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Details

Stereochemistry RACEMIC
Molecular Formula C12H20N2O3S.ClH
Molecular Weight 308.8262
Optical Activity ( + / - )
Defined Stereocenters 0 / 1
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of SOTALOL HYDROCHLORIDE

SMILES

CC(C)NCC(c1ccc(cc1)NS(=O)(=O)C)O.Cl

InChI

InChIKey=VIDRYROWYFWGSY-UHFFFAOYSA-N
InChI=1S/C12H20N2O3S.ClH/c1-9(2)13-8-12(15)10-4-6-11(7-5-10)14-18(3,16)17;/h4-7,9,12-15H,8H2,1-3H3;1H

HIDE SMILES / InChI

Molecular Formula ClH
Molecular Weight 36.4609
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Molecular Formula C12H20N2O3S
Molecular Weight 272.3654
Charge 0
Count
Stereochemistry RACEMIC
Additional Stereochemistry No
Defined Stereocenters 0 / 1
E/Z Centers 0
Optical Activity ( + / - )

Description
Curator's Comment:: description was created based on several sources, including: https://www.drugs.com/mtm/sotalol.html http://www.rxlist.com/betapace-drug.htm http://www.wikidoc.org/index.php/Sotalol

Sotalol has both beta-adrenoreceptor blocking and cardiac action potential duration prolongation antiarrhythmic properties. Sotalol inhibits response to adrenergic stimuli by competitively blocking β1-adrenergic receptors within the myocardium and β2-adrenergic receptors within bronchial and vascular smooth muscle. It is FDA approved for the treatment of ventricular arrhythmias, symptomatic atrial fibtillation, symptomatic atriall flutter. Common adverse reactions include bradyarrhythmia, chest pain, lightheadedness, palpitations, rash, nausea, dizziness, headache, dyspnea, fatigue. Proarrhythmic events were more common in sotalol treated patients also receiving digoxin. Sotalol should be administered with caution in conjunction with calcium blocking drugs because of possible additive effects on atrioventricular conduction or ventricular function. Patients treated with sotalol plus a catecholamine depletor should therefore be closely monitored for evidence of hypotension and/or marked bradycardia which may produce syncope.

Approval Year

TargetsConditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
BETAPACE

Approved Use

Oral sotalol hydrochloride is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of sotalol (see WARNINGS ), including a 1.5 to 2% rate of torsade de pointes or new VT/VF in patients with either NSVT or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of sotalol treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. The response to treatment should then be evaluated by a suitable method (e.g., PES or Holter monitoring) prior to continuing the patient on chronic therapy. Various approaches have been used to determine the response to antiarrhythmic therapy, including sotalol. In the ESVEM Trial, response by Holter monitoring was tentatively defined as 100% suppression of ventricular tachycardia, 90% suppression of non-sustained VT, 80% suppression of paired VPCs, and 75% suppression of total VPCs in patients who had at least 10 VPCs/hour at baseline; this tentative response was confirmed if VT lasting 5 or more beats was not observed during treadmill exercise testing using a standard Bruce protocol. The PES protocol utilized a maximum of three extrastimuli at three pacing cycle lengths and two right ventricular pacing sites. Response by PES was defined as prevention of induction of the following: 1) monomorphic VT lasting over 15 seconds; 2) non-sustained polymorphic VT containing more than 15 beats of monomorphic VT in patients with a history of monomorphic VT; 3) polymorphic VT or VF greater than 15 beats in patients with VF or a history of aborted sudden death without monomorphic VT; and 4) two episodes of polymorphic VT or VF of greater than 15 beats in a patient presenting with monomorphic VT. Sustained VT or NSVT producing hypotension during the final treadmill test was considered a drug failure. In a multicenter open-label long-term study of sotalol in patients with life-threatening ventricular arrhythmias which had proven refractory to other antiarrhythmic medications, response by Holter monitoring was defined as in ESVEM. Response by PES was defined as non-inducibility of sustained VT by at least double extrastimuli delivered at a pacing cycle length of 400 msec. Overall survival and arrhythmia recurrence rates in this study were similar to those seen in ESVEM, although there was no comparative group to allow a definitive assessment of outcome. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias. Sotalol is also indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)

