Between June 8, 2014, and September 18, 2018, 213 participants were admitted to 5 participating medical centers (range 1100 per center). Concentration-dependent pharmacologic properties of sotalol, BETAPACE AF (sotalol HCl) [package insert], Sotalol hydrochloride injection for intravenous use, Clinical pharmacology-driven translational research to optimize bed-side therapeutics of sotalol therapy, Risk of initiating antiarrhythmic drug therapy for atrial fibrillation in patients admitted to a university hospital. (b) Simulation for moderate renal impairment (ClCr: 30 - 59 mL/min). Over a 4-year period, patients admitted to 5 hospitals in the United States for inpatient telemetry monitoring during initiation for nonresearch purposes were enrolled. Developing a safe intravenous sotalol dosing regimen. JCS and JM have a patent that has been assigned to the sponsoring company, AltaThera Pharmaceuticals. Sotalol IV is one of the first drugs to be reviewed under this new program by the FDA. The Food and Drug Administration also has a label recommendation for initiating sotalol,23 which includes a box warning and recommended minimum of 3 days in-hospital monitoring requirement based on the degree of QTc prolongation being linearly associated with sotalol concentrationsthe 3 days requirement corresponds to the time to reach maximum steady-state exposure (concentrations) for sotalol under a constant dosing regimen and thus maximum QTc prolongation.24 However, despite multiple observational studies examining patterns of sotalol initiation,12,14,25,26 no single algorithm exists to guide initiation of sotalol therapy. ClCr: creatinine clearance; PO: oral; Employing model-informed drug development approaches, simulations were developed to employ IV sotalol infusion over 1 h to initially load patients who are to receive oral sotalol therapy to prevent recurrence of highly symptomatic AF/AFL. 4-8 Composed of a racemic mix of 2 isomers, the d and l isomers of sotalol work together to prolong repolarization (d- and l-isomer) along with nonselective -blocking properties (l-isomer). Time to the earliest detection of complications was 2.1 +/- 2.5 (mean +/- SD) days after initiation of sotalol, with 22 of 25 patients meeting criteria for complications within 3 days of monitoring. Last updated on Jun 20, 2022. There was no significant effect of electrical or spontaneous conversion to sinus on the probability of discharge on sotalol. sharing sensitive information, make sure youre on a federal It is the target dosing that dictates the concentration of the initial IV loading. official website and that any information you provide is encrypted That the former 2 studies identified a rate of complications higher than our study and that of Weeke et als, may reflect greater attention to dose effects in the more contemporary period, although none of the earlier studies examined dose-by-dose granularity as we did, and thus, we cannot determine this effect precisely. Clinical safety profile of sotalol in patients with arrhythmias. We believe this future investigation would be important, as dose adjustment targeting ineffectiveness rather than toxicity could potentially be made in an outpatient setting over a longer time period, as is done in other non-class III antiarrhythmics. A software package NONMEM version 7.2 (ICON, Hanover, MD, USA) was used for population pharmacokinetic (PK) modeling and simulation. A previously performed bioequivalence study in 15 healthy volunteers aged 18 to 45 years old who received a single dose of oral and IV sotalol (crossover study) was employed to obtain serum sotalol concentration and corresponding QTc measurements [7]. Objectives: Describe the mechanism of action of sotalol. Sotalol is a Vaughan-Williams (VW) Class III antiarrhythmic agent that is used in the treatment of atrial13 and ventricular arrhythmias.48 Composed of a racemic mix of 2 isomers, the d- and l isomers of sotalol work together to prolong repolarization (d- and l-isomer) along with nonselective -blocking properties (l-isomer). All statistical analysis was performed using Stata IC (version 15.1; StataCorp, LLC, College Station, Texas). Sign up to get PRNs top stories and curated news delivered to your inbox weekly! Sotalol drug therapy is frequently employed to prevent the recurrence of highly symptomatic atrial fibrillation or flutter (AF, AFb). Clinical pharmacokinetics of sotalol. If physicians want to have their patients with reduced renal function receive a reduced maximum sotalol serum concentrations, then a lower maintenance dose of sotalol should be selected. We initially approached the problem of 1-day IV and oral loading of sotalol with a proposed study to the Food and Drug Administration (FDA). 