Foreign marketing experience with sotalol hydrochloride shows an adverse experience profile similar to that described above from clinical trials. Voluntary reports since introduction include rare reports (less than one report per 10,000 patients) of: emotional lability, slightly clouded sensorium, incoordination, vertigo, paralysis, thrombocytopenia, eosinophilia, leukopenia, photosensitivity reaction, fever, pulmonary edema, hyperlipidemia, myalgia, pruritis, alopecia.
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been associated with sotalol during investigational use and foreign marketing experience.
Intentional or accidental overdosage with sotalol hydrochloride has rarely resulted in death.
The most common signs to be expected are bradycardia, congestive heart failure, hypotension, bronchospasm and hypoglycemia. In cases of massive intentional overdosage (2 to 16 grams) of sotalol hydrochloride the following clinical findings were seen: hypotension, bradycardia, cardiac asystole, prolongation of QT interval, Torsade de Pointes, ventricular tachycardia, and premature ventricular complexes. If overdosage occurs, therapy with sotalol should be discontinued and the patient observed closely. Because of the lack of protein binding, hemodialysis is useful for reducing sotalol plasma concentrations. Patients should be carefully observed until QT intervals are normalized and the heart rate returns to levels >50 bpm. The occurrence of hypotension following an overdose may be associated with an initial slow drug elimination phase (half life of 30 hours) thought to be due to a temporary reduction of renal function caused by the hypotension. In addition, if required, the following therapeutic measures are suggested:
Bradycardia or Cardiac Asystole: Atropine, another anticholinergic drug, a beta-adrenergic agonist or transvenous cardiac pacing.
Heart Block: (second and third degree) transvenous cardiac pacemaker.
Hypotension: (depending on associated factors) epinephrine rather than isoproterenol or norepinephrine may be useful.
Bronchospasm: Aminophylline or aerosol beta-2-receptor stimulant.
Torsade de Pointes: DC cardioversion, transvenous cardiac pacing, epinephrine, magnesium sulfate.
As with other antiarrhythmic agents, sotalol hydrochloride tablets, USP should be initiated and doses increased in a hospital with facilities for cardiac rhythm monitoring and assessment (see INDICATIONS AND USAGE). Sotalol hydrochloride tablets, USP should be administered only after appropriate clinical assessment (see INDICATIONS AND USAGE), and the dosage of sotalol hydrochloride tablets, USP must be individualized for each patient on the basis of therapeutic response and tolerance. Proarrhythmic events can occur not only at initiation of therapy, but also with each upward dosage adjustment.
Dosage of sotalol hydrochloride tablets, USP should be adjusted gradually, allowing 3 days between dosing increments in order to attain steady-state plasma concentrations, and to allow monitoring of QT intervals. Graded dose adjustment will help prevent the usage of doses which are higher than necessary to control the arrhythmia. The recommended initial dose is 80 mg twice daily. This dose may be increased, if necessary, after appropriate evaluation to 240 or 320 mg/day (120 to 160 mg twice daily). In most patients, a therapeutic response is obtained at a total daily dose of 160 to 320 mg/day, given in two or three divided doses. Some patients with life-threatening refractory ventricular arrhythmias may require doses as high as 480 to 640 mg/day; however, these doses should only be prescribed when the potential benefit outweighs the increased risk of adverse events, in particular proarrhythmia. Because of the long terminal elimination half-life of sotalol, dosing on more than a BID regimen is usually not necessary.
Pediatric dosing information for sotalol hydrochloride tablets is approved for Berlex Laboratories’ sotalol hydrochloride tablets. However, due to Berlex’s marketing exclusivity rights, this drug product is not labeled for pediatric use.
Because sotalol is excreted predominantly in urine and its terminal elimination half-life is prolonged in conditions of renal impairment, the dosing interval (time between divided doses) of sotalol should be modified (when creatinine clearance is lower than 60 mL/min) according to the following table.
| Creatinine |
| Dosinga |
|<10||Dose should be individualized|
a) The initial dose of 80 mg and subsequent doses should be administered at these intervals. See following paragraph for dosage escalations.
Since the terminal elimination half-life of sotalol hydrochloride is increased in patients with renal impairment, a longer duration of dosing is required to reach steady-state. Dose escalations in renal impairment should be done after administration of at least 5 to 6 doses at appropriate intervals (see table above). Extreme caution should be exercised in the use of sotalol in patients with renal failure undergoing hemodialysis. The half-life of sotalol is prolonged (up to 69 hours) in anuric patients. Sotalol, however, can be partly removed by dialysis with subsequent partial rebound in concentrations when dialysis is completed. Both safety (heart rate, QT interval) and efficacy (arrhythmia control) must be closely monitored.
The use of sotalol in children with renal impairment has not been investigated. Sotalol elimination is predominantly via the kidney in the unchanged form. Use of sotalol in any age group with decreased renal function should be at lower doses or at increased intervals between doses. Monitoring of heart rate and QTc is more important and it will take much longer to reach steady-state with any dose and/or frequency of administration.
Before starting sotalol hydrochloride tablets, USP, previous antiarrhythmic therapy should generally be withdrawn under careful monitoring for a minimum of 2 to 3 plasma half-lives if the patient’s clinical condition permits (see Drug Interactions). Treatment has been initiated in some patients receiving I.V. lidocaine without ill effect. After discontinuation of amiodarone, sotalol hydrochloride tablets, USP should not be initiated until the QT interval is normalized (see WARNINGS).
Information relating to the preparation of an extemporaneous oral solution of sotalol is approved for Berlex Laboratories’ sotalol hydrochloride tablets. However, due to Berlex’s marketing exclusivity rights, this drug product is not labeled with that information.
Patients with a history of symptomatic AFIB/AFL who are currently receiving sotalol hydrochloride tablets, USP for the maintenance of normal sinus rhythm should be transferred to Betapace AF because of the significant differences in labeling (i.e., patient package insert for Betapace AF, dosing administration, and safety information).
Sotalol Hydrochloride Tablets, USP 80 mg are available for oral administration as white to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SO” bisect “80” on the other side; supplied in blisterpacks of 30 (NDC 0615-7888-39).
Sotalol Hydrochloride Tablets, USP 120 mg are available for oral administration as white to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SOT” bisect “120” on the other side.
Sotalol Hydrochloride Tablets, USP 160 mg are available for oral administration as white to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SOT” bisect “160” on the other side.
Sotalol Hydrochloride Tablets, USP 240 mg are available for oral administration as white to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SOT” bisect “240” on the other side.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Dispense in tight, light-resistant container [see USP].
Betapace AF® is a trademark of Berlex.
SOTALOL HYDROCHLORIDE TABLETS, USP
80 mg, 120 mg, 160 mg and 240 mg
|Manufactured by:||Manufactured for:|
|Apotex Inc.||Apotex Corp.|
|Toronto, Ontario||Weston, Florida|
|Canada M9L 1T9||33326|
Revised: February 2012
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.