Example Sotalol IV treatment protocol for initiation*
* Monitor QTc interval every 15 minutes during infusion. Continue to monitor QTc around Tmax (2 to 4 hours post-dose) following the first oral dose (in all patients) and second oral dose (in patients with CrCL ≥60 mL/min).
† 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 the example provided.
Sotalol IV (sotalol hydrochloride injection 10 mL vial (15 mg/mL) has approved dosing for a 1‑hour infusion for initiation or escalation of therapy1
Full QTc expression can be evaluated within 24 hours of IV loading dose administration.1
QTc expression is monitored every 15 minutes during the 1-hour infusion. Continue to monitor QTc around Tmax (2 to 4 hours post-dose) following the first oral dose (in all patients) and second oral dose (in patients with CrCL ≥ 60 mL/min).
1-hour IV loading offers a streamlined 1-day* protocol for determining whether sotalol is appropriate for the patient. (Versus 3 days previously required with oral sotalol)
- Demonstrated bioequivalence to oral sotalol
- Therapy can be halted immediately if patient shows adverse effects
- Potential for shorter stays, more scheduling flexibility
For patients with a Creatinine Clearance of ≥60 mL/min and an oral sotalol dose going from 0 to 120mg. Patient discharge is dependent on overall clinical evaluation, comorbidity, renal function and response to therapy. Creatinine Clearance ≥60mL/min may permit discharge within 20‑24 hours.
1-day* initiation using Sotalol IV
Illustrative pharmacokinetic profile for an intravenous loading dose followed by subsequent oral doses in a typical patient1
Current 3-day standard using oral sotalol2
Illustrative pharmacokinetic profile for oral administration in a typical patient
Sotalol simulation for loading to 80 or 120 mg PO bid. Adapted from Somberg, J., et al. (2020). Model- Informed Development of Sotalol Loading and Dose Escalation Employing an Intravenous Infusion. Cardiology Research, 11(5), 296-297. Copyright 2020. Elmer Press Inc. Adapted with permission.
In addition to 1-hour initiation and the ability to control administration in case of adverse events Sotalol IV also provides:
- Evaluate patient response to initiation of therapy within one hour1
- Ease of escalation and de-escalation as needed1
- Scheduling flexibility for initiation of therapy3
- Patient discharge may occur within 24 hours†
- Potential to shorten hospital stay, freeing up beds and other clinical resources4