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Dosing & Administration of Sotalol IV1

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1-Day Initiation of Atrial Fibrillation (AFib), Atrial Flutter (AFL), & Ventricular Tachycardia (V-Tach) Sotalol Therapy¹

Intravenous sotalol therapy can be initiated for 80mg or 120mg oral dosing, and escalated from 80 to 120 or 120 to 160mg.*

All initiations and dose escalations utilize a Sotalol IV infusion of 1 hour.

* Patient discharge is dependent on overall clinical evaluation, renal function and response to therapy. Creatinine Clearance >60mL/min may permit discharge within 20-24 hours. Timing of patient discharge may vary from examples provided.

Recommended loading dosage

The intravenous loading dose depends on the target oral dose and creatinine clearance; the dosing interval for oral administration of sotalol and the minimum delay between the end of the infusion and the first oral dose also depend on renal function.

1 Day Initiation Dosing Chart

Recommended Monitoring

  • Monitor QTc interval every 15 minutes during infusion
  • Continue to monitor QTc around Tmax after 1st and 2nd oral doses (2 to 4 hours post-dose)

Example 24-hour treatment protocol for sotalol initiation

1 Day Sotalol IV Timeline Example

Pharmacokinetic profile for oral versus intravenous sotalol initiation

3-Day 1-Day Pharmacokinetic Profile for Sotalol Therapy

Substitution of Oral Sotalol¹

Intravenous sotalol therapy can be used as a substitute for oral sotalol in patients unable to take oral medication.

To match the exposure to oral sotalol, use the same dosing frequency with intravenous administration and infuse the adjusted dose over 5 hours

Recommended loading dosage

Oral Substitution Dosing Chart

Use in children¹

As with adult dosing:

  • Initiate sotalol treatment in hospital after appropriate clinical assessment
  • Regimen should be individualized, as appropriate
  • Dosage should be increased gradually, if required
  • Carefully assess therapeutic response and tolerability
  • Conduct frequent monitoring of QTc interval and heart rate

Sotalol IV dose should be reduced by a factor that depends on age.

For children aged about 2 years and greater with normal renal function, doses normalized for body surface area are appropriate for both initial and incremental dosing.

The safety and effectiveness of sotalol in children has not been established. However, the Class III electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (QTc interval and resting heart rate) and drug concentrations have been evaluated in children aged between 3 days and 12 years old.

Suggesting starting doses [mg/kg] in children with normal renal function

Pediatric Dosing Chart

REFERENCES
1 Sotalol IV [package insert]. Chicago, IL: AltaThera Pharmaceuticals; 09/2023.
2 BetaPace AF (sotalol hydrochloride) [Full Prescribing Information]. Zug, CH: Covis Pharma; 06/2023.

Highlights of Prescribing Information

Boxed Warning, Indications, and Important Safety Information

WARNING: LIFE THREATENING PROARRHYTHMIA

Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation. To minimize the risk of drug induced arrhythmia, initiate or uptitrate intravenous sotalol in a facility that can provide continuous electrocardiographic monitoring and cardiac resuscitation [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)].
Do not initiate intravenous sotalol therapy if the baseline QTc is longer than 450 ms. If the QTc prolongs to 500 ms or greater, reduce the dose or discontinue. (2.3)