sotalol

General

Pronunciation:
soe-ta-lole


Trade Name(s)

  • Betapace
  • Betapace AF
  • Rylosol Canadian Trade name
  • Sorine
  • Sotylize

Ther. Class.

antiarrhythmics

(class III)

Indications

  • Life-threatening ventricular arrhythmias.
  • Betapace AF and Sotylize: Maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/atrial flutter (AF/AFL) who are currently in sinus rhythm.

Action

Blocks stimulation of beta1  (myocardial) and beta2  (pulmonary, vascular, and uterine) adrenergic receptor sites.

Therapeutic Effect(s):

Suppression of arrhythmias.

Pharmacokinetics

Absorption: Well absorbed following oral administration (bioavailability 90–100%).

Distribution: Crosses the placenta; enters breast milk.

Metabolism and Excretion: Elimination is mostly renal.

Half-life: 12 hr (↑ in renal impairment).

TIME/ACTION PROFILE (antiarrhythmic effects)

ROUTEONSETPEAKDURATION
POhr2–3 days8–12 hr

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity;
  • Asthma;
  • Cardiogenic shock or decompensated HF;
  • Congenital or acquired long QT syndromes;
  • Baseline QT interval >450 msec (for AF/atrial flutter only);
  • Sinus bradycardia, sick sinus syndrome, or 2nd- and 3rd-degree AV block (unless a functioning pacemaker is present);
  • Hypokalemia (↑ risk of arrhythmias);
  • CCr <40 mL/min in patients who are being treated with Betapace AF or Sotylize;
  • Lactation:  Lactation.

Use Cautiously in:

  • Renal impairment (↑ dosing interval recommended if CCr ≤60 mL/min for patients with ventricular arrhythmias);
  • Hepatic impairment;
  • Diabetes mellitus (may mask signs of hypoglycemia);
  • Thyrotoxicosis (may mask symptoms);
  • Patients with a history of severe allergic reactions (intensity of reactions may be ↑);
  • OB:  May cause fetal/neonatal bradycardia, hypotension, hypoglycemia, or respiratory depression; use during pregnancy only if potential maternal benefit justifies potential fetal risk;
  • Pedi:   Safety and effectiveness not established in children;
  • Geri:   Older adults may have ↑ sensitivity to beta blockers.

Adverse Reactions/Side Effects

CV: arrhythmias, bradycardia, hf, pulmonary edema, orthostatic hypotension, peripheral vasoconstriction

Derm: itching, rash

EENT: blurred vision, dry eyes, nasal stuffiness

Endo: hyperglycemia, hypoglycemia

GI: constipation, diarrhea, nausea

GU: erectile dysfunction, ↓ libido

MS: arthralgia, back pain, muscle cramps

Neuro: fatigue, weakness, anxiety, dizziness, drowsiness, insomnia, memory loss, mental depression, mental status changes, nervousness, nightmares, paresthesia

Resp: bronchospasm, wheezing

Misc: drug-induced lupus syndrome

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

  • Concurrent use with other  class 1A   antiarrhythmics  is not recommended due to ↑ risk of arrhythmias.
  •  General anesthesia,  IV   phenytoin, and  verapamil  may cause additive myocardial depression.
  • Additive bradycardia may occur with  digoxin,  beta-blockers,  verapamil, and  diltiazem.
  • Additive hypotension may occur with other  antihypertensives, acute ingestion of  alcohol, or  nitrates.
  • Concurrent use with  amphetamines,  cocaine,  ephedrine,  epinephrine,  norepinephrine,  phenylephrine, or  pseudoephedrine  may result in unopposed alpha-adrenergic stimulation (excessive hypertension, bradycardia).
  • Concurrent  thyroid hormone  administration may ↓ effectiveness.
  • May alter the effectiveness of  insulin  or  oral hypoglycemic agents  (dose adjustments may be necessary).
  • May ↓ the effectiveness of  beta-adrenergic   bronchodilators  and  theophylline.
  • May ↓ the beneficial beta1  cardiovascular effects of  dopamine  or  dobutamine.
  • Discontinuation of  clonidine  in patients receiving sotalol may result in excessive rebound hypertension.
  • Use cautiously within 14 days of  MAO inhibitors  (may result in hypertension).

Route/Dosage

Ventricular Arrhythmias

PO (Adults): 80 mg twice daily; may be gradually ↑ (usual maintenance dose is 160–320 mg/day in 2–3 divided doses; some patients may require up to 480–640 mg/day).

Renal Impairment 
PO (Adults): CCr 30–59 mL/min– initial dose of 80 mg, with subsequent doses given every 24 hr;   CCr 10–29 mL/min– initial dose of 80 mg, with subsequent doses given every 36–48 hr.

Atrial Fibrillation/Atrial Flutter

PO (Adults): 80 mg twice daily, may be ↑ during careful monitoring to 120 mg twice daily if necessary.

