Patient leaflet - GLYCOPYRROLATE-NEOSTIGMINE INJECTION
1. what is glycopyrrolate-neostigmine injection and what it is used for
Glycopyrrolate-Neostigmine Injection contains two active ingredients:
Neostigmine belongs to a group of medicines called cholinesterase inhibitors.
It can be used to reverse the effects of a group of muscle-relaxing drugs called nondepolarising muscle relaxants.
Glycopyrrolate belongs to a group of medicines called anticholinergic drugs.
It is used to counteract some unwanted effects that may occur with neostigmine.
Glycopyrrolate-Neostigmine Injection is used to reverse the muscle relaxation produced by nondepolarising muscle relaxants.
2. what you need to know before you are given glycopyrrolate-neostigmine injection
Do not use Glycopyrrolate-Neostigmine Injection
- If you are allergic to Glycopyrronium Bromide or Neostigmine Metilsulfate or any of the other ingredients of this medicine (listed in section 6).
- If you think you may have a blockage in the intestine/stomach (pyloric stenosis, paralytic ileus) or urinary passages
- If you have been given suxamethonium, a drug used to relax your muscles during surgery.
- Anticholinesterase-antimuscarinic combinations such as neostigmine plus glycopyrronium should be avoided in patients with a prolonged QT interval (irregular heart rhythm).
Warnings and precautions
Talk to your doctor or nurse before you are given Glycopyrrolate-Neostigmine Injection
- If you suffer from glaucoma (increased pressure in the eye)
- If you have had a recent operation on your intestines (Gut)
- If you suffer from asthma attacks, wheezing or difficulty breathing
- If you are suffering from coronary artery disease, a heart attack, heart failure or heart disease,
- If you have low or high blood pressure.
- If you suffer from cardiac arrhythmia (irregular heart beats) or slow heart rate (less than 60 beats per minute) or you are suffering from coronary artery disease
- If you have an overactive thyroid gland.
- If you have a high temperature (fever).
- If you suffer from kidney problems
- If you suffer from myasthenia gravis (a disease resulting in severe muscle weakness and fatigue)
- If you suffer from enlarged prostate gland
- If you have disorder resulting from overstimulation of the vagus nerve, causing a slowing of the heart rate, fainting, constipation and sweating
- If you suffer from obstruction of the stomach (pyloric stenosis) or bowel causing vomiting, abdominal pain and swelling (paralytic ileus)
- If you are suffering from epilepsy or Parkinsonism (A disorder in the brain causing muscle stiffness and shaking)
- If you suffer from stomach ulcers
- If you are pregnant or breast feeding
- If you are under influence of anaesthetics like Cyclopropane or Halothane
Glycopyrronium bromide should be used with caution in children and elderly people.
Other medicines and Glycopyrrolate-Neostigmine Injection
Tell your doctor if you are taking, have recently taken, or might take any other medicines
A large number of drugs can interact with Glycopyrrolate-Neostigmine Injection which can significantly alter their effects. These drugs include:
- medicines to treat depression (e.g. Tricyclic Antidepressant for example amitriptyline or imipramine, MAOI's for example phenelzine, tranylcypramine)
- medicine used to treat mental illness (e.g. Clozapine)
- medicine used to relieve the pain (e.g. Nefopam)
- Amantadine which is used to treat Parkinson’s disease or viral infection
- Suxamethonium, a muscle relaxant usually given during operations.
- medicines used to treat bacterial infections known as aminoglycoside antibiotics, such as gentamicin and streptomycin;
- medicines used to treat bacterial infections known as polymyxins, such as colistimethate sodium;
- clindamycin, a medicine used to treat bacterial infections;
- medicines used to treat an irregular heartbeat, such as procainamide, propafenone and quinidine;
- chloroquine, a medicine used to treat and prevent malaria;
- lithium, a medicine used to treat bipolar disorder;
- medicines used to relax your muscles during surgery known as non-depolarising muscle relaxants
- propranolol, a medicine used to treat a number of conditions including migraines, heart problems and anxiety
- a type of medicine used to dry body secretions during surgery, known as antimuscarinics
Pregnancy, breast-feeding and fertility
. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
This medicine may cause your eyesight to become weak and this could interfere with your ability to drive or operate machinery safely.
Ask your doctor for advice before you drive or operate machinery.
Glycopyrrolate-Neostigmine Injection contains Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.
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3. How Glycopyrrolate-Neostigmine Injection is given to you
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Glycopyrrolate-Neostigmine Injection is administered by injection into a vein.
The recommended dose is
Adults and elderly: 1–2 ml injected into a vein over a period of 10 to 30 seconds.
Alternatively, a dose of 0.02 ml per kg body weight may be injected into a vein over a period of 10 to 30 seconds.
Use in Children: 0.02ml per kg body weight may be injected into a vein over a period of 10 to 30 seconds.
Alternatively, the medicine may be diluted to 10ml with Water for Injections BP or Sodium Chloride Injection BP 0.9% w/v and 1ml per 5kg body weight may then be injected into a vein.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
If you are given more Glycopyrrolate-Neostigmine Injection than you should:
This is unlikely because the dose will be administered by a health professional. An overdose may cause changes in the speed of heart rate, increased production of saliva and difficulty in breathing.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. possible side effects
Like all medicines this medicine can cause side-effects, although not everybody gets them
All medicines can cause allergic reactions although serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.
Contact a doctor right away if you notice any of the following symptoms – you may need urgent medical treatment:
Swelling of the face, lips or throat which makes it difficult to swallow or breathe, rash, itching, hives and dizziness. This could be a sign of an angioedema or a severe allergic reaction (frequency not known, cannot be estimated from the available data).
The following side effects have been reported but their frequency isnot known:
- a dry mouth,
- dryness of the skin,
- redness of the face and often other areas of the skin (Flushing),
- confusion
- difficulty in passing urine,
- inability to completely empty the bladder (urinary retention),
- uncontrollable urge to pass urine,
- nausea (feeling sick)
- difficulty in passing stools (constipation),
- reduced secretion from the lungs,
- increased secretions of the stomach
- increase in mucus secretion
- visual disturbances,
- enlargement of pupil,
- glaucoma (increased pressure in the eye),
- increased sensitivity of the skin to light (photophobia),
- absence of sweating
- a very slow heart beat,
- too much saliva,
- tummy cramps,
- vomiting (being sick)
- diarrhea.
- palpitations or irregular heart beats (could be related to either glycopyrrolate or neostigmine)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store glycopyrrolate-neostigmine injection
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
The expiry date refers to the last day of that month.
Store below 25°C.
Keep the ampoules in the outer carton in order to protect from light.
Use as directed by physican.
If only part of an ampoule is used, discard the remaining solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
What Glycopyrrolate-Neostigmine Injection contains
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– The active substances are Glycopyrrolate and Neostigmine metilsulfate. Each 1 ml contains Glycopyrrolate 500 micrograms (0.5mg) and Neostigmine metilsulfate 2,500 micrograms (2.5mg).
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– The other ingredients are disodium hydrogen phosphate dodecahydrate, citric acid monohydrate, sodium hydroxide and water for injections.
What Glycopyrrolate-Neostigmine Injection looks like and contents of the pack
Glycopyrrolate-Neostigmine Injection is a clear, colourless sterile solution for injection.
It is available in 1 ml glass ampoule.
Pack sizes: Each pack contains 10 × 1ml ampoules or 5 × 1ml ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK. PL 12762/0580.
Manufacturer
Mercury Pharmaceuticals (Ireland) Ltd., 4045, Kingswood Road, City West
Business Park, Co Dublin, Ireland
This leaflet was last revised in April 2019.