Launch Date

7.2040317E11
Primary
BETAPACE

Approved Use

Oral sotalol hydrochloride is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of sotalol (see WARNINGS ), including a 1.5 to 2% rate of torsade de pointes or new VT/VF in patients with either NSVT or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of sotalol treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. The response to treatment should then be evaluated by a suitable method (e.g., PES or Holter monitoring) prior to continuing the patient on chronic therapy. Various approaches have been used to determine the response to antiarrhythmic therapy, including sotalol. In the ESVEM Trial, response by Holter monitoring was tentatively defined as 100% suppression of ventricular tachycardia, 90% suppression of non-sustained VT, 80% suppression of paired VPCs, and 75% suppression of total VPCs in patients who had at least 10 VPCs/hour at baseline; this tentative response was confirmed if VT lasting 5 or more beats was not observed during treadmill exercise testing using a standard Bruce protocol. The PES protocol utilized a maximum of three extrastimuli at three pacing cycle lengths and two right ventricular pacing sites. Response by PES was defined as prevention of induction of the following: 1) monomorphic VT lasting over 15 seconds; 2) non-sustained polymorphic VT containing more than 15 beats of monomorphic VT in patients with a history of monomorphic VT; 3) polymorphic VT or VF greater than 15 beats in patients with VF or a history of aborted sudden death without monomorphic VT; and 4) two episodes of polymorphic VT or VF of greater than 15 beats in a patient presenting with monomorphic VT. Sustained VT or NSVT producing hypotension during the final treadmill test was considered a drug failure. In a multicenter open-label long-term study of sotalol in patients with life-threatening ventricular arrhythmias which had proven refractory to other antiarrhythmic medications, response by Holter monitoring was defined as in ESVEM. Response by PES was defined as non-inducibility of sustained VT by at least double extrastimuli delivered at a pacing cycle length of 400 msec. Overall survival and arrhythmia recurrence rates in this study were similar to those seen in ESVEM, although there was no comparative group to allow a definitive assessment of outcome. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias. Sotalol is also indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)

Launch Date

7.2040317E11
Primary
BETAPACE

Approved Use

Oral sotalol hydrochloride is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of sotalol (see WARNINGS ), including a 1.5 to 2% rate of torsade de pointes or new VT/VF in patients with either NSVT or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of sotalol treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. The response to treatment should then be evaluated by a suitable method (e.g., PES or Holter monitoring) prior to continuing the patient on chronic therapy. Various approaches have been used to determine the response to antiarrhythmic therapy, including sotalol. In the ESVEM Trial, response by Holter monitoring was tentatively defined as 100% suppression of ventricular tachycardia, 90% suppression of non-sustained VT, 80% suppression of paired VPCs, and 75% suppression of total VPCs in patients who had at least 10 VPCs/hour at baseline; this tentative response was confirmed if VT lasting 5 or more beats was not observed during treadmill exercise testing using a standard Bruce protocol. The PES protocol utilized a maximum of three extrastimuli at three pacing cycle lengths and two right ventricular pacing sites. Response by PES was defined as prevention of induction of the following: 1) monomorphic VT lasting over 15 seconds; 2) non-sustained polymorphic VT containing more than 15 beats of monomorphic VT in patients with a history of monomorphic VT; 3) polymorphic VT or VF greater than 15 beats in patients with VF or a history of aborted sudden death without monomorphic VT; and 4) two episodes of polymorphic VT or VF of greater than 15 beats in a patient presenting with monomorphic VT. Sustained VT or NSVT producing hypotension during the final treadmill test was considered a drug failure. In a multicenter open-label long-term study of sotalol in patients with life-threatening ventricular arrhythmias which had proven refractory to other antiarrhythmic medications, response by Holter monitoring was defined as in ESVEM. Response by PES was defined as non-inducibility of sustained VT by at least double extrastimuli delivered at a pacing cycle length of 400 msec. Overall survival and arrhythmia recurrence rates in this study were similar to those seen in ESVEM, although there was no comparative group to allow a definitive assessment of outcome. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias. Sotalol is also indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)