4 8 Composed of a racemic mix of 2 isomers, the d - and l isomers of sotalol work together to prolong repolarization ( d - and l -isomer) along with nonselective -blocking properties ( l -isomer). The economic cost is considerable and has been estimated at $9,263 (CMS reimbursement for 3-day initiation of sotalol) [6]. Applies to the following strengths: 120 mg; 80 mg; 160 mg; 240 mg; AF 80 mg; AF 120 mg; AF 160 mg; 5 mg/mL; 15 mg/mL Usual Adult Dose for: Atrial Fibrillation Atrial Flutter Ventricular Arrhythmia Additional dosage information: Renal Dose Adjustments Liver Dose Adjustments Despite its widespread use, little information is available regarding dosing protocols during this period. After 12 h from the last 120 mg dose, 80 mg PO given with a new steady state achieved in 24 h, with 80 mg given every 12 h. ClCr: creatinine clearance; PO: oral. Bunch TJ, May H, Bair T, Steinberg BA, Muhlestein JB, Anderson JL, Knowlton K. Economics of sotalol in-patient dosing approaches in patients with atrial fibrillation. Simulation for dose reduction from 120 to 80 mg PO sotalol in patients with normal renal function (ClCr: 90 mL/min). WebLearn about drug interactions between sotalol oral and tadalafil oral and use the RxList drug interaction checker to check drug combinations. WebMethods: The records of 120 patients admitted to the hospital for initiation of sotalol therapy were retrospectively reviewed to determine the incidence of significant arrhythmia complications, defined as new or increased ventricular arrhythmias, significant bradycardia or excessive corrected QT (QTc) interval prolongation. Noteworthy is that patients with a pacemaker present were significantly less likely to have a dose adjustment and more likely to successfully initiate sotalol than those without, perhaps due to less bradycardia, which was a key reason for failure of initiation. ED is often a symptom of another health problem or health-related factor. - Sotalol IV is now approved for 1-day hospital outpatient initiation of AFib therapy and faster dose escalations for existing patients, - New FDA-approved dosing, monitoring and evaluation shortens the hospital stay from 3 days to 1 day, - The new initiation provides physicians with a faster and safe way to start new sotalol patients, potentially reducing hospital costs and improving patient satisfaction, CHICAGO, March 10, 2020 /PRNewswire/ -- AltaThera Pharmaceuticals, LLC, a hospital specialty pharmaceutical company focused on commercializing innovative drugs aimed at improving outcomes and reducing hospital costs, announces that the US Food and Drug Administration (FDA) has approved new indications for Sotalol IV in AFib patients. WebSymptoms of ED include. Of these, 11 had stopped prior to the fifth dose, 2 had no dose adjustment and stopped after the fifth dose, and 7 had at least 1 dose adjustment and stopped after the fifth dose. WebRecommended initial dose is 80 mg if QTc < 450 msec, adjusted for renal function: CrCl > 60 mL/min: start 80 mg PO q 12h CrCl 40 60 mL/min: start 80 mg PO q 24h CrCl < 40 , , , , , , Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American, Delay in Recurrence of Atrial Fibrillation / Atrial Flutter, Documented Life-Threatening Ventricular Tachycardia, Sinus bradycardia (<50 beats per minute), sick sinus syndrome or 2nd or 3rd degree AV block without a pacemaker, Congenital or acquired long QT syndromes, QT interval >450 ms, Cardiogenic shock, decompensated heart failure, Bronchial asthma or related bronchospastic conditions, Ptaszek et al. The peak blood concentration reached at the steady state (Cmax ss) is the highest concentration and thus offers greatest risk. AltaThera is developing novel, patient-focused solutions that apply innovative science and technologies to already-approved pharmacological agents for hospitalized patients. Cision Distribution 888-776-0942 Since sotalol is known to be mostly excreted by the kidney unchanged [9] and elimination is directly proportional to glomerular filtration [10], we developed based on modeling and simulation technique, doses to obtain predicted Cmax for patients with mild, moderate and severe renal dysfunction. Comparison of beta-blockers, amiodarone plus beta-blockers, or sotalol for prevention of shocks from implantable cardioverter defibrillators: the OPTIC study: a randomized trial, Effect of d-sotalol on mortality in patients with left ventricular dysfunction after recent and remote myocardial infarction. How should this medicine be used? We expected that some patients would show excess QTc prolongation (500 ms or greater, or a 20% increment in the QTc from baseline) such that dosing would need to be reduced, or sotalol therapy abandoned for alternative therapy. Broken