• 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.

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.

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.

Drug-Drug:

• Concurrent use with other class 1A antiarrhythmics is not recommended due to ↑ risk of arrhythmias.
• General anesthesia, IVphenytoin, 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).

(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;

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).

Atrial Fibrillation/Atrial Flutter

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

Betapace, Betapace AF, Sorine, Sotylize

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

• Suppression of arrhythmias.

Therapeutic Classification: antiarrhythmics (class III)

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

Distribution: Crosses the placenta; enters breast milk.

Metabolism/Excretion: Elimination is mostly renal.

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

Rylosol

(antiarrhythmic effects)

• 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.
• Advise females of reproductive potential to notify health care professional promptly if pregnancy is planned or suspected and to avoid breastfeeding 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.

SOE-ta-lole