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What should I discuss with my healthcare provider before taking Sorine (sotalol)?
You should not use this medicine if you are allergic to sotalol, or if you have:
a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker);
severe heart failure (that required you to be in the hospital);
asthma or other breathing disorder;
low levels of potassium in your blood;
severe kidney disease;
a personal or family history of Long QT syndrome; or
a history of slow heart beats that have caused you to faint.
To make sure sotalol is safe for you, tell your doctor about your other medical conditions, especially:
breathing problems such as bronchitis or emphysema;
a history of heart disease or congestive heart failure;
coronary artery disease (hardened arteries);
an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
a thyroid disorder;
a history of allergies; or
if you have recently had a heart attack.
Sotalol is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
Sotalol can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using sotalol.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 8 hours away. Do not take extra medicine to make up the missed dose.
Use sotalol regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Sorine (sotalol) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
a light-headed feeling, like you might pass out;
severe diarrhea or vomiting, loss of appetite;
dry mouth, unusual sweating, increased thirst; or
swelling, rapid weight gain.
Common side effects may include:
tired feeling; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Sorine (sotalol)?
Many drugs can interact with sotalol. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with sotalol, especially:
insulin or oral diabetes medicine;
blood pressure medication; or
any other medicine that contains sotalol.
This list is not complete and many other drugs can interact with sotalol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Commonly used brand name(s)
In the U.S.
- Betapace AF
Available Dosage Forms:
Therapeutic Class: Cardiovascular Agent
Pharmacologic Class: Beta-Adrenergic Blocker, Nonselective
Uses For Sorine
Sotalol is used to a treat life-threatening heart rhythm problem called ventricular arrhythmia. It is also used to treat heart rhythm problems called atrial fibrillation or atrial flutter.
Sotalol is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and at a regular rhythm.
This medicine is available only with your doctor's prescription.
Sorine Dosage and Administration
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 [see Drug Interactions (7)].
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 [see Warnings and Precautions (5.1)]. 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 [see Warnings and Precautions (5.1)]. 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 [see Contraindication (4)].
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 [see Clinical Pharmacology (12.1, 12.3)].
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.
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
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.
|Creatinine Clearance mL/min||Dosing Interval (hours)|
|30 to 59||24|
|10 to 29||36 to 48|
|<10||Dose should be individualized|
|Creatinine Clearance mL/min||Dosing Interval (hours)|
|40 to 59||24|
Preparation of Extemporaneous Oral Solution
Sotalol hydrochloride Syrup 5 mg/mL can be compounded using Simple Syrup containing 0.1% sodium benzoate (Syrup, NF) as follows:
- Measure 120 mL of Simple Syrup.
- Transfer the syrup to a 6-ounce amber plastic (polyethylene terephthalate [PET]) prescription bottle. An oversized bottle is used to allow for a headspace, so that there will be more effective mixing during shaking of the bottle.
- Add five (5) Sorine (sotalol hydrochloride) 120 mg tablets to the bottle. These tablets are added intact; it is not necessary to crush the tablets. The addition of the tablets can also be done first. The tablets can also be crushed if preferred. If the tablets are crushed, care should be taken to transfer the entire quantity of tablet powder into the bottle containing the syrup.
- Shake the bottle to wet the entire surface of the tablets. If the tablets have been crushed, shake the bottle until the endpoint is achieved.
- Allow the tablets to hydrate for at least two hours.
- After at least two hours have elapsed, shake the bottle intermittently over the course of at least another two hours until the tablets are completely disintegrated. The tablets can be allowed to hydrate overnight to simplify the disintegration process.
The endpoint is achieved when a dispersion of fine particles in the syrup is obtained.
This compounding procedure results in a solution containing 5 mg/mL of sotalol hydrochloride. The fine solid particles are the water-insoluble inactive ingredients of the tablets.
Stability studies indicate that the suspension is stable for three months when stored at 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature] and ambient humidity.
Sotalol hydrochloride has been studied in life-threatening and less severe arrhythmias. In patients with frequent premature ventricular complexes (VPC), sotalol hydrochloride was significantly superior to placebo in reducing VPCs, paired VPCs and non-sustained ventricular tachycardia (NSVT); the response was dose-related through 640 mg/day with 80% to 85% of patients having at least a 75% reduction of VPCs. Sotalol hydrochloride was also superior, at the doses evaluated, to propranolol (40 to 80 mg TID) and similar to quinidine (200 to 400 mg QID) in reducing VPCs. In patients with life-threatening arrhythmias [sustained ventricular tachycardia/fibrillation (VT/VF)], sotalol hydrochloride was studied acutely [by suppression of programmed electrical stimulation (PES) induced VT and by suppression of Holter monitor evidence of sustained VT] and, in acute responders, chronically.
In a double-blind, randomized comparison of sotalol hydrochloride and procainamide given intravenously (total of 2 mg/kg sotalol hydrochloride vs. 19 mg/kg of procainamide over 90 minutes), sotalol hydrochloride suppressed PES induction in 30% of patients vs. 20% for procainamide (p=0.2).
