Consumer medicine information

Minims Oxybuprocaine

Oxybuprocaine hydrochloride

BRAND INFORMATION

Brand name

Minims Oxybuprocaine Hydrochloride Eye Drops

Active ingredient

Oxybuprocaine hydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Minims Oxybuprocaine.

SUMMARY CMI

Minims® Oxybuprocaine

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® Oxybuprocaine?

Minims® Oxybuprocaine contains the active ingredient oxybuprocaine hydrochloride. Minims® Oxybuprocaine 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).

For more information, see Section 1. Why am I using Minims® Oxybuprocaine? in the full CMI.

2. What should I know before I use Minims® Oxybuprocaine?

Do not use if you are allergic to oxybuprocaine, any other local anaesthetic or any of the ingredients listed at the end of this CMI. Do not use if you have an infection in your eye. Talk to your doctor if you have any other medical conditions or take any other medicines.

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

3. What if I am taking other medicines?

Some medicines may interfere with Minims® Oxybuprocaine 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® Oxybuprocaine?

  • Your doctor will instill Minims® Oxybuprocaine 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® Oxybuprocaine? in the full CMI.

5. What should I know while using Minims® Oxybuprocaine?

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® Oxybuprocaine 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® Oxybuprocaine 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® Oxybuprocaine? 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.

Common side effects include: stinging or burning sensation in the eye. Serious side effects that require urgent medical attention include: ring-like structure in the outer part of the cornea, cardiovascular and central nervous system symptoms 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® Oxybuprocaine

Active ingredient: Oxybuprocaine hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Minims® Oxybuprocaine. 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® Oxybuprocaine.

Where to find information in this leaflet:

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

1. Why am I using Minims® Oxybuprocaine?

Minims® Oxybuprocaine contains the active ingredient oxybuprocaine hydrochloride. Minims® Oxybuprocaine belongs to a class of medicines called local anaesthetics.

Minims® Oxybuprocaine 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® Oxybuprocaine?

Warnings

Do not use Minims® Oxybuprocaine if:

  • You are allergic to oxybuprocaine, 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 have an infection in your eye.

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.

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® Oxybuprocaine may interfere with each other. These medicines may be affected by Minims® Oxybuprocaine or may affect how well it works. These include:

  • 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® Oxybuprocaine.

4. How do I use Minims® Oxybuprocaine?

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).
  • For most procedures one or two drops will be sufficient. For the removal of foreign bodies or minor surgery, three to six drops may be required.
  • 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® Oxybuprocaine

  • Your doctor will put the correct number of drops of Minims® Oxybuprocaine 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® Oxybuprocaine

Minims® Oxybuprocaine can damage the surface of the eye or cause tolerance (when your body becomes less responsive to the effects of a medicine over time, requiring higher doses to achieve the same effect) if it is used too often.

The doctor giving you Minims® Oxybuprocaine 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 warm water (if you are wearing contact lenses, remove them before the rinse).

Accidental swallowing of the solution is unlikely to cause any bad side effects due to the low content of oxybuprocaine.

If you think that you or anyone else may have swallowed any or all of the contents of the container of Minims® Oxybuprocaine, 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® Oxybuprocaine?

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® Oxybuprocaine 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® Oxybuprocaine 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
  • Blurred vision and/or problems seeing clearly
  • Local irritation or feeling of having something in the eye
  • Redness
  • Itching
  • Swelling
  • Dry eye
Skin:
  • Rash
Gastrointestinal symptoms, such as:
  • Nausea and vomiting
  • Difficulty swallowing food, liquids or saliva
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:
  • Ring-like structure in the outer part of the cornea
Cardiovascular symptoms, such as:
  • Slow heartbeat
Central nervous system symptoms, such as:
  • Drowsiness
  • Confusion or disorientation
  • Agitation or feeling of extreme happiness
  • Visual, hearing or speech disorders
  • Tingling sensation in the skin
  • Muscle twitching
  • Seizure
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® Oxybuprocaine contains

Active ingredient
(main ingredient)		oxybuprocaine hydrochloride (0.4% 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® Oxybuprocaine looks like

Minims® Oxybuprocaine 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 (AUST R 32259).

