- March 15, 2022
- Newsletter
- 617-430-5616
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Brand Name :
Sorine, Betapace, Sotylize, Betapace AF,
Synonyms :
sotalol
Class :
Antidysrhythmics, III; Beta-Blockers, Nonselective, Antidysrhythmics, II;
Brand Name :
Sorine, Betapace, Sotylize, Betapace AF,
Synonyms :
sotalol
Class :
Antidysrhythmics, III; Beta-Blockers, Nonselective, Antidysrhythmics, II;
Dosage Forms & Strengths
Tablet
80mg
120mg
160mg
Oral solution
5mg/mL
Injectable solution
15mg/mL
Oral:
The recommended starting dose for life-threatening ventricular arrhythmias is 80 mg taken orally twice daily (BID). The dose may be increased by increments of 80 mg/day every three days if the corrected QT interval (QTc) is less than 500 msec
Patients should be monitored until steady-state levels are achieved. The therapeutic dose is usually obtained at a total daily dose of 160-320 mg/day divided into BID or TID dosing
In refractory cases of life-threatening arrhythmias, doses of 480-640 mg/day have been utilized
For atrial fibrillation/flutter, the starting dose is also 80 mg taken orally BID. The dose may be increased by increments of 80 mg/day every three days if the QTc is less than 500 msec. The typical maintenance dose for atrial fibrillation/flutter is 120 mg taken orally BID
It is important to note that initiation of sotalol in patients with creatinine clearance less than 40 mL/min or QTc greater than 450 msec is contraindicated due to the increased risk of adverse effects
IV sotalol as a substitute for oral sotalol
When using IV sotalol as a substitute for oral sotalol, it is important to match the exposure to the drug as closely as possible
For an 80 mg oral dose of sotalol, substitute with 75 mg IV
For a 120 mg oral dose of sotalol, substitute with 112.5 mg IV
For a 160 mg oral dose of sotalol, substitute with 150 mg IV
For a loading dose of IV sotalol, it should be infused over 1 hour. The loading dose is typically higher than the maintenance dose and is given to rapidly achieve therapeutic levels of the drug
sotalol IV 0-80 mg
CrCl (>90 mL/min): 60 mg IV; maintain 4 hours gap for first PO dose (12 hours oral dose)
CrCl (60-90 mL/min): 82.5 mg IV; maintain 4 hours gap for first PO dose (12 hours oral dose)
CrCl (30-60 mL/min): 75 mg IV; maintain 6 hours gap for first PO dose (24 hours oral dose)
CrCl (10-30 mL/min): 75 mg IV; maintain 12 hours gap for first PO dose (48 hours oral dose)
sotalol IV 0-120 mg
CrCl (>90 mL/min): 90 mg IV; maintain 4 hours gap for first PO dose (12 hours oral dose)
CrCl (60-90 mL/min): 125 mg IV; maintain 4 hours gap for first PO dose (12 hours oral dose)
CrCl (30-60 mL/min): 112.5 mg IV; maintain 6 hours gap for first PO dose (24 hours oral dose)
CrCl (10-30 mL/min): 112.5 mg IV; maintain 12 hours gap for first PO dose (48 hours oral dose)
lower dose Reinitiating from 120-80 mg
If the QTc interval exceeds 500 ms or increases 20% from baseline when starting a 120-mg oral dose, discontinue the drug and consider a lower dose
CrCL (≥60 mL/min): to reinitiate maintain gap for 1 days
CrCL (≥30-<60 mL/min): to reinitiate maintain gap for 3 days
CrCL (≥10-<30 mL/min): to reinitiate maintain gap for 7 days
sotalol IV escalation 80-120 mg
CrCl (>90 mL/min): 75 mg IV; maintain 4 hours gap for first PO dose (12 hours oral dose)
CrCl (60-90 mL/min): 82.5mg IV; maintain 4 hours gap for first PO dose (12 hours oral dose)
CrCl (30-60 mL/min): 82.5 IV; maintain 6 hours gap for first PO dose (24 hours oral dose)
CrCl (10-30 mL/min): 82.5 IV; maintain 12 hours gap for first PO dose (48 hours oral dose)
sotalol IV escalation 120-160 mg
CrCl (>90 mL/min): 90 mg IV; maintain 4 hours gap for first PO dose (12 hours oral dose)
CrCl (60-90 mL/min): 105 mg IV; maintain 4 hours gap for first PO dose (12 hours oral dose)
CrCl (30-60 mL/min): 105 mg IV; maintain 6 hours gap for first PO dose (24 hours oral dose)
CrCl (10-30 mL/min): 105 mg IV; maintain 12 hours gap for first PO dose (48 hours oral dose)
Dosage Forms & Strengths
Tablet
80mg
120mg
160mg
Oral solution
5mg/mL
Injectable solution
15mg/mL
Age >2 years:
30
mg/m²
Orally
3 times a day
in patients with normal renal function which is equivalent to an initial total daily dose of 90 mg/m2 for adults
This initial dose can be titrated up to a maximum of 60 mg/m2 TID, which is equivalent to a total daily dose of 320 mg for adults
The titration should be guided by clinical response, heart rate, and corrected QT interval (QTc), with increased dosing preferably carried out in the hospital
