Sotalol (sotalol hydrochloride)

Para qué se usa Sotalol

Cita de la sección «Indications and Usage» (indicaciones y uso) de la etiqueta aprobada por la FDA. Se muestra en inglés, tal como la publica la FDA.

Betapace/Betapace AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) Limitations of Use Betapace has not been shown to enhance survival in patients with life threatening ventricular arrhythmias Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL …

— Etiqueta de la FDA: Betapace, Legacy Pharma USA, Inc., vigente desde el 16 de diciembre de 2024. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (tablet, oral), Betapace, Legacy Pharma USA, Inc.; abarca 6 productos del directorio NDC de la FDA. Las citas sobre efectos secundarios, interacciones, dosis y embarazo de abajo vienen de esta misma etiqueta.

La FDA tiene 44 etiquetas para productos de este medicamento (distintos fabricantes y presentaciones); los usos pueden variar. Revise la etiqueta de su propio medicamento.

Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.

Enfermedades que menciona la etiqueta

Estos nombres aparecen tal cual en la sección «Indications and Usage» de la etiqueta (según una tabla revisada). Cada página muestra los hospitales cuyos sitios web mencionan la enfermedad.

Especialidades médicas relacionadas

Advertencia en recuadro

La advertencia en recuadro («caja negra») es la advertencia más seria de la FDA en la etiqueta de un medicamento, para riesgos graves o mortales.

Esta etiqueta tiene una advertencia en recuadro. Su título: WARNING: LIFE-THREATENING PROARRHYTHMIA. Leerla en la etiqueta completa →

44 de 44 etiquetas de la FDA de este medicamento tienen advertencia en recuadro.

Sotalol: lo que dice la advertencia en recuadro

Cita de la advertencia en recuadro (Boxed Warning) de la etiqueta aprobada por la FDA. Se muestra en inglés.

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.

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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. Betapace/Betapace AF can cause life-threatening ventricular tachycardia associated with QT interval prolongation. If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug. Initiate or reinitiate in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Adjust the dosing interval based on creatinine clearance.

— Etiqueta de la FDA: Betapace, Legacy Pharma USA, Inc., vigente desde el 16 de diciembre de 2024. Leer la etiqueta completa en DailyMed →

Efectos secundarios de Sotalol

Cita de la sección «Adverse Reactions» (reacciones adversas) de la etiqueta aprobada por la FDA. Se muestra en inglés. Avise a su médico de cualquier efecto secundario que le preocupe.

The most common adverse reactions (≥2%) for Betapace are: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%.

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(6) To report SUSPECTED ADVERSE REACTIONS, contact Legacy Pharma Inc. at 1-800-727-7151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions that are clearly related to sotalol are those which are typical of its Class II (beta-blocking) and Class III (cardiac action potential duration prolongation) effects and are dose related. Ventricular Arrhythmias Serious Adverse Reactions Betapace/Betapace AF can cause serious and potentially fatal ventricular arrhythmias such as sustained VT/VF, primarily Torsade de Pointes (TdP) [see Warnings and Precautions (5.1)]. The effect on QT and the risk of Torsade de Pointes are both dose related. Pediatric Patients In an unblinded multicenter trial of 25 pediatric patients aged ≤ 1 month to 12 years 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. The clinical trial safety profile in pediatric patients was similar to that in adult patients. Both the Class III and beta-blocking effects of sotalol were linearly related to the plasma concentration [see Clinical Pharmacology (12.2)]. Atrial Fibrillation/Atrial Flutter Placebo-controlled Clinical Trials In a pooled clinical trial population consisting of 4 placebo-controlled studies with 275 patients with atrial fibrillation (AFIB)/atrial flutter (AFL) treated with 160 to 320 mg of Betapace AF, the following adverse reactions presented in Table 2 occurred in at least 2% of placebo-treated patients and at a lesser rate than Betapace-treated patients. The data are presented by incidence of reactions in the Betapace AF and placebo groups by body system and daily dose. Table 2: Incidence (%) of Common Adverse Reactions (≥ 2% in the Placebo Group and Less Frequent Than in the Betapace AF Groups) in Four Placebo-controlled Studies of Patients with AFIB/AFL Adverse Reaction Placebo Betapace AF Total Daily Dose N = 282 (%) 160-240 mg N = 153 (%) >240-320 mg N = 122 (%) Bradycardia 3 13 12 Diarrhea 2 5 6 Nausea/Vomiting 5 8 6 Fatigue 9 20 19 Hyperhidrosis 3 5 5 Weakness 3 5 5 Dizziness 12 16 13 Headache 5 3 12 Dyspnea 7 9 10 Overall, discontinuation because of unacceptable adverse events was necessary in 17% of the patients and occurred in 10% of patients less than two weeks after starting treatment.

