Sotalol HCl

A to Z Drug Facts

 Action Blocks beta receptors, which primarily affect heart (slows rate), vascular musculature (decreases blood pressure), and lungs (reduces function).

 Indications Betapace: Management or prevention of life-threatening ventricular arrhythmias. Betapace AF: Maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/atrial flutter (AFIB/AFL) (Betapace AF).

 Contraindications Betapace: Hypersensitivity to beta-blockers; greater than first-degree heart block; CHF unless secondary to tachyarrhythmia treatable with beta-blockers; overt cardiac failure; sinus bradycardia; cardiogenic shock; bronchial asthma or bronchospasm, including severe COPD; congenital or acquired long QT syndromes. Betapace AF: Sinus bradycardia (< 50 bpm during waking hr); sick sinus syndrome or second and third degree AV block (unless a functioning pacemaker is present); congenital or acquired QT syndromes; baseline QT interval > 450 msec; cardiogenic shock; uncontrolled heart failure; hypokalemia (< 4 mEq/L); creatinine clearance < 40 mL/min; bronchial asthma; previous evidence of hypersensitivity to sotalol.

 Route/Dosage

Betapace should not be substituted for Betapace AF because of significant differences in labeling (eg, patient package insert, dosing administration and safety information). Betapace:

Ventricular Arrhythmias

ADULTS: PO 80 mg twice daily; may increase up to 320 mg/day in 2 or 3 divided doses. Patients with a history of symptomatic AFIB/AFL currently receiving Betapace should be transferred to Betapace AF because of the significant differences in labeling. Betapace AF: Therapy with Betapace AF must be initiated and, if necessary, titrated in a setting that provides continuous ECG monitoring and in the presence of personnel trained in the management of serious ventricular arrhythmias. Monitor patients in this way for a min of 3 days on the maintenance dose and do not discharge within 12 hr of electrical or pharmacological conversion to normal sinus rhythm.

ADULTS: PO Initiate therapy at 80 mg twice daily if Ccr is > 60 mL/min, and 80 mg q 4 hr if the Ccr is 40 to 60 mL/min. Begin continuous ECG monitoring with QT interval measurements 2 to 4 hr after each dose. If the 80 mg dose level is tolerated and QT interval remains < 500 msec after ³ 3 days, the patient may be discharged. Alternatively, during hospitalization, if 80 mg level does not reduce the frequency of relapse of AFIB/AFL and is tolerated without excessive QT interval prolongation (ie, > 520 msec), after following the patient for 3 days, the dose level may be increased to 120 mg (q 2 or 4 hr depending on Ccr). The max recommended dose in patients with Ccr > 60 mL/min is 160 mg twice daily.

 Interactions

Amiodarone, disopyramide, procainamide, quinidine: May prolong cardiac refractoriness. Calcium channel blockers: Increase risk of hypotension; possible increased effect on atrioventricular conduction or ventricular function. Clonidine: May enhance or reverse antihypertensive effects; may enhance clonidine rebound hypertension. Guanethidine, reserpine: Increase hypotension or bradycardia. Insulin, oral sulfonylurea hypoglycemic agents: Hyperglycemia; symptoms of hypoglycemia may be masked. NSAIDs: Some agents may impair antihypertensive effect.

 Lab Test Interferences May interfere with glucose or insulin tolerance tests, may result in falsely elevated urinary levels of metanephrine.

 Adverse Reactions

CV: Arrhythmias; sustained ventricular tachycardia or fibrillation; torsades de pointes. CNS: Depression; dizziness; headache; lethargy; paresthesias; vivid dreams. DERM: Rash. GI: Anorexia; constipation; diarrhea; dry mouth; dyspepsia; flatulence; nausea; vomiting. GU: Decreased libido; dysuria; impotence; nocturia; urinary retention or frequency; urinary tract infection. HEPA: Elevated liver enzymes. META: May increase or decrease blood glucose. RESP: Bronchospasm; difficulty breathing; wheezing.

 Precautions

Pregnancy: Category B. Lactation: Excreted in breast milk. Children: Safety and efficacy not established. Abrupt withdrawal: Has been associated with adverse effects; gradually decrease dose over 1 to 2 wk. Anaphylaxis: Deaths have occurred; aggressive therapy may be required. CHF: Administer cautiously in patients with CHF controlled by digitalis and diuretics. Diabetic patients: Drug may mask signs and symptoms of hypoglycemia (eg, tachycardia, BP changes). Drug may potentiate insulin-induced hypoglycemia. Nonallergic bronchospasm: Give drug with caution in patients with bronchospastic disease. Peripheral vascular disease: May precipitate or aggravate symptoms of atrial insufficiency. Proarrhythmia: May provoke new or worsened arrhythmias. Correct hypokalemia or hypomagnesemia before administering sotalol. Anticipate proarrhythmic events with initial dose and with every dose adjustment. Renal/Hepatic function impairment: Alteration of dosage interval and reduced daily dose are advised. Thyrotoxicosis: May mask clinical signs (eg, tachycardia) of developing or continuing hyperthyroidism. Abrupt withdrawal may exacerbate symptoms of hyperthyroidism, including thyroid storm.

 Administration/Storage

• Adjust dosage gradually to attain steady-state plasma concentrations.
• Before initiating therapy, carefully monitor response to withdrawal of previous antiarrhythmic therapy.
• Give on empty stomach.
• Store at room temperature.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Obtain complete cardiac assessment prior to initiation of therapy.
• Closely monitor patient during initiation of therapy and with each dosage change.
• Monitor pulse and BP, ECG, and heart rate and rhythm routinely.
• Monitor potassium, magnesium, and glucose levels routinely.
• Assess apical pulse and blood pressure prior to each dose.
• If extremes in pulse rates are detected, withhold medication and call physician immediately.
• Notify physician immediately of any signs of CHF or of any unexplained respiratory symptoms.

 Patient/Family Education

• Explain importance of not discontinuing drug suddenly, and advise that dosage will be decreased over 1 to 2 wk.
• Explain that drug may mask signs and symptoms of hypoglycemia.
• Teach patient to take pulse daily and to notify physician if pulse drops below 60.
• Tell patient to call physician if adverse reaction occurs.
• Instruct patient not to take otc medications without consulting physician.

Books@Ovid
Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts