Sialanar® is an oral solution for children and adolescents aged 3 years and older with chronic neurological disorders for the management of chronic pathological drooling (severe sialorrhoea).1

It has raspberry flavouring, a titration schedule based upon patient’s weight and is suitable for administration orally and via feeding tubes.1

Designed for Children

Tailored titration for flexible and accurate dosing1

60% less volume vs.1mg/5ml glycopyrronium oral solutions, helping to improve patient acceptability and tolerability1-5

Minimal excipients to reduce toxicity risk - sugar, alcohol and sorbitol free 1,7,8

Why is volume important?
  • The dose volume is a major consideration for the acceptability of a liquid formulation6
  • The maximum recommended single dosing volume for paediatric liquid formulations for typically developing children is <5ml for children under 5 years and <10ml for children of 5 years and older5
  • Initial research suggests even Cerebral Palsy patients at EDACs level I may have a reduced dysphagia limit in comparison to typically developing children, with a median of 7ml.10
  • Eating, drinking and swallowing difficulties (dysphagia) are common in children with neurodisability6

Sialanar® is designed for children and has the lowest volumes for equivalent doses of any licensed glycopyrronium bromide oral solution.1-4

Why are excipients important?
  • Excipients are a necessary component of almost all medicines, but they may be present in quantities which are potentially harmful to babies and children6
  • Excipients used in adult formulations may not be appropriate for paediatric use so have the potential to lead to adverse effects8
  • Oral doses of sorbitol which are greater than 140mg/kg/day may result in increased gastrointestinal (GI) side effects, including osmotic diarrhoea, abdominal pain, bloating and GI discomfort7,8

Watch the excipients animation

Sialanar® is designed for children, using sucralose as a sweetener instead of sorbitol2,3,4 and is suitable for patients on a ketogenic diet (<5mg/ml carbohydrate)1,11

Why is treating drooling important?

Sialorrhoea can cause significant clinical problems and negatively impact quality of life for patients and carers12,13


Physical consequences

  • Posterior sialorrhoea: can lead to aspiration, increasing the risk of respiratory infections, hospitalisations and mortality14-16

  • Anterior sialorrhoea: can cause infections, macerated skin, interference with feeding and dehydration13

  • Aspiration can develop silently so may not be diagnosed prior to development of more serious lung issues14
  • Respiratory illness is the leading cause of hospitalisations and mortality in young people with cerebral palsy, 25% of patients (4-5 GMFCS) suffer from chronic respiratory problems16,17


Management of sialorrhoea is recommended to reduce risk factors for aspiration, helping to prevent further respiratory illness15

Psychosocial concerns

  • Social embarrassment, isolation and low self-esteem
  • Increased dependency and level of care
  • Barriers to education (damage and inability to share books / computers)

Resources

Visit the resources section to find product support materials for patients/carers and educational resources for healthcare professionals.
Resources

References

  1. Sialanar® SmPC (January 2023) https://www.medicines.org.uk/emc/product/2301 – accessed August 2023
  2. Glycopyrronium Bromide 1 mg/5 ml Oral Solution (Colonis Pharma) SmPC (September 2021) https://www.medicines.org.uk/emc/product/7344/smpc#gref - accessed August 2023
  3. Glycopyrronium Bromide 1 mg/5 ml Oral Solution (Rosemont Pharmaceuticals Limited) SmPC (December 2021) https://www.medicines.org.uk/emc/product/13136/smpc – accessed August 2023
  4. Glycopyrronium Bromide 1 mg/5 ml Oral Solution (Strandhaven Limited t/a Somex Pharma UK Limited) SmPC (July 2022) https://www.medicines.org.uk/emc/product/14104/smpc – accessed August 2023
  5. Batchelor H & Marriot J. BJCP 2015. Formulations for Children: Problems and Solutions https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.12268 ) - accessed August 2023
  6. NPPG Positioning statement 2020-21 available at http://nppg.org.uk/choosing-an-oral-liquid-for-a-child/ - accessed August 2023
  7. Rouaz K, et al. Excipients in the paediatric population: a review. Pharmaceutics 2021; 13(3): 387.
  8. Arthur S. How to identify and manage ‘problem’ excipients in medicines for children. The Pharmaceutical Journal 2017. Available at: https://pharmaceutical-journal.com/article/ld/how-to-identify-and-manage-problem-excipients-in-medicines-for-children – accessed August 2023
  9. Taylor H, Pennington L, Craig D, et al. Children with neurodisability and feeding difficulties: a UK survey of parent-delivered interventions. BMJ Paediatrics Open 2021;5:e001095. doi:10.1136/ bmjpo-2021-001095
  10. Schepers, F. V., van Hulst, K., Spek, B., Erasmus, C. E., & van den Engel-Hoek, L. (2022). Dysphagia limit in children with cerebral palsy aged 4 to 12 years. Developmental medicine and child neurology, 64(2), 253–258. https://doi.org/10.1111/dmcn.15031
  11. Data on file
  12. Collins A, et al. Management of drooling in children with cerebral palsy. Paediatrics & Child Heath 2020. 30(12): 425-429.
  13. Güvenç I.A. Sialorrhea: A guide to etiology, assessment, and management. In (Ed.), Salivary Glands - New Approaches in Diagnostics and Treatment. IntechOpen 2018. https://doi.org/10.5772/intechopen.82619.
  14. Erasmus C.E, et al. Swallowing problems in cerebral palsy. European Journal of Pediatrics 2012; 171: 409-414.
  15. American Academy for Cerebral Palsy and Developmental Medicine. Respiratory health in cerebral palsy. Available at: https://www.aacpdm.org/publications/care-pathways/respiratory-health-in-cerebral-palsy. accessed July 2023
  16. Gibson N, et al. Prevention and management of respiratory disease in young people with cerebral palsy: consensus statement. Developmental Medicine & Child Neurology 2021; 63: 172-182.
  17. Gregson E, et al. Pseudomonas aeruginosa infection in respiratory samples in children with neurodisability-to treat or not to treat? Eur J Pediatr. 2021; 180(9): 2897-2905.
  18. Parr J.R, Todhunter E, Pennington L, et al. Drooling Reduction Intervention randomized trial (DRI): comparing the efficacy and acceptability of hyoscine patches and glycopyrronium liquid on drooling in children with neurodisability. Arch Dis Child 2017; 1-6. Doi:10. 1136/ archdischild-2017-313763.
  19. Reid S.M, et al. Anticholinergic medications for reducing drooling in children with developmental disability. Developmental Medicine & Child Neurology 2019; 63(3): 346-353

UK-SIA-23-0109 | August 2023

Please see below for information on how to report an adverse event in the UK or Republic of Ireland:

UK
Adverse events should be reported. Reporting forms and information can be found at:
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Phone: 0333 200 1866 E-Mail: medinfo@proveca.com

Republic of Ireland
Adverse events should be reported. Reporting forms and information can be found at:
www.hpra.ie. Adverse events should also be reported to proveca limited.
Phone: +44 333 200 1866 E-Mail: medinfo@proveca.com

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