— Etiqueta de la FDA: Betapace, Legacy Pharma USA, Inc., vigente desde el 16 de diciembre de 2024. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Interacciones de Sotalol

Cita de la sección «Drug Interactions» (interacciones) de la etiqueta aprobada por la FDA. Se muestra en inglés. Dígale a su farmacéutico todos los medicamentos, vitaminas y productos herbales que toma.

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 (7.4) Aluminum- or magnesium-based antacids reduce sotalol exposure (7.7) 7.1 Antiarrhythmics and Other QT Prolonging Drugs Discontinue Class I or Class III antiarrhythmic agents for at least three half-lives prior to dosing with sotalol.

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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 Betapace/Betapace AF, because of their potential to prolong refractoriness [see Warnings and Precautions (5.2)]. 7.2 Negative Chronotropes Digitalis glycosides, diltiazem, verapamil, and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use with negative chronotropes can increase the risk of bradycardia or hypotension. 7.3 Catecholamine-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. 7.4 Insulin and Oral Antidiabetics Hyperglycemia may occur, and the dosage of insulin or antidiabetic drugs may require adjustment [see Warnings and Precautions (5.7)]. 7.5 Beta-2-Receptor Stimulants Beta-agonists such as albuterol, terbutaline and isoproterenol may have to be administered in increased dosages when used concomitantly with sotalol. 7.6 Clonidine Concomitant use with sotalol increases the risk of bradycardia and AV block. 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. 7.7 Antacids Avoid administration of oral sotalol within 2 hours of antacids containing aluminum oxide and magnesium hydroxide. 7.8 Drug/Laboratory Test Interactions The presence of sotalol in the urine may result in falsely elevated levels of urinary metanephrine when measured by fluorimetric or photometric methods.

— Etiqueta de la FDA: Betapace, Legacy Pharma USA, Inc., vigente desde el 16 de diciembre de 2024. Leer la etiqueta completa en DailyMed →

Dosis de Sotalol

Cita de la sección «Dosage and Administration» (dosis y administración) de la etiqueta aprobada por la FDA. Se muestra en inglés. Su dosis es la que le receta su médico: no la cambie por su cuenta.

Betapace/Betapace AF: Initial dosage in adults is 80 mg twice daily.

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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) 2.1 General Safety Measures for Initiation of Oral Sotalol Therapy Withdraw other antiarrhythmic therapy before starting Betapace/Betapace AF and monitor for a minimum of 2 to 3 plasma half-lives prior to initiating Betapace/Betapace AF therapy if the patient's clinical condition permits [see Drug Interactions (7)]. Hospitalize patients being 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. Monitor QTc 2 to 4 hours after each uptitration in 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. 2.2 Adult 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. Oral doses as high as 480 to 640 mg/day have been utilized in patients with refractory life-threatening arrhythmias. 2.3 Adult 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 QTc >450 msec is contraindicated [see Contraindications (4)]. 2.4 Pediatric 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.

