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

Interactions
PK
Renal impairment
References

Acetylcysteine

Generic name
Acetylcysteine
Brand name
ATC Code
R05CB01

Pharmacokinetics in children

The following PK parameters (mean (range)) were observed in pre-term and new-born infants [Ahola 1999]:

Age GA 24,9 - 31,0 weeks (n=10) GA 25,9 - 29,7 weeks (n=6)
Dosage i.v. 3,4 - 4,6 mg/kg/h 0,3 - 1,3 mg/kg/h
Cmax - Css 161 (60 - 203) µmol/l (n=5)
Tmax - (Css reached in 50 - 70h)
t½ 11 (7.8 - 15.2) h -
Cl 37 (13 - 62) ml/kg/h 33 (20 - 42) ml/kg/h
Vd 573 (167 - 1010) ml/kg -


The PK-Parameters of NAC in pre-term infants depend markedly on weight and gestational age. The elimination of NAC is much slower in pre-term and new-borns than in adults. [Aloha 1999]

 

 

 

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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

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Dosages

Paracetamol intoxication
  • Oral
    • 1 month up to 18 years
      [3] [32]
      • Initial dose: 5% solution: 140 mg/kg/dose, once only.
      • Maintenance dose: 70 mg/kg/dose every 4 hours. The maintenance dose should be continued for at least 24 hours and until monitoring of plasma concentration (<10 mg/L) and ALAT (<50 U/L) shows that continuation of treatment is no longer necessary..

      • Intravenous administration is preferred. Only give orally if intravenous administration is not possible.

  • Intravenous
    • 1 month up to 18 years
      [1] [3] [7] [32]
      • Initial dose: 50 mg/kg/hour, continuous infusion during 2 hours. A higher starting dose of 75 mg/kg/hour during 2 hours may be considered when
        • the ingested paracetamol  ≥ 300 mg/kg or
        • paracetamol levels at 4 hours post ingestion ≥ 300 mg/L
        .
      • Maintenance dose: 20 mg/kg/hour, continuous infusion during 10 hours. Eight hours after starting the maintenance drip, determine the paracetamol concentration, INR and ALAT. Continue the maintenance treatment until all of the following conditions have been met:
        • INR: ≤ 1.3
        • ALAT: < 100 U/L and no more than doubled compared to the initial measurement
        • Paracetamol level: < 20 mg/L
        .
    • Term neonate
      [3] [21] [22] [24] [25] [28] [32]
      • Initial dose: 50 mg/kg/hour, continuous infusion during 2 hours. A higher starting dose of 75 mg/kg/uur during 2 hours may be considered when
        • the ingested paracatemol ≥ 300 mg/kg or
        • paracetamol levels at 4 hours post ingestion ≥ 300 mg/L
        .
      • Maintenance dose: 20 mg/kg/hour, continuous infusion during 10 hours. Eight hours after starting the maintenance drip, determine the paracetamol concentration, INR and ALAT. Continue the maintenance treatment until all of the following conditions have been met:
        • INR: ≤ 1.3
        • ALAT: < 100 U/L and no more than doubled compared to the initial measurement
        • Paracetamol level: < 20 mg/L
        .

      • Neonatal doses are extrapolated from older age groups.
Decrease of mucus after surgical bladder augmentation
  • Intravesical
    • 1 month up to 18 years
      • 50 - 100 ml/dose 3x daily.

      • Ad hoc recipe. 8% solution in physiological saline

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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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

For iv use rash, hives, fever, dystonic reaction, anaphylactic reactions were reported [Perry H.E. 1998, Daoud A. 2020].

For oral use anaphylactic reaction, diffuse erythema may occur [Perry H.E. 1998].

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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 in children

As a mucolytic in children younger than 2 years. Use of formulations containing aspartame in children with phenylketonuria.

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

Using acetylcysteine as a mucolytic is not recommended in children aged under 2 years because paradoxical reactions can occur (“filling up”). Mucolytics can obstruct the respiratory tract of children aged under 2 years as a result of the physiological characteristics of the respiratory tract in this age group. The ability to cough up slime may be limited.

