Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Glycopyrronium Injection belongs to a group of medicines called anticholinergic drugs.
Glycopyrronium Injection may be used • to protect against some of the unwanted effects of drugs such as neostigmine or pyridostigmine, which are used to reverse the effects of certain types of muscle- relaxing drugs (called non-depolarising muscle relaxants) • before an operation, to reduce saliva and other secretions and to make the stomach contents less acid • before or during an operation, to reduce or prevent slowness of the heartbeat surgery.
Do not use Glycopyrronium Injection: • if you are allergic to Glycopyrronium bromide or any of the other ingredients of this medicine (listed in section 6). • if you have glaucoma. • if you suffer from myasthenia gravis (a disorder that causes extreme muscle weakness and fatigue). • if you have an enlarged prostate. • if you have stomach or bowel problems. • if you are taking Anticholinesteraseantimuscarinic combinations such as neostigmine plus glycopyrronium; these should be avoided in patients with a prolonged QT interval (irregular heart rhythm).
Warnings and precautions Talk to your doctor or nurse before using Glycopyrronium Injection: • if you have Down's Syndrome. • if you are over 60 years of age. • if you are a child. • if you have history of heart disease, heart attack, coronary heart disease or irregular heartbeats or high blood pressure. • if you have a condition characterised by rapid heartbeat (including over-active thyroid, heart failure or heart surgery). • if you have gastric reflux (a condition in which the liquid stomach contents backs up (regurgitates) into the gullet). • if you have diarrhoea. • if you have ulcerative colitis (an inflammation of the large intestine). • if you have kidney disease you need to avoid repeated or large doses. • if you have an overactive thyroid gland. • if you have a high temperature (fever) (as the drug will inhibit sweating). • if you have been administered inhalation anesthesia (to put you asleep before an operation) as it may cause a change in your normal heart rhythm. • if you suffer from obstruction of the stomach (pyloric stenosis) or bowel causing vomiting, abdominal pain and swelling (paralytic ileus). • if you are pregnant or are breastfeeding (see section Pregnancy and breast-feeding and fertility below).
Other medicines and Glycopyrronium Injection
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines. A number of drugs can
interact with Glycopyrronium Injection which can significantly alter their effects. These drugs include: • Drugs for depression known as Tricyclic Antidepressants (for example amitriptyline or imipramine) and Monoamine Oxidase Inhibitors (MAOIs) (for example phenelzine, tranylcypramine). • Clozapine which is used to treat severe mental disorders. • Strong pain relievers such as Nefopam. • Amantadine, levodopa which is used to treat Parkinson's disease or viral infection. • Phenothiazines used to treat severe mental problems or nausea, vomiting or vertigo (for example chlorpromazine, fluphenazine, prochlorperazine, trifluoperazine). • Antihistamines used to treat allergies (for example promethazine). • Pethidine (used to treat moderate to severe pain). • Domperidone or metoclopramide (used to treat nausea and vomiting). • Ketoconazole (used to treat fungal infections). • Memantine (used to treat Alzheimer's disease). • Parasympathomimetics (these are drugs that affect chemicals in the body which are involved in transmission of nerve impulses to a muscle) (for example carbachol, neostigmine, physostigmine). • Ritodrine (used to prevent uncomplicated premature labour). • Corticosteroids used to treat various conditions including asthma and inflammatory disease (for example prednisolone). • Slow-dissolving digoxin tablets, disopyramide (used to treat heart problems).
Glyceryl trinitrate tablets (used to treat angina) may not dissolve under the tongue as well as usual owing to the dry mouth which glycopyrronium bromide causes.
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 or nurse for advice before using this medicine.
Driving and using machines You should not drive or use machines after being given this medicine until the doctor advises you that you are safe to do so.
Glycopyrronium Injection contains sodium Glycopyrronium Injection contains less than 1mmol (23mg) of sodium per 2 ml (essentially 'sodium-free').
How Glycopyrronium Injection will be given to you
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The recommended dose is:
Dosage when used before an operation Adults and elderly 200 to 400 micrograms (0.2 to 0.4 mg) may be injected into a vein or into a muscle before the anaesthetic is given. Alternatively, a dose of 4 to 5 micrograms per kilogram of body weight (0.004 to 0.005 mg per kg) may be used, up to a maximum dose of 400 micrograms (0.4 mg).