— Etiqueta de la FDA: Betapace, Legacy Pharma USA, Inc., vigente desde el 16 de diciembre de 2024. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Sotalol en el embarazo

Cita de la parte sobre embarazo (Pregnancy) de la etiqueta aprobada por la FDA. Se muestra en inglés. Pregunte a su médico antes de tomar cualquier medicamento si está embarazada o planea estarlo.

Risk Summary Both the untreated underlying condition in pregnancy and the use of sotalol in pregnancy cause adverse outcomes to the mother and fetus/neonate (see Clinical Considerations). In animal reproduction studies in rats, early resorptions were increased at 15 times the maximum recommended human dose (MRHD). In rabbits an increase in fetal death was observed at 2 times the MRHD administered as a single dose.

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Sotalol did not reveal any teratogenic potential in rats or rabbits at 15 and 2 times the MRHD respectively (see Data). All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the United States (U.S.) general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations The incidence of VT is increased and may be more symptomatic during pregnancy. Most tachycardia episodes are initiated by ectopic beats and the occurrence of arrhythmia episodes may, therefore, increase during pregnancy. Breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to the increased volume of distribution and increased drug metabolism inherent in the pregnant state. Fetal/Neonatal Adverse Reactions Sotalol has been shown to cross the placenta and is found in amniotic fluid. From published observational studies, the potential fetal adverse effects of sotalol use during pregnancy are growth restriction, transient fetal bradycardia, hyperbilirubinemia, hypoglycemia, uterine contractions, and possible intrauterine death. Sotalol may have a greater effect on QT prolongation in the immature heart than in the adult heart, and therefore, conveys an increased risk of serious fetal arrhythmia and/or possible intrauterine death. Monitor the newborn for symptoms of beta blockade. Labor or Delivery Generally, risk of arrhythmias increases during the labor and delivery process; therefore, considering the proarrhythmia potential of the drug, patients treated with sotalol should be monitored continuously during labor and delivery. Data Animal Data Reproduction studies in rats and rabbits administered sotalol during organogenesis at 15 times and 2 times the MRHD as mg/m 2, respectively, did not reveal any teratogenic potential associated with sotalol. In pregnant rats, sotalol doses administered during organogenesis at approximately 15 times the MRHD as mg/m 2, increased the number of early resorptions, while no increase in early resorptions was noted at 2 times the MRHD as mg/m 2. In reproductive studies in rabbits, a sotalol dose (160 mg/kg/day) at 5 times the MRHD as mg/m 2 produced a slight increase in fetal death, and maternal toxicity. However, one study from published data reported an increase in fetal deaths in rabbits receiving a single dose (50 mg/kg) at 2 times the MRHD as mg/m 2 on gestation day 14.

— Etiqueta de la FDA: Betapace, Legacy Pharma USA, Inc., vigente desde el 16 de diciembre de 2024. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Sotalol

Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.

Betapace/Betapace AF is contraindicated in patients with: Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is present Congenital or acquired long QT syndromes Cardiogenic shock or decompensated heart failure Serum potassium <4 mEq/L Bronchial asthma or related bronchospastic conditions Hypersensitivity to sotalol For the treatment of AFIB/AFL, Betapace/Betapace AF is also contraindicated in patients with: Baseline QT …

— Etiqueta de la FDA: Betapace, Legacy Pharma USA, Inc., vigente desde el 16 de diciembre de 2024. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Sobredosis de Sotalol

Cita de la sección «Overdosage» (sobredosis) de la etiqueta aprobada por la FDA. Se muestra en inglés. Si alguien pudo haber tomado demasiado, llame a Poison Help al 1-800-222-1222 (o al 911 en una emergencia).

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.

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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.

— Etiqueta de la FDA: Betapace, Legacy Pharma USA, Inc., vigente desde el 16 de diciembre de 2024. Leer la etiqueta completa en DailyMed →

Presentaciones y vía de administración

Empresas que tienen este medicamento

Empresas en el directorio NDC de la FDA: la empresa que aparece en el envase (fabricante o distribuidor), con su número de productos con receta.