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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. Zambon Nederland BV, SmPC Fluimucil (RVG 09988/20870/10903) 10-11-2020, www.geneesmiddeleninformatiebank.nl
  2. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  3. Nationaal Vergiftigingen Informatie Centrum, Monografie Paracetamol, https://www.vergiftigingen.info/f?p=300:1210:28308004567431:::RP,1210,1040::, Laatste update 03-03-2025
  4. Bisschops LA, et al, Intentional paracetamol intoxication in children, Ned Tijdschr Geneeskd, 2011, 155, A2132
  5. Mallet P, et al , Respiratory paradoxical adverse drug reactions associated with acetylcysteine and carbocysteine systemic use in paediatric patients: a national survey, PLoS One, 2011, 6(7), e22792
  6. Duijvestijn YC et al, Acetylcysteine and carbocysteine for acute upper and lower respiratory tract infections in paediatric patients without chronic broncho-pulmonary disease, Cochrane Database Syst Rev, 2009 , Jan 21;(1), CD003124
  7. Zambon GmbH, SmPC Fluimucil Antidot 20 % Konzentrat zur Herstellung einer Infusionslösung (8709.00.00), 03/2017, https://portal.dimdi.de/amispb/doc/2017/06/10/2108709/Oceddaae4f6144588afdc25ccbb42b9b0.pdf
  8. Zambon GmbH, SmPC Fluimucil 10 % Injektionslösung und Lösung für einen Vernebler (11577.00.00), 03/2017
  9. Hexal AG, SmPC, ACC® injekt (8371.00.00), 05/2015
  10. Fachinformation, Fluimucil Kindersaft 2 % Lösung zum Einnehmen, 03/2017
  11. Hexal, ACC® 200 mg tabs, ACC® 600 mg tabs, 02/2015
  12. Fachinformation, ACC® 200 mg Pulver zur Herstellung einer Lösung zum Einnehmen, 02/2015
  13. Aristo, Bromuc® akut Junior 100 mg Hustenlöser, 09/2015
  14. ratiopharm GmbH, SmPC NAC-ratiopharm® 200 mg Brausetabletten, NAC-ratiopharm® 600 mg Brausetabletten (13782.01.00, 13782.02.00), 08/2016
  15. 1 A Pharma GmbH, SmPC NAC 200 - 1 A Pharma®, NAC 600 - 1 A Pharma® (34175.00.00, 28882.00.00), 02/2015
  16. Zambon GmbH, SmPC Fluimucil 200 mg Brausetabletten (8595.01.01), 03/2017
  17. Hexal AG, SmPC ACC® 100 mg Brausetabletten, ACC® 100 mg tabs, Tabletten (13776.00.00, 22092.01.00), 02/2015
  18. Zambon GmbH, SmPC Fluimucil Kindersaft 2 % Lösung zum Einnehmen (29683.00.00), 03/2017
  19. Hexal AG, SmPC ACC Kindersaft (61108.00.00), 02/2015
  20. UpToDate, Acetylcysteine: Drug Information, Version: 146.0.
  21. Isbister GK, et al., Paracetamol overdose in a preterm neonate, Arch Dis Child Fetal Neonatal Ed, 2001, 85(1), 70-2
  22. Nevin DG, et al., Intravenous paracetamol overdose in a preterm infant during anesthesia, Paediatr Anaesth, 2010, 20(1), 105-7
  23. Tam J, et al., Nebulized and oral thiol derivatives for pulmonary disease in cystic fibrosis, Cochrane Database Syst Rev, 2013, 7
  24. Aw MM, et al., Neonatal paracetamol poisoning, Arch Dis Child Fetal Neonatal Ed, 1999, 81(1), F78
  25. Brener P, et al., Medication error in an extremely low birth weight infant: paracetamol overdose, Arch Argent Pediatr, 2013, 111(1), 53-5
  26. Smyth AR, et al., European Cystic Fibrosis Society Standards of Care: Best Practice guidelines, J Cyst Fibros, 2014, 13 Suppl 1, S23-24
  27. Ahola T, et al., Pharmacokinetics of intravenous N-acetylcysteine in pre-term new-born infants, Eur J Clin Pharmacol, 1999, 55(9), 645-50
  28. Bucaretchi F, et al., Acute liver failure in a term neonate after repeated paracetamol administration, Rev Paul Pediatr, 2014, 32(1), 144-8
  29. Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V. (AWMF), Akuter und chronischer Husten (S3-Leitlinie). AWMF-Leitlinie 2021-02, https://www.awmf.org/leitlinien/detail/ll/053-013.html, 2021
  30. Perry HE, et al., Efficacy of oral versus intravenous N-acetylcysteine in acetaminophen overdose: results of an open-label, clinical trial, J Pediatr, 1998, 132(1), 149-52
  31. Daoud A, et al., Two-bag intravenous N-acetylcysteine, antihistamine pretreatment and high plasma paracetamol levels are associated with a lower incidence of anaphylactoid reactions to N-acetylcysteine, Clin Toxicol (Phila), 2020, 58(7), 698-704
  32. Nationaal Vergiftigingen Informatie Centrum , Treatment protocol "acetylcysteine administration", https://www.vergiftigingen.info/f?p=300:THERAPIE:1468132361171:::RP,1320:P1320_THERAP_NO:73&cs=38PEsRhsEXJKi-2rvWQuUV8KAQa33qoZul5rYdEFN2q-hHqz4IXXQCsC0FtXxTdT3S_ZDNdSP7go4bD1KeH2wYw

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Changes

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