It is important to allow at least 36 hours between dose increments to attain steady-state plasma concentrations of the drug in patients with age-adjusted normal renal function
Steady-state levels of sotalol are necessary to achieve a consistent therapeutic effect and to avoid potential adverse effects associated with rapid dose increases
Refer adult dosing
It may enhance QTc interval when combined with perphenazine
when both drugs are combined, there may be an increase in qtc interval
QTc interval is increased both by lenvatinib and sotalol
both lapatinib and sotalol increase the QTc interval
It enhances the anti-hypertensive channel blocking when combined
may enhance the anti-hypertensive effect when both drugs are combined
glycopyrrolate inhaled and formoterol
may increase the QTc interval when combined
May enhance the hypotensive effect of beta-Blockers
May enhance the hypotensive effect of beta-Blockers
May enhance the hypotensive effect of beta-Blockers
May enhance the hypotensive effect of beta-Blockers
May enhance the hypotensive effect of beta-Blockers
May enhance the hypotensive effect of beta-Blockers
May enhance the hypotensive effect of beta-Blockers
May enhance the hypotensive effect of beta-Blockers
beta-blockers may enhance the vasoconstricting effect of ergot derivatives
beta-blockers may enhance the vasoconstricting effect of ergot derivatives
beta-blockers may enhance the vasoconstricting effect of ergot derivatives
beta-blockers may enhance the vasoconstricting effect of ergot derivatives
beta-blockers may enhance the vasoconstricting effect of ergot derivatives
may reduce the antihypertensive effect of beta-blockers
may reduce the antihypertensive effect of beta-blockers
may reduce the antihypertensive effect of beta-blockers
may reduce the antihypertensive effect of beta-blockers
may reduce the antihypertensive effect of beta-blockers
may increase the hypotensive effect of beta-blockers
may increase the hypotensive effect of beta-blockers
may increase the hypotensive effect of beta-blockers
may increase the hypotensive effect of beta-blockers
may increase the hypotensive effect of beta-blockers
may increase the hypotensive effect of beta-blockers
may increase the hypotensive effect of beta-blockers
may increase the hypotensive effect of beta-blockers
it increases the effect of hypoglycemia of antidiabetic agents
it increases the effect of hypoglycemia of antidiabetic agents
it increases the effect of hypoglycemia of antidiabetic agents
it increases the effect of hypoglycemia of antidiabetic agents
it increases the effect of hypoglycemia of antidiabetic agents
osimertinib and sotalol, when used simultaneously, increase the QTc interval
NSAIDs may diminish the antihypertensive effect of Beta-Blockers
NSAIDs may diminish the antihypertensive effect of Beta-Blockers
NSAIDs may diminish the antihypertensive effect of Beta-Blockers
NSAIDs may diminish the antihypertensive effect of Beta-Blockers
NSAIDs may diminish the antihypertensive effect of Beta-Blockers
it enhances the serum potassium levels
it enhances the serum potassium levels
may increase the bradycardic effect of beta-blockers
may increase the bradycardic effect of beta-blockers
may increase the bradycardic effect of beta-blockers
may increase the bradycardic effect of beta-blockers
may increase the bradycardic effect of beta-blockers
Beta-blockers increase the effect of hypoglycemia of antidiabetic agents
Beta-blockers increase the effect of hypoglycemia of antidiabetic agents
Beta-blockers increase the effect of hypoglycemia of antidiabetic agents
Beta-blockers increase the effect of hypoglycemia of antidiabetic agents
Beta-blockers increase the effect of hypoglycemia of antidiabetic agents
Beta-Blockers decrease the efficacy of dobutamine
NSAIDs may diminish the effect of beta-blockers
NSAIDs may diminish the effect of beta-blockers
NSAIDs may diminish the effect of beta-blockers
NSAIDs may diminish the effect of beta-blockers
NSAIDs may diminish the effect of beta-blockers
may enhance the antiarrhythmic effect
Actions and Spectrum:
Spectrum of activity:
sotalol has a broad spectrum of activity and is effective in treating both supraventricular and ventricular arrhythmias. It can be used to treat a variety of arrhythmias, including:
Actions:
sotalol works by blocking beta-adrenergic receptors in the heart, which reduces the sympathetic nervous system’s activity and decreases the heart rate and contractility. This action also helps to decrease the oxygen demand of the heart muscle, making it useful in the treatment of angina.