Launch Date

7.2040317E11
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
781 ng/mL
80 mg single, oral
dose: 80 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
SOTALOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
10402 ng × h/mL
80 mg single, oral
dose: 80 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
SOTALOL plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
12 h
160 mg single, oral
dose: 160 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
SOTALOL plasma
Homo sapiens
population: UNKNOWN
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
60 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 60 mg, 2 times / day
Route: oral
Route: multiple
Dose: 60 mg, 2 times / day
Sources:
unhealthy, 31.8 years (range: 10-67 years)
n = 82
Health Status: unhealthy
Condition: congenital heart disease
Age Group: 31.8 years (range: 10-67 years)
Population Size: 82
Sources:
Disc. AE: Lethargy, Bradycardia...
Other AEs: Hypotension, Loss of taste...
AEs leading to
discontinuation/dose reduction:
Lethargy (13 patients)
Bradycardia (11 patient)
Bronchospasm (6 patients)
Nausea and vomiting (2 patients)
Erectile dysfunction (2 patients)
Visual disturbance (1 patient)
Depression (1 patient)
Other AEs:
Hypotension (1 patient)
Loss of taste (1 patient)
Sources:
640 mg/day multiple, oral
Highest studied dose
Dose: 640 mg/day
Route: oral
Route: multiple
Dose: 640 mg/day
Sources:
unhealthy, adult
n = 39
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 39
Sources:
Other AEs: Chest pain, Dyspnea...
Other AEs:
Chest pain (15.4%)
Dyspnea (20.5%)
Palpitation (5.1%)
Vasodilation (5.1%)
Asthenia (20.5%)
Dizziness (17.9%)
Fatigue (25.6%)
Headache (7.7%)
Light-headed (5.1%)
Sleep problem (7.7%)
Upper respiratory tract signs and symptoms (12.8%)
Sources:
240 mg/day multiple, oral (max)
Recommended
Dose: 240 mg/day
Route: oral
Route: multiple
Dose: 240 mg/day
Sources:
unhealthy, adult
n = 153
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 153
Sources:
Other AEs: Bradycardia, Diarrhea...
Other AEs:
Bradycardia (13.1%)
Diarrhea (5.2%)
Nausea and vomiting (7.8%)
Abdominal pain NOS (3.9%)
Fatigue (19.6%)
Hyperhidrosis (5.2%)
Weakness (5.2%)
Musculoskeletal pain (2.6%)
Dizziness (16.3%)
Headache (3.3%)
Cough (3.3%)
Dyspnea (9.2%)
Sources:
320 mg/day multiple, oral (max|total daily dose)
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 122
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 122
Sources:
Other AEs: Bradycardia, Diarrhea...
Other AEs:
Bradycardia (12.3%)
Diarrhea (5.7%)
Nausea and vomiting (5.7%)
Abdominal pain NOS (2.5%)
Fatigue (18.9%)
Hyperhidrosis (4.9%)
Weakness (4.9%)
Musculoskeletal pain (4.1%)
Dizziness (13.1%)
Headache (11.5%)
Cough (2.5%)
Dyspnea (9.8%)
Sources:
320 mg/day multiple, oral
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 38
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 38
Sources:
Other AEs: Chest pain, Dyspnea...
Other AEs:
Chest pain (7.9%)
Dyspnea (18.4%)
Palpitation (7.9%)
Asthenia (10.5%)
Dizziness (13.2%)
Fatigue (26.3%)
Headache (5.3%)
Light-headed (15.8%)
Sleep problem (2.6%)
Upper respiratory tract signs and symptoms (2.6%)
Visual disturbance NOS (5.3%)
Sources:
AEs