Use in children and adolescents 4 to 8 micrograms per kilogram of body weight (0.004 to 0.008 mg per kg) up to a maximum of 200 micrograms (0.2 mg) may be injected into a vein or into a muscle before the anaesthetic is given.
Dosage when used during an operation Adults and elderly A single dose of 200 to 400 micrograms (0.2 to 0.4 mg) should be given by injection into a vein. Alternatively, a single dose of 4 to 5 micrograms per kilogram of body weight (0.004 to 0.005 mg per kg) may be used, up to a maximum of 400 micrograms (0.4 mg). This dose may be repeated if necessary.
Use in children and adolescents A single dose of 200 micrograms (0.2 mg) should be given by injection into a vein. Alternatively, a single dose of 4 to 8 micrograms per kilogram of body weight (0.004 to 0.008 mg per kg) may be used, up to a maximum of 200 micrograms (0.2 mg). This dose may be repeated if necessary.
Dosage when reversing the effects of non-depolarising muscle relaxants Adults and elderly: 200 micrograms (0.2 mg) per 1,000 micrograms (l mg) of neostigmine or the equivalent dose of pyridostigmine, by injection into a vein.
Alternatively, a dose of 10 to 15 micrograms per kilogram of body weight (0.01 to 0.015 mg per kg) may be injected into a vein with 50 micrograms per kg (0.05 mg per kg) of neostigmine or equivalent dose of pyridostigmine. Glycopyrronium Injection may be administered at the same time and from the same syringe with the neostigmine or pyridostigmine.
Use in children and adolescents 10 micrograms per kg of body weight (0.01 mg per kg) may be injected into a vein with 50 micrograms per kg (0.05 mg per kg) of neostigmine or the equivalent dose of pyridostigmine. Glycopyrronium Injection may be administered at the same time and from the same syringe with the neostigmine or pyridostigmine.
Method of administration: Glycopyrronium Injection is administered by injection into a vein or muscle. Your doctor will decide the correct dose for you depending on your circumstances. Your dose may be calculated according to your weight. The injection may need to be repeated depending on your response.
If you use more Glycopyrronium Injection than you should This is unlikely because the dose will be administered by a health professional.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Consult a doctor straight away if you notice any of the following symptoms - you may need urgent medical treatment: Swelling mainly of the face, lips or throat which makes it difficult to swallow or breathe, itching and rashes. This could be a sign of a severe allergic reaction or angioedema (frequency not known, cannot be estimated from the available data).
All medicines can cause allergic reactions although serious allergic reactions are very rare.
Other side effects have also been reported under the following frequency
Very rare (may affect up to 1 in 10,000 people) • glaucoma (increased pressure in the eyes).
Not known (frequency cannot be estimated from the available data) • a dry mouth • blurred vision or reduced ability to sweat • palpitations (an awareness of strong, thumping heart beats) • fear of bright light • confusion • vomiting • feeling sick (nausea) • difficulty in passing water (urinating) • a faster heart rate than normal • difficulty in passing stools (constipation) • reduced lung secretion • redness and dryness of the skin • feeling unwell • feeling giddy.
If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor.
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: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
Google Play or App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
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 carton and label after 'EXP'. The expiry date refers to the last day of that month.
Do not store above 25°C.
Once opened, use immediately and discard any remaining contents.
Do not use this medicine if you notice any particles floating in it
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.
What Glycopyrronium Injection contains The active substance is glycopyrronium bromide. The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment) and water for injections.
What Glycopyrronium Injection looks like and contents of the pack Glycopyrronium Injection is a clear, colourless sterile solution for injection.
Each 1 ml glass ampoule contains 200 micrograms (0.2 mg) of glycopyrronium bromide. Each 3 ml glass ampoule contains 600 micrograms (0.6 mg) of glycopyrronium bromide. Each carton contains ten 1 ml ampoules, or ten 3 ml ampoules or three 3 ml ampoules of Glycopyrronium Injection. Not all pack sizes may be marketed.
Marketing Authorisation Holder Morningside Healthcare Ltd. Unit C, Harcourt Way, Leicester, LE19 1WP, UK
Manufacturer Anfarm Hellas S.A. 61st km National Road Athens-Lamia, 32009 Schimatari Viotias, Greece
This leaflet was last revised in June 2022.
Glycopyrronium bromide 200 micrograms/ml Solution for Injection comes as injection containing 200micrograms/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Glycopyrronium bromide 200 micrograms/ml Solution for Injection is glycopyrronium bromide.
