Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Glycopyrronium

Generic name
Glycopyrronium
Brand name
ATC Code
A03AB02

Pharmacokinetics in children

The kinetics of glycopyrronium in children aged > 2 months do not depend on the age. There is high inter-individual variability [Rautakorpi 1994, Rautakorpi 1998]

IV 5 µg/kg

  t½ (min) Vd (l/kg) Cl (l/kg/hour)
> 2 months 46.7–129.5 (28–634.1) 1.3–1.8 (0.7–3.9) 1.01–1.41 (0.32–2.22)

 Oral - 50 µg/kg

  Cmax (µg/l) Tmax (min) F (%)
7-14 years 0.37 90 3.3

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Excess salivation: treatment with RYBRILA
  • Oral
    • 2 months up to 18 years
      • Initial dose: Glycopyrronium: 48 microg./kg/day in 3 doses. Max single dose: 2.4 mg/dose.
      • Maintenance dose: increase every 5-7 days depending on the effect and tolerance with dose increments of 48 microg./kg/day to 96 - 240 microg./kg/day in 3 doses. Max: 7.2 mg/day. Max single dose: 2.4 mg/dose.

      •  

         

    • 2 months up to 18 years
      [2] [3] [4] [5] [7] [8] [9] [13] [14] [15] [16] [19]
      • Initial dose: Glycopyrronium: 48 microg./kg/day in 3 doses. Max single dose: 2.4 mg/dose.
      • Maintenance dose: increase every 5-7 days depending on the effect and tolerance with dose increments of 48 microg./kg/day to 96 - 240 microg./kg/day in 3 doses. Max: 7.2 mg/day. Max single dose: 2.4 mg/dose.

      •  

         
As anticholinergic treatment: pre-operative, intra-operative
  • Intramuscular
    • 1 month up to 12 years
      • Glycopyrroniumbromide: 4 - 8 microg./kg/dose, as required repeat intra-operatively as an intravenous administration. Max single dose: 200 microg./dose.
    • 12 years up to 18 years
      • Glycopyrroniumbromide: 4 - 5 microg./kg/dose, as required repeat intra-operatively as an intravenous administration. Max single dose: 400 microg./dose.
  • Intravenous
    • 1 month up to 12 years
      • Glycoppyroniumbromide: 4 - 8 microg./kg/dose, as required repeat intra-operatively. Max single dose: 200 microg./dose.
    • 12 years up to 18 years
      • Glycoppyroniumbromide: 4 - 5 microg./kg/dose, as required repeat intra-operatively. Max single dose: 400 microg./dose.
CAUTION:
  • Oral
    • 0 years up to 18 years

      • The products Sialanar and Rybrila are NOT interchangeable due to a difference in bioavailability. The bioavailability of Sialanar is 20% higher than that of Rybrila. This has implications for dosing recommendations .

        Both products have different concentrations and thus the volume to be administered per dose is different. This may be relevant in children with swallowing difficulties. 

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Renal impaiment in children > 3 months

If the GFR is < 30 ml/min/1.73m², the risk of anticholinergic side effects is increased. Lowering the dose may be necessary.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Oral administration:

Very common (≥ 10%): irritability. Excessive flushing. Nasal congestion, decreased bronchial secretion. Dry mouth, vomiting, diarrhea, constipation. Urinary retention.

Common (1-10%): upper respiratory tract infection, pneumonia. urinary tract infection. Agitation, feeling drowsy. Nosebleed. Skin rash. Fever.

Uncommon (0.1-1%): headache, nystagmus. Mydriasis. Halitosis, esophageal candidiasis, disturbed gastrointestinal motility, pseudo-obstruction. Dehydration, thirst.

Further reported: restlessness, overactive behavior, concentration disorder, shyness, anxiety, feeling sad, crying, frustration, tantrum, mood changes, insomnia. Closed-chamber glaucoma, photophobia, dry eyes. Temporary bradycardia. Sinusitis. Nausea. Dry skin, decreased perspiration. Micturition urge. Hypersensitivity reaction, angioedema. Decrease in neutrophils, erythrocytes, monocytes, creatinine, carbon dioxide, bicarbonate.



Following intravenous or intramuscular administration:
Malignant hyperthermia and especially in children: cardiac arrhythmias (including bradycardia, ventricular tachycardia and ventricular fibrillation), cardiac arrest, hypertension, hypotension, convulsions and respiratory arrest have been reported.

Boriosi et al. 2022 describes a higher prevalence of airway obstruction, emergency airway intervention and laryngospasm when an anticholinergic (glycopyrronium or atropine) is used compared to no anticholinergic in paediatric procedural sedation.

