sotalol (Rx)

Brand and Other Names:Betapace, Betapace AF, more...Sorine, Sotylize
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 80mg
  • 120mg
  • 160mg
  • 240mg

oral solution

  • 5mg/mL

injectable solution

  • 15mg/mL
more...

Life-Threatening Ventricular Arrhythmias

Perform baseline ECG to determine QT interval and measure and normalize serum potassium and magnesium levels before initiating therapy; measure serum creatinine and calculate estimated creatinine clearance in order to establish appropriate dosing interval (if CrCl ≤60 mL/min dosing interval adjustment necessary); continually monitor patients with each uptitration in dose, until they reach steady state; determine QTc 2- 4 hr after every dose; proarrhythmic event may occur after initiation of therapy and with each upward dosage adjustment

Oral administration

  • 80 mg PO BID; may increase dose in increments of 80 mg/day q3Days if QTc<500 msec; monitor patients until steady state levels achieved; therapeutic dose usually obtained at total daily dose of 160-320 mg/day divided BID/TID; doses of 480-640 mg/day in patients with refractory life-threatening arrhythmias used when benefits outweigh increased risk of adverse events

Intravenous administration

  • Intravenous sotalol can substitute for oral sotalol in patients who are unable to take sotalol orally
  • 75 mg infused IV over 5 hr BID; if initial dose does not reduce frequency of relapse and excessive QTc prolongation does not occur, may increase dose after at least 3 days to 112.5 mg BID; if necessary, may increase dose by 75 mg/day every 3 days; therapeutic dose usually obtained at total daily dose of 150-300 mg/day divided BID; not to exceed 300 mg BID

Limitations of use

  • Therapy may not enhance survival in patients with ventricular arrhythmias; because of proarrhythmic effects of the drug, 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 patients are symptomatic, is generally not recommended; avoid treatment of patients with asymptomatic ventricular premature contractions

Prevention of recurrence of atrial fibrillation/flutter

Oral administration

  • Initial dose is 80 mg twice daily; may increase dose in increments of 80 mg/ day every 3 days provided QTc <500 msec; continually monitor patients until steady state blood levels are achieved; most patients will have satisfactory response with 120 mg PO BID; may further increase to 160 mg BID if response inadequate and QTc prolongation not excessive

Intravenous administration

  • 75 mg (once or twice daily) IV over 5 hr; the dose can be titrated upward to 112.5 or 150 mg after at least 3 days; if dose level, at steady state, does not reduce frequency of early relapse of arrhythmia and is tolerated without excessive QTc prolongation (>520 ms), increase dose to 150 mg orally once or twice daily

Limitations of use

  • Because therapy 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 treated

Conversion from oral to IV sotalol

80 mg oral equivalent to 75 mg IV

120 mg oral equivalent to 112.5 mg IV

160 mg oral equivalent to 150 mg IV

Dosing Modifications

Renal Impairment in Atrial Fibrillation/Flutter (Betapace AF)

  • CrCl >60 mL/min: Give q12hr
  • CrCl 40-60 mL/min: Give once daily
  • CrCl <40 mL/min: Contraindicated

Renal Impairment in Ventricular Arrhythmia (Betapace, Sorine)

  • CrCl >60 mL/min: Give q12hr
  • CrCl 30-59 mL/min: Give once daily
  • CrCl 10-29 mL/min: Give q36-48hr
  • CrCl <10 mL/min: Individualize dosing

Dosage Forms & Strengths

tablet

  • 80mg
  • 120mg
  • 160mg
  • 240mg

oral solution

  • 5mg/mL

injectable solution

  • 15mg/mL
more...

Ventricular Arrhythmia or Atrial Fibrillation/Flutter

≥2 years with normal renal function: 30 mg/m² PO TID initially (90 mg/m² total daily dose) approximately equivalent to initial 160 mg total daily dose for adults; titrate to maximum 60 mg/ m² TID(approximately equivalent to the 320 mg total daily dose for adults); titration should be guided by clinical response, heart rate and QTc, with increased dosing preferably carried out in-hospital; allow at least 36 hr between dose increments to attain steady-state plasma concentrations of drug in patients with age-adjusted normal renal function  

≤2 years: Pediatric dosage should be reduced by a factor that depends heavily upon age, the manufacturer’s graph where age in months is plotted on a logarithmic scale; using the graph, a child aged 20 months, the dosing suggested for children with normal renal function aged ≥2, which is about 30 mg should be multiplied by about 0.97, which is the age factor (30 X 0.97)for a dose of 29.1 mg/m² ; for a child aged about 1 week, initial starting dose (30 mg) should be multiplied by age factor 0.3; the starting dose would be (30 X 0.3) for a dose of 9 mg/m²; see manufacturer's package insert for details

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Interactions

Interaction Checker

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            Adverse Effects

            >10%

            Dyspnea (21%)

            Dizziness (20%)

            Fatigue (20%)

            Bradycardia (16%)

            Chest pain (16%)

            Palpitation (14%)

            Weakness (13%)

            Lightheadedness (12%)

            1-10%

            Nausea/vomiting (10%)

            Edema (8%)

