{
 "query": "sotalol",
 "ingredient": "sotalol",
 "slug": "sotalol",
 "rxcui": "9947",
 "brands": [
  "Betapace",
  "Sotylize"
 ],
 "names": [
  "sotalol",
  "sotalol hydrochloride"
 ],
 "classes": [
  {
   "id": "C07AA",
   "name": "Beta blocking agents, non-selective"
  }
 ],
 "alternatives": [
  "alprenolol",
  "bopindolol",
  "bupranolol",
  "carteolol",
  "mepindolol",
  "nadolol",
  "oxprenolol",
  "penbutolol",
  "pindolol",
  "propranolol",
  "tertatolol",
  "timolol"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 43,
   "INTRAVENOUS": 1
  },
  "boxed_warning": "WARNING: LIFE-THREATENING PROARRHYTHMIA To minimize the risk of drug-induced arrhythmia, initiate or reinitiate oral sotalol in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Sotalol can cause life-threatening ventricular tachycardia associated with QT interval prolongation. If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug. Calculate creatinine clearance to determine appropriate dosing [see Dosage and Administration ( 2.5 )] . WARNING: LIFE THREATENING PROARRHYTHMIA See full prescribing information for complete boxed warning. Sotalol hydrochloride/ Sotalol hydrochloride AF can cause life-threatening ventricular tachycardia associated with QT interval prolongation. If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug. Initiate or reinitiate in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Adjust the dosing interval based on creatinine clearance.",
  "indications_and_usage": "Sotalol hydrochloride/Sotalol hydrochloride AF tablets are an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias ( 1.1 ) the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) ( 1.2 ) Limitations of Use Sotalol hydrochloride has not been shown to enhance survival in patients with life threatening ventricular arrhythmias (1.1) Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL ( 1.2 ) 1.1 Life-Threatening Ventricular Arrhythmias Sotalol hydrochloride/Sotalol hydrochloride AF tablets are indicated for the treatment of documented, life-threatening, ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use: Sotalol hydrochloride/Sotalol hydrochloride AF has not been shown to enhance survival in patients with life-threatening ventricular arrhythmias. 1.2 Delay in Recurrence of Atrial Fibrillation/Atrial Flutter (AFIB/AFL) Sotalol hydrochloride/Sotalol hydrochloride AF tablets are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of AFIB/AFL) in patients with highly symptomatic AFIB/AFL who are currently in sinus rhyt...",
  "contraindications": "Sotalol hydrochloride/Sotalol hydrochloride (AF) is contraindicated in patients with: Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is present Congenital or acquired long QT syndromes Cardiogenic shock or decompensated heart failure Serum potassium <4 mEq/L Bronchial asthma or related bronchospastic conditions Hypersensitivity to sotalol For the treatment of AFIB/AFL, sotalol hydrochloride/sotalol hydrochloride AF is also contraindicated in patients with: Baseline QT interval >450 msec For the treatment of AFIB/AFL or ventricular arrythmias Sinus bradycardia, 2 nd or 3 rd degree AV block, sick sinus syndrome ( 4 ) Congenital or acquired long QT syndrome ( 4 ) Serum potassium <4 mEq/L (4) Cardiogenic shock, decompensated heart failure ( 4 ) Bronchial asthma or related bronchospastic conditions ( 4 ) Hypersensitivity to sotalol ( 4 ) For the treatment of AFIB/AFL also contraindicated for: QT interval >450 msec ( 4 )",
  "warnings_and_cautions": "prolongation, bradycardia, AV block, hypotension, worsening heart failure: Reduce dose or discontinue ( 5.1 ) Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue ( 5.5 ) Correct any electrolyte disturbances ( 5.1 ) May mask symptoms of hypoglycemia or worsen hyperglycemia in diabetic patients; monitor ( 5.7 ) 5.1 QT Prolongation and Proarrhythmia Sotalol hydrochloride/Sotalol hydrochloride AF can cause serious and potentially fatal ventricular arrhythmias such as sustained VT/VF, primarily Torsade de Pointes (TdP) type ventricular tachycardia, a polymorphic ventricular tachycardia associated with QT interval prolongation. Factors such as reduced creatinine clearance, female sex, higher doses, reduced heart rate and history of sustained VT/VF or heart failure increase the risk of TdP. The risk of TdP can be reduced by adjustment of the sotalol dose according to creatinine clearance and by monitoring the ECG for excessive increases in the QT interval [see Dosage and Administration ( 2.1 )] . Correct hypokalemia or hypomagnesemia prior to initiating sotalol hydrochloride/sotalol hydrochloride AF, as these conditions can exaggerate the d...",
  "warnings": "",
  "adverse_reactions": "The most common adverse reactions (\u22652%) for sotalol hydrochloride are: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions that are clearly related to sotalol are those which are typical of its Class II (beta-blocking) and Class III (cardiac action potential duration prolongation) effects and are dose related. Ventricular Arrhythmias Serious Adverse Reactions Sotalol hydrochloride/sotalol hydrochloride AF tablets can cause serious and potentially fatal ventricular arrhythmias such as sustained VT/VF, primarily Torsade de Pointes (TdP) [see Warnings and Precautions ( 5.1 )] . The effect on QT and the risk of Torsade de Pointes are both dose related. Pediatric Patients In an unblinded mult...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise patients to contact their healthcare provider in the event of syncope, pre-syncopal symptoms or cardiac palpitations. Advise patients that their electrolytes and ECG will be monitored during treatment [see Warnings and Precautions ( 5.1 )]. Advise patients to contact their healthcare provider in the event of conditions that could lead to electrolyte changes such as severe diarrhea, unusual sweating, vomiting, less appetite than normal, or excessive thirst [see Warnings and Precautions ( 5.1 )]. Advise patients not to change the sotalol hydrochloride/sotalol hydrochloride AF tablets dose prescribed by their healthcare provider. Advise patients that they should not miss a dose, but if they do miss a dose they should not double the next dose to compensate for the missed dose: they should take the next dose at the regularly scheduled time [see Dosage and Administration ( 2 )] . Advise patients to not interrupt or discontinue sotalol hydrochloride/sotalol hydrochloride AF tablets without their physician\u2019s advice, that they should get their prescription for sotalol filled and refilled on time, so they do not interrupt treatment [see Dosage and Administration ( 2 )]. Advise patient...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Ventricular Arrhythmias In patients with life-threatening arrhythmias [sustained ventricular tachycardia/fibrillation (VT/VF)], sotalol hydrochloride was studied acutely [by suppression of programmed electrical stimulation (PES) induced VT and by suppression of Holter monitor evidence of sustained VT] and, in acute responders, chronically. In a double-blind, randomized comparison of sotalol hydrochloride and procainamide in 104 patients given intravenously (total of 2 mg/kg sotalol hydrochloride vs. 19 mg/kg of procainamide over 90 minutes), sotalol hydrochloride suppressed PES induction in 30% of patients vs. 20% for procainamide (P=0.2). In a randomized clinical trial (Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) Trial) in 486 patients comparing the choice of antiarrhythmic therapy by PES suppression vs. Holter monitor selection (in each case followed by treadmill exercise testing) in patients with a history of sustained VT/VF who were also inducible by PES, the effectiveness acutely and chronically of sotalol hydrochloride was compared with that of 6 other drugs (procainamide, quinidine, mexiletine, propafenone, imipramine, and pirmenol). The Over...",
  "brand_name": "Sotalol Hydrochloride",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA076140",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20230808",
  "set_id": "5e005309-4eca-4536-8743-c6ed9e5b3195",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 14785,
  "serious": 11664,
  "death": 1492,
  "hospitalization": 6301,
  "primary_suspect": 14694,
  "top_reactions": [
   [
    "Atrial Fibrillation",
    911
   ],
   [
    "Drug Ineffective",
    868
   ],
   [
    "Fatigue",
    813
   ],
   [
    "Dyspnoea",
    798
   ],
   [
    "Off Label Use",
    691
   ],
   [
    "Diarrhoea",
    656
   ],
   [
    "Dizziness",
    644
   ],
   [
    "Nausea",
    595
   ],
   [
    "Asthenia",
    551
   ],
   [
    "Fall",
    511
   ],
   [
    "Hypotension",
    508
   ],
   [
    "Death",
    489
   ],
   [
    "Drug Interaction",
    481
   ],
   [
    "Malaise",
    450
   ],
   [
    "Headache",
    413
   ]
  ],
  "by_year": {
   "2019": 1553,
   "2020": 1356,
   "2021": 1080,
   "2022": 963,
   "2023": 998,
   "2024": 755,
   "2025": 1175,
   "2026": 439
  },
  "by_year_primary": {
   "2019": 1552,
   "2020": 1354,
   "2021": 1068,
   "2022": 952,
   "2023": 964,
   "2024": 744,
   "2025": 1167,
   "2026": 431
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 21,
  "nda": 4,
  "anda": 17,
  "first_approval": "19921030",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 14,
  "labeling_recent": 4,
  "sponsors": [
   "AIPING PHARM INC",
   "ALTATHERA PHARMS LLC",
   "APOTEX",
   "AUROBINDO PHARMA USA",
   "AZURITY",
   "EPIC PHARMA LLC",
   "IMPAX PHARMS",
   "LEGACY"
  ],
  "unapproved": false,
  "first_approval_fmt": "10/30/1992"
 },
 "trials": {
  "total": 74,
  "completed": 37,
  "terminated": 10,
  "with_results": 12,
  "industry": 25,
  "phase3": 14,
  "results_share": 0.32432432432432434,
  "terminated_share": 0.13513513513513514
 },
 "pubmed": {
  "rct": 155,
  "meta": 9,
  "recent_rct": 1,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "sotalol",
   "Betapace",
   "Sotylize"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1148328,
  "beneficiaries": 282515,
  "spend": 24310630.48,
  "by_brand": [
   {
    "brand": "Sotalol",
    "claims": 1092985,
    "per_claim": 20.079596957,
    "is_generic": false
   },
   {
    "brand": "Sotalol Af",
    "claims": 54999,
    "per_claim": 28.687140857,
    "is_generic": false
   },
   {
    "brand": "Betapace",
    "claims": 197,
    "per_claim": 2713.5201015,
    "is_generic": false
   },
   {
    "brand": "Betapace Af",
    "claims": 112,
    "per_claim": 1777.8907143,
    "is_generic": false
   },
   {
    "brand": "Sotylize",
    "claims": 35,
    "per_claim": 1499.4548571,
    "is_generic": false
   }
  ],
  "per_claim": 21.17045868427836
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2342,
  "fills": 1148328,
  "per_million": 2039.4869758466223,
  "ratio": 0.7365561520409497,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 65,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,039 FDA reports naming it as the suspect drug per million Medicare fills, 0.7x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.1x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 43,
   "letter": "F",
   "why": [
    "155 randomized trials and 9 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 32% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 96,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "4 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (17 applications)",
    "12 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 73,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are atrial fibrillation, fatigue, dyspnoea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over alprenolol, bopindolol, bupranolol? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}