Sorine

Last updated on RxList: 2/22/2021
Sorine Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Sorine?

Sorine (sotalol hydrochloride tablets) 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 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

Dosage for Sorine

As with other antiarrhythmic agents, Sorine should be initiated and doses increased in a hospital with facilities for cardiac rhythm monitoring and assessment.

What Drugs, Substances, or Supplements Interact with Sorine?

Sorine may interact with other antiarrhythmic drugs, calcium-blocking drugs, catecholamine-depleting drugs (such as reserpine and guanethidine), insulin or antidiabetic drugs, beta-agonists (such as salbutamol, terbutaline, and isoprenaline), clonidine, antacids containing aluminum oxide and magnesium hydroxide, phenothiazines, tricyclic antidepressants, astemizole, bepridil, oral macrolides, and quinolone antibiotics. Tell your doctor all medications and supplements you use.

Sorine During Pregnancy and Breastfeeding

During pregnancy, Sorine should be taken only if prescribed. It is unknown if it would affect a fetus. Sorine passes into breast milk and breastfeeding while using Sorine is not recommended.

Additional Information

Our Sorine (sotalol hydrochloride tablets) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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Sorine Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • chest pain;
  • fast or pounding heartbeats, fluttering in your chest;
  • sudden dizziness (like you might pass out);
  • slow heartbeats (especially if you feel light-headed);
  • swelling, rapid weight gain; or
  • feeling short of breath.

Common side effects may include:

  • slow heartbeats;
  • trouble breathing;
  • dizziness; or
  • feeling weak or tired.

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.

Read the entire detailed patient monograph for Sorine (Sotalol Hydrochloride Tablets, USP)

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Sorine Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse reactions that are clearly related to sotalol are those which are typical of its Class II (beta-blocking) and Class III (cardiac action potential duration prolongation) effects and are dose related.

Ventricular Arrhythmias

Serious Adverse Reactions

In patients with a history of sustained ventricular tachycardia, the incidence of Torsade de Pointes during oral sotalol treatment was 4% and worsened VT was about 1%; in patients with other less serious ventricular arrhythmias the incidence of Torsade de Pointes was 1% and new or worsened VT was about 0.7%. Incidence of Torsade de Pointes arrhythmias in patients with VT/VF are shown in Table 3 below.

Table 3: Percent Incidence of Torsade de Pointes and Mean QTc Interval by Dose For Patients With Sustained VT/VF

Daily Dose (mg)Torsade de Pointes IncidenceMean QTc* (msec)
800 (69)463 (17)
1600.5 (832)467 (181)
3201.6 (835)473 (344)
4804.4 (459)483 (234)
6403.7 (324)490 (185)
>6405.8 (103)512 (62)
( ) Number of patients assessed
* highest on-therapy value

Table 4 below relates the incidence of Torsade de Pointes to on-therapy QTc and change in QTc from baseline in patients with ventricular arrhythmias. It should be noted, however, that the highest on-therapy QTc was in many cases the one obtained at the time of the Torsade de Pointes event, so that the table overstates the predictive value of a high QTc.

Table 4: Relationship Between QTc Interval Prolongation and Torsade de Pointes

On-Therapy QTc Interval (msec)Incidence of Torsade de PointesChange from Baseline in QTc (msec)Incidence of Torsade de Pointes
<5001.3% (1787)<651.6% (1516)
500 to 5253.4% (236)65 to 803.2% (158)
525 to 5505.6% (125)80 to 1004.1% (146)
>55010.8% (157)100 to 1305.2% (115)
>1307.1% (99)
( ) Number of patients assessed

Table 5: Incidence (%) of Common Adverse Reactions (≥2% in the Placebo group and less frequent than in the Sotalol Hydrochloride groups) in a Placebo-controlled Parallel-group Comparison Study of Patients with Ventricular Ectopy

