Sotalol Hydrochloride 80 mg Tablet, 60-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Antiarrhythmic class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- That's a fair question — and I understand it feels like a lot. The reason is that sotalol can actually trigger the very type of dangerous heart rhythm it's supposed to treat, espec...
- Why do I have to start this medicine in the hospital? Can't I just take it at home?
- Some things like mild fatigue, a slightly slower heart rate, or feeling a bit lightheaded are common and often settle down. But there are symptoms you should never sit on — if you...
- What side effects should I just ride out, and which ones mean I need to call for help right away?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Sotalol Hydrochloride — tap one for details:
Sotalol Hydrochloride may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1725 | $10.35 / 60 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sotalol Hydrochloride 80 mg 00093-1061-01 | Teva | 100 tablets | $0.070 | AB | Availability likely | — |
| Sotalol Hydrochloride 80 mg 00904-7143-61 | Major | 100 tablets | $0.070 | AB | Availability likely | — |
| Sotalol Hydrochloride 80 mg 11788-0051-01 | AiPing | 100 tablets | $0.070 | AB | Availability likely | — |
| Sotalol Hydrochloride 80 mg 50268-0724-15 | AvPAK | 50 tablets | $0.070 | AB | Availability likely | — |
| Sotalol Hydrochloride 80 mg 60505-0080-00 | Apotex | 100 tablets | $0.070 | AB | Discontinued | — |
| Sotalol Hydrochloride 80 mg 68084-0654-01 | American | 100 tablets | $0.070 | AB | Availability likely | — |
| Sotalol Hydrochloride 80 mg 69584-0841-10 | Oxford | 100 tablets | $0.070 | AB | Availability likely | — |
| Sotalol 80 mg 76385-0114-01 | UNICHEM | 100 tablets | $0.070 | AB | Availability likely | — |
| Sotalol hydrochloride 80 mg 42806-0121-01 | Epic | 100 tablets | $0.070 | AB | Availability likely | — |
| Sotalol Hydrochloride 80 mg 59651-0775-01 | Aurobindo | 100 tablets | $0.070 | AB | Availability likely | — |
| Sotalol Hydrochloride 80 mg 60505-0222-01 | Apotex | 100 tablets | $0.070 | AB | Availability likely | — |
| Sotalol Hydrochloride 80 mg 50090-1299-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 50090-7796-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 55154-8179-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 60429-0748-01 | Golden | 100 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 63187-0804-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 63629-2422-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mgthis 71205-0046-60 | Proficient | 60 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 71335-0260-01 | Bryant | 60 tablets | — | AB | FDA listed | — |
| Sotalol 80 mg 71335-1189-01 | Bryant | 60 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 71335-1917-01 | Bryant | 60 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 71335-2823-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 71610-0474-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 71610-0723-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 71610-0849-80 | Aphena | 180 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 71610-0889-80 | Aphena | 180 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 72162-1931-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 72162-2118-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Sotalol 80 mg 72162-2524-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 72162-2583-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 72789-0137-01 | PD-Rx | 100 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 82804-0974-00 | Proficient | 100 tablets | — | AB | FDA listed | — |
| Betapace 80 mg 83107-0005-10 | Legacy | 100 tablets | — | AB | FDA listed | — |
| Sotalol Hydrochloride 80 mg 71610-0074-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Betapace Af 80 mg 83107-0008-60 | Legacy | 60 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71205-0046-30 | 30 TABLET in 1 BOTTLE (71205-046-30) | 2018-06-01 | Active |
| 71205-0046-60 You're viewing this | 60 TABLET in 1 BOTTLE (71205-046-60) | 2018-06-01 | Active |
| 71205-0046-90 | 90 TABLET in 1 BOTTLE (71205-046-90) | 2018-06-01 | Active |
You're viewing one of 3 pack sizes for this product.
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What quantity is in NDC 71205-0046-60?
