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

Interactions
PK
Renal impairment
References

Atropine

Generic name
Atropine
Brand name
ATC Code
A03BA01

Pharmacokinetics in children

The following pharmacokinetic parameters were found in 13 children (1 month – 10 years) after a single intravenous dose of 0.02 mg/kg atropine (Virtanen 1982):

Mean (± SD)

1 month - <2 years      (n=7)

>2 – 10 years       (n=6)

t½ (h)

6,9 ± 3,3

2,5 ± 1,2

Cl (ml/min/kg)

6,8 ± 5,3

6,5 ± 0,5

Vd (l/kg)

3,2 ± 1,5

1,3 ± 0,5

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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

Sinus bradycardia and/or AV block
  • Intravenous
    • Premature neonates Gestational age < 37 weeks
      [3] [11]
      • (Atropinesulphate monohydrate) 0.02 mg/kg/dose, once only. Max single dose: 0.5 mg/dose.
    • Term neonate
      [3] [6] [7] [11]
      • (Atropinesulphate monohydrate) 0.02 mg/kg/dose, once only. Max single dose: 0.5 mg/dose.
    • 1 month up to 18 years
      [2] [3] [6] [7] [11]
      • (Atropinesulphate monohydrate) 0.02 mg/kg/dose, once only. Max: 1mg/day Max single dose: 0.5 mg/dose.
Premedication
  • Oral
    • 1 month up to 18 years
      • 30-60 min prior to the procedure 0.01 - 0.02 mg/kg/dose, once only. Max single dose: 0.6 mg/dose.
  • Intravenous
    • 1 month up to 18 years
      [4] [5] [7]
      • (Atropinesulphate monohydrate) 30-60 min before the procedure 0.01 - 0.02 mg/kg/dose, once only. Max: 0.6 mg/dose.
    • Premature and Term neonate
      [6] [7] [9] [20]
      • (Atropinesulphate monohydrate) 0.01 - 0.02 mg/kg/dose, once only. Max: 0.6 mg/dose.
  • Intramuscular
    • Term neonate
      [6] [7]
      • (Atropinesulphate monohydrate) 30-60 min before the procedure 0.01 - 0.02 mg/kg/dose, once only. Max: 0.6 mg/dose.
    • 1 month up to 18 years
      [4] [5]
      • (Atropinesulphate monohydrate) 30-60 min before the procedure 0.01 - 0.02 mg/kg/dose, once only. Max: 0.6 mg/dose.
  • Subcutaneous
    • 1 month up to 18 years
      [4] [5]
      • (Atropinesulphate monohydrate) 30-60 minutes before the procedure 0.01 - 0.02 mg/kg/dose, once only. Max: 0.6 mg/dose.
Spasmolytic agent
  • Oral
    • 1 month up to 18 years
      • 0.01 mg/kg/dose, as required every 4-6 hours. Max single dose: 0.4 mg/dose.
  • Intramuscular
    • 1 month up to 18 years
      • (Atropinesulphate monohydrate) 0.01 mg/kg/dose, as required every 4-6 hours. Max single dose: 0.4 mg/dose.
  • Subcutaneous
    • 1 month up to 18 years
      • (Atropinesulphate monohydrate) 0.01 mg/kg/dose, as required every 4-6 hours. Max single dose: 0.4 mg/dose.
  • Intravenous
    • 1 month up to 18 years
      • (Atropinesulphate monohydrate)  0.01 mg/kg/dose, as required every 4-6 hours. Max single dose: 0.4 mg/dose.
Antagonize organic phosphate compounds and (acetyl)cholinesterase inhibitors
  • Intravenous
    • Term neonate
      [6] [7] [15] [17] [18]
      • (Atropinesulphate monohydrate) 0.02 mg/kg/dose, as required may be repeated every 10-15 min if necessary until signs and symptoms disappear.
    • 1 month up to 18 years
      [5]
      • (Atropinesulphate monohydrate) 0.05 mg/kg/dose, as required may be repeated every 10-30 min if necessary until signs and symptoms disappear. Max single dose: 2 mg/dose.
  • Intramuscular
    • 1 month up to 18 years
      [5]
      • (Atropinesulphate monohydrate) 0.05 mg/kg/dose, as required repeat every 10-30 minutes until signs and symptoms disappear.. Max single dose: 2 mg/dose.
Postoperative in combination with neostigmine (to limit its muscarine effects)
  • Intravenous
    • Term neonate
      [6] [7]
      • (Atropinesulphate monohydrate) 0.02 mg/kg/dose, once only. Lower doses possibly thereafter, depending on the clinical picture.
    • 1 month up to 2 years
      • (Atropinesulphate monohydrate) 0.2 mg/dose, once only. Lower doses possibly thereafter, depending on the clinical picture.
    • 2 years up to 4 years
      • (Atropinesulphate monohydrate) 0.3 mg/dose, once only. Lower doses possibly thereafter, depending on the clinical picture.
    • 4 years up to 10 years
      • (Atropinesulphate monohydrate) 0.6 mg/dose, once only. Lower doses possibly thereafter, depending on the clinical picture.
    • 10 years up to 18 years
      • (Atropinesulphate monohydrate) 1 mg/dose, once only. Lower doses possibly thereafter, depending on the clinical picture.