 

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Children under the age of 1 year and children with Down's syndrome, spastic paralysis or brain damage can be particularly sensitive to anticholinergic effects. Monitor carefully in patients with kidney damage due to the prolonged clearance. Paradoxical excitation can occur in young children.
The injection contains benzyl alcohol.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Synthetic anticholinergics, esters with tertiary amino group
A03AA04
Other drugs for functional gastrointestinal disorders
A03AX15
A03AX13

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References

  1. Rautakorpi P, et al, Pharmacokinetics of glycopyrrolate in children, J Clin Anesth, 1994, May-Jun;6(3), 217-20
  2. Mier RJ, et al, Treatment of sialorrhea with glycopyrrolate.A double-blind, dose-ranging study, Arch Pediatr Adolesc Med, 2000, Dec;154(12), 1214-8
  3. Bachrach SJ, et al, Use of glycopyrrolate and other anticholinergic medications for sialorrhea in children with cerebral palsy, Clin Pediatr (Phila, 1998, Aug;37(8), 485-90
  4. Tscheng DZ, Sialorrhea - therapeutic drug options, Ann Pharmacother, 2002, Nov;36(11), 1785-90
  5. Blasco PA, et al, Glycopyrrolate treatment of chronic drooling, Arch Pediatr Adolesc Med, 1996, Sep;150(9), 932-5
  6. Annila P, et al, Effect of pre-treatment with intravenous atropine or glycopyrrolate on cardiac arrhythmias during halothane anaesthesia for adenoidectomy in children, Br J Anaesth, 1998, Jun;80(6), 756-60
  7. Swart EL, Welk middel heeft de voorkeur bij de behandeling van speekselvloed, Apothekers Vademecum, 2002
  8. Koopmann M, Als de vloed tot wanhoop drijft: medicamenteuze behandeling van hypersalivatie, een literatuuroverzicht, Pharm Weekbl, 2004, Jul:139(27/28), 942-945
  9. Mikart Inc, FDA label Cuvposa (10-2015), www.cuvposa.com
  10. Anpharm Ltd, SPC Robinul (UK) (10-2012), www.mhra.gov.uk
  11. Rautakorpi P et al. , Pharmacokinetics and oral bioavailability of glycopyrrolate in children. , Pharmacol Toxicol., 1998, Sep;83(3), 132-4
  12. Eiland LS et al., Glycopyrrolate for chronic drooling in children., Clin Ther., 2012, Apr;34(4), 735-42
  13. Evatt ML et al. , Oral glycopyrrolate for the treatment of chronic severe drooling caused by neurological disorders in children. , Neuropsychiatr Dis Treat., 2011, 7, 543-7
  14. Garnock-Jones KP et al., Glycopyrrolate oral solution: for chronic, severe drooling in pediatric patients with neurologic conditions., Paediatr Drugs., 2012, Aug 1;14(4), 263-9
  15. Zeller RS et al., Randomized Phase III evaluation of the efficacy and safety of a novel glycopyrrolate oral solution for the management of chronic severe drooling in children with cerebral palsy or other neurologic conditions., Ther Clin Risk Manag., 2012, 8, 15-23
  16. Zeller RS et al., Safety and efficacy of glycopyrrolate oral solution for management of pathologic drooling in pediatric patients with cerebral palsy and other neurologic conditions., Ther Clin Risk Manag., 2012, 8, 25-32
  17. Proveca Pharma Limited, SmPC Sialanar (EU/1/16/1135/001-2) 15-04-2019
  18. Boriosi et al., Anticholinergics and serious adverse events in pediatric procedural sedation: a report of the Pediatric Sedation Research Consortium, Paediatr Anaesth, 2022
  19. Clinigen Healthcare B.V., SmPC Rybrila (RVG 125858) 15-10-2021, www.geneesmiddeleninformatiebank.nl
  20. Martindale Pharma, an Ethypharm Group Company, SmPC Glycopyrronium Bromide 200 micrograms/ml Solution for Injection (UK) 05-11-2019, https://www.medicines.org.uk/emc
  21. European Medicins Agency, EPAR Sialanar (EMEA/H/C/003883/0000), www.ema.europa.eu, 21 July 2016
  22. Rautakorpi P et al., Pharmacokinetics and oral bioavailability of glycopyrrolate in children., Pharmacol Toxicol., 1998, Sep;83(3), 132-4
  23. Evatt ML et al., Oral glycopyrrolate for the treatment of chronic severe drooling caused by neurological disorders in children., Neuropsychiatr Dis Treat., 2011, 7, 543-7

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Changes

Changes