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🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 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 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 ▾
1 INDICATIONS AND USAGE Sotalol hydrochloride 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 • Avoid use in patients with asymptomatic ventricular premature contraction ( 1.1 ) • Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL ( 1.2 )
1.1Life-Threatening Ventricular Arrhythmias Sotalol hydrochloride tablets are indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use: Sotalol hydrochloride tablets may not enhance survival in patients with ventricular arrhythmias. Because of the proarrhythmic effects of sotalol hydrochloride tablets, including a 1.5 to 2% rate of Torsade de Pointes (TdP) or new ventricular tachycardia/fibrillation (VT/VF) in patients with either non-sustained ventricular tachycardia (NSVT) or supraventricular arrhythmias (SVT), its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended.
Avoid treatment of patients with asymptomatic ventricular premature contractions [see Warnings and Precautions ( 5.2 )].
1.2Delay in Recurrence of Atrial Fibrillation/Atrial Flutter (AFIB/AFL) Sotalol hydrochloride tablets are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of AFIB/AFL) in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Limitation of Use: Because sotalol hydrochloride tablets can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB that is easily reversed (by Valsalva maneuver, for example) should usually not be given sotalol hydrochloride tablets.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Sotalol hydrochloride tablets: 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 ( 2.2 ) • Pediatrics: Dosage depends on age ( 2.4 )
2.1General Safety Measures for Initiation of Oral Sotalol Therapy Withdraw other antiarrhythmic therapy before starting sotalol hydrochloride tablets and monitor carefully for a minimum of 2 to 3 plasma half-lives if the patient's clinical condition permits [see Drug Interactions ( 7 )] . Hospitalize patients initiated or re-initiated on sotalol for at least 3 days or until steady-state drug levels are achieved, in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Initiate oral sotalol therapy in the presence of personnel trained in the management of serious arrhythmias.
Perform a baseline ECG to determine the QT interval and measure and normalize serum potassium and magnesium levels before initiating therapy. Measure serum creatinine and calculate an estimated creatinine clearance in order to establish the appropriate dosing interval (insert cross ref to renal dosing). Continually monitor patients with each uptitration in dose, until they reach steady state.
Determine QTc 2 to 4 hours after every dose. Discharge patients on sotalol therapy from an in-patient setting with an adequate supply of sotalol to allow uninterrupted therapy until the patient can fill a sotalol prescription. Advise patients who miss a dose to take the next dose at the usual time.
Do not double the dose or shorten the dosing interval.
2.2Adult Dose for Ventricular Arrhythmias The recommended initial dose is 80 mg twice daily. This dose may be increased in increments of 80 mg per day every 3 days provided the QTc <500 msec [see Warnings and Precautions ( 5.1 )] . Continually monitor patients until steady state blood levels are achieved.
In most patients, a therapeutic response is obtained at a total daily dose of 160 to 320 mg/day, given in two or three divided doses (because of the long terminal elimination half-life of sotalol, dosing more than a two times a day is usually not necessary). Oral doses as high as 480 to 640 mg/day have been utilized in patients with refractory life-threatening arrhythmias.
2.3Adult Dose for Prevention of Recurrence of AFIB/AFL The recommended initial dose is 80 mg twice daily. This dose may be increased in increments of 80 mg per day every 3 days provided the QTc <500 msec [see Warnings and Precautions ( 5.1 )] . Continually monitor patients until steady state blood levels are achieved.
Most patients will have satisfactory response with 120 mg twice daily. Initiation of sotalol in patients with creatinine clearance < 40 ml/min or QTc >450 is contraindicated [see Contraindications ( 4 )] .
2.4Pediatric Dose for Ventricular Arrhythmias or AFIB/AFL Use the same precautionary measures for children as you would use for adults when initiating and re-initiating sotalol treatment. For children aged about 2 years and older For children aged about 2 years and older, with normal renal function, doses normalized for body surface area are appropriate for both initial and incremental dosing. Since the Class III potency in children is not very different from that in adults, reaching plasma concentrations that occur within the adult dose range is an appropriate guide [see Clinical Pharmacology ( 12.1 , 12.3 )] .
From pediatric pharmacokinetic data the following is recommended: For initiation of treatment, 30 mg/m 2 three times a day (90 mg/m 2 total daily dose) is approximately equivalent to the initial 160 mg total daily dose for adults. Subsequent titration to a maximum of 60 mg/m 2 (approximately equivalent to the 360 mg total daily dose for adults) can then occur. Titration should be guided by clinical response, heart rate and QTc, with increased dosing being preferably carried out in-hospital.
At least 36 hours should be…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Sotalol hydrochloride tablets USP, 80 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers “93” and “61” on each side of the score, and plain on the other side. Sotalol hydrochloride tablets USP, 120 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers “93” and “1060” on each side of the score, and plain on the other side. Sotalol hydrochloride tablets USP, 160 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers “93” and “62” on each side of the score, and plain on the other side.
Sotalol hydrochloride tablets USP, 240 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers “93” and “63” on each side of the score, and plain on the other side. 80 mg, 120 mg, 160 mg, and 240 mg tablets ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Sotalol hydrochloride tablets are 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 tablets are also contraindicated in patients with: • Baseline QT interval >450 ms • Creatinine clearance <40 mL/min For the treatment of AFIB/AFL or ventricular arrhythmias • 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 ms ( 4 ) • Creatine clearance <40 ml/min ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • QT 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 )
5.1QT Prolongation and Proarrhythmia Sotalol hydrochloride 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, as these conditions can exaggerate the degree of QT prolongation, and increase the potential for Torsade de Pointes. Special attention should be given to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhea or patients receiving concomitant diuretic drugs. Proarrhythmic events must be anticipated not only on initiating therapy, but with every upward dose adjustment [see Dosage and Administration ( 2.1 )] .
In general, do not use sotalol with other drugs known to cause QT prolongation [see Drug Interactions ( 7.1 )] .
5.2Bradycardia/Heart Block/Sick Sinus Syndrome Sinus bradycardia (heart rate less than 50 bpm) occurred in 13% of patients receiving sotalol in clinical trials, and led to discontinuation in about 3% of patients. Bradycardia itself increases the risk of Torsade de Pointes. Sinus pause, sinus arrest and sinus node dysfunction occur in less than 1% of patients.
The incidence of 2nd- or 3rd-degree AV block is approximately 1%. Sotalol hydrochloride is contraindicated in patients with sick sinus syndrome because it may cause sinus bradycardia, sinus pauses or sinus arrest.
5.3Hypotension Sotalol produces significant reductions in both systolic and diastolic blood pressures and may result in hypotension. Monitor hemodynamics in patients with marginal cardiac compensation.
5.4Heart Failure New onset or worsening heart failure may occur during initiation or uptitration of sotalol because of its beta-blocking effects. Monitor for signs and symptoms of heart failure and discontinue treatment if symptoms occur.
5.5Cardiac Ischemia after Abrupt Discontinuation Following abrupt cessation of therapy with beta adrenergic blockers, exacerbations of angina pectoris and myocardial infarction may occur. When discontinuing chronically administered sotalol hydrochloride, particularly in patients with ischemic heart disease, gradually reduce the dosage over a period of 1 to 2 weeks, if possible, and monitor the patient. If angina markedly worsens or acute coronary ischemia develops, treat appropriately (consider use of an alternative beta blocker).
Warn patients not to interrupt therapy without their physician’s advice. Because coronary artery disease may be common, but unrecognized, in patients treated with sotalol, abrupt discontinuation may unmask latent coronary insufficiency.
5.6Bronchospasm Patients with bronchospastic diseases (for example chronic bronchitis and emphysema) should not receive beta-blockers. If sotalol hydrochloride is to be administered, use the smallest effective dose, to minimize inhibition of bronchodilation produced by endogenous or exogenous catecholamine stimulation of beta 2 receptors.
