Common use of Dosage Clause in Contracts

Dosage. Child 1 month to 18 years1: The licensed dosing schedule (children of 3 years and over#) for glycopyrronium is based on the weight of the child, starting with approximately 12.8 micrograms/kg per dose three times per day and increasing by the doses listed in the SPC 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) three times a day, whichever is less. Following the dose titration period, the child's sialorrhoea should be monitored, in conjunction with the carer at no longer than 3 monthly intervals, to assess changes in efficacy and/or tolerability over time, and the dose adjusted accordingly. # Sialanar is not recommended in children below the age of 3 years since there is very limited data on the efficacy and safety of glycopyrronium in this age group Adult population - Sialanar® is indicated for the paediatric population only. There is limited clinical trial evidence on the use of glycopyrronium in the adult population with pathological drooling. Prescribers may consider the unlicensed use of Sialanar for the treatment of hypersalivation in this population following current evidence based guidance3,4 Dosing should be at ≥1 hour before or at least 2 hours after meals or at consistent times with respect to food intake. Avoid high fat food.