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sotalol (Rx)Brand and Other Names:Betapace, Betapace AF, more...Sorine, Sotylize

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

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

oral solution

  • 5mg/mL

injectable solution

  • 15mg/mL
more...

Ventricular & Supraventricular Arrhythmias

Betapace or Sorine: 80 mg PO q12hr initially; increased PRN to 120-160 mg q12hr (2-3 days between increments)

IV (substitute for PO): 75 mg over 5 hr q12hr initially; adjusted if necessary (on basis of monitoring of clinical efficacy, QTc interval, and adverse effects) every 3 days; not to exceed 150 mg q12hr

Refractory Life-Threatening Ventricular Arrhythmias

Betapace or Sorine: 80 mg PO q12hr initially; increased PRN to 120-160 mg q12hr (2-3 days between increments) to 160-320 mg/day divided q8-12hr; up to 480-640 mg/day may be required if benefits outweigh increased adverse effects

Atrial Fibrillation/Flutter

75 mg IV over 5 hr q12hr initially; adjusted if necessary every 3 days; not to exceed 150 mg IV q12hr

Betapace AF: 80 mg PO q12hr; increased PRN to 120-160 mg q12hr

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...

Supraventricular Tachycardia

<2 years old: Reduce dose; see manufacturer's package insert for details

≥2 years old: 30 mg/m² PO q8hr initially; may be titrated up to 180 mg/m²/day PO  

Ventricular Arrhythmias (Orphan)

Orphan designation for treatment of life-threatening ventricular arrhythmias in pediatric patients

Orphan sponsor

  • Arbor Pharmaceuticals, LLC; 980 Hammond Drive, Bldg Two, Suite 1250; Atlanta, GA 30328
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Interactions

Interaction Checker

sotalol and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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 patient at least 3 days while on maintenance dose in facility that provides cardiac resuscitation, continuous ECG monitoring, and estimated CrCl

            Calculate CrCl before initiating sotalol therapy

            Sotalol has proarrhythmic effects and can cause life-threatening ventricular tachycardia associated with QT interval prolongation; reduce dose, prolong infusion time, or discontinue use if QTc is greater than 500 msec during therapy

            Do not substitute sotalol for sotalol AF, because of significant differences in labeling (ie, patient package insert, dosing administration, safety information)

            Betapace AF indicated for atrial fibrillation; Betapace indicated for ventricular arrhythmias

            Contraindications

            Asthma, 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

            May worsen arrhythmias

            May cause or worsen congestive heart failure

            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

            Formulations indicated for ventricular and atrial arrhythmias are different (eg, Betapace versus Betapace AF); follow instructions as applicable

            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

            Do not discontinue abruptly; acute exacerbation of coronary artery disease may occur upon abrupt cessation of therapy

            Correct any electrolyte disturbances

            May mask symptoms of hypoglycemia or worsen hyperglycemia 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.

            more...
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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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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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