5.7Masked Signs of Hypoglycemia in Diabetics Beta blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions (≥2%) 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 TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or [email protected]; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 In patients with a history of sustained ventricular tachycardia, the incidence of Torsade de Pointes during oral sotalol treatment was 4% and worsened VT was about 1%; in patients with other less serious ventricular arrhythmias the incidence of Torsade de Pointes was 1% and new or worsened VT was about 0.7%.
Incidence of Torsade de Pointes arrhythmias in patients with VT/VF are shown in Table 3 below. Table 3: Percent Incidence of Torsade de Pointes and Mean QTc Interval by Dose For Patients With Sustained VT/VF Daily Dose (mg) Torsade de Pointes Incidence Mean QTc highest on-therapy value (msec) 80 0 (69) 463 (17) 160 0.5 (832) 467 (181) 320 1.6 (835) 473 (344) 480 4.4 (459) 483 (234) 640 3.7 (324) 490 (185) >640 5.8 (103) 512 (62) ( ) Number of patients assessed Table 4 below relates the incidence of Torsade de Pointes to on-therapy QTc and change in QTc from baseline in patients with ventricular arrhythmias.
It should be noted, however, that the highest on-therapy QTc was in many cases the one obtained at the time of the Torsade de Pointes event, so that the table overstates the predictive value of a high QTc. Table 4: Relationship Between QTc Interval Prolongation and Torsade de Pointes On-Therapy QTc Interval (msec) Incidence of Torsade de Pointes Change from Baseline in QTc (msec) Incidence of Torsade de Pointes <500 1.3% (1787) <65 1.6% (1516) 500 to 525 3.4% (236) 65 to 80 3.2% (158) 525 to 550 5.6% (125) 80 to 100 4.1% (146) >550 10.8% (157) 100 to 130 5.2% (115) >130 7.1% (99) ( ) Number of patients assessed Table 5: Incidence (%) of Common Adverse Reactions (≥ 2% in the Placebo group and less frequent than in the sotalol hydrochloride groups) in a Placebo-controlled Parallel-group Comparison Study of Patients with Ventricular Ectopy Body System/Adverse Reaction (Preferred Term) Placebo Sotalol hydrochloride Total Daily Dose N = 37 (%) 320 mg N = 38 (%) 640 mg N = 39 (%) CARDIOVASCULAR Chest Pain 5.4 7.9
15.4Dyspnea 2.7 18.4
20.5Palpitation 2.7 7.9
5.1Vasodilation 2.7 0.0
5.1NERVOUS SYSTEM Asthenia 8.1 10.5
20.5Dizziness 5.4 13.2
17.9Fatigue 10.8 26.3
25.6Headache 5.4 5.3
7.7Lightheaded 8.1 15.8
5.1Sleep Problem 2.7 2.6
7.7RESPIRATORY Upper Respiratory Tract Problem 2.7 2.6
12.8SPECIAL SENSES Visual Problem 2.7 5.3
0.0The most common adverse reactions leading to discontinuation of sotalol hydrochloride in trials of patients with ventricular arrhythmias are: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%. Incidence of discontinuation for these adverse reactions was dose related. One case of peripheral neuropathy that resolved on discontinuation of sotalol hydrochloride and recurred when the patient was rechallenged with the drug was reported in an early dose tolerance study.
Pediatric Patients In an unblinded multicenter trial of 25 pediatric patients with SVT and/or VT receiving daily doses of 30, 90 and 210 mg/m 2 with dosing every 8 hours for a total of 9 doses, no Torsade de Pointes or other serious new arrhythmias were observed. O…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Class I or III Antiarrhythmics or other drugs that prolong the QT interval: Avoid concomitant use ( 7.1 ) • Digoxin, calcium channel blocker: increased risk of bradycardia, hypotension, heart failure ( 7.2 ) • Dosage of insulin or antidiabetic drugs may need adjustment ( 7.5 ) • Aluminum or magnesium-based antacids reduce sotalol exposure ( 7.7 )
7.1Antiarrhythmics and other QT Prolonging Drugs Sotalol has not been studied with other drugs that prolong the QT interval such as antiarrhythmics, some phenothiazines, tricyclic antidepressants, certain oral macrolides and certain quinolone antibiotics. Discontinue Class I or Class III antiarrhythmic agents for at least three half-lives prior to dosing with sotalol. Class Ia antiarrhythmic drugs, such as disopyramide, quinidine and procainamide and other Class III drugs (for example, amiodarone) are not recommended as concomitant therapy with sotalol hydrochloride, because of their potential to prolong refractoriness [see Warnings and Precautions ( 5.2 )] .
