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

Interactions
PK
Renal impairment
References

Sotalol

Generic name
Sotalol
Brand name
ATC Code
C07AA07

Pharmacokinetics in children

The following pharmacokinetic parameters have been reported in the literature (Saul et al. 2001):
≤ 1 month: T½ = 8.4 hours on average, apparent clearance: 11 ml/min.
1 to 24 months: T½ = 7.4 hours on average, apparent clearance: 32 ml/min.
> 2 yrs to < 7 yrs: T½ = 9.1 hours on average, apparent clearance: 63 ml/min.
7-12 yrs: T½ = 9.2 hours on average, apparent clearance: 95 ml/min.
T max (4 days – 12 yrs): average of 2 – 3 hours

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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

Conversion of arrhythmias
  • Intravenous
    • 1 month up to 18 years
      • 0.2 - 1.5 mg/kg/dose, once only in 5-10 minutes. Under IC monitoring and with checks of the QT interval.
Ventricular and supraventricular arrhythmias
  • Oral
    • Term neonate
      • Initial dose: (Sotalolhydrochloride) 2 mg/kg/day in 3 doses.
      • Maintenance dose: depending on the effect, increase every 3 days to 4 mg/kg/day in 3 doses. Max: 10 mg/kg/day.

      • If there is insufficient effect or side effects, the concentrations can be measured (0.4-1 mg/l).

    • 1 month up to 6 months
      • Initial dose: (Sotalolhydrochloride) 3 mg/kg/day in 3 doses.
      • Maintenance dose: depending on the effect, increase every 3 days to 5 mg/kg/day in 3 doses. Max: 10 mg/kg/day.

      • If there is insufficient effect or side effects, the concentrations can be measured (0.4-1 mg/l).

    • 6 months up to 2 years
      • Initial dose: (Sotalolhydrochloride) 3 mg/kg/day in 3 doses.
      • Maintenance dose: depending on the effect, increase every 3 days to 6 mg/kg/day in 3 doses. Max: 10 mg/kg/day.

      • If there is insufficient effect or side effects, the concentrations can be measured (0.4-1 mg/l).

    • 2 years up to 6 years
      • Initial dose: (Sotalolhydrochloride) 3 mg/kg/day in 3 doses.
      • Maintenance dose: depending on the effect, increase every 3 days to 5 mg/kg/day in 3 doses. Max: 10 mg/kg/day.

      • If there is insufficient effect or side effects, the concentrations can be measured (0.4-1 mg/l).

    • 6 years up to 18 years
      • Initial dose: (Sotalolhydrochloride) 2 mg/kg/day in 3 doses.
      • Maintenance dose: depending on the effect, increase every 3 days to 3 mg/kg/day in 3 doses. Max: 10mg/kg/day, but not exceeding 320 mg/day.

      • If there is insufficient effect or side effects, the concentrations can be measured (0.4-1 mg/l).

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Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Adjustment not necessary.
GFR 30-50 ml/min/1.73 m2
50 percentage of single dose and dosing interval : 8 uur
do not adjust the one-time intravenous dose in cases of reduced renal function.
GFR 10-30 ml/min/1.73 m2
25 percentage of single dose and dosing interval : 8 uur
do not adjust the one-time intravenous dose in cases of reduced renal function.
GFR < 10 ml/min/1.73 m2
No generalized dose recommendations are given
Clinical consequences

In reduced renal function, the renal elimination of sotalol decreases. This extends the half-life and increases the plasma concentration, elevating the risk of side effects as a result: Hypotension, bradycardia, AV block, widened QRS-complex, bronchial spasms, hypoglycaemia, extension of the QTc-interval, torsade de pointes and ventricular tachycardia.

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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

Pro-arrhythmic effects, fatigue, dizziness, headaches, dyspnoea, torsades de pointes due to QTc extension, provocation of congestive heart failure or hypoglycaemia.

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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

Extended QT interval, sinus bradycardia, AV block, hypotension, bradycardia,  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

Before the start of the treatment and before changes to the dosage ECG checks with measurement of the corrected QT interval should be made. Caution should be used when taking Verapamil (Isoptin) at the same time, as severe cardiac arrhythmias may occur. Measurement of the renal function and electrolyte balance is also required. Caution is needed in patients with diabetes because sotalol can mask some important symptoms of acute hypoglycaemia.

Information from adults shows that sotalol is fully absorbed after oral administration. The bioavailability is more than 90%. Food reduces the absorption by about 20%. It is therefore recommended that sotalol should be taken at least half an hour before eating. We also recommend this for children. If this is not possible due to practical objections we recommend always giving sotalol at the same time with respect to the nutrition.

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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
Beta blocking agents, selective
C07AB03
C07AB07
C07AB09
C07AB02
Alpha and beta blocking agents
C07AG02
C07AG01

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References

  1. Beaufort-Krol GC, et al., Effectiveness of sotalol for atrial flutter in children after surgery for congenital heart disease., Am J Cardiol, 1997, 79, 92-4
  2. Läer S, et al., Development of a safe and effective pediatric dosing regimen for sotalol based on population pharmacokinetics and pharmacodynamics in children with supraventricular tachycardia., J Am Coll Cardiol, 2005, 46, 1322-30
  3. Pfammatter JP, et al., New antiarrhythmic drug in pediatric use: sotalol., Pediatr Cardiol, 1997, 18, 28-34
  4. Pfammatter JP, et al, Efficacy and proarrhythmia of oral sotalol in pediatric patients, J Am Coll Cardiol, 1995, 26, 1002-7
  5. Saul JP, et al., Pharmacokinetics and pharmacodynamics of sotalol in a pediatric population with supraventricular and ventricular tachyarrhythmia., Clin Pharmacol Ther, 2001, 69, 145-57
  6. Saul JP, et al., Single-dose pharmacokinetics of sotalol in a pediatric population with supraventricular and/or ventricular tachyarrhythmia., J Clin Pharmacol, 2001, 41, 35-43
  7. Tanel RE, et al., Sotalol for refractory arrhythmias in pediatric and young adult patients: initial efficacy and long-term outcome., Am Heart J, 1995, 130, 791-7
  8. Knudson JD et al., High-dose sotalol is safe and effective in neonates and infants with refractory supraventricular tachyarrhythmias., Pediatr Cardiol., 2011, Oct;32(7), 896-903
  9. Rademaker C.M.A., et al., Geneesmiddelen-Formularium voor Kinderen, 2007
  10. Hyloris S.A., SmPC Sotalol injectievloeistof (RVG 117148) 17-01-2025, www.geneesmiddelinformatiebank.nl

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Changes

Changes