In a randomized clinical trial [Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) Trial] comparing choice of antiarrhythmic therapy by PES suppression vs. Holter monitor selection (in each case followed by treadmill exercise testing) in patients with a history of sustained VT/VF who were also inducible by PES, the effectiveness acutely and chronically of sotalol hydrochloride was compared with that of 6 other drugs (procainamide, quinidine, mexiletine, propafenone, imipramine and pirmenol). Overall response, limited to first randomized drug, was 39% for sotalol hydrochloride and 30% for the pooled other drugs. Acute response rate for first drug randomized using suppression of PES induction was 36% for sotalol hydrochloride vs. a mean of 13% for the other drugs. Using the Holter monitoring endpoint (complete suppression of sustained VT, 90% suppression of NSVT, 80% suppression of VPC pairs, and at least 70% suppression of VPCs), sotalol hydrochloride yielded 41% response vs. 45% for the other drugs combined. Among responders placed on long-term therapy identified acutely as effective (by either PES or Holter), sotalol hydrochloride, when compared to the pool of other drugs, had the lowest two-year mortality (13% vs. 22%), the lowest two-year VT recurrence rate (30% vs. 60%), and the lowest withdrawal rate (38% vs. about 75% to 80%). The most commonly used doses of sotalol hydrochloride in this trial were 320 to 480 mg/day (66% of patients), with 16% receiving 240 mg/day or less and 18% receiving 640 mg or more.
It cannot be determined, however, in the absence of a controlled comparison of sotalol hydrochloride vs. no pharmacologic treatment (for example, in patients with implanted defibrillators) whether sotalol hydrochloride response causes improved survival or identifies a population with a good prognosis.
Sotalol hydrochloride has not been shown to enhance survival in patients with ventricular arrhythmias.
Clinical Studies in Supra-ventricular Arrhythmias
Sotalol hydrochloride has been studied in patients with symptomatic AFIB/AFL in two principal studies, one in patients with primarily paroxysmal AFIB/AFL, the other in patients with primarily chronic AFIB.
In one study, a U.S. multicenter, randomized, placebo-controlled, double-blind, dose-response trial of patients with symptomatic primarily paroxysmal AFIB/AFL, three fixed dose levels of sotalol hydrochloride (80 mg, 120 mg and 160 mg) twice daily and placebo were compared in 253 patients. In patients with reduced creatinine clearance (40 to 60 mL/min) the same doses were given once daily. Patients were excluded for the following reasons: QT >450 msec; creatinine clearance <40 mL/min; intolerance to beta-blockers; bradycardia-tachycardia syndrome in the absence of an implanted pacemaker; AFIB/AFL was asymptomatic or was associated with syncope, embolic CVA or TIA; acute myocardial infarction within the previous 2 months; congestive heart failure; bronchial asthma or other contraindications to beta-blocker therapy; receiving potassium losing diuretics without potassium replacement or without concurrent use of ACE-inhibitors; uncorrected hypokalemia (serum potassium <3.5 meq/L) or hypomagnesemia (serum magnesium <1.5 meq/L); received chronic oral amiodarone therapy for >1 month within previous 12 weeks; congenital or acquired long QT syndromes; history of Torsade de Pointes with other antiarrhythmic agents which increase the duration of ventricular repolarization; sinus rate <50 bpm during waking hours; unstable angina pectoris; receiving treatment with other drugs that prolong the QT interval; and AFIB/AFL associated with the Wolff-Parkinson-White (WPW) syndrome. If the QT interval increased to ≥520 msec (or JT ≥430 msec if QRS >100 msec) the drug was discontinued. The patient population in this trial was 64% male, and the mean age was 62 years. No structural heart disease was present in 43% of the patients. Doses were administered once daily in 20% of the patients because of reduced creatinine clearance.
Sotalol hydrochloride was shown to prolong the time to the first symptomatic, ECG-documented recurrence of AFIB/AFL, as well as to reduce the risk of such recurrence at both 6 and 12 months. The 120 mg dose was more effective than 80 mg, but 160 mg did not appear to have an added benefit. Note that these doses were given twice or once daily, depending on renal function. The results are shown in Figure 2, Table 7 and Table 8.
|Placebo||Sotalol Hydrochloride Dose|
|80 mg||120 mg||160 mg|
|Note that columns do not add up to 100% due to discontinuations (D/C) for "other" reasons.|
|* Symptomatic AFIB/AFL † Efficacy endpoint of Study 1; study treatment stopped.|
|On treatment in NSR at 12 months without recurrence*||23%||22%||29%||23%|
|D/C for AEs||6%||12%||18%||29%|
|Sotalol Hydrochloride Dose|
|80 mg |
|120 mg |
|160 mg |
|P-value vs. placebo||0.325||0.018||0.029|
|Relative Risk (RR) to placebo||0.81||0.59||0.59|
|Median time to recurrence (days)||27||106||229||175|
Discontinuation because of adverse events was dose related.