There is only limited experience with the concomitant use of Class Ib or Ic antiarrhythmics. Additive Class II effects would also be anticipated with the use of other beta-blocking agents concomitantly with sotalol hydrochloride.
7.2Digoxin Proarrhythmic events were more common in sotalol treated patients also receiving digoxin; it is not clear whether this represents an interaction or is related to the presence of CHF, a known risk factor for proarrhythmia, in the patients receiving digoxin. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
7.3Calcium-Channel Blocking Drugs Sotalol and calcium-blocking drugs can be expected to have additive effects on atrioventricular conduction or ventricular function. Monitor such patients for evidence of bradycardia and hypotension.
7.4Catecholamine-Depleting Agents Concomitant use of catecholamine-depleting drugs, such as reserpine and guanethidine, with a beta-blocker may produce an excessive reduction of resting sympathetic nervous tone. Monitor such patients for evidence of hypotension and/or marked bradycardia which may produce syncope.
7.5Insulin and Oral Antidiabetics Hyperglycemia may occur, and the dosage of insulin or antidiabetic drugs may require adjustment [see Warnings and Precautions 5.7 )] .
7.6Clonidine Concomitant use with sotalol increases the risk of bradycardia. Because beta-blockers may potentiate the rebound hypertension sometimes observed after clonidine discontinuation, withdraw sotalol several days before the gradual withdrawal of clonidine to reduce the risk of rebound hypertension.
7.7Antacids Avoid administration of oral sotalol within 2 hours of antacids containing aluminum oxide and magnesium hydroxide.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Sotalol has been shown to cross the placenta, and is found in amniotic fluid. In animal studies there was no increase in congenital anomalies, but an increase in early resorptions occurred at sotalol doses 18 times the maximum recommended human dose (MRHD, based on surface area).
Animal reproductive studies are not always predictive of human response. Reproduction studies in rats and rabbits during organogenesis at 9 and 7 times the MRHD (based on surface area), respectively, did not reveal any teratogenic potential associated with sotalol. In rabbits, a dose of sotalol 6 times the MRHD produced a slight increase in fetal death as well as maternal toxicity.
This effect did not occur at sotalol dose 3 times the MRHD. In rats a sotalol dose 18 times the MRHD increased the number of early resorptions, while a dose 2.5 times the MRHD, produced no increase in early resorptions.
8.3Nursing Mothers Sotalol is excreted in the milk of laboratory animals and has been reported to be present in human milk. Discontinue nursing on sotalol hydrochloride.
8.4Pediatric Use The safety and effectiveness of sotalol in children have not been established. However, the Class III electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (QTc interval and resting heart rate) and drug concentrations have been evaluated in children aged between 3 days and 12 years old [see Dosage and Administration ( 2.4 ) and Clinical Pharmacology ( 12.2 )] .
8.6Renal Impairment Sotalol is mainly eliminated via the kidneys. Dosing intervals should be adjusted based on creatinine clearance [see Dosage and Administration ( 2.5 )] .
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Sotalol has been shown to cross the placenta, and is found in amniotic fluid. In animal studies there was no increase in congenital anomalies, but an increase in early resorptions occurred at sotalol doses 18 times the maximum recommended human dose (MRHD, based on surface area).