Medicines with the same active substance, strength and form include: Glycopyrronium Bromide 200 micrograms/ml Solution for Injection, Glycopyrronium Bromide 200 micrograms/ml Solution for Injection. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Glycopyrronium bromide 200 micrograms/ml Solution for Injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
1. To protect against the peripheral muscarinic actions of anticholinesterases such as neostigmine and pyridostigmine, used to reverse residual neuromuscular blockade produced by non-depolarising muscle relaxants.
2. As a pre-operative antimuscarinic agent to reduce salivary tracheobronchial and pharyngeal secretions and to reduce the acidity of the gastric contents.
3. As a pre-operative or intra-operative antimuscarinic to attenuate or prevent intra-operative bradycardia associated with the use of suxamethonium or due to cardiac vagal reflexes.
Posology
Premedication
Adults and Elderly: 200 to 400 micrograms (0.2mg to 0.4mg) intravenously or intramuscularly before the induction of anaesthesia. Alternatively, a dose of 4 to 5 micrograms/kg (0.004 to 0.005mg/kg) up to a maximum of 400 micrograms (0.4mg) may be used. Larger doses may result in profound and prolonged antisialagogue effect which may be unpleasant for the patient.
Paediatric population:4 to 8 micrograms/kg (0.004 to 0.008mg/kg) up to a maximum of 200 micrograms (0.2mg) intravenously or intramuscularly before the induction of anaesthesia. Larger doses may result in profound and prolonged antisialagogue effect which may be unpleasant for the patient.
Intra-operative use:
Adults and Elderly: A single dose of 200 to 400 micrograms (0.2 to 0.4mg) by intravenous injection should be used. Alternatively, a single dose of 4 to 5 micrograms/kg (0.004 to 0.005mg/kg) up to a maximum of 400 micrograms (0.4mg) may be used. This dose may be repeated if necessary.
Paediatric population: A single dose of 200 micrograms (0.2mg) by intravenous injection should be used. Alternatively, a single dose of 4 to 8 micrograms/kg (0.004 to 0.008mg/kg) up to a maximum of 200 micrograms (0.2mg) may be used. This dose may be repeated if necessary.
Reversal of residual non-depolarising neuromuscular block:
Adults and Elderly: 200 micrograms (0.2mg) intravenously per 1000 micrograms (1mg) neostigmine or the equivalent dose of pyridostigmine. Alternatively, a dose of 10 to 15 micrograms/kg (0.01 to 0.015mg/kg) intravenously with 50 micrograms/kg (0.05mg/kg) neostigmine or equivalent dose of pyridostigmine. Glycopyrrolate Injection may be administered simultaneously from the same syringe with the anticholinesterase; greater cardiovascular stability results from this method of administration.
Paediatric population:10 micrograms/kg (0.01mg/kg) intravenously with 50 micrograms/kg (0.05mg/kg) neostigmine or the equivalent dose of pyridostigmine. Glycopyrrolate Injection may be administered simultaneously from the same syringe with the anticholinesterase; greater cardiovascular stability results from this method of administration.
Method of Administration:
Glycopyrronium Injection is for intravenous or intramuscular injection.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
In common with other antimuscarinic drugs caution is advised in patients with prostatic hypertrophy, paralytic ileus, pyloric stenosis and closed angle glaucoma. Quaternary ammonium compounds in large dose have been shown to block the nicotinic muscle end plate receptors. This must be evaluated prior to its administration in patients with myasthenia gravis.
Anticholinesterase-antimuscarinic combinations such as neostigmine plus glycopyrronium should be avoided in patients with a prolonged QT interval.
Antimuscarinics should be used with caution (due to increased risk of side effects) in Down's syndrome, in children and in the elderly.
Extreme caution is advised in patients with gastro-oesophageal reflux disease, diarrhoea, ulcerative colitis, acute myocardial infarction, thyrotoxicosis, coronary artery disease, cardiac dysarythmias, hypertension, congestive heart failure conditions characterised by tachycardia (including hyperthyroidism, cardiac insufficiency, cardiac surgery) because of the increase in heart rate produced by their administration, coronary artery disease and cardiac arrhythmias, pyrexia (due to inhibition of sweating), pregnancy and breast feeding.. As glycopyrrolate inhibits sweating, patients with increased temperature (especially children) should be observed closely.