Body System/ Adverse Reaction (Preferred Term)PlaceboSotalol Hydrochloride Total Daily Dose
N=37
(%)
320 mg
N=38
(%)
640 mg
N=39
(%)
Cardiovascular
  Chest Pain5.47.915.4
  Dyspnea2.718.420.5
  Palpitation2.77.95.1
  Vasodilation2.70.05.1
Nervous System
  Asthenia8.110.520.5
  Dizziness5.413.217.9
  Fatigue10.826.325.6
  Headache5.45.37.7
  Lightheaded8.115.85.1
  Sleep Problem2.72.67.7
Respiratory
  Upper Respiratory Tract Problem2.72.612.8
Special Senses
  Visual Problem2.75.30.0

The most common adverse reactions leading to discontinuation of sotalol hydrochloride in trials of patients with ventricular arrhythmias are: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%. Incidence of discontinuation for these adverse reactions was dose related.

One case of peripheral neuropathy that resolved on discontinuation of sotalol hydrochloride and recurred when the patient was rechallenged with the drug was reported in an early dose tolerance study.

Pediatric Patients

In an unblinded multicenter trial of 25 pediatric patients with SVT and/or VT receiving daily doses of 30, 90 and 210 mg/m2 with dosing every 8 hours for a total of 9 doses, no Torsade de Pointes or other serious new arrhythmias were observed. One (1) patient, receiving 30 mg/m2 daily, was discontinued because of increased frequency of sinus pauses/bradycardia. Additional cardiovascular AEs were seen at the 90 and 210 mg/m2 daily dose levels. They included QT prolongation (2 patients), sinus pauses/bradycardia (1 patient), increased severity of atrial flutter and reported chest pain (1 patient). Values for QTc ≥525 msec were seen in 2 patients at the 210 mg/m2 daily dose level. Serious adverse events including death, Torsade de Pointes, other proarrhythmias, high-degree AV blocks, and bradycardia have been reported in infants and/or children.

Atrial Fibrillation/Atrial Flutter

Placebo-controlled Clinical Trials

In a pooled clinical trial population consisting of 4 placebo-controlled studies with 275 patients with atrial fibrillation (AFIB)/atrial flutter (AFL) treated with 160 to 320 mg doses of sotalol hydrochloride, the following adverse reactions presented in Table 6 occurred in at least 2% of placebo-treated patients and at a lesser rate than sotalol hydrochloride-treated patients. The data are presented by incidence of reactions in the sotalol hydrochloride and placebo groups by body system and daily dose.

Table 6: Incidence (%) of Common Adverse Reactions (≥2% in the Placebo group and less frequent than in the Sotalol Hydrochloride groups) in Four Placebo-controlled Studies of Patients with AFIB/AFL

Body System/ Adverse Reaction (Preferred Term)PlaceboSotalol Hydrochloride Total Daily Dose
N=282
(%)
160 to 240 mg
N=153
(%)
>240 to 320 mg
N=122
(%)
Cardiovascular
  Bradycardia2.513.112.3
Gastrointestinal
  Diarrhea2.15.25.7
  Nausea/Vomiting5.37.85.7
  Pain abdomen2.53.92.5
General
  Fatigue8.519.618.9
  Hyperhidrosis3.25.24.9
  Weakness3.25.24.9
Musculoskeletal/Connective Tissue
  Pain musculoskeletal2.82.64.1
Nervous System
  Dizziness12.416.313.1
  Headache5.33.311.5
Respiratory
  Cough2.53.32.5
  Dyspnea7.49.29.8

Overall, discontinuation because of unacceptable adverse events was necessary in 17% of the patients, and occurred in 10% of patients less than two weeks after starting treatment. The most common adverse reactions leading to discontinuation of sotalol hydrochloride were: fatigue 4.6%, bradycardia 2.4%, proarrhythmia 2.2%, dyspnea 2%, and QT interval prolongation 1.4%.

Postmarketing Experience

The following adverse drug reactions have been identified during post-approval use of sotalol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Voluntary reports since introduction include 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.

Read the entire FDA prescribing information for Sorine (Sotalol Hydrochloride Tablets, USP)

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Heart Disease: Symptoms, Signs, and Causes See Slideshow

© Sorine Patient Information is supplied by Cerner Multum, Inc. and Sorine Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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