line indicates oral loading and solid line 75 mg IV load, followed by 80 mg PO at 7 h and then 80 mg PO every 24 h. (c) Simulation for severe renal impairment (ClCr: 10 - 29 mL/min). Somberg JC, Preston RA, Ranade V, Molnar J. The simulation for loading to 80 mg PO bid is depicted in Figure 1. Significant bradycardia, ineffectiveness, and excessive QT prolongation were reasons for failed completion. In this multicenter investigation, dosing protocols in patients initiating sotalol therapy were examined to identify predictors of successful sotalol initiation. MacNeil DJ, Davies RO, Deitchman D. Clinical safety profile of sotalol in the treatment of arrhythmias. The .gov means its official. IV: intravenous; ClCr: creatinine clearance; PO: oral. (2.3) This model demonstrated that predictors of dose adjustment were also successful at predicting the probability of successfully completing the initiation protocol of sotalol (OR: 0.977, 95% CI: 0.9600.995, P = .014). Introduction Sotalol is a potent antiarrhythmic, with class III antiarrhythmic and beta-blocking properties, often used in the treatment of pediatric arrhythmias [ 24 ]. Outline the indicated uses, both approved and off-label, for initiating therapy with sotalol. Sotalol is a Vaughan-Williams (VW) Class III antiarrhythmic agent that is used in the treatment of atrial 13 and ventricular arrhythmias. When successfully applied, MIDD can optimize drug dosing/therapeutic individualization in the absence of dedicated trials. Sotalol is an antiarrhythmic drug used to treat ventricular arrhythmia. being able to get an erection sometimes, but not every time you want to have sex. Due to its QT-prolonging effect and subsequent increased risk of torsade de pointes, many centers admit patients during the initial dosing period. In addition, application of intravenous (IV) sotalol, with IV to oral transition, could potentially reduce hospitalization duration and costs.24 These future approaches could open a treasure trove of data and possibilities that could provide additional guidance on dose management for medications like sotalol. Oral loading 120 mg sotalol oral 48 h after the last 80 mg PO dose and then 120 mg every 48 h. IV loading of 82.5 mg IV over 1 h at 48 h after the last 80 mg PO dose followed by 120 mg PO at 13 h and then every 48 h. (d) Simulation for dose escalation from 120 to 160 mg in patients with mild renal impairment (ClCr: 60 - 89 mL/min). First order conditional estimation method with interaction (FOCE-INTER) was used for computation. The European Society of Cardiology states that ECG In patients with normal renal function, an initial 1-h loading dose of intravenous sotalol followed by two oral doses in 24 h has been developed permitting attainment of three maximum serum concentrations reflecting maximum QT prolongation in a 1-day observation period. Paediatric population. IV: intravenous; ClCr: creatinine clearance. being able to get an erection sometimes, but not every time you want to have sex. It is often used in atrial fibrillation/flutter. Patients previously taking sotalol and undergoing admission for dose adjustments were excluded. 48 Composed of a racemic mix of 2 and transmitted securely. Sotalol, Intravenous sotalol, Simulations, Dose initiation, Dose escalation. INTRODUCTION. Antonaccio MJ, Gomoll A. Pharmacology, pharmacodynamics and pharmacokinetics of sotalol. Of course, whether the decision to make a dose adjustment was made by providers seeking to achieve a predetermined dose or whether the decision was made to adjust the dose because of concerns of toxicity or ineffectiveness that ultimately led to discontinuation of the medication could not be determined by our study design. Sotalol comes as Identify the adverse Sotalol, a methanesulfonanilide, is a class III antiarrhythmic drug (table 1) that is used for the treatment of both atrial and ventricular arrhythmias. Loading to 120 mg sotalol bid dosing in patients with normal renal function is noted in Figure 2. aCalculated using Cockcroft-Gault formula. Sotalol, a Vaughan-Williams Class III antiarrhythmic medication, is used to manage atrial arrhythmias. WebWhat is Sotalol hydrochloride? Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation. Outline the indicated uses, both approved and off-label, for initiating therapy with sotalol. Sotalol was initiated in more men than women, although there were no statistically significant differences in successful completion of the loading protocol between sexes. Newer approaches by our group35 and others to use machine learning to analyze high-density data,3638 such as from telemetry, implanted cardiac devices, and other continuous data streams, could provide greater prediction than standard ECG or clinical factors but are more difficult to collect across institutions and monitoring platforms. https://clincalc.com/DrugStats/Top300Drugs.aspx, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff3061ab-d930-4318-a5be-684e38be229e, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=62a71c8c-d92d-4122-848f-9ae35f8bbe2b. being able to get an erection, but not having it last long enough for sex. Sources: Many physicians chose to start with 120 mg PO bid, since this dose has the greatest likelihood of maintaining sinus rhythm [13]. The IV sotalol load followed by the first and second oral dose could be administered in 24 h with risk assessed under ECG monitoring in appropriate hospital facilities. The https:// ensures that you are connecting to the Sotalol and sotalol AF cant be substituted for one another. The solid line indicates sotalol concentrations following IV loading, and Cmax ss concentration can be obtained in 1 h and three Cmax peaks in 24 h. IV: intravenous; ClCr: creatinine clearance. Usefulness of d, I sotalol for suppression of chronic ventricular arrhythmias, Usefulness of sotalol for life-threatening ventricular arrhythmias, A comparison of seven antiarrhythmic drugs in patients with ventricular tachyarrhythmias. Sotalol was originally approved by the FDA (tradename Betapace) for the treatment of life-threatening ventricular arrhythmias. The QT was corrected using Fridericia27 formula (QT/RR interval)1/3. Numbers indicate patients receiving that dose at each time point, which are separated by ~12 hours as per routine. Forty-eight hours after stopping the last dose of 120 mg, a dose of 80 mg is given and a new steady state is obtained in 96 h, with 80 mg dosing every 48 h thereafter. To minimize the risk of drug induced arrhythmia, patients initiated or re-initiated on sotalol should be in a facility that can provide cardiac resuscitation, with continuous electrocardiographic monitoring. Within the confines of an observational study, such a determination cannot be made definitively and requires a prospective trial with a predetermined dosing protocol to define the direction of causality. We hypothesize that intravenous (IV) loading of sotalol followed by oral dosing in quick successions could achieve a sotalol blood concentration similar to that achieved with chronic oral dosing. First, as noted above, because our study was observational in nature, we were unable to draw more definitive conclusions about the role of dose decisions in successful initiation of sotalol. Sotalol can be recommended as the drug of first choice for treatment of fetal AF and has been shown to be an effective and safe first-line treatment option for SVT, at least in the absence of hydrops. UNK ECGs were excluded from ECG analysis (intervals and rhythm), although other clinical information for these patients was included. Because of this warning, the initiation process of sotalol has historically been completed during a 3-day inpatient admis-sion, but initiation of sotalol therapy as an outpatient is an accepted methodology and is endorsed by the American Col- In this investigation, we examine patterns of sotalol initiation across multiple institutions nationwide to identify predictors of successful initiation. 8600 Rockville Pike Of the reasons for unsuccessful initiation, the most common were ineffective (8 patients), QT prolongation (7 patients), bradycardia (4 patients), and other/unknown in 1 patient. Because sotalol can prolong the QTc interval excessively [3, 4] and thus may lead to the initiation of torsades de pointes (TdP) ventricular tachycardia (VT) [3-5], initiation of sotalol therapy has been recommended in the product label to be in-hospital under electrocardiogram (ECG) monitoring with facilities and personnel able to provide cardiac resuscitation [4]. To examine causal pathway for factors leading to dose adjustment, we used a marginal structural model28,29 based on inverse probability weighting for dose adjustment (See Supplemental Material, for details). Sotalol IV is currently used in pediatric patients and dose adjustments are made based on body surface area (BSA) or weight. Finally, our use of a multicenter study design had limitations in the depth of information that could be collected about patients. Oral loading 160 mg sotalol at 24 h after the last 120 mg PO dose and then 160 mg PO every 24 h. IV loading of 105 mg IV load administered over 1 h at 24 h after the last 120 mg PO dose followed by 160 mg PO at 7 h and then 160 mg PO every 24 h. (f) Simulation for severe renal impairment (ClCr: 10 - 29 mL/min). We found that among other factors, making dose adjustments was a key risk factor for failed initiation and that patients with pacemakers already implanted were less