AEs

AESignificanceDosePopulation
Hypotension 1 patient
60 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 60 mg, 2 times / day
Route: oral
Route: multiple
Dose: 60 mg, 2 times / day
Sources:
unhealthy, 31.8 years (range: 10-67 years)
n = 82
Health Status: unhealthy
Condition: congenital heart disease
Age Group: 31.8 years (range: 10-67 years)
Population Size: 82
Sources:
Loss of taste 1 patient
60 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 60 mg, 2 times / day
Route: oral
Route: multiple
Dose: 60 mg, 2 times / day
Sources:
unhealthy, 31.8 years (range: 10-67 years)
n = 82
Health Status: unhealthy
Condition: congenital heart disease
Age Group: 31.8 years (range: 10-67 years)
Population Size: 82
Sources:
Depression 1 patient
Disc. AE
60 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 60 mg, 2 times / day
Route: oral
Route: multiple
Dose: 60 mg, 2 times / day
Sources:
unhealthy, 31.8 years (range: 10-67 years)
n = 82
Health Status: unhealthy
Condition: congenital heart disease
Age Group: 31.8 years (range: 10-67 years)
Population Size: 82
Sources:
Visual disturbance 1 patient
Disc. AE
60 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 60 mg, 2 times / day
Route: oral
Route: multiple
Dose: 60 mg, 2 times / day
Sources:
unhealthy, 31.8 years (range: 10-67 years)
n = 82
Health Status: unhealthy
Condition: congenital heart disease
Age Group: 31.8 years (range: 10-67 years)
Population Size: 82
Sources:
Bradycardia 11 patient
Disc. AE
60 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 60 mg, 2 times / day
Route: oral
Route: multiple
Dose: 60 mg, 2 times / day
Sources:
unhealthy, 31.8 years (range: 10-67 years)
n = 82
Health Status: unhealthy
Condition: congenital heart disease
Age Group: 31.8 years (range: 10-67 years)
Population Size: 82
Sources:
Lethargy 13 patients
Disc. AE
60 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 60 mg, 2 times / day
Route: oral
Route: multiple
Dose: 60 mg, 2 times / day
Sources:
unhealthy, 31.8 years (range: 10-67 years)
n = 82
Health Status: unhealthy
Condition: congenital heart disease
Age Group: 31.8 years (range: 10-67 years)
Population Size: 82
Sources:
Erectile dysfunction 2 patients
Disc. AE
60 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 60 mg, 2 times / day
Route: oral
Route: multiple
Dose: 60 mg, 2 times / day
Sources:
unhealthy, 31.8 years (range: 10-67 years)
n = 82
Health Status: unhealthy
Condition: congenital heart disease
Age Group: 31.8 years (range: 10-67 years)
Population Size: 82
Sources:
Nausea and vomiting 2 patients
Disc. AE
60 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 60 mg, 2 times / day
Route: oral
Route: multiple
Dose: 60 mg, 2 times / day
Sources:
unhealthy, 31.8 years (range: 10-67 years)
n = 82
Health Status: unhealthy
Condition: congenital heart disease
Age Group: 31.8 years (range: 10-67 years)
Population Size: 82
Sources:
Bronchospasm 6 patients
Disc. AE
60 mg 2 times / day multiple, oral (mean)
Recommended
Dose: 60 mg, 2 times / day
Route: oral
Route: multiple
Dose: 60 mg, 2 times / day
Sources:
unhealthy, 31.8 years (range: 10-67 years)
n = 82
Health Status: unhealthy
Condition: congenital heart disease
Age Group: 31.8 years (range: 10-67 years)
Population Size: 82
Sources:
Upper respiratory tract signs and symptoms 12.8%
640 mg/day multiple, oral
Highest studied dose
Dose: 640 mg/day
Route: oral
Route: multiple
Dose: 640 mg/day
Sources:
unhealthy, adult
n = 39
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 39
Sources:
Chest pain 15.4%
640 mg/day multiple, oral
Highest studied dose
Dose: 640 mg/day
Route: oral
Route: multiple
Dose: 640 mg/day
Sources:
unhealthy, adult
n = 39
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 39
Sources:
Dizziness 17.9%
640 mg/day multiple, oral
Highest studied dose
Dose: 640 mg/day
Route: oral
Route: multiple
Dose: 640 mg/day
Sources:
unhealthy, adult
n = 39
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 39
Sources:
Asthenia 20.5%
640 mg/day multiple, oral
Highest studied dose
Dose: 640 mg/day
Route: oral
Route: multiple
Dose: 640 mg/day
Sources:
unhealthy, adult
n = 39
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 39
Sources:
Dyspnea 20.5%
640 mg/day multiple, oral
Highest studied dose
Dose: 640 mg/day
