Glycopyrronium oral solution in 250 ml bottle, 1 ml contains 320 micrograms glykopyrronium (equivalent to 400 micrograms/ml or 2 mg/5ml glycopyrroniumbromide).
Sialanar® (320mcg/ml glykopyrronium bromide) is indicated for the treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.
Sialanar acts on the salivary glands to reduce production of saliva.
Sialanar should be prescribed by physicians experienced in the treatment of paediatric patients with neurological disorders.
Paediatric population – children and adolescents aged 3 years and older
The dosing schedule for glycopyrronium is based on the weight of the child, starting with approximately 12.8 micrograms/kg per dose (equivalent to 16 micrograms/kg per dose glycopyrronium bromide), three times per day and increasing by the doses.
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.
Undesirable effects may be minimised by using the lowest effective dose necessary to control symptoms. It is important that the carer checks the dose volume in the syringe before administration. The maximum volume of the highest dose is 6ml.
In the event of a known anticholinergic adverse event occurring when the dose is increased, the dose should be reduced to the previous lower dose and the event monitored. If the event does not resolve treatment should be discontinued. In the event of constipation, urinary retention or pneumonia treatment should be stopped and the prescribing physician contacted.
Younger children may be more susceptible to adverse events and this should be borne in mind when any dose adjustments are carried out.
Sidan uppdaterades senast 2020-10-20