Recommended Dosing & Safety Information for Sotalol IV in Pediatrics
Sotalol IV is indicated for pediatric use.
Use in Pediatric Patients¹
In pediatrics, sotalol is indicated for:
- The treatment of documented, life-threatening VT in pediatric patients
- The maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in pediatric patients with highly symptomatic AFIB/AFL who are currently in sinus rhythm.
Same molecule, different formulation.
Sotalol IV offers the same active molecule as oral sotalol but in an intravenously infused formulation. Sotalol IV bypasses the GI tract, supporting more predictable exposure and use in patients with limited oral or GI tolerance. In addition, the rapid onset of Sotalol IV allows for faster assessment of therapeutic response than oral dosing alone.
Suggesting starting doses [mg/kg] in children with normal renal function1
Sotalol's pharmacokinetics in children¹
The combined analysis of two unblinded, multicenter trials of oral sotalol with 59 children, aged between 3 days and 12 years, showed the pharmacokinetics of sotalol to be first order, or that a constant proportion is eliminated over time.1 BSA was the most important covariate and more relevant than age for the pharmacokinetics of sotalol. The smallest pediatric patients exhibited a greater drug exposure than the larger pediatric patients who showed a uniform drug concentration profile.1
- The short mean elimination half-life of sotalol offers clinicians greater control, enabling rapid discontinuation and seamless transition to other care options when needed.
- Sotalol’s linear pharmacokinetics provide flexible dosing and facilitate smooth IV-to-oral transition.
The Class III electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects and drug concentrations have been evaluated in pediatric patients between 3 days and 12 years of age.1
Safety Considerations
- Toxicity: Sotalol is hydrophilic and does not bind to plasma proteins. It crosses the blood brain barrier poorly, and is not metabolized.
- Labs: Potassium and magnesium should be measured and normalized prior to administration.
Close inpatient monitoring is recommended until steady state drug levels are achieved.1
Proarrhythmic effects of sotalol in pediatric patients included increased ventricular ectopy and exacerbation of bradycardia, the latter predominantly in patients with sinus node dysfunction following surgery for congenital cardiac defects.
Side effects of other sotalol-containing drug products in pediatric patients are those typical of a beta blocking agent, and led to discontinuation of drug in 3-6% of patients.1
- As in adults, the Class III antiarrhythmic action of sotalol in pediatric patients is associated with a significant proarrhythmic potential.
- In pediatric patients, the incidence of proarrhythmic side effects of sotalol varies from 0 to 22%; and the smallest pediatric patients tended to exhibit greater QTC-prolongation.
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1 Sotalol IV [package insert]. Chicago, IL: AltaThera Pharmaceuticals; 07/2025.