Route: oral
Route: multiple
Dose: 640 mg/day
Sources:
unhealthy, adult
n = 39
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 39
Sources:
Fatigue 25.6%
640 mg/day multiple, oral
Highest studied dose
Dose: 640 mg/day
Route: oral
Route: multiple
Dose: 640 mg/day
Sources:
unhealthy, adult
n = 39
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 39
Sources:
Light-headed 5.1%
640 mg/day multiple, oral
Highest studied dose
Dose: 640 mg/day
Route: oral
Route: multiple
Dose: 640 mg/day
Sources:
unhealthy, adult
n = 39
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 39
Sources:
Palpitation 5.1%
640 mg/day multiple, oral
Highest studied dose
Dose: 640 mg/day
Route: oral
Route: multiple
Dose: 640 mg/day
Sources:
unhealthy, adult
n = 39
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 39
Sources:
Vasodilation 5.1%
640 mg/day multiple, oral
Highest studied dose
Dose: 640 mg/day
Route: oral
Route: multiple
Dose: 640 mg/day
Sources:
unhealthy, adult
n = 39
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 39
Sources:
Headache 7.7%
640 mg/day multiple, oral
Highest studied dose
Dose: 640 mg/day
Route: oral
Route: multiple
Dose: 640 mg/day
Sources:
unhealthy, adult
n = 39
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 39
Sources:
Sleep problem 7.7%
640 mg/day multiple, oral
Highest studied dose
Dose: 640 mg/day
Route: oral
Route: multiple
Dose: 640 mg/day
Sources:
unhealthy, adult
n = 39
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 39
Sources:
Bradycardia 13.1%
240 mg/day multiple, oral (max)
Recommended
Dose: 240 mg/day
Route: oral
Route: multiple
Dose: 240 mg/day
Sources:
unhealthy, adult
n = 153
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 153
Sources:
Dizziness 16.3%
240 mg/day multiple, oral (max)
Recommended
Dose: 240 mg/day
Route: oral
Route: multiple
Dose: 240 mg/day
Sources:
unhealthy, adult
n = 153
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 153
Sources:
Fatigue 19.6%
240 mg/day multiple, oral (max)
Recommended
Dose: 240 mg/day
Route: oral
Route: multiple
Dose: 240 mg/day
Sources:
unhealthy, adult
n = 153
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 153
Sources:
Musculoskeletal pain 2.6%
240 mg/day multiple, oral (max)
Recommended
Dose: 240 mg/day
Route: oral
Route: multiple
Dose: 240 mg/day
Sources:
unhealthy, adult
n = 153
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 153
Sources:
Cough 3.3%
240 mg/day multiple, oral (max)
Recommended
Dose: 240 mg/day
Route: oral
Route: multiple
Dose: 240 mg/day
Sources:
unhealthy, adult
n = 153
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 153
Sources:
Headache 3.3%
240 mg/day multiple, oral (max)
Recommended
Dose: 240 mg/day
Route: oral
Route: multiple
Dose: 240 mg/day
Sources:
unhealthy, adult
n = 153
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 153
Sources:
Abdominal pain NOS 3.9%
240 mg/day multiple, oral (max)
Recommended
Dose: 240 mg/day
Route: oral
Route: multiple
Dose: 240 mg/day
Sources:
unhealthy, adult
n = 153
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 153
Sources:
Diarrhea 5.2%
240 mg/day multiple, oral (max)
Recommended
Dose: 240 mg/day
Route: oral
Route: multiple
Dose: 240 mg/day
Sources:
unhealthy, adult
n = 153
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 153
Sources:
Hyperhidrosis 5.2%
240 mg/day multiple, oral (max)
Recommended
Dose: 240 mg/day
Route: oral
Route: multiple
Dose: 240 mg/day
Sources:
unhealthy, adult
n = 153
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 153
Sources:
Weakness 5.2%
240 mg/day multiple, oral (max)
Recommended
Dose: 240 mg/day
Route: oral
Route: multiple
Dose: 240 mg/day
Sources:
unhealthy, adult
n = 153
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 153
Sources:
Nausea and vomiting 7.8%
240 mg/day multiple, oral (max)
Recommended
Dose: 240 mg/day
Route: oral
Route: multiple
Dose: 240 mg/day
Sources:
unhealthy, adult
n = 153
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 153
Sources:
Dyspnea 9.2%
240 mg/day multiple, oral (max)
Recommended
Dose: 240 mg/day
Route: oral
Route: multiple
Dose: 240 mg/day
Sources:
unhealthy, adult
n = 153
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 153
Sources:
Headache 11.5%
320 mg/day multiple, oral (max|total daily dose)
