Dosing table for children and adolescents with normal renal function1

  Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4 Dose Level 5
µg glycopyrronium
bromide
(~16µg/kg) (~32µg/kg) (~48µg/kg) (~64µg/kg) (~80µg/kg)
Weight (kg) ml ml ml ml ml
13-17 0.6 1.2 1.8 2.4 3*
18-22 0.8 1.6 2.4 3.2 4*
23-27 1 2 3 4 5*
28-32 1.2 2.4 3.6 4.8 6*
33-37 1.4 2.8 4.2 5.6 6*
38-42 1.6 3.2 4.8 6* 6*
43-47 1.8 3.6 5.4 6* 6*
≥48 2 4 6* 6* 6*

*Maximum individual dose in this weight range

Dosing table for children and adolescents with mild to moderate renal impairment (eGFR <90 - ≥30 ml/min/1.73m2)1

  Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4 Dose Level 5
µg glycopyrronium
bromide
(~11µg/kg) (~22µg/kg) (~34µg/kg) (~45µg/kg) (~56µg/kg)
Weight (kg) ml ml ml ml ml
13-17 0.4 0.8 1.2 1.7 2.1*
18-22 0.6 1.1 1.7 2.2 2.8*
23-27 0.7 1.4 2.1 2.8 3.5*
28-32 0.8 1.7 2.5 3.4 4.2*
33-37 1 2 2.9 3.9 4.2*
38-42 1.1 2.2 3.4 4.2* 4.2*
43-47 1.2 2.5 3.8 4.2* 4.2*
≥48 1.4 2.8 4.2* 4.2* 4.2*

*Maximum individual dose in this weight range

Please refer to the SmPC for full dosing information

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References

  1. Sialanar® SmPC (January 2023) https://www.medicines.org.uk/emc/product/2301 – accessed July 2023
  2. 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.
  3. 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-23-0111 | 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

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UK-SIA-23-0102 | August 2023