients being treated with sulphonamides.
In view of the immaturity of the enzyme system that metabolises the ester type of local anaesthetics in premature babies, tetracaine should be avoided in these patients.
Chronic use of local anaesthetic drops to the eye is contraindicated as repeated instillations have been associated with corneal damage; see Section 4.4 Special Warnings and Precautions for Use.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Minims Amethocaine Eye Drops are for topical ophthalmic application only. The solution should not be injected.
The cornea may be damaged by prolonged or frequent application of anaesthetic eye drops. Prolonged use of topical ophthalmic local anaesthetics has been associated with severe keratitis and permanent corneal opacification and scarring with accompanying reduction of visual acuity or visual loss. To avoid corneal damage, do not exceed the recommended dosage, especially in patients with compromised corneas.
Patients should be warned not to rub or touch the eye while anaesthesia persists.
The anaesthetised eye should be protected from dust and bacterial contamination.
Tetracaine may give rise to allergic reaction in hypersensitive patients.
On instillation an initial burning sensation may be experienced. This may last for up to 30 seconds.
Systemic toxicity typical of local anaesthetics could occur if sufficient amounts were absorbed systemically (see Section 4.9 Overdose). Systemic absorption of tetracaine may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the nasolacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)

Use in the elderly.

Tetracaine should be used with caution in the elderly, as this group is more susceptible to the effects of local anaesthetics.

Paediatric use.

Tetracaine should be used with caution in children, as this group is more susceptible to the effects of local anaesthetics.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Tetracaine is metabolised to p-amino benzoic acid and can antagonise the actions of sulphonamides (see Section 4.3 Contraindications).
Metabolism of local anaesthetics derived from esters may be inhibited by anticholinesterases and thus prolong the effects of tetracaine. Ester type local anaesthetics may competitively enhance the neuromuscular blocking action of suxamethonium. Avoid tetracaine use until after topical staining.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Studies have not been performed in either animals or humans to evaluate the potential for impairment of fertility with tetracaine.
(Category B2)
Safety for use in pregnancy has not been established, therefore, Minims Amethocaine Eye Drops should be used only when considered essential.
It is not known whether tetracaine and/or its metabolites are excreted in milk. Safety for use in lactation has not been established, therefore, Minims Amethocaine Eye Drops should be used only when considered essential.

4.7 Effects on Ability to Drive and Use Machines

The eye must be protected until normal sensation has returned, and patients should be warned not to drive or use machines with impaired vision.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.
Local burning and stinging sensation upon instillation. Other adverse reactions, such as blurred vision, keratitis, hyperaemia, lacrimation and allergic conjunctivitis, have been reported.
Superficial punctate keratitis (SPK) may occur due to ineffective tearing.
Severe keratitis (such as diffuse SPK, corneal edema) is uncommon but could occur in an estimated 1/1000 patients. Symptoms may include: grey appearance of cornea, development of folds in Descemet's membrane, hyperaemic conjunctiva, blurred vision, photophobia, lacrimation, ocular pain.
Reactions including toxic epitheliopathy (after frequent short-term application or prolonged application) and contact dermatitis theoretically could occur.

4.9 Overdose

Due to the small volume of each Minims Amethocaine Eye Drop unit, overdose is not expected. However, local anaesthetics are absorbed rapidly from mucosal surfaces and the gastrointestinal tract and systemic toxicities typical of local anaesthetics (CNS, cardiovascular, respiratory) could be expected, though this is rare.
For decontamination after eye exposure the advice is to remove contact lenses and irrigate exposed eyes with copious amounts of room temperature 0.9% saline or water for at least 15 minutes. If irritation, pain, swelling, lacrimation or photophobia persist after 15 minutes of irrigation, an ophthalmologic examination should be performed.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Tetracaine hydrochloride is a local anaesthetic, which acts by reversibly blocking the propagation and conduction of nerve impulses along nerve axons. Tetracaine stabilises the nerve membrane, preventing the increase in sodium permeability necessary for the production of an action potential.
Onset of anaesthesia after instillation into the eye is 10 to 20 seconds, and duration of anaesthesia is 10 to 20 minutes. It has been reported, however, that the 1% solution produces anaesthesia lasting nearly an hour.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Tetracaine is a weak base (pKa 8.5), therefore, significant changes in the rate of ionised lipid soluble drug uptake may occur with changes in the acid base balance.
In vitro studies have shown that tetracaine has a high affinity for melanin, therefore, differences in duration of action may be expected between deeply pigmented eyes and less pigmented eyes.

Metabolism.

The primary site of metabolism for tetracaine is the plasma.

Excretion.

Tetracaine is hydrolysed by plasma esterases (pseudocholinesterases) to para-amino benzoic acid and other metabolites and is excreted mainly by the kidneys. Unmetabolised drug is excreted in the urine.

5.3 Preclinical Safety Data

Genotoxicity.

Tetracaine was not mutagenic in bacteria in limited studies. No studies to investigate the clastogenic potential of the drug have been performed.

Carcinogenicity.

Studies have not been performed in either animals or humans to evaluate the carcinogenic potential of tetracaine.

6 Pharmaceutical Particulars

6.1 List of Excipients

Hydrochloric acid and purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store at 2°C to 8°C. (Refrigerate. Do not freeze.). Protect from light.

6.5 Nature and Contents of Container

Minims Amethocaine Eye Drops are supplied in a single use polypropylene tube (unit) overwrapped in a polyester/paper blister. The blisters are packed in cartons of 20 units. Each unit contains approximately 0.5 mL of solution.
Minims Amethocaine Eye Drops are available in two strengths 0.5% (5 mg/mL) and 1% (10 mg/mL).

6.6 Special Precautions for Disposal

Each Minims unit should be discarded after a single use.
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

Chemical name: 2-(dimethylamino)ethyl 4-(butylamino)benzoate hydrochloride.
Molecular formula: C₁₅H₂₄N₂O₂.HCl.
Molecular weight: 300.8.

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Minims Amethocaine (Tetracaine) Eye Drops

Tetracaine (amethocaine) hydrochloride

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