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 122
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 122
Sources:
Bradycardia 12.3%
320 mg/day multiple, oral (max|total daily dose)
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 122
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 122
Sources:
Dizziness 13.1%
320 mg/day multiple, oral (max|total daily dose)
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 122
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 122
Sources:
Fatigue 18.9%
320 mg/day multiple, oral (max|total daily dose)
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 122
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 122
Sources:
Abdominal pain NOS 2.5%
320 mg/day multiple, oral (max|total daily dose)
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 122
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 122
Sources:
Cough 2.5%
320 mg/day multiple, oral (max|total daily dose)
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 122
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 122
Sources:
Musculoskeletal pain 4.1%
320 mg/day multiple, oral (max|total daily dose)
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 122
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 122
Sources:
Hyperhidrosis 4.9%
320 mg/day multiple, oral (max|total daily dose)
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 122
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 122
Sources:
Weakness 4.9%
320 mg/day multiple, oral (max|total daily dose)
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 122
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 122
Sources:
Diarrhea 5.7%
320 mg/day multiple, oral (max|total daily dose)
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 122
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 122
Sources:
Nausea and vomiting 5.7%
320 mg/day multiple, oral (max|total daily dose)
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 122
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 122
Sources:
Dyspnea 9.8%
320 mg/day multiple, oral (max|total daily dose)
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 122
Health Status: unhealthy
Condition: atrial fibrillation (AFIB) | atrial flutter (AFL)
Age Group: adult
Population Size: 122
Sources:
Asthenia 10.5%
320 mg/day multiple, oral
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 38
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 38
Sources:
Dizziness 13.2%
320 mg/day multiple, oral
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 38
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 38
Sources:
Light-headed 15.8%
320 mg/day multiple, oral
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 38
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 38
Sources:
Dyspnea 18.4%
320 mg/day multiple, oral
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 38
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 38
Sources:
Sleep problem 2.6%
320 mg/day multiple, oral
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 38
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 38
Sources:
Upper respiratory tract signs and symptoms 2.6%
320 mg/day multiple, oral
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 38
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 38
Sources:
Fatigue 26.3%
320 mg/day multiple, oral
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 38
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 38
Sources:
Headache 5.3%
320 mg/day multiple, oral
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 38
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 38
Sources:
Visual disturbance NOS 5.3%
320 mg/day multiple, oral
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 38
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 38
Sources:
Chest pain 7.9%
320 mg/day multiple, oral
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 38
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 38
Sources:
Palpitation 7.9%
320 mg/day multiple, oral
Recommended
Dose: 320 mg/day
Route: oral
Route: multiple
Dose: 320 mg/day
Sources:
unhealthy, adult
n = 38
Health Status: unhealthy
Condition: ventricular ectopy
Age Group: adult
Population Size: 38
Sources:
Overview

