Dosing and Titration

Sialanar® is licensed for the symptomatic treatment of severe sialorrhoea in children and adolescents aged 3 years and older with chronic neurological disorders.1

Patients should start titration from dose level 1, increasing every 7 days until efficacy is balanced with undesirable effects1

  • The dosing schedule is based upon the weight of the child, starting with dose level 1 at 16mcg/kg per dose glycopyrronium bromide three times per day, then increasing the dose as per doses shown every 7 days
  • Dose titration should be continued until efficacy is balanced with undesirable effects and amended up or down, as appropriate, to a maximum individual dose of 80mcg/kg glycopyrronium bromide or 6ml (2.4mg glycopyrronium bromide) TDS
  • Doses should be reduced by 30% in patients with mild to moderate renal impairment (eGFR <90 - ≥30 ml/min/1.73m2) as per doses shown here
  • Undesirable effects may be minimised by using the lowest effective dose necessary to control symptoms
Titration schedule based on a 30kg child

Dose titrations should be conducted in discussion with the carer to assess both efficacy and undesirable effects until an acceptable maintenance dose is achieved.

Dose level should be titrated up until drooling is appropriately managed but reduced in the event of a known anticholinergic reaction.

BNFC Guidance on glycopyrronium bromide2
  • Oral preparations are not interchangeable on a microgram-for-microgram basis due to differences in bioavailability.
  • Sialanar® oral solution has approximately 25% higher bioavailability and therefore equivalent doses will be lower than for tablets and generic oral solutions.
  • The prescriber should state the specific branded or generic oral preparation to be used.

To ensure your patients receive a product designed for children, prescribe as Sialanar®

Dose Timing
  • Sialanar® should be administered three times per day:
    • Dose 1 – Morning
    • Dose 2 – Afternoong
    • Dose 3 – Evening
  • 1 hour before mealtime OR 2 hours after OR at consistent times with respect to food intake

References

  1. Sialanar® SmPC (January 2023) https://www.medicines.org.uk/emc/product/2301 – accessed August 2023
  2. BNFC Glycopyrronium Bromide https://bnfc.nice.org.uk/drugs/glycopyrronium-bromide/ - accessed August 2023 

UK-SIA-23-0110 | August 2023

Reporting of side effects

UK
If you/your child experience(s) any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. 

Republic of Ireland
If you/your child experience(s) any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. Adverse event should be reported, reporting forms and information can be found at: www.hpra.ie.

By reporting side effects, you can help provide more information on the safety of this medicine.

Side effects should also be reported to Proveca Limited.
Phone: +44 333 200 1866 E-Mail: medinfo@proveca.com

You are now leaving a Proveca website.

Proveca are not responsible for the content on this website.

Continue

This website is for UK and ROI Healthcare Professionals

By entering this site, you are confirming that you are a UK or ROI Healthcare Professional. This site contains promotional information.

I am a UK or ROI Healthcare Professional I am a patient or parent/carer of a patient prescribed Sialanar in the UK or ROI I am a member of the public
UK-SIA-23-0102 | August 2023