sotalol (Rx)

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

AdultPediatric

Dosage Forms & Strengths

tablet (Betapace, Betapace AF, Sorine, generic)

  • 80mg
  • 120mg
  • 160mg

oral solution

  • 5mg/mL (Sotylize)

injectable solution

  • 15mg/mL

Arrhythmias

Indications

  • Indicated for treatment of life-threatening ventricular tachycardia; antiarrhythmic drugs may not enhance survival in patients with ventricular arrhythmias
  • Indicated for maintenance of normal sinus rhythm in patient with highly symptomatic atrial fibrillation/flutter (AFIB/AFL) who are currently in sinus rhythm

Oral

  • Life-threatening ventricular arrhythmias
    • 80 mg PO BID; may increase by increments of 80 mg/day q3Days if QTc <500 msec
    • Monitor 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 have been utilized with refractory life-threatening arrhythmias
  • Atrial fibrillation/flutter
    • 80 mg PO BID; may increase by increments of 80 mg/day q3Days if QTc <500 msec
    • Monitor until steady state levels achieved; typical dose is 120 mg BID
    • Initiation of sotalol in patients with creatinine clearance <40 mL/min or QTc >450 msec is contraindicated

Use IV for substitution of PO

  • To match the exposure to oral sotalol, use the same dosing frequency with IV administration and infuse the adjusted dose over 5 hr
  • 80 mg PO: Substitute 75 mg IV
  • 120 mg PO: Substitute 112.5 mg IV
  • 160 mg PO: Substitute 150 mg IV

Use for IV loading dose

  • Infuse loading dose over 1 hr
  • IV sotalol initiation from 0 mg to 80 mg
    • CrCl >90 mL/min: 60 mg IV; wait at least 4 hr for first PO dose (12 hr PO dose interval)
    • CrCl 60-90 mL/min: 82.5 mg IV; wait at least 4 hr for first PO dose (12 hr PO dose interval)
    • CrCl 30-60 mL/min: 75 mg IV; wait at least 6 hr for first PO dose (24 hr PO dose interval)
    • CrCl 10-30 mL/min: 75 mg IV; wait at least 12 hr for first PO dose (48 hr PO dose interval)
    • If the QTc interval prolongs to >500 ms or increases 20% from baseline when initiating for an oral dose of 80 mg, discontinue drug
  • IV sotalol initiation 0 to 120 mg
    • CrCl >90 mL/min: 90 mg IV; wait at least 4 hr for first PO dose (12 hr PO dose interval)
    • CrCl 60-90 mL/min: 125 mg IV; wait at least 4 hr for first PO dose (12 hr PO dose interval)
    • CrCl 30-60 mL/min: 112.5 mg IV; wait at least 6 hr for first PO dose (24 hr PO dose interval)
    • CrCl 10-30 mL/min: 112.5 mg IV; wait at least 12 hr for first PO dose (48 hr PO dose interval)
  • Reinitiating at lower dose from 120-mg to 80-mg
    • If the QTc interval prolongs to >500 ms or increases 20% from baseline when initiating for an oral dose of 120-mg, discontinued drug and consider a lower dose
    • CrCL ≥60 mL/min: Wait at least 1 day to reinitiate
    • CrCL ≥30 to <60 mL/min: Wait at least 3 days to reinitiate
    • CrCL ≥10 to <30 mL/min: Wait at least 7 days to reinitiate
  • IV sotalol escalation 80 to 120 mg
    • CrCl >90 mL/min: 75 mg IV; wait at least 4 hr for first PO dose (12 hr PO dose interval)
    • CrCl 60-90 mL/min: 82.5 mg IV; wait at least 4 hr for first PO dose (12 hr PO dose interval)
    • CrCl 30-60 mL/min: 82.5 mg IV; wait at least 6 hr for first PO dose (24 hr PO dose interval)
    • CrCl 10-30 mL/min: 82.5 mg IV; wait at least 12 hr for first PO dose (48 hr PO dose interval)
  • IV sotalol escalation 120 to 160 mg
    • CrCl >90 mL/min: 90 mg IV; wait at least 4 hr for first PO dose (12 hr PO dose interval)
    • CrCl 60-90 mL/min: 105 mg IV; wait at least 4 hr for first PO dose (12 hr PO dose interval)
    • CrCl 30-60 mL/min: 105 mg IV; wait at least 6 hr for first PO dose (24 hr PO dose interval)
    • CrCl 10-30 mL/min: 105 mg IV; wait at least 12 hr for first PO dose (48 hr PO dose interval)

Dosing Modifications

Renal impairment

  • Ventricular arrhythmia (PO)
    • CrCl >60 mL/min: Give q12hr
    • CrCl 30-59 mL/min: Give q24hr
    • CrCl 10-29 mL/min: Give q36-48hr
    • CrCl <10 mL/min: Individualize dose
  • Atrial fibrillation/flutter (PO)
    • CrCl >60 mL/min: Give q12hr
    • CrCl 40-59 mL/min: Give q24hr
    • CrCl <40 mL/min: Contraindicated

