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

Interactions
PK
Renal impairment
References

Metoprolol

Generic name
Metoprolol
Brand name
ATC Code
C07AB02

Pharmacokinetics in children

Passes the blood-brain barrier easily. Metabolization: by the liver into inactive metabolites, primarily by CYP2D6. Elimination: almost entirely via the kidneys, 5% unchanged. The pharmacokinetic profile of metoprolol in children aged 6 to 17 years with hypertension is comparable to
the pharmacokinetic profile already known for adults. The apparent clearance after oral administration (Cl/F) increased linearly with the bodyweight
The elimination half-life in neonates is 5-10 hours.

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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

Hypertension
  • Oral
    • Normal preparation (immediate release)
      • Term neonate
        • (metoprololtartrate) 1 - 3 mg/kg/day in 2 doses.

        • A very low oral dose is used initially. Increase cautiously each week to the maximum dose unless clinical side effects or worsening occurs.

          There have been no studies published on the use of metoprolol in neonates.

      • 1 month up to 12 years
        • (metoprololtartrate) 1 - 3 mg/kg/day in 2 doses. Max: 200 mg/day.

        • A very low oral dose is used initially. Increase cautiously each week to the maximum dose unless clinical side effects or worsening occurs.

    • Tablet with regulated release
      • 12 years up to 18 years
        • (metoprolol tartrate) 100 - 200 mg/day in 1 dose. Max: 200 mg/day.

        • In the controlled-release tablet, the active ingredient is present in microgranules. These are covered in a membrane that controls the release of the substance, giving constant serum concentrations for a 24-hour period.  

      • 12 years up to 18 years
        [17] [18] [19] [20]
        • (metoprolol tartrate) 100 - 200 mg/day in 1 dose. Max: 200 mg/day.

        • In the controlled-release tablet, the active ingredient is present in microgranules. These are covered in a membrane that controls the release of the substance, giving constant serum concentrations for a 24-hour period.  

      • 6 years up to 12 years
        • (metoprolol tartrate) 0.5 - 2 mg/kg/day in 1 dose. Max: 200 mg/day.
          • A very low oral dose is used initially. Increase cautiously each week to the maximum dose unless clinical side effects or worsening occurs.
  • Intravenous
    • 1 month up to 18 years
      • Initial dose: (metoprololtartrate) 0.1 mg/kg/dose in 5 min. Repeat twice if necessary (after 5 min).
      • Maintenance dose: Depending on the effect 1 - 5 microg./kg/minute, continuous infusion.

      • Intravenous administration should be done in a clinic with monitoring of the ECG and blood pressure.

        There is limited data known about the intravenous administration of this drug in children
Dilated cardiomyopathy with heart failure
  • Oral
    • 2 years up to 18 years

      • Only apply in dilated cardiomyopathy with cardiac failure after consulting a paediatric cardiologist.

        The safety and efficacy of metoprolol for this indication have not been studied in extensive controlled clinical trials. In one study (N=15, 2.5-15 years), the following dosage (salt unknown) was used:  initial dose 0.2 mg/kg/day in 2 doses, average 1.1 ± 0.1 mg/kg/day (range 0.5-2.3 mg/kg/day).

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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

Orthostatic hypotension, bradycardia, congestive heart failure, fatigue, dizziness, headaches, nightmares, dry mouth, nausea, abdominal pain, vomiting and diarrhoea.

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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

Sinus bradycardia, AV block, hypotension, asthma and congestive heart failure.

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

Be aware of the conversion factor between OR and IV: metoprolol undergoes a first-pass effect in the liver, resulting in a bioavailability in adults of 35-50% (the bioavailability in children is not known). Intravenous administration of metoprolol for acute treatment in an intensive care unit should only be given with monitoring of the ECG and the blood pressure. Excessively rapid intravenous administration can result in severe hypotension and shock. Great caution is needed in concomitant use of verapamil because of the risk of hypotension, AV-conduction disorders and left ventricular insufficiency. In metabolic conditions, it should only be prescribed in consultation with a paediatrician specializing in metabolic disorders because of the link with hypoglycaemia.

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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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Beta blocking agents, non-selective
C07AA05
C07AA07
Beta blocking agents, selective
C07AB03
C07AB07
C07AB09
Alpha and beta blocking agents
C07AG02
C07AG01

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Shaddy RE, et al, Beta-blocker treatment of dilated cardiomyopathy with congestive heart failure in children: a multi-institutional experience., J Heart Lung Transplant, 1999, 18, 269-74
  3. Saqan R et al, Evalutaion of the safety and efficacy of metoprolol infusion for children and adolescents with hypertensive crises: a retrospective case series, Pediatr Nephrol, 2017, 32, 2107-13
  4. Uptodate: UpToDate®, Pediatric Drug information: Metoprolol Topic 12605 Version 305.0, accessed 03/19
  5. betapharm, Metobeta® 100 retard, Metobeta® 200 retard, 11/2015
  6. AbZ-Pharma GmbH, SmPC, Metoprolol AbZ 50 mg/100 mg Tabletten (11738.00.00), 10/13
  7. ratiopharm GmbH, SmPC, Metoprolol-ratiopharm® Succinat 23,75/47,5/95/190 mg Retardtabletten (64889.00.00), 10/13
  8. RECORDATI Industria Chimica e Farmaceutica S.p.A., SmPC, Beloc® i. v. 5 mg/5 ml Injektionslösung (4895.00.02), 04/18
  9. RECORDATI Industria Chimica e Farmaceutica S.p.A., SmPC, Beloc-Zok® 23,75/47,5/90/190 mg Retardtabletten (48563.03.00), 11/17
  10. Ratiopharm Nederland BV, SPC Metoprolol tablet MGA (RVG 34438) 08-03-2014, www.cbg-meb.nl
  11. Lurbe E, et al, , ,, Management of high blood pressure in children and adolescents: recommendations of the European Society of Hypertension, J Hypertens, 2009, Sep;27(9), 1719-42
  12. Actavis BV, SmPC Metoprololtartraat tablet MGA 200 mg (RVG 30149) 15-08-2014, www.geneesmiddeleninformatiebank.nl
  13. Williams RV, et al, Intermediate effects of treatment with metoprolol or carvedilol in children with left ventricular systolic dysfunction., J Heart Lung Transplant., 2002, 21, 906-9
  14. National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents., Fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents, Pediatrics, 2004, 114, 555-76
  15. Morselli PL, et al., Pharmacokinetics of antihypertensive drugs in the neonatal period, Dev Pharmacol Ther, 1989, 13, 190-8
  16. Falkner B, et al., The pharmacodynamic effectiveness of metoprolol in adolescent hypertension., Pediatr Pharmacol, 1982, 2, 49-55
  17. Batisky DL, et al., Toprol-XL Pediatric Hypertension Investigators. Efficacy and safety of extended release metoprolol succinate in hypertensive children 6 to 16 years of age: a clinical trial experience, J Pediatr, 2007, 150, 134-9
  18. European Medicins Agency, Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended Metoprolol succinate Selokeen ZOK controlled release tablets NL/W/0037/pdWS/001, www.ema.europa.eu, 09 sept 2013
  19. Lurbe E, et al., European Society of Hypertension guidelines for the management of high blood pressure in children and adolescents, J Hypertens., 2016, Oct;34(10), 1887-920
  20. Recordati Ireland Ltd., SmPC Selokeen (RVG 25209) 16-08-2023, www.geneesmiddeleninformatiebank.nl

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Changes

Changes