Consumer medicine information

Minims Tetracaine (Amethocaine)

Tetracaine (amethocaine) hydrochloride

BRAND INFORMATION

Brand name

Minims Amethocaine Eye Drops

Active ingredient

Tetracaine (amethocaine) hydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Minims Tetracaine (Amethocaine).

SUMMARY CMI

Minims® Tetracaine (Amethocaine)

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Minims® Tetracaine (Amethocaine)?

Minims® Tetracaine (Amethocaine) contains the active ingredient tetracaine (amethocaine) hydrochloride. Minims® Tetracaine (Amethocaine) is used to numb or block the feeling of pain in your eye(s) during short-term medical procedures.

For more information, see Section 1. Why am I using Minims® Tetracaine (Amethocaine)? in the full CMI.

2. What should I know before I use Minims® Tetracaine (Amethocaine)?

Do not use if you are allergic to tetracaine (amethocaine), any other local anaesthetic or any of the ingredients listed at the end of this CMI. Do not use if you are being treated with a group of medicines called sulphonamides. Do not use in premature babies. Do not use this medicine continuously for a long period of time. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Minims® Tetracaine (Amethocaine)? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Minims® Tetracaine (Amethocaine) and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Minims® Tetracaine (Amethocaine)?

  • Your doctor will instill Minims® Tetracaine (Amethocaine) eye drops into your eye(s) before starting a procedure on your eye(s).
  • The usual dose is one drop instilled into the eye.
  • 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.

More instructions can be found in Section 4. How do I use Minims® Tetracaine (Amethocaine)? in the full CMI.

5. What should I know while using Minims® Tetracaine (Amethocaine)?

Things you should do
  • Protect your numb eye from dust particles, which could cause infections.
Things you should not do
  • Do not touch or rub your eye while your eye is numb.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how Minims® Tetracaine (Amethocaine) affects you.
  • Keep the patch that your doctor puts on your eye until normal feeling returns.
  • Do not drive or operate hazardous machinery until you regain clear vision.
Looking after your medicine
  • Your doctor will keep Minims® Tetracaine (Amethocaine) in a refrigerator (2-8°C). The eye drops should not be frozen or exposed to strong light.

For more information, see Section 5. What should I know while using Minims® Tetracaine (Amethocaine)? in the full CMI.

6. Are there any side effects?

All medicines can have side effects. If they do occur, they are usually minor and temporary. Do not be alarmed by this list. You may not experience any of them.

Less serious side effects include: stinging or burning sensation in the eye, blurred vision or decreased vision, watery eyes, pain, swelling, redness, itching, eye fatigue, sensitivity to light and the feeling of having something in the eye. Serious side effects that require urgent medical attention include: grey appearance of the cornea and symptoms of an allergic reaction.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Minims® Tetracaine (Amethocaine)

Active ingredient: Tetracaine (Amethocaine) hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Minims® Tetracaine (Amethocaine). You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Minims® Tetracaine (Amethocaine).

Where to find information in this leaflet:

1. Why am I using Minims® Tetracaine (Amethocaine)?
2. What should I know before I use Minims® Tetracaine (Amethocaine)?
3. What if I am taking other medicines?
4. How do I use Minims® Tetracaine (Amethocaine)?
5. What should I know while using Minims® Tetracaine (Amethocaine)?
6. Are there any side effects?
7. Product details

1. Why am I using Minims® Tetracaine (Amethocaine)?

Minims® Tetracaine (Amethocaine) contains the active ingredient tetracaine (amethocaine) hydrochloride. Minims® Tetracaine (Amethocaine) belongs to a class of medicines called local anaesthetics.

Minims® Tetracaine (Amethocaine) 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).

2. What should I know before I use Minims® Tetracaine (Amethocaine)?

Warnings

Do not use Minims® Tetracaine (Amethocaine) if:

  • You are allergic to tetracaine (amethocaine), any other local anaesthetic or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
  • You are being treated with a group of medicines called sulphonamides.

Check with your doctor if:

  • You have had an allergy to any other medicines, foods, preservatives or dyes.
  • You have any other medical conditions.
  • You take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

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

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Elderly

Minims® Tetracaine (Amethocaine) should be used with caution in the elderly.

Infants

Minims® Tetracaine (Amethocaine) should not be used in premature babies.

Long-term Use

Do not use Minims® Tetracaine (Amethocaine) continuously for a long period of time.

