Consumer medicine information

Neostigmine Juno Solution for Injection

Neostigmine methylsulfate

BRAND INFORMATION

Brand name

Neostigmine Juno

Active ingredient

Neostigmine methylsulfate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Neostigmine Juno Solution for Injection.

What is in this leaflet

This leaflet answers some of the common questions about Neostigmine Juno Solution for Injection. It does not contain all the information that is known about Neostigmine Juno Solution for Injection. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you being given Neostigmine Juno Solution for Injection against the benefits they expect it will have for you.

If you have any concerns about this medicine talk to your doctor or pharmacist.

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

What Neostigmine Juno is used for

Neostigmine Juno Solution for Injection increases movement of the muscles in the body.

It can be used:

  • To reverse the effects of medicines that are used to stop muscles moving;
  • To activate the muscles in the bladder, stomach and intestines following surgery
  • For myasthenia gravis.

Neostigmine is known as a cholinesterase inhibitor. It works by stopping a chemical called acetylcholine, which stimulates muscles movement, from breaking down.

Your doctor will have explained why you are being treated with Neostigmine Juno Solution for Injection.

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

Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.

Neostigmine Juno Solution for Injection is not addictive.

Before you are given Neostigmine Juno

You may already have been given Neostigmine Juno Solution for Injection. Your doctor will have considered the situation carefully and decided to use it. However, if any of any of the following applies to you, tell your doctor immediately.

When you must not use it

You should not be given Neostigmine Juno Solution for Injection if you are breastfeeding unless your doctor says so. Ask your doctor about the risks and benefits involved.

It may make your baby arrive early if you are given it in the last weeks before your baby is due.

Your baby can take in very small amounts of Neostigmine Juno Solution for Injection from breast milk if you are breastfeeding.

You must not be given Neostigmine Juno Solution for Injection if:

  • You are sensitive to neostigmine
  • You have an allergy to any ingredient listed at the end of this leaflet or any other related medicines.
    If you have an allergic reaction, you may get a skin rash, hayfever, asthma or feel faint.

You should not be given Neostigmine Juno Solution for Injection if you have the following medical conditions:

  • Blockage of the intestines or urinary tract
  • Peritonitis

Neostigmine Juno Solution for Injection will only be used if the solution is clear, the package is undamaged and the use by (expiry) date marked on the pack has not been passed.

Before you are given it

You must tell your doctor if you have any of these medical conditions:

  • Recent surgery involving the intestine or bladder
  • Other intestinal or bladder problems
  • Asthma or any difficulty with breathing
  • Heart disease or other heart problems
  • Any obstruction to your coronary arteries
  • Epilepsy
  • Low blood pressure
  • Parkinsons disease
  • Stomach ulcer
  • Kidney problems
  • Addison’s disease
  • An overactive thyroid gland

It may not be safe for you to be given Neostigmine Juno Solution for Injection if you have any of these conditions.

Taking other medicines

You must tell your doctor if you are taking any other medicines, including medicines that you can buy at the chemist, supermarket or health food shop.

Some medicines and Neostigmine Juno Solution for Injection may interfere with each other. These include:

  • Corticosteroids
  • Atropine or glycopyrrolate
  • Antibiotics
  • Medicine for heart problems including beta blockers
  • Lithium
  • Chloriquinine, hydroxychloroquinine
  • Quinine

These medicines may affect the way Neostigmine Juno Solution for Injection works. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

If you have not told your doctor about any of these things, tell them before you are given any Neostigmine.

How Neostigmine Juno is given

Neostigmine Juno Solution for Injection will be given to you by a doctor or a specially trained nurse.

It may be given just under the skin, into a muscle, or directly into the bloodstream. The dose you will be given will be carefully worked out depending on the procedure and your body weight.

Overdose

The doctor or nurse giving you Neostigmine Juno Solution for Injection will be experienced in its use, so it is extremely unlikely that you will be given too much. However, the first signs of overdose can be nausea, vomiting, muscle cramps, sweating, increased saliva and changes in heart rate.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are receiving Neostigmine Juno Solution for Injection.