            Headache (8%)

            Sleep disturbances (8%)

            Abnormal ECG (7%)

            Diarrhea (7%)

            Extremity pain (7%)

            Hypotension (6%)

            Mental confusion (6%)

            Congestive heart failure (5%)

            Itching/rash (5%)

            Syncope (5%)

            Anxiety (4%)

            Depression (4%)

            Torsades de pointes or new ventricular tachycardia/fibrillation in patients with supraventricular arrhythmia (4%)

            Peripheral vascular disorders (3%)

            Impotence (2%)

            Proarrhythmic effect (1.5-2%)

            Torsades de pointes with history of sustained ventricular tachycardia (1%)

            Frequency Not Defined

            Catechol hypersensitivity after abrupt withdrawal

            Increased insulin requirement in diabetics

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            Warnings

            Black Box Warnings

            Hospitalize patients initiated or re-initiated on sotalol for at least 3 days or until steady-state drug levels achieved, in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring; initiate oral sotalol therapy in presence of personnel trained in the management of serious arrhythmias

            Calculate CrCl before initiating sotalol therapy; adjust dosing interval based on creatinine clearance

            Sotalol has proarrhythmic effects and can cause life-threatening ventricular tachycardia associated with QT interval prolongation; do not initiate therapy if baseline QTc is >than 450 ms; if QT interval prolongs to 500 ms or greater, dose must be reduced, duration of infusion prolonged or drug discontinued

            Contraindications

            Bronchial asthma or related bronchospastic conditions, sinus bradycardia, sick sinus syndrome or 2°/3° AV block unless pacemaker in place

            Prolonged QT syndromes, cardiogenic shock, uncontrolled congestive heart failure, hypersensitivity, hypokalemia (<4 mEq/L), hypomagnesemia

            Betapace AF & IV: CrCl <40 mL/min

            Easily reversible atrial fibrillation/flutter

            QT interval >450 ms when treating for AFIB

            Cautions

            Therapy 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; correct hypokalemia or hypomagnesemia prior to initiating therapy, as these conditions can exaggerate degree of QT prolongation, and increase potential for Torsade de Pointes; give special attention 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; in general, do not use sotalol with other drugs known to cause QT prolongation; may worsen arrhythmias

            Patients with history of hypersensitivity reactions to allergens may have a more severe reaction on exposure to them and may be unresponsive to usual doses of epinephrine used to treat the allergic reaction

            Long-term administration of beta blockers should not be routinely discontinued before major surgery; however, impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures

            Patients with bronchospastic diseases (chronic bronchitis and emphysema) should not receive beta-blockers; if therapy is to be administered, use smallest effective dose, to minimize inhibition of bronchodilation produced by endogenous or exogenous catecholamine stimulation of beta 2 receptors

            Antacids given 2 hours or less before sotalol may reduce bioavailability

            Reduce or discontinue therapy if QT prolongation, bradycardia, AV block, hypotension, worsening or heart failure occur; 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

            Therapy produces significant reductions in both systolic and diastolic blood pressures and may result in hypotension; monitor hemodynamics in patients with marginal cardiac compensation

            Do not discontinue abruptly; acute exacerbation of coronary artery disease may occur upon abrupt cessation of therapy; following abrupt cessation of therapy with beta adrenergic blockers, exacerbations of angina pectoris and myocardial infarction may occur; when discontinuing chronically administered therapy, particularly in patients with ischemic heart disease, gradually reduce dosage over a period of 1–2 weeks, if possible, and monitor 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, abrupt discontinuation may unmask latent coronary insufficiency

            Avoid abrupt withdrawal of beta-blockade in patients with thyroid disease because may lead to exacerbation of symptoms of hyperthyroidism, including thyroid storm; beta-blockade may mask certain clinical signs (for example, tachycardia) of hyperthyroidism

            Correct any electrolyte disturbances

            May mask symptoms of hypoglycemia or worsen hyperglycemia in diabetic patients; elevated blood glucose levels and increased insulin requirements can occur in diabetic patients; monitor

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            Pregnancy & Lactation

            Pregnancy category: B

            Lactation: Drug present in breast milk; do not nurse while taking

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Antiarrhythmic: Class II (beta blockade) and class III (action potential prolongation) properties

            Has adrenoceptor-blocking effect and markedly prolongs action potential and repolarization

            Absorption

            Bioavailability: 90-100%

            Onset: IV, 1-2 hr; 5-10 min for ongoing VT

            Peak plasma time: 2.5-4 hr

            Distribution

            Protein bound: None

            Vd: 1.2-2.4 L/kg

            Metabolism

            None

            Elimination

            Half-life: Adults, 12 hr; children, 9.5 hr; prolonged in renal impairment

            Excretion: Urine (unchanged)

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            Administration

            IV Preparation

            Vial is 10 mL

            Dilute with NS, D5W, or lactated Ringer solution to 100-250 mL

            80 mg PO = 75 mg IV; 120 mg PO = 112.5 mg IV; 160 mg PO = 150 mg IV

            IV Administration

            Infuse over 5 hours

            Monitor QT interval

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            Formulary

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            Tier Description
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