OverviewOther

Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
no [IC50 >100 uM]
no [IC50 >100 uM]
no [IC50 >100 uM]
no [IC50 >100 uM]
no [IC50 >100 uM]
no [IC50 >100 uM]
no [IC50 >100 uM]
no [IC50 >100 uM]
no [IC50 >100 uM]
no
no
no
no
no
no
yes
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
yes
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
PubMed

PubMed

TitleDatePubMed
[Effect of sotalol on systemic hemodynamics and electrophysiology in patients with life-threatening ventricular tachyarrhythmias].
1999 Jan
Therapeutic drug monitoring: antiarrhythmic drugs.
2001
[Cardiac arrhythmias in pregnancy].
2001
Importance of QT interval determination and renal function assessment during antiarrhythmic drug therapy.
2001 Apr
CIBIS, MERIT-HF, and COPERNICUS trial outcomes: do they complete the chapter on beta-adrenergic blockers as antiarrhythmic and antifibrillatory drugs?
2001 Apr
Correlation between the effective refractory period and activation-recovery interval calculated from the intracardiac unipolar electrogram of humans with and without dl-sotalol treatment.
2001 Aug
Effects of oral sotalol administration before electrical cardioversion of persistent atrial fibrillation.
2001 Aug
Sotalol: a fool's deal?
2001 Aug
Dual-site atrial pacing for atrial fibrillation in patients without bradycardia.
2001 Aug 15
A case series of drug-induced long QT syndrome and Torsade de Pointes.
2001 Dec
A multicentre, double-blind randomized crossover comparative study on the efficacy and safety of dofetilide vs sotalol in patients with inducible sustained ventricular tachycardia and ischaemic heart disease.
2001 Dec
Control of heart rate during thermoregulation in the heliothermic lizard Pogona barbata: importance of cholinergic and adrenergic mechanisms.
2001 Dec
Cellular basis for complex T waves and arrhythmic activity following combined I(Kr) and I(Ks) block.
2001 Dec
[Supraventricular tachycardia and premature atrial contractions in fetus].
2001 Feb 17
"Stable" ventricular tachycardia is not a benign rhythm : insights from the antiarrhythmics versus implantable defibrillators (AVID) registry.
2001 Jan 16
Efficacy of sequential antiarrhythmic treatment in sinus rhythm maintenance after successful electrocardioversion in patients with chronic non-valvular atrial fibrillation.
2001 Jan-Feb
Shortening the second phase duration of biphasic shocks: effects of class III antiarrhythmic drugs on defibrillation efficacy in humans.
2001 Jul
[Current management of patients with ventricular tachycardia].
2001 Jul-Aug
Transplacental treatment of fetal tachycardia: implications of drug transporting proteins in placenta.
2001 Jun
Phase 2 early afterdepolarization as a trigger of polymorphic ventricular tachycardia in acquired long-QT syndrome : direct evidence from intracellular recordings in the intact left ventricular wall.
2001 Jun 12
[Protocols for the treatment of supraventricular tachycardias in the fetus].
2001 Jun 23
Global distribution of atrial ectopic foci triggering recurrence of atrial tachyarrhythmia after electrical cardioversion of long-standing atrial fibrillation: a bi-atrial basket mapping study.
2001 Mar 1
Drug-disease interactions: reduced beta-adrenergic and potassium channel antagonist activities of sotalol in the presence of acute and chronic inflammatory conditions in the rat.
2001 May
Post-training injections of catecholaminergic drugs do not modulate fear conditioning in rats and mice.
2001 May 4
Amiodarone -- waxed and waned and waxed again.
2001 Nov
Scavenger effect of experimental and clinically used cardiovascular drugs.
2001 Nov
Is it rational, reasonable or excessive, and consistently applied? One view of the increasing FDA emphasis on safety first for the release and use of antiarrhythmic drugs for supraventricular arrhythmias.
2001 Oct
Effect of Sotalol in the prevention of atrial fibrillation following coronary artery bypass grafting.
2001 Oct
Influence of age, the autonomic nervous system and anxiety on QT-interval variability.
2001 Oct
[Ventricular tachycardia associated with isolated right ventricular dysfunction as indicator of arrhythmogenic dysplasia of the right ventricle].
2001 Oct-Dec
Multi-morphology wide QRS tachycardias in a patient without structural heart disease: an unusual presentation of ventricular tachycardia.
2001 Sep
Long-term efficacy and safety of propafenone and sotalol for the maintenance of sinus rhythm after conversion of recurrent symptomatic atrial fibrillation.
2001 Sep 15
Pharmacologic conversion of atrial fibrillation: a systematic review of available evidence.
2001 Sep-Oct
Sotalol: the mechanism of its antiarrhythmic-defibrillating effect.
2001 Summer
Drug treatment of fetal tachycardias.
2002
Amiodarone vs. sotalol as prophylaxis against atrial fibrillation/flutter after heart surgery: a meta-analysis.
2002 Apr
Dauricine-induced changes in monophasic action potentials and effective refractory period of rabbit left ventricle in situ.
2002 Apr
Maintainance of sinus rhythm after electrical cardioversion of persistent atrial fibrillation.
2002 Apr
New antiarrhythmic drugs for the treatment of atrial fibrillation.
2002 Feb
Proarrhythmic effects of intravenous quinidine, amiodarone, D-sotalol, and almokalant in the anesthetized rabbit model of torsade de pointes.
2002 Feb
[Why is QT interval interesting?].
2002 Feb 4
Flecainide and sotalol: a new combination therapy for refractory supraventricular tachycardia in children <1 year of age.
2002 Feb 6
Combination IK1 and IKr channel blockade: no additive lowering of the defibrillation threshold.
2002 Jan
New use of antiarrhythmia drugs in Saskatchewan.
2002 Jan
Comparison of the affinity of beta-blockers for two states of the beta 1-adrenoceptor in ferret ventricular myocardium.
2002 Jan
[Sudden cardiac death (part 2)].
2002 Mar
Unique topographical distribution of M cells underlies reentrant mechanism of torsade de pointes in the long-QT syndrome.
2002 Mar 12
[Advanced prehospital treatment of heart arrest by the mobile emergency unit in Aarhus. 1-year survival after out-of-hospital heart arrest--with focus on response time, survival, the given treatment and admission].
2002 Mar 4
Prenatal ultrasound may predict fetal response to therapy in non-hydropic fetuses with supraventricular tachycardia.
2002 Mar-Apr
Preconditioning attenuates the shortening of recovery during coronary occlusion in isolated rabbit hearts with D-sotalol-induced long QT intervals.
2002 May
Patents