Animal reproductive studies are not always predictive of human response. Reproduction studies in rats and rabbits during organogenesis at 9 and 7 times the MRHD (based on surface area), respectively, did not reveal any teratogenic potential associated with sotalol. In rabbits, a dose of sotalol 6 times the MRHD produced a slight increase in fetal death as well as maternal toxicity.
This effect did not occur at sotalol dose 3 times the MRHD. In rats a sotalol dose 18 times the MRHD increased the number of early resorptions, while a dose 2.5 times the MRHD, produced no increase in early resorptions.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of sotalol in children have not been established. However, the Class III electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (QTc interval and resting heart rate) and drug concentrations have been evaluated in children aged between 3 days and 12 years old [see Dosage and Administration ( 2.4 ) and Clinical Pharmacology ( 12.2 )] .
🆘 Overdosage ▾
10 OVERDOSAGE Intentional or accidental overdosage with sotalol has resulted in death. Symptoms and Treatment of Overdosage The most common signs to be expected are bradycardia, congestive heart failure, hypotension, bronchospasm and hypoglycemia. In cases of massive intentional overdosage (2 to 16 grams) of sotalol the following clinical findings were seen: hypotension, bradycardia, cardiac asystole, prolongation of QT interval, Torsade de Pointes, ventricular tachycardia, and premature ventricular complexes.
If overdosage occurs, therapy with sotalol should be discontinued and the patient observed closely. Because of the lack of protein binding, hemodialysis is useful for reducing sotalol plasma concentrations. Patients should be carefully observed until QT intervals are normalized and the heart rate returns to levels >50 bpm.
The occurrence of hypotension following an overdose may be associated with an initial slow drug elimination phase (half-life of 30 hours) thought to be due to a temporary reduction of renal function caused by the hypotension. In addition, if required, the following therapeutic measures are suggested: Bradycardia or Cardiac Asystole: Atropine, another anticholinergic drug, a beta-adrenergic agonist or transvenous cardiac pacing. Heart Block: (second and third degree) transvenous cardiac pacemaker.
Hypotension: (depending on associated factors) epinephrine rather than isoproterenol or norepinephrine may be useful. Bronchospasm: Aminophylline or aerosol beta-2-receptor stimulant. Higher than normal doses of beta-2 receptor stimulants may be required.
Torsade de Pointes: DC cardioversion, transvenous cardiac pacing, epinephrine, magnesium sulfate.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Sotalol has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. The two isomers of sotalol have similar Class III antiarrhythmic effects, while the l-isomer is responsible for virtually all of the beta-blocking activity. The beta-blocking effect of sotalol is non-cardioselective, half maximal at about 80 mg/day and maximal at doses between 320 and 640 mg/day.
Sotalol does not have partial agonist or membrane stabilizing activity. Although significant beta-blockade occurs at oral doses as low as 25 mg, significant Class III effects are seen only at daily doses of 160 mg and above. In children, a Class III electrophysiologic effect can be seen at daily doses of 210 mg/m 2 body surface area (BSA).
A reduction of the resting heart rate due to the beta-blocking effect of sotalol is observed at daily doses ≥ 90 mg/m 2 in children.
12.2Pharmacodynamics Cardiac Electrophysiological Effects Sotalol hydrochloride prolongs the plateau phase of the cardiac action potential in the isolated myocyte, as well as in isolated tissue preparations of ventricular or atrial muscle (Class III activity). In intact animals it slows heart rate, decreases AV nodal conduction and increases the refractory periods of atrial and ventricular muscle and conduction tissue. In man, the Class II (beta-blockade) electrophysiological effects of sotalol are manifested by increased sinus cycle length (slowed heart rate), decreased AV nodal conduction and increased AV nodal refractoriness.
The Class III electrophysiological effects in man include prolongation of the atrial and ventricular monophasic action potentials, and effective refractory period prolongation of atrial muscle, ventricular muscle, and atrio-ventricular accessory pathways (where present) in both the anterograde and retrograde directions. With oral doses of 160 to 640 mg/day, the surface ECG shows dose-related mean increases of 40 to 100 msec in QT and 10 to 40 msec in QTc [see Warnings and Precautions ( 5.1 )] . No significant alteration in QRS interval is observed.
