Consumer medicine information

Minims Oxybuprocaine Eye Drops

Oxybuprocaine hydrochloride

BRAND INFORMATION

Brand name

Minims Oxybuprocaine Eye Drops

Active ingredient

Oxybuprocaine hydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

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

What is in this leaflet

This leaflet answers some common questions about Minims Oxybuprocaine.

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 you using Minims Oxybuprocaine 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 Oxybuprocaine is used for

Minims Oxybuprocaine 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 Oxybuprocaine

When you must not be given it

Do not use Minims Oxybuprocaine if you have an allergy to:

  • Any medicine containing Oxybuprocaine
  • 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 have an infection in your eye.

Do not use this medicine if you are pregnant or breast-feeding.

Your doctor will discuss the risks and benefits involved.

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.

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 Oxybuprocaine.

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 Oxybuprocaine may interfere with each other. These include a group of medicines called anticholinesterases.

These medicines may be affected by Minims Oxybuprocaine 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 Oxybuprocaine.

How Minims Oxybuprocaine 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 Oxybuprocaine 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).

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. 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 during the procedure.

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) will 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 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.

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, immediately telephone your doctor or Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) for advice.

After being given Minims Oxybuprocaine

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

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.

Things to be careful of

Be careful driving or operating machinery until you know how Minims Oxybuprocaine affects you.

This medicine generally does not cause any problems with your ability to drive a car or operate machinery.

However, it may cause transient blurred vision at the time of application and 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 Oxybuprocaine.

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 and / or problems seeing clearly
  • Local irritation or feeling of having something in the eye
  • Inflammation of the eye
  • Skin rash
  • Nausea and vomiting

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

Tell your doctor immediately or visit Accident and Emergency at your nearest hospital if you notice any of the following:

  • Swelling of the face, lips, mouth, tongue or throat or other parts of the body
  • Slow heart beat
  • Drowsiness, confusion, agitation, feeling of extreme happiness, disorientation, visual, hearing or speech disorders

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

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

After using Minims Oxybuprocaine

Storage

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

Product description

What it looks like

Minims Oxybuprocaine comes in single dose units containing 0.5mL of a clear, colourless solution.

Each carton contains 20 single dose units.

Ingredients

Minims Oxybuprocaine contains 0.4%w/v of Oxybuprocaine as the active ingredient.

It also contains:

  • Water - Purified
  • Hydrochloric acid

The eye drops do not contain any preservatives.

Manufacturer/Supplier

In Australia, Minims Oxybuprocaine is supplied by:

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

Minims Oxybuprocaine 0.4%
AUST R 32259

In New Zealand, Minims Oxybuprocaine 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 February 2018

BRAND INFORMATION

Brand name

Minims Oxybuprocaine Eye Drops

Active ingredient

Oxybuprocaine hydrochloride

Schedule

S4

 

1 Name of Medicine

Oxybuprocaine hydrochloride.

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.

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.

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.

4 Clinical Particulars

4.1 Therapeutic Indications

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

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.

4.8 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.

4.2 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.

4.7 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.

4.9 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).

7 Medicine Schedule (Poisons Standard)

S4.

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.

Summary Table of Changes