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

Interactions
PK
Renal impairment
References

Salbutamol

Generic name
Salbutamol
Brand name
ATC Code
R03AC02

Pharmacokinetics in children

No information

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

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Available formulations

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Dosages

Acute asthma attack
  • Oral
    • 1 month up to 2 years
      • 0.1 mg/kg/dose, as required, max. 4x daily. Max single dose: 1 mg/dose.

      • If inhalation therapy is possible, the oral form should not be used.

    • 2 years up to 6 years
      • 1 - 2 mg/dose, as required, max. 4x daily.

      • If inhalation therapy is possible, the oral form should not be used.

    • 6 years up to 12 years
      • 2 mg/dose, as required, max. 4x daily.

      • If inhalation therapy is possible, the oral form should not be used.

    • 12 years up to 18 years
      • 4 mg/dose, as required, max. 4x daily.

      • If inhalation therapy is possible, the oral form should not be used.

  • Intravenous
    • 1 month up to 18 years
      [1]
      • 0.1 microg./kg/minute, continuous infusion. Depending on the clinical picture, tachycardia and arterial blood gases, increase the salbutamol at 10 minutes:
        0.1-0.5 mcg/kg/min: 0.1 mcg/kg/min/step
        0.5-1.0 mcg/kg/min: 0.2 mcg/kg/min/step
        1.0-10 mcg/kg/min: 0.5 mcg/kg/min/step.

      • Administer at intensive care while monitoring, check hypokalaemia.
        The necessity of an initial loading dose (15 mcg/kg in 10 minutes through intravenous administration) is a matter of discussion, especially if frequent nebulization was done.

  • Inhalation
    • Solution for nebulization
      • < 5 years
        [1] [20] [21]
        • (where SpO2 ≤ 94%) 2.5 mg/dose, once only. in combination with ipratropium bromide, 0.25 mg/dose.
          • If the child is badly out of breath, nebulization should continue as frequently as necessary with salbutamol and (at least) twice with ipratropium bromide for the initial inhalations.
          • After 1 to 2 times inhaling with insufficient effect: start low-threshold prednisone
      • 5 years up to 18 years
        [1] [20]
        • (where SpO2 ≤ 94%) 5 mg/dose, once only. in combination with ipratropium bromide, 0.5 mg/dose. .
          • If the child is badly out of breath, nebulization should continue as frequently as necessary with salbutamol and (at least) twice with ipratropium bromide for the initial inhalations.
          • After 1 to 2 times inhaling with insufficient effect: start low-threshold prednisone
    • Aerosol
      • 1 month up to 18 years
        [1] [21]
        • (where SpO2 > 94%) with a holding chamber: 400 - 800 microg./dose, once only. in combination with ipratropium bromide, 80 mcg/dose.
          • If the child is badly out of breath, nebulization should continue as frequently as necessary with salbutamol and (at least) twice with ipratropium bromide for the initial inhalations.
          • After 1 to 2 times inhaling with insufficient effect: start low-threshold prednisone


          ADMINISTRATION
          0-3 yrs: dosing aerosol + holding chamber with a mask.
          4-6 yrs: dosing aerosol + holding chamber with a mouthpiece.

           
Bronchial dilation (short-acting) in intermittent asthma complaints
  • Inhalation
    • Inhalation powder
      • 6 years up to 18 years
        [1] [6]
        • 100 - 200 microg./dose, as required 1-4 times daily.
          • Maximum dose in the home situation: 8x daily 200 mcg If more is needed, the patient must be assessed.
    • Aerosol
      • 1 month up to 18 years
        [1] [6]
        • 100 - 400 microg./dose, as required 1-4x daily, max 8x daily. Max: 3.200 microg./day.
          • Maximum dose in the home situation: 8x daily 200 mcg If more is needed, the patient must be assessed.

           

          ADMINISTRATION
          0-3 yrs: dosing aerosol + holding chamber with a mask.
          4-6 yrs: dosing aerosol + holding chamber with a mouthpiece.

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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

No information is present at this moment.

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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

When administering a beta-2-sympathomimetic to children younger than 1 year, possible increases of dyspnoea and/or (transient) hypoxaemia due to a counterproductive effect of the relaxation of the bronchus musculature should be taken into account.

Short-acting sympathomimetics are used in episodes of bronchoconstriction. As a monotherapy, they have no effect or even an unfavourable effect on the bronchial hyperreactivity.