Because of prolongation of renal elimination, repeated or large doses of Glycopyrronium Bromide should be avoided in patients with uraemia.
Anticholinergic drugs can cause ventricular arrhythmias when administered during inhalation anaesthesia especially in association with the halogenated hydrocarbons.
Unlike atropine, glycopyrrolate is a quaternary ammonium compound and does not cross the blood-brain barrier. It is therefore less likely to cause postoperative confusion which is a particular concern in the elderly patients. Compared to atropine, glycopyrrolate has reduced cardiovascular and ocular effects.
Many drugs have antimuscarinic effects; concomitant use of two or more of such drugs can increase side-effects such as dry mouth, urine retention and constipation. Concomitant use can also lead to confusion in the elderly.
Anticholinergic agents may delay absorption of other medication given concomitantly.
Concurrent administration of anticholingergics and corticosteroids may result in increased intraocular pressure.
Concurrent use of antocholinergic agents with slow-dissolving tablets of digoxin may cause increased serum digoxin levels.
Ritodrine: tachycardia.
There is increased risk of antimuscarinic side effects in patients taking drugs with antimuscarinic effects such as MAOIs, amantadine, clozapine, tricyclic antidepressants, disopyramaide, antihistamines, pethidine, phenothiazines (increased antimuscarinic side effects of phenothiazines but reduced plasma concentrations) and nefopam.
Domperidone/Metoclopramide: antagonism of effect on gastro-intestinal activity Ketoconazole: reduced absorption of ketoconazole.
Levodopa: absorption of levodopa possibly reduced.
Memantine: effects possibly enhanced by memantine.
Nitrates: possibly reduced effect of sublingual nitrates (failure to dissolve under the tongue owing to dry mouth).
Parasympathomimetics: antagonism of effect.
Pregnancy:
For use as indicated, animal studies are of very limited relevance (see section 5.3). Use in human pregnancy has not been systematically evaluated. This product should only be used in pregnancy if considered essential.
Breast-feeding
May reach breast milk but in amounts probably too small to be harmful.
Caution is advised when considering administration to a nursing mother.
Fertility
No data available.
Glycopyrrolate has moderate influence on the ability to drive and use machines. However, systemic administration of antimuscarinics may cause blurred vision, dizziness and other effects that may impair a patient's ability to perform skilled tasks such as driving. These activities should not be undertaken until any disturbance of visual accommodation or balance has resolved. Do not operate or drive heavy machinery unless the drug has been shown not to interfere with mental or physical ability.
Adverse reactions listed by System Organ Class. Frequencies are defined using the following convention: Very common: (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known: cannot be estimated from the available data.
Tabulated list of the adverse reaction:
System Organ Class
Adverse reactions
Frequency
Immune system disorders
Hypersensitivity, Angioedema
Not known
Cardiac disorders
Tachycardia, Palpitations
Not known
Eye disorders
Accommodation disorder
Not known
Gastrointestinal disorders
Dry mouth
Not known
Renal and urinary disorders
Micturition disorder
Not known
Skin and subcutaneous tissue disorders
Anhidrosis
Not known
Other side effects of anti-muscarinics include-
System Organ Class
Adverse reactions
Frequency
Cardiac disorders
Bradycardia*
Not known
Eye disorders
Accommodation disorder
Photophobia
Angle closure glaucoma
Not known
Very rare
Gastrointestinal disorders
Constipation
Nausea
Vomiting
Not known
Nervous system disorders
Confusion**
Dizziness
Not known
Renal and urinary disorders
Micturition urgency
Urinary retention
Not known
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
Not known
Skin and subcutaneous tissue disorders
Flushing
Dry skin
Not known
*Followed by tachycardia, palpitation and arrhythmias
**Particularly in elderly
However, the use of Glycopyrronium Injection as a preoperative anticholinergic is associated with less effect on the cardiovascular system compared to atropine.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms:
Since glycopyrrolate is a quaternary ammonium agent, symptoms of overdosage are peripheral rather than central in nature.
Management:
To combat peripheral anticholinergic effects, a quaternary ammonium anticholinesterase such as neostigmine methylsulphate may be given in a dose of 1000 micrograms (1.0mg) for each 1000 micrograms (1.0mg) of glycopyrrolate known to have been administered by the parenteral route.
Ask anything about Glycopyrronium bromide 200 micrograms/ml Solution for Injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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