Glycopyrronium bromide oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of glycopyrronium bromide.
Drugs List
Therapeutic Indications
Uses
Severe sialorrhoea: children and adolescents with neurological disorders
Unlicensed Uses
Excessive respiratory secretions
Hypersalivation
Dosage
To be prescribed only by a physician experienced in the treatment of paediatric patients with neurological disorders. Dosage is based on the child's weight.
Note that doses are expressed as glycopyrronium bromide. Oral solutions are not interchangeable on a microgram for microgram basis due to differences in bioavailability.
Children
Children aged over 3 years
1mg/5ml oral solution and tablets
Initial dose: 20micrograms/kg three times per day.
Titration: dose should be increased by 20micrograms/kg three times a day every 5 to 7 days.
Following the dose titration period, the child's sialorrhoea should be monitored at no longer than 3 monthly intervals in order to assess if any dose changes are needed for optimal efficacy and/or tolerability.
The maximum dose is 100micrograms/kg three times per day and must not exceed 1.5mg to 3mg per dose based upon weight.
400micrograms/ml oral solution
Initial dose: 16micrograms/kg three times per day.
Titration: dose should be increased by 16micrograms/kg three times a day every 7 days and continued until efficacy is balanced with undesirable effects and an acceptable maintenance dose is achieved.
Following the dose titration period, the child's sialorrhoea should be monitored at no longer than 3 monthly intervals in order to assess if any dose changes are needed for optimal efficacy and/or tolerability.
The maximum dose is 80micrograms/kg three times a day and must not exceed 2.4mg per dose based upon weight.
Control of upper airways secretion and hypersalivation (unlicensed)
1mg/5ml oral solution
20micrograms/kg three times a day, increased in steps of 20micrograms/kg three times a day every 7 days. Dose should be adjusted according to response. Maximum dose 100micrograms/kg three times a day (maximum per dose 3mg).
400microgram/ml oral solution
16micrograms/kg three times a day, increased in steps of 16micrograms/kg three times a day every 7 days. Dose should be adjusted according to response. Maximum dose 80micrograms/kg three times a day (maximum per dose 2.4mg).
Patients with Renal Impairment
Doses should be reduced by 30% in mild to moderate renal impairment (eGFR less than 90 to greater than or equal to 30ml/min/1.73m squared).
Contraindications
Children under 3 years
Benign prostatic hyperplasia
Breastfeeding
Gastrointestinal obstruction
Glaucoma
Myasthenia gravis
Paralytic ileus
Pregnancy
Pyloric stenosis
Severe renal impairment
Ulcerative colitis
Urinary retention
Precautions and Warnings
Diarrhoea
Pyrexia
Atherosclerosis
Brain neoplasm
Cardiac arrhythmias
Cardiac surgery
Cardiorespiratory insufficiency
Chronic constipation
Encephalitis
Galactosaemia
Gastroesophageal reflux
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Hypertension
Hyperthyroidism
Lactose intolerance
Mild renal impairment
Myocardial infarction
Tachycardia
Uraemia
Reduce dose in patients with mild renal impairment
Reduce dose in patients with moderate renal impairment
Advise patient blurred vision may affect ability to drive/operate machinery
Advise patient dizziness may affect ability to drive or operate machinery
Treatment to be initiated and supervised by a specialist
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Some formulations contain propylene glycol
Monitor patients for behavioural changes
Advise patients/carers to seek medical advice if changes in behaviour/mood
Advise to stop treatment and report if anticholinergic side effects
Decreased salivary secretions may lead to dental caries
May cause heat prostration when used in high environmental temperatures
Discontinue if patient develops respiratory symptoms
Only recommended for short term use
Female: Ensure adequate contraception during treatment
Advise patient on need for adequate dental hygiene & regular dental checks
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.
Advise the carer to measure the pulse rate if the child seems unwell and report very fast or very slow heart rate.
Pregnancy and Lactation
Pregnancy
Glycopyrronium bromide is contraindicated during pregnancy.
The manufacturer advises that this medication is not recommended in pregnancy and that effective contraception should be considered prior to treating women of childbearing age. There is no or limited data from the use of glycopyrronium bromide in pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Lactation
Glycopyrronium bromide is contraindicated during breastfeeding.
The manufacturer advises that this medication is not recommended during breastfeeding. No data are available on its transfer into human milk, but 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, it is very remote that glycopyrronium bromide would pose a significant risk to a breastfeeding infant (Hale 2014).
Counselling
Advise patient/carer that high fat foods should be avoided.
Advise patient/carer to stop treatment and seek medical advice if anticholinergic side effects such as constipation, urinary retention, pneumonia, allergic reaction, pyrexia or changes in behaviour occur.
Advise patient/carer that it is important that patients receive adequate daily dental hygiene and regular dental health checks.
Ensure adequate contraception prior to treating women of childbearing age, where appropriate.
Advise patient that side effects such as blurred vision or dizziness may affect the ability to drive or operate machinery.
Side Effects
Agitation
Allergic reaction
Angioedema
Arrhythmias
Attention disturbances
Behavioural disturbances
Bradycardia
Constipation
Decreased bronchial secretions
Decreased sweating
Dehydration
Diarrhoea
Difficulty in micturition
Dilatation of pupils
Disturbances in accommodation
Dizziness
Drowsiness
Dry mouth
Dry skin
Epistaxis
Flushing
Frustration
Gastro-intestinal motility decreased
Glaucoma (closed angle)
Headache
Hives
Hyperactivity
Insomnia
Irritability
Mood changes
Mydriasis
Nasal congestion
Nausea
Nystagmus
Oesophageal candidiasis
Otitis media
Palpitations
Pharyngitis
Photophobia
Pneumonia
Pseudo-obstruction of the large intestine
Rash
Restlessness
Rise in body temperature
Seizures
Sinusitis
Tachycardia
Temper tantrum
Thirst
Unpleasant breath
Upper respiratory tract infection
Urinary retention
Urinary tract infections
Urinary urgency
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: October 2021
Reference Sources
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Summary of Product Characteristics: Assicco 1mg Tablets. Morningside Healthcare Ltd. Revised March 2021.
Summary of Product Characteristics: Assicco 2mg Tablets. Morningside Healthcare Ltd. Revised March 2021.
Summary of Product Characteristics: Glycopyrronium Bromide 1mg/5ml oral solution. Colonis Pharma Limited. Revised September 2021.
Summary of Product Characteristics: Glycopyrronium Bromide 1mg Tablets. Morningside Healthcare Ltd. Revised March 2021.
Summary of Product Characteristics: Glycopyrronium Bromide 2mg Tablets. Morningside Healthcare Ltd. Revised March 2021.
Summary of Product Characteristics: Sialanar 320 micrograms/ml Oral Solution. Proveca Pharma Limited. Revised July 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 08 November 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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