Who distributes Minims® Oxybuprocaine

In Australia, Minims® Oxybuprocaine 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 Oxybuprocaine Hydrochloride Eye Drops

Active ingredient

Oxybuprocaine hydrochloride

Schedule

S4

 

1 Name of Medicine

Oxybuprocaine hydrochloride.

2 Qualitative and Quantitative Composition

Minims Oxybuprocaine Hydrochloride Eye Drops contain oxybuprocaine hydrochloride 0.4% (4 mg/mL). No preservatives are included 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 Oxybuprocaine Hydrochloride Eye Drops are clear, colourless sterile ophthalmic solution. No preservatives are included in the formulation.

4 Clinical Particulars

4.1 Therapeutic Indications

To produce local anaesthesia in the eye for short ophthalmological procedures.

4.2 Dose and Method of Administration

All patients.

One drop of 0.4% oxybuprocaine solution instilled into each eye has been shown sufficient for tonometry after one minute. Addition of a further drop after 90 seconds provides adequate anaesthesia for fitting of a contact lens. To obtain a deeper anaesthetic effect, further drops may be instilled at intervals of no less than 90 seconds. For most procedures one to two drops is sufficient, however for removal of foreign bodies or minor surgery, three to six drops is suggested.
One drop a minute for 10 minutes was shown to provide adequate anaesthesia for patients undergoing pterygium surgery.
One drop instilled in each eye of a 0.2% oxybuprocaine solution prior to tonometry, was shown to be sufficient in patients over 40 years, suggesting that older patients may achieve sufficient anaesthetic effect with a lower dose of drug.
Corneal sensitivity is normal again after about 1 hour.
Each Minims unit should be discarded after a single use.

4.3 Contraindications

Known hypersensitivity to anaesthetics in this group.
Concomitant infection of the eye.
Patient instillation of drug. To be given only by a clinician.

4.4 Special Warnings and Precautions for Use

Identified precautions.

The anaesthetized eye should be protected from dust and bacterial contamination.
Systemic absorption 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.
This preparation may cause transient blurring of vision. Patients should be advised not to drive or operate hazardous machinery until their vision is clear.
Oxybuprocaine has the potential to cause severe corneal damage and morbidity.
Use of oxybuprocaine 1% solution for long-term ventilator bronchoscopy had no effect on cardiovascular function, but produced a decline in mean arterial oxygen pressure (paO2) from 100 to 78 which persisted for over 30 minutes in one patient.
Anaesthesia of the respiratory system with oxybuprocaine has rarely resulted in hypersensitivity reactions including lung oedema.

Warnings.

Oxybuprocaine eye drops should not be used for prolonged periods. Frequent or chronic use may result in severe corneal damage, keratitis and acquired tolerance. Not for injection. Topical ophthalmic use only.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Metabolism of local anaesthetics derived from esters may be inhibited by anticholinesterases and thus prolong the effects of oxybuprocaine. Ester type local anaesthetics may competitively enhance the neuromuscular blocking action of suxamethonium.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category D)
Safety for use in pregnancy has not been established. The use of Minims Oxybuprocaine Eye Drops should be used only when it is considered essential by a physician.
 No studies have established the safety of Minims Oxybuprocaine Eye Drops during lactation. This medication should therefore be used only when it is considered essential by a physician.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

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.
In rare cases, local anaesthetic preparations have been associated with allergic reactions (in the most severe instances, anaphylactic shock).

Ocular.

Instillation of drops commonly causes a transient stinging or burning sensation.
Stromal infiltration, oedema, candida keratitis, disciform keratitis and peripheral corneal ring formation have all been reported as a result of the frequent use of oxybuprocaine.
Frequent or chronic use can also result in acquired tolerance, epithelial cell damage, irreversible apical cell damage at the level of the corneal endothelial cells and keratitis.
Local anaesthetics are known to inhibit the rate of movement of corneal epithelial cells migrating to cover wounds.
Reductions in tear film stability have also been documented as a result of oxybuprocaine treatment.
A fibrinous iritis has been observed in two patients following minor surgery, believed to be the result of drug entering the anterior chamber.
Frequency unknown: eye allergy, allergic blepharitis.