Dosing Considerations

Monitoring before initiating or re-initiating

  • 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 CrCl to establish appropriate dosing interval (if CrCl ≤60 mL/min dosing interval adjustment necessary)
  • Continue ECG monitoring with each uptitration in dose, until steady state reached
  • Determine QTc 2-4 hr after every dose; proarrhythmic event may occur after initiation of therapy and with each upward dosage adjustment

Limitations of use

  • AFIB/AFL: Because therapy with sotalol can cause life-threatening ventricular arrhythmias, reserve 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

Dosage Forms & Strengths

tablet (Betapace, betapace AF, Sorine, generic)

  • 80mg
  • 120mg
  • 160mg

oral solution

  • 5mg/mL (Sotylize)

injectable solution

  • 15mg/mL

Arrhythmias

Indications

  • Indicated for treatment of life-threatening ventricular tachycardia; antiarrhythmic drugs may not enhance survival in patients with ventricular arrhythmias
  • Indicated for maintenance of normal sinus rhythm in patient with highly symptomatic atrial fibrillation/flutter (AFIB/AFL) who are currently in sinus rhythm

2 years or older

  • Normal renal function: 30 mg/m2 PO TID initially (90 mg/m2 total daily dose) is approximately equivalent to initial 160 mg total daily dose for adults  
  • Subsequent titration to maximum 60 mg/m2 TID (approximately equivalent to the 320 mg total daily dose for adults) can then occur
  • Guide titration 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
  • Use graph in prescribing information where age in months is plotted on a logarithmic scale; see manufacturer's package insert for details
  • Examples
    • Child aged 20 months: 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
    • Child aged 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
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Interactions

Interaction Checker

and sotalol

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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

            Minimize risk of drug-induced arrhythmia by initiating or uptitrating IV or PO sotalol in a facility that can provide continuous ECG monitoring and cardiac resuscitation

            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 >450 msec; if QT interval prolongs to ≥500 msec, dose must be reduced, duration of infusion prolonged or drug discontinued

            Contraindications

            Sinus bradycardia (<50 bpm), sick sinus syndrome or second or third degree AV block without a pacemaker

            Congenital or acquired long QT syndromes, QT interval >450 ms

            Cardiogenic shock, decompensated heart failure

            Serum potassium <4 mEq/L

            Bronchial asthma or related bronchospastic conditions

            Known hypersensitivity to sotalol

            If treating AFIB/AFL

            • Baseline QT interval >450 ms
            • CrCl <40 mL/min

            Cautions

            Significant reductions of both systolic and diastolic blood pressure may occur; monitor hemodynamics in patients with marginal cardiac compensation

            New onset or worsening heart failure may occur during initiation or uptitration of sotalol owing to its beta-blocking effects; monitor for signs and symptoms of heart failure and discontinue treatment if symptoms occur

            Abrupt discontinuation of beta blockers may exacerbate angina and MI may occur; when discontinuing chronically administered sotalol (particularly in patients with ischemic heart disease), gradually reduce dose over 1-2 weeks is possible

            Patients with bronchospastic diseases (eg, chronic bronchitis, emphysema) should not receive beta-blockers; if sotalol must be used, use smallest effective dose to minimize inhibition of bronchodilation produced by endogenous or exogenous catecholamine stimulation of beta2 receptors

            May mask sign of hypoglycemia (ie, tachycardia)

            Avoid abrupt withdrawal in patients with thyroid disease, as it may exacerbate symptoms of hyperthyroidism

            While taking beta-blockers, patients with a history of anaphylactic reaction to allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic or therapeutic; may be unresponsive to usual epinephrine doses

            Chronically administered beta-blocking therapy should not be routinely withdrawn before major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures

            Proarrhythmia

            • Can cause serious ventricular arrhythmias, primarily Torsade de Pointes (TdP) type ventricular tachycardia, a polymorphic ventricular tachycardia associated with QTc prolongation
            • QTc prolongation is directly related to sotalol serum concentration
            • Factors such as reduced creatinine clearance, gender (female) and higher dose, bradycardia, history of sustained VT/VF, atrial fibrillation with sinus node dysfunction, heart failure increase the risk of TdP
            • TdP risk can be reduced by dose adjustment according to CrCl and by ECG monitoring for excessive QTc increases
            • Correct hypokalemia or hypomagnesemia before initiating and avoid with other drugs known to prolong QT

            Bradycardia/heart block/sick sinus syndrome

            • Sinus bradycardia (HR <50 bpm) may occur
            • Contraindicated in patients with sick sinus syndrome because it may cause sinus bradycardia, sinus pauses or sinus arrest

            Drug interaction overview

            Digoxin: Proarrhythmic events were more common in sotalol treated patients also receiving digoxin

            Calcium channel blockers: Expected to have additive effects on atrioventricular conduction or ventricular function; monitor for bradycardia and hypotension

            Catecholamine-depleting drugs: May produce excessive reduction of resting sympathetic nervous tone; monitor for bradycardia and hypotension

            Insulin and oral antidiabetics: Hyperglycemia may occur; adjust dose of diabetes therapies if needed

            Clonidine: Coadministration may increase risk of bradycardia; because beta-blockers may potentiate rebound hypertension sometimes observed after clonidine discontinuation, withdraw sotalol several days before the gradual withdrawal of clonidine to reduce the risk of rebound hypertension

            Antacids: Avoid oral sotalol within 2 hr of aluminum oxide- and/or magnesium hydroxide-containing antacids

            • Antiarrhythmics and other QT prolonging drugs
              • Coadministration with other drugs that prolong QT interval (eg, phenothiazines, tricyclic antidepressants, certain oral macrolides, certain quinolone antibiotics) may increase risk of life-threatening arrhythmias
              • Discontinue Class I or Class III antiarrhythmic agents for at least three half-lives prior to dosing with sotalol; Class Ia antiarrhythmic drugs (eg, disopyramide, quinidine, procainamide) and other Class III drugs (eg, amiodarone) are not recommended as concomitant therapy
              • Limited experience with concomitant use of Class Ib or Ic antiarrhythmics
              • Additive Class II effects anticipated with concomitant use of other beta-blocking agents
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            Pregnancy & Lactation

            Pregnancy

            Both the untreated underlying condition in pregnancy and the use of sotalol in pregnancy cause adverse outcomes to the mother and fetus/neonate

            Clinical considerations

            • Incidence of VT increases and may be more symptomatic during pregnancy
            • Most tachycardia episodes are initiated by ectopic beats and 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 effects
              • Crosses placenta and is found in amniotic fluid
              • Observational studies showed growth restriction, transient fetal bradycardia, hyperbilirubinemia, hypoglycemia, uterine contractions, and possible intrauterine death with exposure during pregnancy
              • Sotalol may elicit a greater effect on QT prolongation in immature hearts than in adult hearts, and therefore, conveys an increased risk of serious fetal arrhythmia and/or possible intrauterine death
              • Monitor newborns for symptoms of beta blockade
            • Labor or delivery
              • Generally, risk of arrhythmias increases during the labor and delivery process; therefore, considering sotalol’s proarrhythmia potential, monitor patients continuously during labor and delivery

            Animal studies

            • 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 single dose
            • Sotalol did not reveal any teratogenic potential in rats or rabbits at 15 and 2 times the MRHD respectively

            Infertility

            • Beta blockers (including sotalol) may cause erectile dysfunction

            Lactation

            Sotalol present in human milk in high levels

            Owing to the potential of serious adverse effects in breastfed children and the high level of sotalol in breast milk, advise women not to breastfeed during treatment

            Estimated daily infant dose of sotalol received from breastmilk is 0.8-3.4 mg/kg, estimated at 22-25.5% of the maternal weight-adjusted dosage of sotalol

            The amount of the drug in breast milk is similar to the neonatal therapeutic dosage; therefore, there is potential for bradycardia and other symptoms of beta blockade such as dry mouth, skin or eyes, diarrhea or constipation in breastfed infants

            Data are not available regarding effects on milk production

            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, oral: 90-100%

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

            Peak plasma time: 2.5-4 hr (PO)

            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 150 mg/10 mL

            Dilute with 0.9% NaCl, D5W, or lactated Ringer solution to volume convenient for administration and consistent with fluid restriction

            IV Administration

            Infuse over 5 hr using volumetric infusion pump

            IV loading dose

            • Measure and normalize serum potassium and magnesium levels before initiation
            • Sotalol not recommended if baseline QTc >450 ms (JT >330 ms if QRS over 100 ms)
            • Infuse IV loading dose over 1 hr
            • Initiating PO dose after IV loading dose
              • Monitor QTc interval q15min during infusion; continue monitoring around peak plasma time (2-4 hr postdose) following the first PO dose (all patients) and second PO dose (patients with CrCl ≥60 mL/min)
              • Initiating 80-mg dose: If QTc interval prolongs to >500 ms or increases 20% from baseline when initiating, discontinue drug
              • Initiating 120-mg dose: If QTc interval prolongs to >500 ms or increases 20% from baseline when initiating, consider lower dose

            Oral Administration

            Discharge patients on sotalol therapy from inpatient setting with an adequate supply of sotalol to allow uninterrupted therapy until the patient can fill a sotalol prescription to avoid having to reinitiate drug in the hospital

            Missed dose: Take next dose at the usual time; do not double the dose or shorten dosing interval

            Storage

            Tablets: Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)

            IV: Store at 20-25ºC (58-77ºF); excursions permitted to 15-30ºC (59-86ºF); protect from freezing and light

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            Images

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            Formulary

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            Tier Description
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