Glycopyrronium bromide parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injectable formulations of glycopyrronium bromide
Drugs List
Therapeutic Indications
Uses
Premedication to reduce saliva
Prevention of intraoperative bradycardia
Reversal of competitive neuromuscular block - adjunct to anticholinesterase
Protection against the peripheral muscarinic actions of anticholinesterases (such as neostigmine and pyridostigmine, used to reverse residual neuromuscular blockade produced by non-depolarising muscle relaxants).
Pre-operative antimuscarinic agent to reduce salivary tracheobronchial and pharyngeal secretions and to reduce the acidity of gastric contents.
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.
Unlicensed Uses
Bowel colic in palliative care
Reducing respiratory secretions in palliative care
Dosage
Adults
Pre-medication
200micrograms to 400micrograms before the induction of anaesthesia by intravenous or intramuscular injection.
Alternatively, a dose of 4micrograms/kg to 5micrograms/kg bodyweight may be used (up to a maximum of 400micrograms).
Larger doses may result in profound and prolonged antisialogogue (leading to decreased saliva production) effect which may be unpleasant for the patient.
Intra-operative bradycardia
A single dose of 200micrograms to 400micrograms by intravenous injection.
Alternatively, a single dose of 4micrograms/kg to 5micrograms/kg bodyweight may be used (up to a maximum of 400micrograms).
Control of muscarinic side effects during reversal of non-depolarising neuromuscular block
200micrograms intravenously per 1mg of neostigmine or the equivalent dose of pyridostigmine.
Alternatively, a dose of 10micrograms/kg to 15micrograms/kg intravenously with 50micrograms/kg of neostigmine or the equivalent dose of pyridostigmine.
In palliative care (unlicensed)
Glycopyrronium bromide has been used to treat bowel colic or to dry excessive respiratory secretions by giving 200micrograms every 4 hours when required (hourly use is occasionally necessary) or by continuous subcutaneous infusion 0.6mg to 1.2mg over 24 hours.
Children
Pre-medication
4micrograms/kg to 8micrograms/kg before the induction of anaesthesia by intramuscular or intravenous injection.
Maximum dose: 200micrograms. An unlicensed maximum of 400micrograms may be suitable in children aged 12 to 18 years.
Larger doses may result in profound and prolonged antisialogogue (leading to decreased saliva production) effect which may be unpleasant for the patient.
Intra-operative bradycardia
A single dose of 200micrograms by intravenous injection.
Alternatively, a single dose of 4micrograms/kg to 8micrograms/kg may be used (up to a maximum of 200 micrograms).
These doses may be repeated if necessary
Control of muscarinic side effects during reversal of non-depolarising neuromuscular block
10micrograms/kg intravenously with 50micrograms/kg of neostigmine or equivalent dose of pyridostigmine.
The following alternative dosing schedule may be suitable:
Children aged 12 to 18 years: 200micrograms per 1mg of neostigmine, or 10microgram/kg to 15micrograms/kg.
Children aged 1 month to 12 years: 10micrograms/kg (up to 500micrograms per dose).
Control of hypersalivation and upper airway secretions (unlicensed)
Oral
For administration by mouth, injection solution may be given or crushed tablets suspended in water.
40micrograms/kg to 100micrograms/kg (up to 2mg per dose) three or four times daily, titrated according to response.
Subcutaneous infusion
Children aged 12 to 18 years: 0.6mg to 1.2mg daily.
Children aged 1 month to 12 years: 12micrograms/kg to 40micrograms/kg daily (up to 1.2mg per dose).
Subcutaneous, intramuscular or intravenous injection
Children aged 12 to 18 years: 200micrograms every 4 hours when required.
Children aged 1 month to 12 years: 4micrograms/kg to 10micrograms/kg (up to 200micrograms per dose) four times a day when required.
Neonates
Pre-medication (unlicensed)
5micrograms/kg by intravenous or intramuscular injection.
Intra-operative bradycardia (unlicensed)
10microgram/kg by intravenous injection.
This dose may be repeated if necessary.
Control of muscarinic side effects during reversal of non-depolarising neuromuscular block (unlicensed)
10micrograms/kg by intravenous injection.
Administration
For intravenous or intramuscular injection.
For the reversal of non-depolarising neuromuscular block, glycopyrronium bromide may be administered simultaneously from the same syringe containing the anticholinesterase. This method of administration results in greater cardiovascular stability.
The following unlicensed routes have been employed for the control of respiratory secretions and hypersalivation: subcutaneous injection, continuous subcutaneous infusion, oral use of injection in children.
Contraindications
None known
Precautions and Warnings
Diarrhoea
Down's syndrome
Elderly
Pyrexia
Autonomic neuropathy
Benign prostatic hyperplasia
Breastfeeding
Cardiac arrhythmias
Cardiac surgery
Cardiovascular disorder
Congestive cardiac failure
Gastroesophageal reflux
Hypertension
Hyperthyroidism
Ischaemic heart disease
Myasthenia gravis
Myocardial infarction
Narrow angle glaucoma
Paralytic ileus
Pregnancy
Pyloric stenosis
Thyrotoxicosis
Toxic megacolon
Ulcerative colitis
Uraemia
Advise ability to drive/operate machinery may be affected by side effects
Admin. during inhalation anaesthesia may cause ventricular arrhythmias
Use with caution in pyrexial patients as glycopyrronium bromide inhibits sweating.
Antimuscarinics should not be given to patients with myasthenia gravis except to reduce adverse muscarinic effects of an anticholinesterase. Large doses of quaternary ammonium anticholinergic agents have been shown to block end plate nicotinic receptors. This effect should be considered when treating patients with myasthenia gravis.
Pregnancy and Lactation
Pregnancy
Use glycopyrronium bromide with caution in pregnancy.
Safety of glycopyrronium bromide administration during human pregnancy other than at delivery has not been established.
Animal studies revealed no teratogenic effects. However, dose-related diminished rates of conception (due to reduced seminal secretion) and reduced survival at weaning have been observed.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Use glycopyrronium bromide with caution in breastfeeding.
Safety of glycopyrronium bromide administration during breastfeeding has not been established. Due to its short plasma half life and its quaternary structure, it is very unlikely that significant quantities would penetrate milk. Along with the poor oral bioavailability of glycopyrronium bromide, it is unlikely that it would pose a significant risk to a breastfeeding infant.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Counselling
Patients should be advised that glycopyrronium bromide may cause side effects such as visual disturbances and giddiness. Patients should not drive or operate machinery until the drug ceases to have an effect on mental and physical ability.
Side Effects
Bradycardia
Confusion
Constipation
Decreased bronchial secretions
Decreased sweating
Difficulty in micturition
Dilatation of pupils
Disturbances in accommodation
Dry mouth
Dry skin
Flushing
Giddiness
Glaucoma (closed angle)
Nausea
Palpitations
Photophobia
Tachycardia
Urinary retention
Urinary urgency
Ventricular arrhythmias
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: September 2015
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Summary of Product Characteristics: Glycopyrronium Bromide 200micrograms/ml Injection. Accord Healthcare Ltd. Revised October 2013.
Summary of Product Characteristics: Glycopyrronium Bromide U.S.P. 200micrograms/ml Injection,1ml and 3ml. Amdipharm Mercury Company Limited. Revised September 2012.
Summary of Product Characteristics: Glycopyrronium Bromide 200micrograms/ml Solution for Injection. Martindale Pharmaceuticals Ltd. Revised April 2011.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 September 2017
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