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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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

Hyperthermia may occur in infants and young children due to inhibition of sweat secretion and central disorder of thermoregulation even at therapeutic dosages [SmPC].

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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

Caution is needed in neonates and infants due to higher susceptibility to the side effects, as are patients with Down syndrome.

In febrile patients, especially in children, and when the air temperature is high, special care should be taken when using atropine sulfate, as hyperthermia may occur more quickly.

Infants, children and children with spastic paralysis or brain damage or children with Down syndrome could be susceptible to antimuscarinic effects [SmPC].

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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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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-formularium voor Kinderen, 2007
  2. de Caen AR et al., Pediatric Advanced Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Circulation, 2015, Nov 3;132(18 Suppl 2), S526-42
  3. Werkgroep Neonatale Farmacologie NVK sectie Neonatologie, Expert opinie, 28 maart 2018
  4. Laboratoire Aguettant, SmPC Atropinsulfat Aguettant 0,1 mg/ml Inj.lsg. in Fspr. (1-36431), 10/2015
  5. Takeda, SmPC Atropinsulfat “Nycomed” 0,5 mg Amp. (3087), 08/2018
  6. Laboratoire Aguettant, SmPC Atropinesulfate 0,1 mg.ml (RVG 116913) 20-02-2019, www.geneesmiddeleninformatiebank.nl
  7. Accord Healthcare B.V., SmPC Atropinesulfate 0,1 mg.ml (RVG 124780) 29-10-2020, www.geneesmiddeleninformatiebank.nl
  8. Lemyre B, et al., Atropine, fentanyl and succinylcholine for non-urgent intubations in newborns., Arch Dis Child Fetal Neonatal Ed, 2009, 94(6), F439-42
  9. Kelly MA, Finer NN., Nasotracheal intubation in the neonate: physiologic responses and effects of atropine and pancuronium., J Pediatr., 1984, 105(2), 303-9
  10. Jones P, et al. , Atropine for critical care intubation in a cohort of 264 children and reduced mortality unrelated to effects on bradycardia., PLoS One, 2013, 8(2), e57478
  11. Van de Voorde P, et al. , European Resuscitation Council Guidelines 2021: Paediatric Life Support., Resuscitation, 2021, 161, 327-87
  12. Chang SL, et al., Atropine use may lead to post-operative respiratory acidosis in neonates receiving ductal ligation: A retrospective cohort study., Pediatr Neonatol., 2018, 59(2), 136-40
  13. Rizzi RR, Ho J. , Post resuscitation central anticholinergic syndrome, Resuscitation, 2004, 61(1), 101-2
  14. Barrington KJ., The myth of a minimum dose for atropine, Pediatrics, 2011, 127(4), 783-4
  15. Jajoo M, et al., Transplacentally acquired organophosphorus poisoning in a newborn: case report., Ann Trop Paediatr., 2010, 30(2), 137-9
  16. Durrmeyer X, et al. , Assessment of atropine-sufentanil-atracurium anaesthesia for endotracheal intubation: an observational study in very premature infants. , BMC Pediatr., 2014, 14, 120
  17. Das JC, et al., Organophosphorus Compounds Poisoning in a Neonate: A Case Report., Mymensingh Med J., 2019, 28(2), 470-3
  18. O'Reilly DA, et al., Organophosphate poisoning in a 12-day-old infant: case report. , Ann Trop Paediatr., 2011, 31(3), 263-7
  19. Virtanen R, et al., Pharmacokinetic Studies on Atropine with Special Reference to Age. , Acta Anaesthesiologica Scandinavica, 1982, 26(4), 297-300
  20. Andriessen P, et al. , Cardiovascular autonomic regulation in preterm infants: the effect of atropine., Pediatr Res, 2004, 56(6), 939-46
  21. Barois J, Tourneux P. , Ketamine and atropine decrease pain for preterm newborn tracheal intubation in the delivery room: an observational pilot study., Acta Paediatr. , 2013, 102(12), e534-8
  22. Barrington KJ, et al., Succinylcholine and atropine for premedication of the newborn infant before nasotracheal intubation: a randomized, controlled trial., Crit Care Med, 1989, 17(12), 1293-6
  23. Bourgoin L, et al., Administering atropine and ketamine before less invasive surfactant administration resulted in low pain scores in a prospective study of premature neonates, Acta Paediatr, 2018, 107(7), 1184-90
  24. Oei J, et al., Facilitation of neonatal nasotracheal intubation with premedication: a randomized controlled trial., J Paediatr Child Health, 2002, 38(2), 146-50
  25. Truong L, et al., Haemodynamic effects of premedication for neonatal intubation: an observational study., Arch Dis Child Fetal Neonatal Ed., 2020, 105(2), 123-7
  26. Venkatesh V, et al., Endotracheal intubation in a neonatal population remains associated with a high risk of adverse events. , Eur J Pediatr., 2011, 170(2), 223-7
  27. Zemlin M, et al., Different Effects of Two Protocols for Pre-Procedural Analgosedation on Vital Signs in Neonates during and after Endotracheal Intubation., Klin Padiatr, 2021, 233(4), 181-8
  28. Gillick JS. , Atropine toxicity in a neonate., Br J Anaesth, 1974, 46(10), 793-4
  29. Ross EL, et al., Development of recommendations for dosing of commonly prescribed medications in critically ill obese children., American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2015, 72(7), 542-56

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Changes

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