sotalol also prolongs the cardiac action potential duration by blocking potassium channels, which results in increased refractoriness of the cardiac tissue. This effect is responsible for the drug’s class III antiarrhythmic properties, making it effective in treating atrial and ventricular arrhythmias.
Frequency defined
>10%
Dizziness (20%)
Dyspnea (21%)
Fatigue (20%)
Chest pain (16%)
Bradycardia (16%)
Palpitation (14%)
Lightheadedness (12%)
Weakness (13%)
1-10%
Headache (8%)
Edema (8%)
Sleep disturbances (8%)
Diarrhea (7%)
Abnormal ECG (7%)
Nausea/vomiting (10%)
Extremity pain (7%)
Mental confusion (6%)
Hypotension (6%)
Congestive heart failure (5%)
Syncope (5%)
Itching/rash (5%)
Black Box Warning:
The black box warning for sotalol is related to its potential to cause a type of abnormal heart rhythm called torsades de pointes. This is a serious condition that can lead to fainting or sudden cardiac arrest.
Contraindication / Caution:
Contraindications:
Caution:
Pregnancy warnings:
Pregnancy category: N/A
Lactation: Excreted into human milk is known
Pregnancy Categories:
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.
Category B: There were lack of studies on pregnant women and no evidence of risk to the foetus in animal experiments.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology:
sotalol is a medication used to treat certain types of irregular heartbeats, such as atrial fibrillation, atrial flutter, and ventricular tachycardia. It belongs to the class of drugs known as beta-blockers with additional class III antiarrhythmic properties.
Pharmacodynamics:
sotalol involves its ability to block beta-adrenergic receptors, which are responsible for regulating the heart’s rhythm and rate. By blocking these receptors, sotalol reduces the heart’s sensitivity to adrenaline and other stress hormones, which can cause irregular heartbeats.
Additionally, sotalol blocks potassium channels in the heart, which prolongs the action potential duration and the refractory period. This results in the suppression of early and delayed after-depolarizations and decreases the risk of ventricular arrhythmias.
Pharmacokinetics:
Absorption
sotalol is well absorbed orally, with peak plasma concentrations occurring within 2-3 hours of administration. The bioavailability of sotalol after oral administration is about 90%.
Distribution
sotalol is widely distributed throughout the body, with a volume of distribution of approximately 2-4 L/kg. It is highly protein-bound (greater than 90%) in the plasma.
Metabolism
sotalol is primarily metabolized in the liver, through N-dealkylation and hydroxylation. The major metabolite of sotalol is N-desethylsotalol, which is also pharmacologically active.
Elimination and Excretion
sotalol is excreted in the urine (approximately 80-90% of a dose) and feces (approximately 10-20% of a dose). The elimination half-life of sotalol is approximately 12 hours in patients with normal renal function.
Administration:
sotalol is a medication that is primarily used to treat certain heart rhythm disorders, such as atrial fibrillation and ventricular arrhythmias. It is typically administered orally in the form of a tablet or solution.
The recommended dosage of sotalol may vary depending on the individual patient and the condition being treated.
Patient information leaflet
Generic Name: sotalol
Why do we use sotalol?
sotalol is primarily used to treat certain heart rhythm disorders, such as atrial fibrillation and ventricular arrhythmias. These conditions occur when the electrical impulses that regulate the heartbeat become irregular, causing the heart to beat too quickly, too slowly, or in an erratic pattern. sotalol helps to regulate the heartbeat by blocking certain electrical signals in the heart, which can help to restore a normal heart rhythm.