Renal Impairment 
PO (Adults): CCr 40–60 mL/min– Administer every 24 hr.

Availability (generic available)

Tablets : 80 mg, 120 mg, 160 mg, 240 mg

Tablets (Betapace AF): 80 mg, 120 mg, 160 mg

Oral solution (Sotylize) (grape flavor): 5 mg/mL

Assessment

  • Monitor ECG prior to and periodically during therapy. May cause life-threatening ventricular tachycardia associated with QT interval prolongation. Do not initiate sotalol therapy if baseline QTc is longer than 450 ms. If QT interval becomes ≥500 ms, reduce dose, prolong duration of infusion, or discontinue therapy.
  • Monitor BP and pulse frequently during dose adjustment period and periodically during therapy. Assess for orthostatic hypotension when assisting patient up from supine position.
  • Monitor intake and output ratios and daily weight. Assess patient routinely for evidence of fluid overload (peripheral edema, dyspnea, rales/crackles, fatigue, weight gain, jugular venous distention).

Lab Test Considerations:

Calculate creatinine clearance prior to dosing.

  • May cause ↑ BUN, serum lipoprotein, potassium, triglyceride, and uric acid levels.
  • May cause increased ANA titers.
  • May cause increase in blood glucose levels.

Toxicity and Overdose:

Monitor patients receiving beta blockers for signs of overdose (bradycardia, severe dizziness or fainting, severe drowsiness, dyspnea, bluish fingernails or palms, seizures). Notify health care professional immediately if these signs occur.

  • Glucagon has been used to treat bradycardia and hypotension.

Implementation

  • Do not confuse sotalol with Sudafed (pseudoephedrine).

  • Patients should be hospitalized and monitored for arrhythmias for at least 3 days during initiation of therapy and dose increases.

    • Do not substitute Betapace for Betapace AF. Make sure patients transferred from Betapace to Betapace AF have enough Betapace AF upon leaving the hospital to allow for uninterrupted therapy until Betapace AF prescription can be filled.
  • PO Take apical pulse prior to administering. If <50 bpm or if arrhythmia occurs, withhold medication and notify health care professional.
    • Administer on an empty stomach, 1 hr before or 2 hr after meals. Administration with food, especially milk or milk products, reduces absorption by approximately 20%.
    • Avoid administering antacids containing aluminum or magnesium within 2 hr of sotalol.
    • For patients unable to swallow pills, pharmacist can convert tablets to a solution.

Patient/Family Teaching

  • Instruct patient to take medication as directed, at the same time each day, even if feeling well; do not skip or double up on missed doses. Take missed doses as soon as possible up to 8 hr before next dose. Abrupt withdrawal may precipitate life-threatening arrhythmias, hypertension, or myocardial ischemia. Advise patients taking  Betapace AF  to read the  Medication Guide  before starting and with each Rx refill in case of changes.
  • Advise patient to make sure enough medication is available for weekends, holidays, and vacations. A written prescription may be kept in wallet in case of emergency.
  • Caution patient to avoid taking antacids containing aluminum or magnesium within 2 hr of sotalol.
  • Teach patient and family how to check pulse and BP. Instruct them to check pulse daily and BP biweekly. Advise patient to hold dose and contact physician or other health care professional if pulse is <50 bpm or if BP changes significantly.
  • May cause drowsiness or dizziness. Caution patients to avoid driving or other activities that require alertness until response to the drug is known.
  • Advise patients to change positions slowly to minimize orthostatic hypotension, especially during initiation of therapy or when dose is increased.
  • Caution patient that this medication may increase sensitivity to cold.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially cold preparations.
  • Diabetic patients should closely monitor blood glucose, especially if weakness, malaise, irritability, or fatigue occurs. Medication may mask tachycardia and increased BP as signs of hypoglycemia, but dizziness and sweating may still occur.
  • Advise patient to notify health care professional immediately if new fast heartbeats with lightheadedness and fainting occurs, or if slow pulse, difficulty breathing, wheezing, cold hands and feet, dizziness, confusion, depression, rash, fever, sore throat, unusual bleeding, bruising, or if pain or swelling at the infusion site occurs.
  • Instruct patient to inform health care professional of medication regimen prior to treatment or surgery.
  • Rep:  Advise females of reproductive potential to notify health care professional promptly if pregnancy is planned or suspected and to avoid breast feeding during therapy. May cause growth restriction, transient fetal bradycardia, hyperbilirubinemia, hypoglycemia, uterine contractions, and possible intrauterine death in the exposed fetus. Monitor newborns exposed to sotalol for symptoms of beta blockade. May impair fertility by causing erectile dysfunction.
  • Advise patient to carry identification describing disease process and medication regimen at all times.

Evaluation/Desired Outcomes

Control of arrhythmias without appearance of detrimental side effects.

sotalolis the Davis's Drug Guide Word of the day!