In a small study (n=25) of patients with implanted defibrillators treated concurrently with sotalol hydrochloride, the average defibrillatory threshold was 6 joules (range 2 to 15 joules) compared to a mean of 16 joules for a nonrandomized comparative group primarily receiving amiodarone. Twenty-five children in an unblinded, multicenter trial with SVT and/or ventricular tachyarrhythmias, aged between 3 days and 12 years (mostly neonates and infants), received an ascending titration regimen with daily doses of 30, 90 and 210 mg/m 2 with dosing every 8 hours for a total 9 doses.
During steady-state, the respective average increases above baseline of the QTc interval were 2, 14, and 29 msec at the 3 dose levels. The respective mean maximum increases above baseline of the QTc interval were 23, 36, and 55 msec at the 3 dose levels. The steady-state percent increases in the RR interval were 3, 9 and 12%.
The smallest children (BSA<0.33 m 2 ) showed a tendency for larger Class III effects (ΔQTc) and an increased frequency of prolongations of the QTc interval as compared with larger children (BSA ≥0.33 m 2 ). The beta-blocking effects also tended to be greater in the smaller children (BSA <0.33 m 2 ). Both the Class III and beta-blocking effects of sotalol were linearly related to the plasma concentrations.
Hemodynamics In a study of systemic hemodynamic function measured invasively in 12 patients with a mean LV ejection fraction of 37% and ventricular tachycardia (9 sustained and 3 non-sustained), a median dose of 160 mg twice daily of sotalol hydrochloride produced a 28% reduction in heart rate and a 24% decrease in cardiac index at 2 hours post-dosing at steady-state. Concurrently, systemic vascular resistance and stroke volume showed nonsignificant increases of 25% and 8%, re…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Sotalol has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. The two isomers of sotalol have similar Class III antiarrhythmic effects, while the l-isomer is responsible for virtually all of the beta-blocking activity. The beta-blocking effect of sotalol is non-cardioselective, half maximal at about 80 mg/day and maximal at doses between 320 and 640 mg/day.
Sotalol does not have partial agonist or membrane stabilizing activity. Although significant beta-blockade occurs at oral doses as low as 25 mg, significant Class III effects are seen only at daily doses of 160 mg and above. In children, a Class III electrophysiologic effect can be seen at daily doses of 210 mg/m 2 body surface area (BSA).
A reduction of the resting heart rate due to the beta-blocking effect of sotalol is observed at daily doses ≥ 90 mg/m 2 in children.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Sotalol hydrochloride tablets USP, 80 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers “93” and “61” on each side of the score, and plain on the other side. They are available in bottles of 30 (NDC 71205-046-30), 60 (NDC 71205-046-60) and 90 (NDC 71205-046-90). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
📋 Description ▾
11 DESCRIPTION Sotalol hydrochloride tablets USP contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties Sotalol hydrochloride tablets USP are supplied as a light blue, oval-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform.
Chemically, sotalol hydrochloride, USP is d,l- N -[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C 12 H 20 N 2 O 3 S∙HCl and is represented by the following structural formula: Sotalol hydrochloride tablets USP contain the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, povidone, and FD&C Blue No. 2. structural formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION • 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 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 without their physician’s 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 patients to not start taking other medications without first discussing new medications with their healthcare provider. • Advise patients that they should avoid taking sotalol hydrochloride within two hours of taking antacids that contain aluminum oxide or magnesium hydroxide [see Drug Interactions ( 7.7 )] .
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA. Manufactured In Czech Republic By: TEVA CZECH INDUSTRIES s.r.o. Opava-Komarov, Czech Republic Manufactured For: TEVA PHARMACEUTICALS USA, INC.
North Wales, PA 19454 Rev. M 6/2016 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320