Sotalol Hydrochloride
Common Brand Name: Betapace
Generic Available
Common Dosage Forms:
Tablets: 80 mg, 120 mg, 160 mg, 240 mg
Tablets, AF: 80 mg, 120 mg, 160 mg
FDA Indications/Dosages:
For the treatment of documented ventricular arrhythmias, such as ventricular tachycardia, that are potentially life-threatening: Initiation of therapy and increases in dosages should be carried out in a hospital setting with appropriate cardiac rhythm monitoring and assessment equipment. The recommended initial dose is 80 mg twice a day. Dosage adjustment should occur no sooner than every 2-3 days in order to reach steady state plasma concentrations, and to allow monitoring of QT intervals. The normal dosage range is 80-160 mg twice a day. Some patients with life-threatening refractory ventricular arrhythmias may require doses as high as 480-640 mg/day.
Dosage in renal impairment: If CrCl is between 30-59 mL/min, doses should be given every 24 hours. If between 10-29 mL/min, the doses intervals should be 36-48 hours. If below 10 mL/min, the dosing interval should be individualized. Dosage adjustments in patients with renal impairment should be made not sooner than every 5-6 days.
Monitor: CrCl, K
Pharmacology/Pharmacokinetics: Sotalol HCl has both beta-adrenergic blocking (Class II) and cardiac action potential duration prolongation (Class III) antiarrhythmic properties. It is a racemic mixture of d- and l-sotalol with both isomers having Class III properties with the l-isomer responsible for the Class II properties. Electrophysiology effects include slowed heart rate, decreased AV nodal conduction, and increased nodal refractoriness (Class II), as well as prolongation of the atrial and ventricular monophasic action potentials, and effective refractory period prolongation of atrial muscle, ventricular muscle, and atrio-ventricular accessory pathways (Class III). Peak plasma levels are reached in 0.5-4 hours after an oral dose, and steady state plasma levels are reached in 2-3 days (5-6 days in patients with renal impairment). Mean elimination terminal half-life is 12 hours. Sotalol does not bind to plasma proteins and is not metabolized. Elimination occurs via the kidney as unchanged drug.
Drug Interactions: Class Ia antiarrhythmic drugs (disopyramide, quinidine, procainamide) and other Class III drugs (amiodarone) are not recommended during therapy with sotalol due to their potential to prolong refractoriness. Additive effects may be seen with calcium-channel blocking hypotension. Use with reserpine or guanethidine may cause excessive hypotension. Sotalol may decrease the effects of salbutamol, terbutaline, and isoprenaline. Antacids may bind to sotalol and should be avoided within 2 hours of dosing.
Contraindications/Precautions: Contraindicated in patients with bronchial asthma, sinus bradycardia, second- and third-degree AV block (without a functioning pacemaker), congenital or acquired long QT syndromes, cardiogenic shock, and uncontrolled congestive heart failure. Use with caution in patients being treated for congestive heart failure. Any electrolyte imbalances should be corrected before initiating therapy, especially hypokalemia, and hypomagnesemia. MAY CAUSE LIFE-THREATENING VENTRICULAR TACHYCARDIA ASSOCIATED WITH QT INTERVAL PROLONGATION. Caution should be used in patients with a history of sustained ventricular tachycardia/fibrillation. Caution should be used when initiating therapy and when dosage increases are made. Use caution in patients with diabetes mellitus since beta-blockers may mask the symptoms of hypoglycemia. Abrupt withdrawal of beta-blocker should be avoided. Use caution in patients with renal impairment. Pregnancy Category B.
Adverse Effects: Adverse effects are dose related. The most common reasons for discontinuing of treatment are fatigue (4%), bradycardia (3%), dyspnea (3%), proarrhythmia (3%), asthenia (2%), and dizziness (2%). Torsade de pointes and other serious new ventricular arrhythmias occur in 4 % and 1% of patients, respectively.
Patient Consultations:
If a dose is missed, take it as soon as possible. If it is closer to the time of your next dose than the dose you missed, skip the missed dose and return to your dosing schedule. Do not double doses.
Contact a physician if the above side effects are severe or persistent.
Do not discontinue therapy without first consulting physician.
May cause drowsiness. Use caution while operating machinery or when mental alertness is required.
Patients with diabetes need to be aware that this agent can cause masking of hypoglycemic symptoms.
Avoid nonprescription cough, cold, and allergy medications unless otherwise directed.
Store in a cool, dry place away from sunlight and children.
