Active or Salt Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4 Dose Level 5
320 µg/ml glycopyrronium (~12.8µg/kg) (~25.6µg/kg) (~38.4µg/kg) (~51.2µg/kg) (~64µg/kg)
400 µg/ml (2mg/5ml)
glycopyrronium bromide
(~16.0µg/kg) (~32.0µg/kg) (~48.0µg/kg) (~64.0µg/kg) (~80.0µg/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 dose for this weight/dose level

The table below shows the dose of glycopyrronium bromide in milligrams for each 0.2mls of Sialanar.

mls of Sialanar mg of glycopyrronium
bromide
    mls of Sialanar mg of glycopyrronium
bromide
0.2 0.08 3.2 1.28
0.4 0.16 3.4 1.36
0.6 0.24 3.6 1.44
0.8 0.32 3.8 1.52
1.0 0.40 4.0 1.60
1.2 0.48 4.2 1.68
1.4 0.56 4.4 1.76
1.6 0.64 4.6 1.86
1.8 0.72 4.8 1.92
2.0 0.80 5.0 2.00
2.2 0.88 5.2 2.08
2.4 0.96 5.4 2.16
2.6 1.04 5.6 2.24
2.8 1.12 5.8 2.32
3.0 1.20 6.0 2.40

 

Paediatric population – children and adolescents aged 3 years and older

To effectively treat the symptoms of severe chronic drooling whilst managing potential side effects, Sialanar should be started at a low dose based on the weight of the child, starting with approximately 12.8 micrograms/kg glycopyrronium per dose (equivalent to 16 micrograms/kg glycopyrronium bromide per dose). This should be given three times per day, increasing by the doses shown in the table below 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 64 micrograms/kg body weight glycopyrronium or 6 ml (1.9 mg glycopyrronium, equivalent to 2.4 mg glycopyrronium bromide) three times a day, whichever is less. Dose titrations should be conducted in discussion with the carer to assess both efficacy and undesirable effects until an acceptable maintenance dose is achieved.