Neostigmine Juno Solution for Injection helps most people with muscle weakness but may have some unwanted side effects in a few people.

All medicines have side effects. Sometimes they are serious, most of the time they are not.

You may need medical treatment if you get some of the side effects.

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:

  • Shivering
  • Low oxygen levels
  • Muscle weakness
  • Difficulty speaking or breathing
  • Nausea and vomiting
  • Diarrhoea
  • Stomach cramps or flatulence
  • Involuntary urination or defecation
  • Sweating
  • Increased saliva or mucous production
  • Faintness, dizziness or weakness
  • Changes in vision
  • Muscle cramps or twitching
  • Drowsiness or restlessness
  • Increased secretion of tears from the eyes
  • Headache
  • Slurred speech
  • Agitation or fear
  • Itching

These are all mild side effects of Neostigmine Juno Solution for Injection.

Tell your doctor or nurse immediately or go to casualty at your nearest hospital if you notice any of the following:

  • General weakness
  • Inability to smile, swallow or speak
  • Slowed heart rate or palpitations
  • Shortness of breath, tightness in the chest or wheezing
  • Severe rash
  • Irritation
  • Swollen face
  • Convulsions

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice anything else that is making you feel unwell.

Storage

Neostigmine Juno Solution for Injection will be stored by your doctor or pharmacist under the recommended conditions.

It should be kept in a cool, dry place where the temperature stays below 25 degrees C.

Disposal

Any Neostigmine Juno Solution for Injection which is not used will be disposed of in a safe manner by your doctor or pharmacist.

Product description

Neostigmine Juno Solution for Injection is a clear, colourless solution presented in clear glass ampoules.

It contains neostigmine methylsulfate 2.5 mg/ml as the active ingredient, plus sodium chloride and water for injections.

Sponsor

Juno Pharmaceuticals Pty Ltd
42 Kelso Street,
Cremorne,
VIC 3121
medical-enquiries@junopharm.com.au.

This leaflet was prepared in August 2021.

Australian Registration Number: 2.5 mg/ml ampoule AUSTR 219054

Published by MIMS November 2021

BRAND INFORMATION

Brand name

Neostigmine Juno

Active ingredient

Neostigmine methylsulfate

Schedule

S4

 

1 Name of Medicine

Neostigmine methylsulfate.

2 Qualitative and Quantitative Composition

Neostigmine Juno injection contains 2.5 mg neostigmine methylsulfate in 1 mL solution.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Neostigmine Juno Solution for Injection is a clear, colourless sterile solution.

4 Clinical Particulars

4.9 Overdose

Overdosage with neostigmine can cause cholinergic crisis, which is characterised by increasing muscle weakness. Myasthenic crisis is due to an increase in severity of the disease and may be difficult to distinguish from cholinergic crisis on a symptomatic basis. Cholinergic crisis can lead to respiratory paralysis, which may result in death, while myasthenic crisis is extreme muscle weakness. The differentiation between the two crises is extremely important as treatment is different for each. The two types of crises can be differentiated by the use of edrophonium and clinical judgement.
Symptoms. Signs of overdosage due to muscarinic effects may include abdominal cramps, increased peristalsis, diarrhoea, nausea and vomiting, increased bronchial secretion, salivation, diaphoresis and miosis. Nicotinic effects consist of muscular cramps, fasciculations and general weakness. Bradycardia and hypotension may also occur.
Treatment. The treatment of cholinergic crisis requires the discontinuation of all cholinergic medication. The immediate use of atropine is also recommended, muscarinic effects are controlled with IV atropine sulfate (1 to 2 mg) followed by IM atropine sulfate every 2 to 4 hours. Assistance of ventilation may be required if respiration is severely depressed.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical Name: (3-dimethyl-carbamoxyloxy) trimethylanilinium methyl sulfate.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSNEOMET.gif CAS number. 51-60-5.
Molecular weight: 334.4.
Molecular formula: C13H22N2O6S.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription only Medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/NEOSJUST.gif