Sample Use Guides

In Vivo Use Guide
Curator's Comment:: The recommended initial intravenous dose of sotalol is 75 mg (once or twice daily). The 75 mg dose can be titrated upward to 112.5 or 150 mg after at least 3 days. https://www.drugs.com/pro/sotalol-injection.html
Initial dosage in adults is 80 mg twice daily. Increase the dose as needed in increments of 80 mg/day, every 3 days to a maximum 320 mg total daily dose.
Route of Administration: Other
In Vitro Use Guide
Sotalol caused significant stimulation of neutrophil motility at concentrations of more than 10−4 M.
Substance Class Chemical
Created
by admin
on Fri Jun 25 21:01:54 UTC 2021
Edited
by admin
on Fri Jun 25 21:01:54 UTC 2021
Record UNII
HEC37C70XX
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
SOTALOL HYDROCHLORIDE
EP   JAN   MART.   MI   ORANGE BOOK   USAN   USP   USP-RS   VANDF   WHO-DD  
USAN  
Official Name English
SOTALOL HYDROCHLORIDE [USP-RS]
Common Name English
NSC-337251
Code English
SOTALOL HYDROCHLORIDE [USAN]
Common Name English
SOTALOL HYDROCHLORIDE [USP MONOGRAPH]
Common Name English
SOTALOL HYDROCHLORIDE COMPONENT OF SOTYLIZE
Brand Name English
SOTALOL HYDROCHLORIDE [MART.]
Common Name English
METHANESULFONAMIDE, N-(4-(1-HYDROXY-2-((1-METHYLETHYL)AMINO)ETHYL)PHENYL)-, MONOHYDROCHLORIDE
Common Name English
SOTACOR
Brand Name English
SOTALOL HYDROCHLORIDE [JAN]
Common Name English
SOTYLIZE COMPONENT SOTALOL HYDROCHLORIDE
Brand Name English
SORINE
Brand Name English
SOTALEX
Brand Name English
SOTALOL HCL
Common Name English
MJ-1999
Code English
4'-(1-HYDROXY-2-(ISOPROPYLAMINO)ETHYL)METHANESULFONANILIDE MONOHYDROCHLORIDE
Systematic Name English
METHANESULFONAMIDE, N-(4-(1-HYDROXY-2-((1-METHYLETHYL)AMINO)ETHYL)PHENYL)-, HYDROCHLORIDE (1:1)
Systematic Name English
SOTALOL HYDROCHLORIDE [EP MONOGRAPH]
Common Name English
DAROB
Brand Name English
SOTALOL HYDROCHLORIDE [WHO-DD]
Common Name English
DL-MJ-1999
Code English
SOTALOL HYDROCHLORIDE [ORANGE BOOK]
Common Name English
BETAPACE
Brand Name English
MJ 1999
Code English
NSC-760358
Code English
SOTALOL HYDROCHLORIDE [VANDF]
Common Name English
SOTYLIZE
Brand Name English
SOTALOL HYDROCHLORIDE [MI]
Common Name English
Classification Tree Code System Code
FDA ORPHAN DRUG 30088
Created by admin on Fri Jun 25 21:01:54 UTC 2021 , Edited by admin on Fri Jun 25 21:01:54 UTC 2021
FDA ORPHAN DRUG 397613
Created by admin on Fri Jun 25 21:01:54 UTC 2021 , Edited by admin on Fri Jun 25 21:01:54 UTC 2021
NCI_THESAURUS C29576
Created by admin on Fri Jun 25 21:01:54 UTC 2021 , Edited by admin on Fri Jun 25 21:01:54 UTC 2021
Code System Code Type Description
FDA UNII
HEC37C70XX
Created by admin on Fri Jun 25 21:01:54 UTC 2021 , Edited by admin on Fri Jun 25 21:01:54 UTC 2021
PRIMARY
PUBCHEM
66245
Created by admin on Fri Jun 25 21:01:54 UTC 2021 , Edited by admin on Fri Jun 25 21:01:54 UTC 2021
PRIMARY
NCI_THESAURUS
C29463
Created by admin on Fri Jun 25 21:01:54 UTC 2021 , Edited by admin on Fri Jun 25 21:01:54 UTC 2021
PRIMARY
EVMPD
SUB04512MIG
Created by admin on Fri Jun 25 21:01:54 UTC 2021 , Edited by admin on Fri Jun 25 21:01:54 UTC 2021
PRIMARY
CAS
4201-00-7
Created by admin on Fri Jun 25 21:01:54 UTC 2021 , Edited by admin on Fri Jun 25 21:01:54 UTC 2021
SUPERSEDED
CAS
959-24-0
Created by admin on Fri Jun 25 21:01:54 UTC 2021 , Edited by admin on Fri Jun 25 21:01:54 UTC 2021
PRIMARY
EPA CompTox
959-24-0
Created by admin on Fri Jun 25 21:01:54 UTC 2021 , Edited by admin on Fri Jun 25 21:01:54 UTC 2021
PRIMARY
DRUG BANK
DBSALT000318
Created by admin on Fri Jun 25 21:01:54 UTC 2021 , Edited by admin on Fri Jun 25 21:01:54 UTC 2021
PRIMARY
MERCK INDEX
M10124
Created by admin on Fri Jun 25 21:01:54 UTC 2021 , Edited by admin on Fri Jun 25 21:01:54 UTC 2021
PRIMARY Merck Index
RXCUI
7008
Created by admin on Fri Jun 25 21:01:54 UTC 2021 , Edited by admin on Fri Jun 25 21:01:54 UTC 2021
PRIMARY RxNorm
USP_CATALOG
1617408
Created by admin on Fri Jun 25 21:01:54 UTC 2021 , Edited by admin on Fri Jun 25 21:01:54 UTC 2021
PRIMARY USP-RS
ECHA (EC/EINECS)
213-496-0
Created by admin on Fri Jun 25 21:01:54 UTC 2021 , Edited by admin on Fri Jun 25 21:01:54 UTC 2021
PRIMARY
ChEMBL
CHEMBL471
Created by admin on Fri Jun 25 21:01:54 UTC 2021 , Edited by admin on Fri Jun 25 21:01:54 UTC 2021
PRIMARY
Related Record Type Details
ENANTIOMER -> RACEMATE
BASIS OF STRENGTH->SUBSTANCE
ASSAY (TITRATION)
EP
ENANTIOMER -> RACEMATE
BASIS OF STRENGTH->SUBSTANCE
ASSAY (HPLC)
USP
PARENT -> SALT/SOLVATE
Related Record Type Details
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
UNSPECIFIED
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
IMPURITY -> PARENT
UNSPECIFIED
EP
IMPURITY -> PARENT
UNSPECIFIED
EP
Related Record Type Details
ACTIVE MOIETY