Consumer medicine information

Miochol-E

Acetylcholine chloride

BRAND INFORMATION

Brand name

Miochol-E

Active ingredient

Acetylcholine chloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Miochol-E.

What is in this leaflet

This leaflet answers some common questions about Miochol-E.

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

The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up-to-date information on the medicine.

Those updates may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risk of you being given Miochol-E against the benefits they expect it will have for you.

If you have any concerns about being given Miochol-E, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What Miochol-E is used for

Miochol-E is used to constrict the pupil of the eye during cataract surgery and other types of eye surgery.

It belongs to a group of medicines called parasympathomimetics.

It works by mediating nerve impulse transmission.

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

This medicine is not addictive.

It is available only with a doctor's prescription.

There is not enough information to recommend the use of this medicine for children.

Before you are given Miochol-E

When you must not be given it

You must not be given Miochol-E if you have an allergy to:

  • any medicine containing acetylcholine chloride
  • 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.

You must not be given Miochol-E 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.

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 are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about the above, tell him/her before you are given Miochol-E.

Taking other medicines

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

Your doctor and pharmacist have more information on medicines to be careful with or avoid when you are given Miochol-E.

How Miochol-E is given

Miochol-E is given as a single dose during eye surgery. If the surgery is for removal of a cataract, it is given following placement of the intraocular lens.

Your doctor will prepare and administer Miochol-E for you.

How much is given

In most cases, 0.5 to 2 mL is enough to constrict the pupil of the eye sufficiently.

How it is given

Miochol-E is made into a solution immediately before use. This solution is run through a small tube into the front chamber of the eye.

If you are given too much(overdose)

If you are given more Miochol-E than you need, your doctor may need to give you an injection of either atropine sulfate or adrenaline to control symptoms.

Symptoms of overdose may include slow heart rate, low blood pressure, flushing, breathing difficulties and sweating.

Because acetylcholine is rapidly broken down by the body, symptoms of overdose are unlikely to occur.

While you are being given Miochol-E

Things you must do

Keep all of your doctor's appointments so that your progress can be checked.

Things to be careful of

Do not drive or operate machinery until you have recovered from your eye surgery and your vision is normal.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being treated with Miochol-E.

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 list of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

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

  • slow heart rate
  • dizziness or lightheadedness due to low blood pressure
  • breathing difficulties
  • flushing, sweating
  • abnormal vision.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.

Product description

What it looks like

Miochol-E comes in a vial and an ampoule: the vial contains a white powder and the ampoule contains a clear, colourless solution. The contents are mixed immediately before use to form a clear, colourless solution.

Ingredients

Miochol-E contains 20 mg of acetylcholine chloride as the active ingredient. It also contains:

  • mannitol
  • sodium acetate
  • magnesium chloride
  • potassium chloride
  • calcium chloride
  • water for injections.

Sponsor

In Australia, Miochol-E is supplied by:

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

In New Zealand, Miochol-E 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

AUST R 118510

Published by MIMS April 2018

BRAND INFORMATION

Brand name

Miochol-E

Active ingredient

Acetylcholine chloride

Schedule

S4

 

1 Name of Medicine

Acetylcholine chloride.

2 Qualitative and Quantitative Composition

Each vial of powder contains acetylcholine chloride 20 mg as the active ingredient. Miochol-E contains acetylcholine chloride 10 mg/mL upon reconstitution with the 2 mL of diluent in the ampoule.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for solution for irrigation and diluent.

Powder.

White solid or powder in clear glass vials.

Diluent.

Clear colourless solution in glass ampoules.

4 Clinical Particulars

4.1 Therapeutic Indications

Miochol-E is used to obtain complete miosis of the iris in seconds after placement of the intraocular lens (IOL) in cataract surgery and in penetrating keratoplasty, iridectomy and other anterior segment surgery where rapid miosis may be required.

4.2 Dose and Method of Administration

In most cases 0.5 to 2 mL produces satisfactory miosis.
The syringe containing the reconstituted preparation must be fitted with a suitable irrigation cannula for intraocular irrigation.
The Miochol-E solution is instilled into the anterior chamber before or after securing one or more sutures. Instillation should be gentle and parallel to the iris face and tangential to pupil border.
If there are no mechanical hindrances, the pupil starts to constrict in seconds and the peripheral iris is drawn away from the angle of the anterior chamber. Any anatomical hindrance to miosis, such as anterior or posterior synechiae, must be released to permit the desired effect of the drug.
The solution should be reconstituted immediately before use since aqueous solutions of acetylcholine are unstable.

Instructions for use and handling.

Warning.

Do not use if blister or peelable backing is damaged or broken. Open under aseptic conditions only, at the time of surgery.

Directions for preparing Miochol-E.

