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Prescribing Information

Rybrila 160 micrograms/ml Oral Solution (glycopyrronium)

Rybrila is licensed for the symptomatic treatment of severe sialorrhoea in children and adolescents aged 3 years and older with chronic neurological disorders.9

Click below for prescribing information for Rybrila 160 micrograms/ml Oral Solution (glycopyrronium).
Strawberry Flavour
Lactose Free9
Ethanol Free9

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Glycopyrronium bromide is used for the treatment of sialorrhoea in children and young people with neurological disorders. There have been several studies looking into the efficacy and safety of glycopyrronium.

  • Drooling Reduction Intervention randomised trial (DRI): Comparing the efficacy and acceptability of hyoscine patches and glycopyrronium liquid on drooling in children with neurodisability
    Parr et al., 2018. DOI: 10.1136/ archdischild-2017-313763
  • Safety and efficacy of glycopyrrolate oral solution for management of pathologic drooling in paediatric patients with cerebral palsy and other neurologic conditions
    Zeller et al., 2012. DOI: 10.2147/TCRM.S27362
  • Treatment of sialorrhea with glycopyrrolate: A double-blind, dose-ranging study
    Mier et al., 2000. DOI:10.1001/archpedi.154.12.1214
  • Randomized Phase III evaluation of the efficacy and safety of a novel glycopyrrolate oral solution for the management of chronic severe drooling in children with cerebral palsy or other neurologic conditions
    Zeller et al., 2012. DOI: 10.2147/TCRM.S26893
  • Anticholinergic medications for reducing drooling in children with developmental disability
    Reid et al., 2019. DOI: 10.1111/dmcn.14350
Rybrila is licensed for oral use and use with nasogastric or PEG tubes9
Due to its tolerability profile, glycopyrronium bromide liquid should be prescribed first choice for the treatment of severe sialorrhoea.23
Parr et al. (2018) and Reid et al. (2019) found that glycopyrronium presented fewer problematic side effects compared to alternative anticholinergic medications.23,26 Thus, glycopyrronium had a lesser chance of treatment cessation.23
Children’s bodies grow and develop rapidly, which can alter the way they react to certain medications.12
Therefore, treatment formulations that offer flexible dosing may be required. Liquid formulations provide maximal dosing flexibility, and it is possible to use a single formulation over a wide age range in children.4
Rybrila allows flexible dosing and simple administration.
cartoon family of children, parent or carer and grandparent all smiling

Product Characteristics

Mechanism of Action

Anticholinergic (antimuscarinic)

Excipients

Glycerol, Sorbitol (E420), Sodium methyl parahydroxybenzoate (E219), Sodium propyl parahydroxybenzoate (E217), Citric acid monohydrate (E330), Trisodium citrate dihydrate (E331), Purified water
Strawberry flavour: Flavouring substance, Maltodextrin (maize), Acacia (E414), Triacetin (E1518)

Flavour

Strawberry

Pharmaceutical Form

Oral Solution

Shelf Life

24 months. Once opened, the product may be stored for up to 28 days at a maximum of 25°C. Other in use storage times and conditions are the responsibility of the user

Suitability For Feeding Tubes

PEG and Nasogastric

Appearance

Clear and colourless

Storage Conditions

Store below 25°C. Store in the original bottle. Keep bottle in the original carton in order to protect from light

Dosing Calculator

Click on the patient’s weight below to find the recommended Rybrila dose

13-17kg

    Dose level 1 (~16 µg/kg)*
  • 1.5 ml
    Dose level 2 (~32 µg/kg)*
  • 3 ml
    Dose level 3 (~48 µg/kg)*
  • 4.5 ml
    Dose level 4 (~64 µg/kg)*
  • 6 ml
    Dose level 5 (~80 µg/kg)*
  • 7.5 ml

*refers to µg/kg Glycopyrronium

A graduated syringe is provided in each pack of Rybrila to assist with dosing.

The dosage must be measured and administered with the graduated syringe.

Dosing should be reduced in mild to moderate renal impairment (severe renal impairment is a contraindication) - see SmPC for details.

Rybrila should be given at least one hour before or two hours after meals. If the patient’s specific needs determine that co-administration with food is required, see SmPC for details.

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