Compounded glycopyrrolate is a compelling choice for drooling children: five years of facility experience

Ital J Pediatr. 2021 Nov 6;47(1):222. doi: 10.1186/s13052-021-01173-7.

Abstract

Background: Describe the efficacy of a galenic glycopyrrolate formulation and its impact on patients with sialorrhea Quality of Life (QoL), including costs analysis.

Methods: We performed a retrospective observational study on 21 patients who received a custom-formulated galenic glycopyrrolate syrup for sialorrhea for an average period of 14.3 months. We analyzed the telephone interviews with elaborated and validated questionnaires and the therapy costs comparing the brand marketed drug with the galenic formulation.

Results: Overall, 16 out of 21 patients (76.2%) reported a significant improvement in sialorrhea and QoL. In 14 subjects (66.7%), there was a remarkable decrease in the drooling severity; 10 individuals (47.6%) reported a reduction in drooling frequency. Nine patients experienced at least one adverse effect of glycopyrrolate therapy, and three of them stopped the treatment. No severe side effects were observed. The galenic drug significantly reduced costs for patients.

Conclusions: An oral glycopyrrolate solution easily administered to children with brain injuries is not commercially available in many European countries. This study demonstrates the efficacy of a compounded glycopyrrolate syrup on drooling severity, frequency and ensures a better QoL in patients and their caregivers.

Keywords: Compounded drug; Drooling; Galenic; Glycopyrrolate; Sialorrhea.

Publication types

  • Observational Study

MeSH terms

  • Administration, Oral
  • Adolescent
  • Child
  • Child, Preschool
  • Female
  • Glycopyrrolate / therapeutic use*
  • Humans
  • Male
  • Muscarinic Antagonists / therapeutic use*
  • Quality of Life
  • Retrospective Studies
  • Sialorrhea / drug therapy*
  • Young Adult

Substances

  • Muscarinic Antagonists
  • Glycopyrrolate