1. Inspect unopened blister to ensure that it is intact. The outer package is not sterile. Peel open blister.
2. Aseptically transfer the ampoule, vial and filter hub to sterile field. Maintain asepsis during preparation of solution. Sterile gloves and gowns should be used.
3. Aseptically attach a sterile 18 to 20 gauge, bevelled needle to the luer tip of a sterile disposable syringe with twisting motion to assure secure fit.
4. Break open the ampoule containing the diluent. The One Point Cut (OPC) ampoule must be opened as follows: hold the bottom part of the ampoule with the thumb pointing to the coloured point; grasp the top of the ampoule with the other hand, positioning the thumb at the coloured point and press back to break at the existing cut under the point.
5. Remove the needle protector and withdraw the diluent from the ampoule into the syringe. Discard ampoule.
6. Remove and discard plastic cap from top of vial.
7. Insert the needle through the centre of the vial stopper.
8. Transfer the diluent from the syringe to the vial.
9. Shake gently to dissolve drug.
10. Slowly withdraw the solution from the vial through the needle into the syringe.
11. Discard needle.
12. Aseptically open filter hub pouch.
13. Aseptically attach filter hub onto luer tip of syringe with a twisting motion to assure secure fit.
14. Aseptically attach a sterile blunt tip irrigation cannula to male luer of filter prior to intraocular irrigation.
15. Discard appropriately after use. Do not reuse the filter hub.
The solution must be mixed just before use, since aqueous solutions of acetylcholine are unstable. Only clear and colourless solutions should be used. To reduce microbiological hazard, use as soon as practicable after reconstitution. If storage is necessary, hold at 2-8°C for not more than 6 hours. Any residual quantities of acetylcholine chloride solution should be discarded after a maximum of 6 hours for stability reasons.
Contains no antimicrobial agent. Product is for single use in one patient only. Discard any residue.
Miochol-E should not be resterilised. The filter hub is recommended only for use with Miochol-E. Aspiration through the filter is not recommended. However, if utilised, discard needle and syringe filter to prevent recontamination of fluids during injection.
Do not aspirate and inject through the same filter.

Incompatibilities.

Reconstitute the solution only with the supplied diluent.
The filter hub is recommended only for use with Miochol-E.

4.3 Contraindications

Known hypersensitivity to acetylcholine or to any of the excipients.

4.4 Special Warnings and Precautions for Use

In cataract surgery, use Miochol-E only after placement of the IOL. Miochol-E cannot be resterilised. Do not gas sterilise. If the blister or peelable packing is damaged or broken, sterility of the enclosed bottle cannot be assured. Open under aseptic conditions only.
Aqueous solutions of acetylcholine chloride are unstable. Prepare solution immediately before use. Only solutions that are clear and colourless should be used. Unused residual amounts should be discarded.

Use in the elderly.

No data available.

Paediatric use.

Safety and effectiveness in children have not been established.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

None known.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

It is not known if Miochol-E can affect reproductive capacity.
(Category B2)
Animal reproduction studies have not been conducted with Miochol-E. It is not known whether Miochol-E can cause foetal harm when administered to a pregnant woman. Miochol-E should be given to pregnant women only if clearly needed.
 It is not known whether Miochol-E is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Miochol-E is administered to nursing women.

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.
Adverse events considered possibly related or related to use of intraocular acetylcholine and classified according to incidence are reported in Table 1.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia). Systemic toxicity is low because of rapid local breakdown. Symptoms of overdose are likely to be effects resulting from systemic absorption (see Section 4.8 Adverse Effects (Undesirable Effects)). In case of overdose, atropine sulfate (0.5 to 1 mg) should be given intramuscularly or intravenously and should be readily available. Adrenaline (0.1 to 1 mg sc) is also of value in overcoming severe cardiovascular or bronchoconstrictor responses.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Acetylcholine is a naturally occurring neurohormone which mediates nerve impulse transmission at all cholinergic sites involving somatic and autonomic nerves. After release from the nerve ending, acetylcholine is rapidly inactivated by the enzyme acetylcholinesterase by hydrolysis to acetic acid and choline.
Direct application of acetylcholine to the iris will cause rapid miosis of short duration. Topical ocular instillation of acetylcholine to the intact eye causes no discernible responses as cholinesterase destroys the molecule more rapidly than it can penetrate the cornea.

Clinical trials.

Clinical studies with Miochol-E have shown it to be clinically and statistically superior to placebo in inducing miosis following cataract surgery when administered at doses of 0.5-2.0 mL (see Table 2).

5.2 Pharmacokinetic Properties

Topical: Not applicable.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The vial contains mannitol as excipient; the ampoule contains diluent which consists of sodium acetate, magnesium chloride hexahydrate, potassium chloride, calcium chloride dihydrate, water for injections.

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 below 25°C. Do not freeze.

6.5 Nature and Contents of Container

Miochol-E is presented in a blister pack containing one 2 mL Type 1 glass vial with grey rubber stopper and aluminium flip-off cap and one 2 mL Type 1 glass ampoule.
Miochol-E is supplied in a pack containing 1 or 12* blisters and 1 or 12* filter hubs with 5 micron filter, luer lock, respectively.
*Not marketed.

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 structure.

Structural formula:
Chemical name: 2-acetoxyethyltrimethylammonium chloride.
Molecular formula: C7H16ClNO2.
Molecular weight: 181.7.

CAS number.

60-31-1.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes