Betapace


sotalol hydrochloride

Apo-Sotalol (CA), Beta-Cardone (UK), Betapace, Betapace AF, Co Sotalol (CA), Dom-Sotalol (CA), Gen-Sotalol (CA), Med Sotalol (CA), Novo-Sotalol (CA), Nu-Sotalol (CA), PHL-Sotalol (CA), PMS-Sotalol (CA), Ratio-Sotalol (CA), Rhoxal-Sotalol (CA), Rylosol (CA), Sandoz Sotalol (CA), Sorine, Sotacor (CA) (UK)

Pharmacologic class: Beta-adrenergic blocker (nonselective)

Therapeutic class: Antiarrhythmic (classes II and III)

Pregnancy risk category B

FDA Box Warning

• To minimize risk of induced arrhythmia, patients starting or restarting drug should be placed for at least 3 days (on maintenance dosage) in facility that can provide cardiac resuscitation, continuous ECG monitoring, and creatinine clearance calculations.

• Drug also is indicated to treat documented life-threatening ventricular arrhythmias and marketed as Betapace. However, don't substitute Betapace for Betapace AF because of significant labeling differences.

Action

Blocks stimulation of cardiac beta1-adrenergic and pulmonary, vascular, and uterine beta2-adrenergic receptor sites. This action reduces cardiac output and blood pressure, depresses sinus heart rate, and prolongs refractory period in atria and ventricles.

Availability

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

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

Indications and dosages

➣ Ventricular arrhythmias

Adults: 80 mg P.O. b.i.d. (Betapace); may increase dosage gradually. For maintenance, 160 to 320 mg/day in two to three divided doses; some patients may require 240 to 320 mg/day in divided doses. For refractory ventricular fibrillation, may increase to 480 to 640 mg/day in divided doses.

➣ Atrial fibrillation or atrial flutter

Adults: 80 mg P.O. b.i.d. (Betapace AF). With careful monitoring, may increase to 120 mg b.i.d. p.r.n., to a maximum of 160 P.O. b.i.d.

Dosage adjustment

• Renal impairment

Contraindications

• Hypersensitivity to drug

• Uncontrolled heart failure

• Bronchial asthma, chronic obstructive pulmonary disease

• Congenital or acquired long-QT syndrome

• Sinus bradycardia, second- or third-degree atrioventricular (AV) block (unless patient has pacemaker)

• Sick sinus syndrome

• Cardiogenic shock

• Hypokalemia

• Creatinine clearance below 40 ml/minute

Precautions

Use cautiously in:

• renal or hepatic impairment, diabetes mellitus, hyperthyroidism, patients undergoing major surgery

• history of severe allergic reactions

• elderly patients

• pregnant or breastfeeding patients

• children (safety not established).

Administration

• Give 1 hour before or 2 hours after meals or antacids.

• Keep in mind that Betapace and Betapace AF have different indications and are not interchangeable or therapeutically equivalent.

Adverse reactions

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

CV: orthostatic hypotension, peripheral vasoconstriction, bradycardia, arrhythmias, heart failure, AV block

EENT: blurred vision, dry eyes, nasal stuffiness

GI: nausea, constipation, diarrhea

GU: erectile dysfunction, decreased libido

Metabolic: hyperglycemia, hypoglycemia

Musculoskeletal: joint pain, back pain, muscle cramps

Respiratory: wheezing, bronchospasm

Skin: itching, rash

Other: lupus syndrome, hypersensitivity reaction

Interactions

Drug-drug. Amphetamines, ephedrine, epinephrine, norepinephrine, phenylephrine, pseudoephedrine: unopposed alpha-adrenergic stimulation, causing excessive hypotension and bradycardia

Beta-adrenergic bronchodilators, theophylline: decreased efficacy of these drugs

Calcium channel blockers: increased risk of adverse cardiovascular reactions

Class IA antiarrhythmics (such as amiodarone, quinidine): increased risk of arrhythmias

Clonidine: excessive rebound hypertension with clonidine withdrawal

Ergot alkaloids: peripheral ischemia or gangrene

General anesthestics, phenytoin (I.V.), verapamil: additive myocardial depression

Lidocaine: increased lidocaine blood level, resulting in toxicity

Sulfonylureas: increased hypoglycemic effect

Drug-diagnostic tests. Antinuclear antibody: increased titers

Blood urea nitrogen, glucose, lipoproteins, potassium, triglycerides, uric acid: increased levels

Drug-food. Any food: decreased drug absorption

Patient monitoring

• Monitor ECG, electrolyte levels, and vital signs closely for first 3 days of therapy.

• Assess patient closely for signs and symptoms of heart failure.

• In long-term use, watch for signs and symptoms of drug-induced lupus syndrome.

Patient teaching

• Tell patient drug may cause significant cardiac effects. Explain need for ECG monitoring during first few days of therapy.

See Teach patient to recognize and immediately report signs and symptoms of heart failure and electrolyte imbalances.

• Inform patient that drug can cause serious interactions with many common drugs. Instruct him to tell all prescribers he's taking it.

See Teach patient to recognize and promptly report signs and symptoms of drug-induced lupus syndrome.

• Advise patient that drug may cause CNS effects that increase his injury risk. Encourage him to use appropriate safety precautions.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.

sotalol

(soe-ta-lole) sotalol,

Betapace

(trade name),

Betapace AF

(trade name),

Rylosol

(trade name),

Sorine

(trade name)

Classification

Therapeutic: antiarrhythmics
Pregnancy Category: B

Indications

Management of life-threatening ventricular arrhythmias.Betapace AF: 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 effects

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

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Uncompensated HF;Pulmonary edema;Asthma;Cardiogenic shock;Congenital or acquired long QT syndromes;Sinus bradycardia, 2nd- and 3rd-degree AV block (unless a functioning pacemaker is present);CCr <40 mL/min in patients who are being treated with Betapace AF.Use Cautiously in: Renal impairment (↑ dosing interval recommended if CCr ≤60 mL/min for patients with ventricular arrhythmias);Hepatic impairment;Hypokalemia (↑ risk of arrhythmias); Geriatric: ↑ sensitivity to beta blockers;Diabetes mellitus (may mask signs of hypoglycemia);Thyrotoxicosis (may mask symptoms);Patients with a history of severe allergic reactions (intensity of reactions may be increased); Obstetric / Lactation / Pediatric: Safety not established; may cause fetal/neonatal bradycardia, hypotension, hypoglycemia, or respiratory depression.

Adverse Reactions/Side Effects

Central nervous system

  • fatigue (most frequent)
  • weakness (most frequent)
  • anxiety
  • dizziness
  • drowsiness
  • insomnia
  • memory loss
  • mental depression
  • mental status changes
  • nervousness
  • nightmares

Ear, Eye, Nose, Throat

  • blurred vision
  • dry eyes
  • nasal stuffiness

Respiratory

  • bronchospasm
  • wheezing

Cardiovascular

  • arrhythmias (life-threatening)
  • bradycardia (life-threatening)
  • hf (life-threatening)
  • pulmonary edema (life-threatening)
  • orthostatic hypotension
  • peripheral vasoconstriction

Gastrointestinal

  • constipation
  • diarrhea
  • nausea

Genitourinary

  • erectile dysfunction (most frequent)
  • ↓ libido

Dermatologic

  • itching
  • rash

Endocrinologic

  • hyperglycemia
  • hypoglycemia

Musculoskeletal

  • arthralgia
  • back pain
  • muscle cramps

Neurologic

  • paresthesia

Miscellaneous

  • drug-induced lupus syndrome

Interactions

Drug-Drug interaction

Concurrent use with other class 1Aantiarrhythmics 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-adrenergicbronchodilators 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

Oral (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

Oral (Adults) CCr 30–59 mL/min—initial dose of 80 mg, with subsequent doses given q 24 hr; CCr 10 –29 mL/min—initial dose of 80 mg, with subsequent doses given q 36–48 hr.

Atrial Fibrillation/Atrial Flutter

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

Renal Impairment

Oral (Adults) CCr 40–60 mL/min—Administer q 24 hr.

Availability (generic available)

Tablets : 80 mg, 120 mg, 160 mg, 240 mg Tablets (Betapace AF): 80 mg, 120 mg, 160 mg

Nursing implications

Nursing 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.
    • 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.

Potential Nursing Diagnoses

Decreased cardiac output (Side Effects)
Noncompliance (Patient/Family Teaching)

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.
  • Oral: 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 before administration 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 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.
  • 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 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.

Betapace®

Sotalol, see there.