• Bryant Ranch Prepack19 productos
• Apotex Corp.7 productos
• Unichem Pharmaceuticals (USA), Inc.6 productos
• Legacy Pharma USA Inc.6 productos
• Aphena Pharma Solutions - Tennessee, LLC5 productos
• AiPing Pharmaceutical, Inc.4 productos
• Teva Pharmaceuticals USA, Inc.4 productos
• Oxford Pharmaceuticals, LLC4 productos
• Proficient Rx LP4 productos
• PD-Rx Pharmaceuticals, Inc.4 productos
• Epic Pharma, LLC3 productos
• Aurobindo Pharma Limited3 productos
• A-S Medication Solutions2 productos
• AvPAK2 productos
• Golden State Medical Supply, Inc.1 producto
• American Health Packaging1 producto
• Major Pharmaceuticals1 producto
• Azurity Pharmaceuticals, Inc.1 producto
• Northwind Health Company, LLC1 producto
• Cardinal Health 107, LLC1 producto
• ALTATHERA Pharmaceuticals, LLC1 producto

Historial de aprobación de la FDA

• NDA: Solicitud de nuevo medicamento (NDA): así se aprueba un medicamento nuevo, normalmente de marca.
• ANDA: Solicitud abreviada (ANDA): así se aprueba una versión genérica.

Aprobaciones de genéricos (9)

• ANDA075429Teva · 1 de mayo de 2000
• ANDA075500Aiping Pharm Inc · 27 de abril de 2001
• ANDA076140Apotex · 26 de septiembre de 2002
• ANDA076214Apotex · 27 de agosto de 2003
• ANDA075563Oxford Pharms · 7 de noviembre de 2003
• ANDA077070Epic Pharma LLC · 4 de noviembre de 2005
• ANDA077616Aurobindo Pharma USA · 7 de febrero de 2007
• ANDA207428Regcon Holdings · 21 de octubre de 2016
• ANDA207429Regcon Holdings · 2 de noviembre de 2018

Escasez

La lista de escasez de la FDA no incluye estos productos.

Base de datos de escasez de medicamentos de la FDA →

Retiros del mercado

No aparece ningún retiro vinculado a estos productos (por su código NDC) en los informes de la FDA.

Identificadores oficiales

Siguientes pasos

• Encuentre una farmacia cerca de ustedPregunte qué precio le corresponde y si su producto está afectado por un retiro
• Últimos retiros de medicamentos de la FDATodos los medicamentos, los más recientes primero
• BetapacePágina de marca: productos, fabricante y precio
• Betapace AfPágina de marca: productos, fabricante y precio
• SotylizePágina de marca: productos, fabricante y precio
• Fibrilación auricularEnfermedad que menciona la etiqueta: hospitales que la tratan
• Bryant Ranch PrepackFabricante o distribuidor
• Apotex Corp.Fabricante o distribuidor
• Unichem Pharmaceuticals (USA), Inc.Fabricante o distribuidor
• Todos los medicamentos con receta de la A a la ZBusque por nombre genérico, de marca o en español

Fuentes

1. Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Betapace, Legacy Pharma USA, Inc., vigente desde el 16 de diciembre de 2024; vía openFDA, datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
2. NDC Directory (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
3. Drugs@FDA (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
4. Drug recall enforcement reports (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 27 de octubre de 2026, consultados el 31 de octubre de 2026
5. Drug shortages (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
6. Nombre en español: RxNorm (Biblioteca Nacional de Medicina de EE. UU.) y Wikidata, vinculados por el identificador RxNorm (RxCUI) del principio activo, sin coincidencias aproximadas.

La FDA ofrece los datos de openFDA tal cual; pueden estar incompletos. Guíese siempre por la etiqueta que viene con su medicamento. Buscador de informes de retiros de la FDA →

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