In a second multicenter, randomized, placebo-controlled, double-blind study of 6 months duration in 232 patients with chronic AFIB, sotalol hydrochloride was titrated over a dose range from 80 mg/day to 320 mg/day. The patient population of this trial was 70% male with a mean age of 65 years. Structural heart disease was present in 49% of the patients. All patients had chronic AFIB for >2 weeks but <1 year at entry with a mean duration of 4.1 months. Patients were excluded if they had significant electrolyte imbalance, QTc >460 msec, QRS >140 msec, any degree of AV block or functioning pacemaker, uncompensated cardiac failure, asthma, significant renal disease (estimated creatinine clearance <50 mL/min), heart rate <50 bpm, myocardial infarction or open heart surgery in past 2 months, unstable angina, infective endocarditis, active pericarditis or myocarditis, ≥3 DC cardioversions in the past, medications that prolonged QT interval, and previous amiodarone treatment. After successful cardioversion patients were randomized to receive placebo (n=114) or sotalol hydrochloride (n=118), at a starting dose of 80 mg twice daily. If the initial dose was not tolerated it was decreased to 80 mg once daily, but if it was tolerated it was increased to 160 mg twice daily. During the maintenance period 67% of treated patients received a dose of 160 mg twice daily, and the remainder received doses of 80 mg once daily (17%) and 80 mg twice daily (16%).
Tables 9 and 10 show the results of the trial. There was a longer time to ECG-documented recurrence of AFIB and a reduced risk of recurrence at 6 months compared to placebo.
|Sotalol hydrochloride |
|* Symptomatic or asymptomatic AFIB/AFL † Efficacy endpoint of Study 2; study treatment stopped.|
|On treatment in NSR at 6 months without recurrence*||29%||45%|
|D/C for AEs||3%||6%|
|Sotalol hydrochloride |
|P-value vs. placebo||0.002|
|Relative Risk (RR) to placebo||0.55|
|Median time to recurrence (days)||44||>180|
Clinical Studies in Patients with Myocardial Infarction
In a large double-blind, placebo controlled secondary prevention (postinfarction) trial (n=1,456); sotalol hydrochloride was given as a non-titrated initial dose of 320 mg once daily. Sotalol hydrochloride did not produce a significant increase in survival (7.3% mortality on sotalol hydrochloride vs. 8.9% on placebo, p=0.3), but overall did not suggest an adverse effect on survival. There was, however, a suggestion of an early (i.e., first 10 days) excess mortality (3% on sotalol hydrochloride vs. 2% on placebo).
In a second small trial (n=17 randomized to sotalol hydrochloride) where sotalol hydrochloride was administered at high doses (for example, 320 mg twice daily) to high-risk post-infarction patients (ejection fraction <40% and either >10 VPC/hr or VT on Holter), there were 4 fatalities and 3 serious hemodynamic/electrical adverse events within two weeks of initiating sotalol hydrochloride.
PRINCIPAL DISPLAY PANEL - 240 mg Tablet Bottle Label
sotalol hydrochloride tablet
sotalol hydrochloride tablet
sotalol hydrochloride tablet
sotalol hydrochloride tablet
|Labeler - Upsher-Smith Laboratories, Inc. (047251004)|
|Upsher-Smith Laboratories, Inc.||079111820||MANUFACTURE(0245-0012, 0245-0013, 0245-0014, 0245-0015), LABEL(0245-0012, 0245-0013, 0245-0014, 0245-0015), PACK(0245-0012, 0245-0013, 0245-0014, 0245-0015)|
|Upsher-Smith Laboratories, Inc.||047251004||ANALYSIS(0245-0012, 0245-0013, 0245-0014, 0245-0015)|
For Healthcare Professionals
Applies to sotalol: intravenous solution, oral solution, oral tablet
Very common (10% or more): Bradycardia (up to 16%), chest pain (up to 16%), palpitation (up to 14%)
Common (1% to 10%): Edema, abnormal ECG, hypotension, proarrhythmia (including Torsade de Pointes), syncope, heart failure, presyncope, vasodilation, Automatic Implantable Cardioverter-Defibrillator (AICD) discharge, hypertension, stroke[Ref]
Very common (10% or more): Fatigue (up to 20%), dizziness (up to 20%), asthenia (up to 13%), light headedness (up to 12%)
Common (1% to 10%): Headache, perspiration, paresthesia[Ref]
Very common (10% or more): Dyspnea (up to 21%)
Common (1% to 10%): Pulmonary problem, upper respiratory tract problem, asthma[Ref]
Very common (10% or more): Nausea/vomiting (up to 10%)
Common (1% to 10%): Appetite disorder, diarrhea, dyspepsia, abdominal pain, colon problem, flatulence, cramps[Ref]
Common (1% to 10%): Weight change[Ref]
Common (1% to 10%): Rash[Ref]
Common (1% to 10%): Extremity pain, back pain[Ref]
Common (1% to 10%): Genitourinary disorder, sexual dysfunction[Ref]
Common (1% to 10%): Bleeding[Ref]
Common (1% to 10%): Infection[Ref]
Common (1% to 10%): Localized pain[Ref]
Common (1% to 10%): Vision problem[Ref]
Common (1% to 10%): Fever, abnormal lab value
Frequency not reported: Taste abnormalities, hearing disturbances[Ref]
Common (1% to 10%): Depression, sleep problem, altered consciousness, anxiety, mood change[Ref]
Some side effects of Sorine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.