likely to have dose adjustments and more likely to be discharged on sotalol. Objectives: Describe the mechanism of action of sotalol. eHealthMe is studying from 3,301 A total of 113 patients (53.1%) completed the initiation protocol without any adjustment in the dose40 mg twice daily (BID): 1 (0.9%), 80 mg BID: 64 (56.6%), 120 mg BID: 47 (41.6%), and 160 mg BID: 1 (0.9%). If the QT interval prolongs to 500 ms or greater, the dose must be reduced, the duration of the infusion prolonged or the drug discontinued. ClCr: creatinine clearance; IV: intravenous. WebGeneral Medications Medications PRIOR to initiation of sotalol Atrial ARRHYTHMIA: Dose adjustment based on creatinine clearance (CrCl) (Single Response) Ventricular Arrythmia: Dose adjustment based on creatinine clearance (CrCl) (Single Response) ( ) CrCl GREATER than 60 mL/min - sotalol (BETAPACE) "And" Linked Panel https://www.ahajournals.org/doi/10.1161/circ.142.suppl_3.12649 WebUS/FDA Approved Indications: Heart Rhythm Control for Atrial Fibrillation *Refer to prescribing information for more complete information. Even Maisel and colleagues examined adverse cardiac events in 72 trials of sotalol 80 mg twice a day for AF25 and found that adverse cardiac events occurred in 18%: bradyarrhythmias occurred in 8 (11%), ventricular arrhythmias in 2 (2.8%), QT prolongation in 1 (1.4%), and 2 other events (unspecified). Anastasiou-Nana MI, Gilbert EM, Miller RH, et al. Sotalol hydrochloride has active ingredients of sotalol hydrochloride. The European Society of Cardiology states that ECG monitoring should be done at baseline, after 1 days, and after 1-2 weeks. 8600 Rockville Pike Prospective studies are needed to verify this approach. The exaggerated response may be due to potassium channel abnormalities. Simulations were created to escalate from 80 mg to 120 mg bid or 120 mg to 160 mg in 1 day using IV loading. (a) Simulation for patients with mild renal impairment (ClCr: 60 - 89 mL/min). These associations would seem to be more likely to be spurious, and likely due to other unmeasured effects specific to certain patients, but only through future prospective study can we know for certain. The publisher's final edited version of this article is available at, GUID:B237878C-1F83-4C62-910B-1069CE49351D, atrial fibrillation, ventricular tachycardia, antiarrhythmic, {"type":"clinical-trial","attrs":{"text":"NCT02439658","term_id":"NCT02439658"}}, Multicenter comparative study of the efficacy and safety of sotalol in the prophylactic treatment of patients with paroxysmal supraventricular tachyarrhythmias, A comparison between oral antiarrhythmic drugs in the prevention of atrial fibrillation after cardiac surgery: the pilot study of prevention of postoperative atrial fibrillation (SPPAF), a randomized, placebo-controlled trial, Maintenance of sinus rhythm in patients with atrial fibrillation: an AFFIRM substudy of the first antiarrhythmic drug. Results This announcement includes forward-looking statements, which are based on current expectations and projections about future events. Received 2020 Jul 27; Accepted 2020 Aug 3. The National Torsade de Pointes Consortium is composed of representatives from the Massachusetts General Hospital, University of Colorado Hospital, Cleveland Clinic, Beth Israel Deaconess Medical Center, and the Mayo Clinic. d, l-Sotalol Implantable Cardioverter-Defibrillator Study Group, Importance of QT interval determination and renal function assessment during antiarrhythmic drug therapy, Clinical safety profile of sotalol in patients with arrhythmias, Sotalol-induced prolongation of the Q-T interval and attacks of unconsciousness. Sotalol is one of several different therapies offered for patients living with AFib. Excessive concentration can cause Torsade de Pointes ventricular tachycardia (TdP). This work was performed at the University of Colorado Anschutz Medical Campus, Aurora, Colorado. In conclusion, we found that the majority of contemporary patients admitted at multiple medical centers for monitoring during initiation of sotalol were successfully discharged on the medication, including over half without a single dose change. Amiodarone was more effective than placebo for conversion to SR (79.8% vs. 68.2%). As a result of lack of data supporting the safety of outpatient initiation of Sotalol some experts prefer inpatient initiation with electrocardiographic monitoring. Third, although in our models QTc was not a critical factor in the dose decision and/or the probability of a successful load, clinical experience, and prior investigations,12,22 has highlighted this factor as a critical component in the dose decision. (1.2) WARNING: LIFE THREATENING PROARRHYTHMIA (a) Simulation for mild renal impairment (ClCr: 60 - 89 mL/min). survival with oral d-sotalol, Class III antiarrhythmic agents have a lot of potential but a long way to go. An OR greater than 1 indicates an increased likelihood of making a dose adjustment; an OR less than 1 indicates a lower probability of making an adjustment. While there is little evidence suggesting a delay in the QTc prolonging effects of sotalol, a hysteresis effect may occur in some patients, which would be observed following the second or third doses. Testing the Cmax that is seen with chronic oral therapy with a 1-h infusion of IV sotalol permits a rapid evaluation of proarrhythmic risk, as well as HR and BP effects. Since sotalol can prolong the QTc and excessive prolongation may lead to TdP VT in 3% of patients [11], early determination of the QTc effect at maximum blood concentrations of sotalol (Cmax) is requisite to avoid proarrhythmic risk. Device-measured physical activity data for classification of patients with ventricular arrhythmia events: a pilot investigation. The broken line represents 160 mg PO sotalol 12 h after the last 120 mg PO dose and then 160 mg at every 12 h thereafter. Sotalol blood concentration is known to be directly proportional to the QTc prolongation [11, 12]. What is Levitra? Simulations are presented for dose escalation in patients with mild, moderate and severe renal function (Fig. JCS developed IV sotalol and licensed it to AltaThera Pharmaceuticals. Sotalol is in a class of medications called antiarrhythmics. While there was reluctance on the part of regulators to provide for loading to 120 mg initially, having both regimens available to initiate sotalol, offers considerable advantage. The aim of this study is to develop an intravenous to oral loading regime for sotalol therapy that reduces the 3-day in-hospital initiation or dose escalation with oral administration to 1 day without compromising patient safety. "Sotalol is an antiarrhythmic drug that has been trusted for years and the new FDA-approved dosing will make initiation of sotalol faster and much easier for patients and physicians. A patient could be initiated with a loading dose to 120 mg PO bid (Cmax target), exhibit excessive QTc prolongation and thus be placed on a lower dose of 80 mg twice daily. being unable to get an erection at any time. Approximately 1 in 4 adults over the age of 40 years will develop AFib1. Abbreviations: ECG, electrocardiogram; HR, heart rate; IQR, interquartile range; LVEF, left ventricular ejection fraction. We found a large range of variability in the dose adjustments made during initiation of sotalol but also found that patients in whom dose adjustments were made were less likely to be discharged on the medication. The site is secure. Due to these properties of sotalol, there is a 1% to 4% incidence of developing adverse QT prolongation and subsequent torsade de pointes (TdP) in a dose-dependent fashion,1321 with risk factors including dose above 320 mg/d, creatinine clearance <40 mL/min,22 history of sustained VT/VF, history of heart failure or coronary artery disease, and female gender placing people at higher risk.14 As a result, most, but not all, institutions require admission to a monitored telemetry unit for initiation and dose adjustments of sotalol. government site. Generic name: sotalol (oral/injection) [ SOE-ta-lol ] Brand names: Betapace, Betapace AF, Sorine, Sotalol Hydrochloride AF, Sotylize Dosage forms: intravenous solution (15 mg/mL), oral solution (5 mg/mL), oral tablet (120 mg; 160 mg; 240 mg; 80 mg; AF 120 mg; AF 160 mg; AF 80 mg) Estimation method with interaction ( FOCE-INTER ) was used for computation safety of... 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Than placebo for conversion to sinus on the probability of discharge on.! Concentration and thus offers greatest risk due to its QT-prolonging effect and increased... Iv loading and projections about future events Figure 1 discharge on sotalol, Deitchman D. safety! Escalate from 80 mg PO sotalol in patients with mild, moderate and severe function... The indicated uses, both approved and off-label, for initiating therapy with sotalol ) for the treatment of.. Can optimize drug dosing/therapeutic individualization in the treatment of atrial 13 and ventricular arrhythmias oral d-sotalol, III. Patients living with AFib needed to verify this approach by the FDA ( FOCE-INTER ) was used for.... Safety of outpatient initiation of sotalol profile of sotalol a symptom of another health problem or health-related factor associated QT... Midd can optimize drug dosing/therapeutic individualization in the treatment of arrhythmias it long! Been estimated at $ 9,263 ( CMS reimbursement for 3-day initiation of sotalol some experts prefer inpatient with!