Sotalol (Oral route)

Pronunciation:

SOE-ta-lol

Brand Names:

Betapace
Betapace AF
Sorine
Sotylize

Dosage Forms:

Tablet
Solution

Warnings:

Oral route(Solution)

To minimize the risk of induced arrhythmia, patients initiated or reinitiated on oral sotalol or converted from IV sotalol to oral administration should be placed in a facility that can provide cardiac resuscitation, continuous electrocardiographic monitoring and calculations of creatinine clearance. Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation. Do not initiate sotalol therapy if the baseline QTc is longer than 450 ms. If the QT interval prolongs to 500 ms or greater, the dose must be reduced, the interval between doses prolonged, or the drug discontinued. Adjust the dosing interval based on creatinine clearance .

Oral route(Tablet)

To minimize the risk of drug-induced arrhythmia, initiate or reinitiate oral sotalol in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation. If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug. Calculate creatinine clearance to determine appropriate dosing .

Classifications:

Therapeutic—

Cardiovascular Agent

Pharmacologic—

Beta-Adrenergic Blocker, Nonselective

Uses of This Medicine:

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.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of sotalol in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sotalol oral solution or Betapace® and Betapace® AF tablets in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

No information is available on the relationship of age to the effects of sotalol tablets in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil
Cisapride
Dronedarone
Fingolimod
Grepafloxacin
Levoketoconazole
Levomethadyl
Mesoridazine
Pimozide
Piperaquine
Saquinavir
Sparfloxacin
Terfenadine
Thioridazine
Vernakalant
Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide
Acetazolamide
Adagrasib
Albuterol
Alfuzosin
Amiloride
Amiodarone
Amisulpride
Amitriptyline
Amoxapine
Anagrelide
Apomorphine
Arformoterol
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Artemether
Asenapine
Astemizole
Atazanavir
Azithromycin
Azosemide
Bambuterol
Bedaquiline
Bemetizide
Bendroflumethiazide
Benzthiazide
Bitolterol
Broxaterol
Bumetanide
Buprenorphine
Buserelin
Canrenoate
Ceritinib
Chloral Hydrate
Chloroquine
Chlorpromazine
Chlorthalidone
Ciprofloxacin
Citalopram
Clarithromycin
Clenbuterol
Clofazimine
Clomipramine
Clonidine
Clopamide
Clothiapine
Clozapine
Colterol
Crizotinib
Cyclobenzaprine
Cyclothiazide
Dabrafenib
Darunavir
Dasatinib
Degarelix
Delamanid
Desipramine
Deslorelin
Deutetrabenazine
Dexmedetomidine
Dibenzepin
Digoxin
Diltiazem
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Droperidol
Ebastine
Efavirenz
Eliglustat
Encainide
Encorafenib
Enflurane
Entrectinib
Epinephrine
Eribulin
Erythromycin
Escitalopram
Ethacrynic Acid
Etozolin
Famotidine
Felbamate
Fenoldopam
Fenoterol
Fenquizone
Fexinidazole
Flecainide
Fluconazole
Fluoxetine
Formoterol
Foscarnet
Fosphenytoin
Fostemsavir
Furosemide
Galantamine
Gatifloxacin
Gemifloxacin
Gepirone
Glasdegib
Gonadorelin
Goserelin
Granisetron
Halofantrine
Haloperidol
Halothane
Hexoprenaline
Histrelin
Hydrochlorothiazide
Hydroflumethiazide
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Ibutilide
Iloperidone
Imipramine
Indacaterol
Indapamide
Indecainide
Inotuzumab Ozogamicin
Iobenguane I 131
Iohexol
Isoetharine
Isoflurane
Isradipine
Itraconazole
Ivabradine
Ivosidenib
Ketoconazole
Lacosamide
Lapatinib
Lefamulin
Lenvatinib
Leuprolide
Levalbuterol
Levofloxacin
Lidocaine
Lidoflazine
Lofexidine
Lopinavir
Lumefantrine
Macimorelin
Mannitol
Mefloquine
Metaproterenol
Methadone
Methotrimeprazine
Metolazone
Metronidazole
Mexiletine
Mifepristone
Mirtazapine
Mizolastine
Moricizine
Moxifloxacin
Nafarelin
Nelfinavir
Nilotinib
Norfloxacin
Nortriptyline
Octreotide
Ofloxacin
Olanzapine
Olodaterol
Ondansetron
Osilodrostat
Osimertinib
Oxaliplatin
Oxymetazoline
Ozanimod
Pacritinib
Paliperidone
Panobinostat
Papaverine