Cardiovascular.

One incidence of sinus bradycardia after one drop of 0.4% oxybuprocaine solution was instilled into each eye occurred in one patient.

Central nervous system.

Abuse or overdose of oxybuprocaine may cause sedation, confusion, agitation, euphoria, disorientation, hearing, visual or speech disorders, paraesthesia, muscle twitching and, if severe enough, seizures, respiratory depression and coma. These symptoms would be very rare in therapeutic doses.

Gastrointestinal.

Occasional nausea, vomiting and dysphagia have been observed during therapy.

Immunological.

Use of local anaesthetics of the ester type, especially when frequent, has the potential to cause allergic reactions including contact allergy, urticaria and angioneurotic oedema.
Frequency unknown: hypersensitivity, anaphylactic reaction/shock.

4.9 Overdose

Overdose of any local anaesthetic may cause various serious neurological, cardiovascular and respiratory events. These are overwhelmingly associated with oral and parenteral use/ abuse and are unlikely to occur in therapeutic, topical doses. Treatment for the various clinical effects is complex, however cessation of drug and supportive management including oxygen, intravenous fluids and management of any seizures is essential.
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.

Surface or topical anaesthesia blocks conduction of sensory, motor and autonomic nerve fibres, the excitability of nociceptors and the conducting system of the heart. A 0.4% solution of oxybuprocaine has been shown to give effective surface anaesthesia in short ophthalmological procedures. Sensation of pain is locally and reversibly reduced, with the possibility of temperature and pressure sensitivity also affected. Anaesthetic activity is ten times that of cocaine and twice that of tetracaine (amethocaine).
Surface anaesthesia occurs in approximately one minute with 0.4% intraocular solution and peak response is between 1 and 15 minutes. Anaesthesia persists for about 20 to 30 minutes, with full corneal sensitivity taking 40 minutes or more to return.
Oxybuprocaine has demonstrated a concentration related inhibition of platelet activating factor induced aggregation of human blood samples taken from volunteers. 50% inhibition was demonstrated at 170 micromoles.
A 1% oxybuprocaine solution demonstrated significant bactericidal activity against Pseudomonas aeruginosa, Escherichia coli, Haemophilus influenzae and Streptococcus pneumoniae.
Oxybuprocaine, like several local anaesthetics, competitively inhibits the exchange transport of glucose in human erythrocytes.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Most local anaesthetics are readily absorbed through mucous membranes and through damaged skin.

Distribution.

Local anaesthetics at tissue pH can diffuse through connective tissue and cellular membranes to reach the nerve fibre where ionisation can occur.

Metabolism.

Oxybuprocaine is metabolized by esterases in the plasma and, to a lesser extent, in the liver. There are at least nine metabolites, with 3-butoxy-4-aminobenzoic acid making up 70-90%. Their activity is unknown.

Excretion.

Urinary excretion of the drug and its metabolites at 9 h after an oral dose is approximately 90%.

5.3 Preclinical Safety Data

Genotoxicity.

No data is available regarding the mutagenicity of oxybuprocaine in humans.

Carcinogenicity.

No data is available regarding the carcinogenicity of oxybuprocaine in humans.

6 Pharmaceutical Particulars

6.1 List of Excipients

Hydrochloric acid, 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.) Do not expose to strong light.

6.5 Nature and Contents of Container

Minims Oxybuprocaine Hydrochloride 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.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical name: 2-Diethylaminoethyl-4-amino- 3-butoxybenzoate hydrochloride.
Molecular formula: C17H28N2O3.HCl.
Molecular weight: 344.9.
Oxybuprocaine hydrochloride is a local, surface anaesthetic of the ester type. It is a white or off white crystal or crystalline powder, odourless or with a slight characteristic odour. It is freely soluble in water, alcohol and chloroform and practically insoluble in ether. Aqueous solutions have a pH of 4.5 to 6.

Chemical structure.


CAS number.

5987-82-6.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes