Sorine (sotalol): Tachycardia & Arrhythmia Drug Warnings

Generic drug: sotalol hydrochloride

Brand name: Sorine

What is Sorine (sotalol hydrochloride), and how does it work?

Sorine tablets (sotalol hydrochloride) is an antiarrhythmic drug indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening.

What are the side effects of Sorine?

Common side effects of Sorine include:

fatigue
slow heart rate (less than 50 bpm)
shortness of breath
new or more frequent arrhythmias
weakness, and
dizziness

To minimize the risk of induced arrhythmia, patients initiated or reinitiated
on sotalol should be placed for a minimum of three days (on their maintenance
dose) in a facility that can provide cardiac resuscitation and continuous
electrocardiographic monitoring.

Creatinine clearance should be calculated prior
to dosing. For detailed instructions regarding dose selection and special
cautions for people with renal impairment.

Sotalol is also indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm and is marketed under the brand name Betapace AF. This product is not approved for the AFIB/AFL indication and should not be substituted for
Betapace AF because only Betapace AF is distributed with a patient package insert that is appropriate for patients with AFIB/AFL.

What is the dosage for Sorine?

General Safety Measures For Initiation Of Oral Sotalol Therapy

Withdraw other antiarrhythmic therapy before starting SORINE (sotalol hydrochloride) tablets and monitor carefully for a minimum of 2 to 3 plasma half-lives if the patient's clinical condition permits.
Hospitalize patients initiated or re-initiated on sotalol for at least 3 days or until steady-state drug levels are achieved, in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring.
Initiate oral sotalol therapy in the presence of personnel trained in the management of serious arrhythmias. Perform a baseline ECG to determine the QT interval and measure and normalize serum potassium and magnesium levels before initiating therapy.
Measure serum creatinine and calculate an estimated creatinine clearance in order to establish the appropriate dosing interval (insert cross ref to renal dosing). Continually monitor patients with each uptitration in dose, until they reach steady state.
Determine QTc 2 to 4 hours after every dose.
Discharge patients on sotalol therapy from an in-patient setting with an adequate supply of sotalol to allow uninterrupted therapy until the patient can fill a sotalol prescription.
Advise patients who miss a dose to take the next dose at the usual time. Do not double the dose or shorten the dosing interval.

Adult Dose For Ventricular Arrhythmias

The recommended initial dose is 80 mg twice daily. This dose may be increased in increments of 80 mg per day every 3 days provided the QTc <500 msec.
Continually monitor patients until steady state blood levels are achieved. 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 (because of the long terminal elimination half-life of sotalol, dosing more than a two times a day is usually not necessary).
Oral doses as high as 480 to 640 mg/day have been utilized in patients with refractory life-threatening arrhythmias.

Adult Dose For Prevention Of Recurrence Of AFIB/AFL

The recommended initial dose is 80 mg twice daily. This dose may be increased in increments of 80 mg per day every 3 days provided the QTc <500 msec.
Continually monitor patients until steady state blood levels are achieved.
Most patients will have satisfactory response with 120 mg twice daily. Initiation of sotalol in patients with creatinine clearance <40 mL/min or QTc >450 is contraindicated.

Pediatric Dose For Ventricular Arrhythmias Or AFIB/AFL

Use the same precautionary measures for children as you would use for adults when initiating and re-initiating sotalol treatment.

For Children Aged About 2 Years And Older

For children aged about 2 years and older, with normal renal function, doses normalized for body surface area are appropriate for both initial and incremental dosing. Since the Class III potency in children is not very different from that in adults, reaching plasma concentrations that occur within the adult dose range is an appropriate guide.

From pediatric pharmacokinetic data the following is recommended:

For initiation of treatment, 30 mg/m² three times a day (90 mg/m² total daily dose) is approximately equivalent to the initial 160 mg total daily dose for adults.
Subsequent titration to a maximum of 60 mg/m² (approximately equivalent to the 360 mg total daily dose for adults) can then occur.
Titration should be guided by clinical response, heart rate and QTc, with increased dosing being preferably carried out in-hospital. At least 36 hours should be allowed between dose increments to attain steady-state plasma concentrations of sotalol in patients with age-adjusted normal renal function.

For Children Aged About 2 Years Or Younger

For children aged about 2 years or younger, the above pediatric dosage should be reduced by a factor that depends heavily upon age, as shown in the following graph, age plotted on a logarithmic scale in months.

Age plotted on a logarithmic scale in months – Graph – Illustration

For a child aged 20 months, the dosing suggested for children with normal renal function aged 2 years or greater should be multiplied by about 0.97; the initial starting dose would be (30 × 0.97) = 29.1 mg/m², administered three times daily.
For a child aged 1 month, the starting dose should be multiplied by 0.68; the initial starting dose would be (30 × 0.68) = 20 mg/m², administered three times daily.
For a child aged about 1 week, the initial starting dose should be multiplied by 0.3; the starting dose would be (30 × 0.3) = 9 mg/m².
Use similar calculations for dose titration.
Since the half-life of sotalol decreases with decreasing age (below about 2 years), time to steady-state will also increase. Thus, in neonates the time to steady-state may be as long as a week or longer.

Dosage For Patients With Renal Impairment

Adults

Use of sotalol in any age group with decreased renal function should be at lower doses or increased intervals between doses. It will take much longer to reach steady-state with any dose and/or frequency of administration. Closely monitor heart rate and QTc.
Dose escalations in renal impairment should be done after administration of at least 5 doses at appropriate intervals (Table 1). Sotalol is partly removed by dialysis; specific advice is unavailable on dosing patients on dialysis.
The initial dose of 80 mg and subsequent doses should be administered at the intervals listed in Table 1 or Table 2.

Table 1: Dosing Intervals for treatment of Ventricular Arrhythmias in renal impairment

Creatinine Clearance mL/min
Dosing Interval (hours)

>60
12

30 to 59
24

10 to 29
36 to 48

<10
Dose should be individualized

Table 2: Dosing Intervals for treatment of AFIB/AFL in renal impairment

Creatinine Clearance mL/min
Dosing Interval (hours)

>60
12

40 to 59
24

<40
Contraindicated

QUESTION

In the U.S., 1 in every 4 deaths is caused by heart disease.
See Answer

What drugs interact with Sorine?

Antiarrhythmics And Other QT Prolonging Drugs

Sotalol has not been studied with other drugs that prolong the QT
interval such as antiarrhythmics, some phenothiazines, tricyclic
antidepressants, certain oral macrolides and certain quinolone antibiotics.
Discontinue Class I or Class III antiarrhythmic agents for at least
three half-lives prior to dosing with sotalol.
Class Ia antiarrhythmic drugs, such as disopyramide, quinidine and
procainamide and other Class III drugs (for example, amiodarone) are not
recommended as concomitant therapy with sotalol hydrochloride, because of
their potential to prolong refractoriness. There is only limited experience with the concomitant use of Class Ib or Ic antiarrhythmics.
Additive Class II effects would also be anticipated with the use of other beta-blocking agents concomitantly with sotalol hydrochloride.

Digoxin

Proarrhythmic events were more common in sotalol treated patients also receiving digoxin; it is not clear whether this represents an interaction or is related to the presence of CHF, a known risk factor for proarrhythmia, in the patients receiving digoxin.
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.

Calcium-Channel Blocking Drugs

Sotalol and calcium-blocking drugs can be expected to have additive effects on atrioventricular conduction or ventricular function.
Monitor such patients for evidence of bradycardia and hypotension.

Catecholamine-Depleting Agents

Concomitant use of catecholamine-depleting drugs, such as reserpine and guanethidine, with a beta-blocker may produce an excessive reduction of resting sympathetic nervous tone.
Monitor such patients for evidence of hypotension and/or marked bradycardia which may produce syncope.

Insulin And Oral Antidiabetics

Hyperglycemia may occur, and the
dosage of insulin or antidiabetic drugs may require adjustment.

Clonidine

Concomitant use with sotalol increases the risk of bradycardia.
Because beta-blockers may potentiate the rebound hypertension sometimes observed after clonidine discontinuation, withdraw sotalol several days before the gradual withdrawal of clonidine to reduce the risk of rebound hypertension.

Antacids

Avoid administration of oral sotalol within 2 hours of antacids containing aluminum oxide and magnesium hydroxide.

Is Sorine safe to use while pregnant or breastfeeding?

There are no adequate and well-controlled studies in pregnant women.
Sotalol has been shown to cross the placenta, and is found in amniotic fluid.
Sotalol is excreted in the milk of laboratory animals and has been reported to be present in human milk. Discontinue nursing on SORINE.