3. What if I am taking other medicines?

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

Some medicines and Minims® Tetracaine may interfere with each other. These medicines may be affected by Minims® Tetracaine (Amethocaine) or may affect how well it works. These include:

  • Special dyes that your doctor may use to stain your eyes for examination.
  • A group of medicines called sulphonamides.
  • A group of medicines called anticholinesterases.
  • A medicine called suxamethonium.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Minims® Tetracaine (Amethocaine).

4. How do I use Minims® Tetracaine (Amethocaine)?

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.

How much to use

  • The usual dose is one drop into your eye(s) before starting a 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.

How to use Minims® Tetracaine (Amethocaine)

  • Your doctor will put the correct number of drops of Minims® Tetracaine (Amethocaine) into your eye(s) before starting a procedure on your eye(s).
  • 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.
  • In children, the doctor may compress the small part of the child's eye near the corner of his/her nose for a minute during and following the instillation of the drops.

If you use too much Minims® Tetracaine (Amethocaine)

Minims® Tetracaine (Amethocaine) can damage the surface of the eye or cause vision loss if it is used too much or too often, especially if your eye is already damaged.

The doctor giving you Minims® Tetracaine (Amethocaine) 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 at least 15 minutes (if you are wearing contact lenses, remove them before the rinse).
  • 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 (amethocaine).

If you think that you or anyone else may have swallowed any or all of the contents of the container of Minims® Tetracaine (Amethocaine), you should immediately:

  • phone the Poisons Information Centre
    (in Australia, call 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Minims® Tetracaine (Amethocaine)?

Things you should do

  • Protect your numb eye from dust particles, which could cause infections.

Things you should not do

  • Do not touch or rub your eye while your eye is numb.
    Your eye(s) may remain numb for up to one hour after the last drop is put in.
    Your doctor will put a patch over your eye after finishing the procedure to protect your eye from dust and bacterial contamination and stop you from touching it, scratching the surface of the eye and damaging it.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Minims® Tetracaine (Amethocaine) affects you.

Keep the patch that your doctor puts on your eye until normal feeling returns. Do not drive or operate hazardous machinery until you regain clear vision.

Looking after your medicine

Your doctor will keep Minims® Tetracaine (Amethocaine) in a refrigerator (2-8°C). The eye drops should not be frozen or exposed to strong light.

When to discard your medicine

Your doctor will discard each single dose unit and any remaining solution in it immediately after use. He/she will not save unused contents.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
Eyes:
  • Stinging or burning sensation (that may last for up to 30 seconds after instillation of the drops)
  • Blurred vision or decreased vision
  • Watery eyes
  • Pain
  • Swelling
  • Redness
  • Itching
  • Eye fatigue
  • Sensitivity to light
  • Feeling of having something in the eye
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Eyes:

Grey appearance of the cornea (the clear and shiny part at the front of your eye)

Symptoms of an allergic reaction, such as:
  • 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
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects online (in Australia, go to www.tga.gov.au/reporting-problems).By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

What Minims® Tetracaine (Amethocaine) contains

Active ingredient
(main ingredient)		tetracaine (amethocaine) hydrochloride (0.5% or 1% w/v)
Other ingredients
(inactive ingredients)
  • Purified water
  • Hydrochloric acid

Do not take this medicine if you are allergic to any of these ingredients.

The eye drops do not contain any preservatives.

What Minims® Tetracaine (Amethocaine) looks like

Minims® Tetracaine (Amethocaine) comes in single-dose units (tubes) containing 0.5 mL of a clear, colourless solution. Each tube is wrapped in a polyester/paper blister. The blisters are packed in cartons of 20 units.

Minims® Tetracaine (Amethocaine) is available in two strengths: 0.5% w/v (AUST R 32252) and 1% w/v (AUST R 32254).

Who distributes Minims® Tetracaine (Amethocaine)

In Australia, Minims® Tetracaine (Amethocaine) is supplied by:

Bausch & Lomb (Australia) Pty Ltd
Level 2, 12 Help Street
Chatswood, NSW 2067
Phone: 1800 251 150

This leaflet was prepared in January 2025.

Published by MIMS February 2025

BRAND INFORMATION

Brand name

Minims Amethocaine Eye Drops

Active ingredient

Tetracaine (amethocaine) hydrochloride

Schedule

S4

 

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.

CAS number.

136-47-0.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes