Medical term:
Betapace
sotalol hydrochloride
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.
☞ 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.
☞ 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) ,Betapace
(trade name),Betapace AF
(trade name),Rylosol
(trade name),Sorine
(trade name)Classification
Therapeutic: antiarrhythmicsIndications
Action
Therapeutic effects
Pharmacokinetics
Time/action profile (antiarrhythmic effects)
| ROUTE | ONSET | PEAK | DURATION |
|---|---|---|---|
| PO | hr | 2–3 days | 8–12 hr |
Contraindications/Precautions
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
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
Renal Impairment
Oral (Adults) CCr 40–60 mL/min—Administer q 24 hr.Availability (generic available)
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.Latest Searches:
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