When insufficiently monitoring asthma according to the GINA guideline step 2 must be switched to according to SKL asthma consensus (adding an inhalation corticosteroids)
The choice of formulation is dependent on the age and preference of the patient. It is preferable to prescribe a dosing aerosol in combination with a holding chamber due to better lung deposition: Babyhaler (1-4 years), Volumatic (> 4 years), AeroChamber with baby mask 0-1 years; with child mask 1-4 years; with mouthpiece > 4 years). A holding chamber should be used in combination with a mask in children aged under 4 years. In children of > 7 years there is the option for an autohaler or dry powder inhaler (Diskus, Novolizer, Cyclohaler, Easyhaler, Clickhaler). The use of dry powder inhalers (DPI) by children: most clinical studies were done with the Turbuhaler and the Diskus). There are little to no known studies about the use of other DPIs by children aged under 12 years.

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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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Selective beta-2-adrenoreceptor agonists
R03AC03

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References

  1. NVK , Richtlijn Astma bij Kinderen, 29 sep 2021
  2. Brand PLP et al, Werkboek Kinderlongziekten, VU Uitgeverij, 2001, 1e druk
  3. GlaxoSmithKline BV, SPC Ventolin drank (RVG 06450), www.cbg-meb.nl, Geraadpleegd 12 aug 2010, http://db.cbg-meb.nl/IB-teksten/h06450.pdf
  4. Global Initiative for Asthma (GINA), Pocket guide for asthma management and prevention in Children, Revised 2006, 8
  5. Sectie Intensive Care Kinderen Nederlandse Vereniging voor Kindergeneeskunde, Concept richtlijn Acuut astma, 2011
  6. BIndels PJE et al, NHG Standaard Astma bij Kinderen (derde herziening), Huisarts Wet, 2014, 57(2), 70-80
  7. UpToDate®, Pediatric Drug information: Albuterol (salbutamol) Lexicomp® Version 219.0, accessed 08/2018
  8. MMI, Online GL. Gelbe Liste Online, Accessed July 10, 2018
  9. Dexcel, SmPC Volmac® 8 mg retard Retardtabletten (30243.00.00), 11/2016
  10. Infectopharm, SmPC SALBUBRONCH® forte 5 mg/ml (17371.00.00), 09/2017
  11. PB Pharma, SmPC Cyclocaps Salbutamol 400µg Hartkaps. mit Pulver zur Inhalation (18421.01.00), 03/2011
  12. Orion, SmPC Salbu Easyhaler 0,1 mg/Dosis, 0,2 mg/Dosis Pulver zur Inhalation (32940.00.00), 08/2014
  13. PB Pharma, SmPC Cyclocaps Salbutamol 200µg Hartkaps. mit Pulver zur Inhalation (18421.00.00), 03/2011
  14. Hexal, SmPC SalbuHEXAL® Fertiginhalat, 1,5 mg/2,5 ml Lösung für einen Vernebler SalbuHEXAL® Inhalationslösung, 5 mg/ml Lösung für einen Vernebler (17377.00.00, 17373.00.00), 11/2015
  15. TEVA, SmPC Salbulair® N 100 μg Autohaler Druckgasinhalation, Suspension (41205.00.00), 04/2015
  16. GlaxoSmithKline, SmPC Sultanol® Dosier-Aerosol (40393.00.00), 11/2013
  17. GlaxoSmithKline, SmPC Sultanol® Fertiginhalat 1,25 mg/2,5 ml Lösung für einen Vernebler Sultanol® forte Fertiginhalat 2,5 mg/2,5 ml Lösung für einen Vernebler (3940.00.00, 3940.01.00), 11/2013
  18. GlaxoSmithKline, SmPC Sultanol® Inhalationslösung 5 mg/1 ml Lösung für einen Vernebler (6080387.00.00), 10/2014
  19. Infectopharm, SmPC SALBUBRONCH® Elixier (6120715.00.00), 02/2014
  20. Teva Nederland B.V. , SmPC Salamol-Steri-Neb (RVG 100332) 21-01-2015, www.geneesmiddeleninformatiebank.nl
  21. Global Initiative for Asthma (GINA), Report, Global Strategy for Asthma Management and Prevention, https://ginasthma.org/gina-reports/, 2022

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Changes

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