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Perphenazine
Phenobarbital
Pimavanserin
Pipamperone
Pirbuterol
Piretanide
Pitolisant
Polythiazide
Ponesimod
Posaconazole
Prilocaine
Primidone
Probucol
Procainamide
Procaterol
Prochlorperazine
Promethazine
Propafenone
Protriptyline
Quetiapine
Quinethazone
Quinidine
Quinine
Quizartinib
Ranolazine
Relugolix
Reproterol
Ribociclib
Rimiterol
Risperidone
Ritodrine
Ritonavir
Rivastigmine
Salmeterol
Selpercatinib
Sertindole
Sertraline
Sevoflurane
Siponimod
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Spiramycin
Spironolactone
Sulfamethoxazole
Sulpiride
Sultopride
Sunitinib
Tacrolimus
Tamoxifen
Telaprevir
Telavancin
Telithromycin
Terbutaline
Tetrabenazine
Ticrynafen
Tocainide
Tolterodine
Toremifene
Torsemide
Trazodone
Tretoquinol
Triamterene
Trichlormethiazide
Triclabendazole
Trifluoperazine
Trimethoprim
Trimipramine
Triptorelin
Tulobuterol
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Verapamil
Vilanterol
Vinflunine
Voclosporin
Voriconazole
Vorinostat
Xipamide
Zolmitriptan
Zotepine
Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abarelix
Acarbose
Aceclofenac
Acemetacin
Albiglutide
Alogliptin
Aluminum Carbonate, Basic
Aluminum Hydroxide
Aluminum Phosphate
Amtolmetin Guacil
Aspirin
Bromfenac
Bufexamac
Bunazosin
Canagliflozin
Celecoxib
Chlorpropamide
Choline Salicylate
Clonixin
Dapagliflozin
Dexibuprofen
Dexketoprofen
Diclofenac
Diflunisal
Dihydroxyaluminum Aminoacetate
Dihydroxyaluminum Sodium Carbonate
Dipyrone
Doxazosin
Droxicam
Dulaglutide
Empagliflozin
Ertugliflozin
Etodolac
Etofenamate
Etoricoxib
Exenatide
Felbinac
Fenoprofen
Fepradinol
Feprazone
Floctafenine
Flufenamic Acid
Flurbiprofen
Glimepiride
Glipizide
Glyburide
Ibuprofen
Indomethacin
Insulin Aspart, Recombinant
Insulin Degludec
Insulin Detemir
Insulin Glargine, Recombinant
Insulin Glulisine
Insulin Human Inhaled
Insulin Human Isophane (NPH)
Insulin Human Regular
Insulin Lispro, Recombinant
Ketoprofen
Ketorolac
Linagliptin
Liraglutide
Lixisenatide
Lornoxicam
Loxoprofen
Lumiracoxib
Magaldrate
Magnesium Carbonate
Magnesium Hydroxide
Magnesium Oxide
Magnesium Peroxide
Magnesium Trisilicate
Meclofenamate
Mefenamic Acid
Meloxicam
Metformin
Methyldopa
Miglitol
Morniflumate
Moxisylyte
Nabumetone
Naproxen
Nateglinide
Nepafenac
Niflumic Acid
Nimesulide
Nimesulide Beta Cyclodextrin
Oxaprozin
Oxyphenbutazone
Parecoxib
Phenoxybenzamine
Phentolamine
Phenylbutazone
Piketoprofen
Pioglitazone
Piroxicam
Pramlintide
Pranoprofen
Prazosin
Proglumetacin
Propyphenazone
Proquazone
Repaglinide
Rofecoxib
Rosiglitazone
Salicylic Acid
Salsalate
Saxagliptin
Sitagliptin
Sodium Salicylate
St John's Wort
Sulindac
Tamsulosin
Tenoxicam
Terazosin
Tiaprofenic Acid
Tolazamide
Tolbutamide
Tolfenamic Acid
Tolmetin
Trimazosin
Urapidil
Valdecoxib
Vildagliptin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Angina or
Bronchospasm or
Heart attack, recent or
Heart disease (eg, coronary insufficiency, heart failure, ischemic heart disease) or
Heart rhythm problem (eg, QT prolongation) or
Hypomagnesemia (low magnesium levels in the blood) or
Hypotension (low blood pressure)—Use with caution. May make these conditions worse.

Asthma or
Bradycardia (slow heartbeat), without a pacemaker or
Cardiogenic shock (shock caused by heart attack) or
Heart block, without a pacemaker or
Heart failure, uncontrolled or
Heart rhythm problem (eg, long QT syndrome) or
Hypokalemia (low potassium levels in the blood) or
Kidney disease, severe or
Sick sinus syndrome (type of abnormal heart rhythm), without a pacemaker or—Should not be used in patients with these conditions.

Diabetes or
Hyperthyroidism (overactive thyroid) or
Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat.

Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Lung disease (eg, bronchitis, emphysema)—May cause difficulty with breathing in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

For the first three days, you will receive this medicine in a hospital where your heart rhythm can be monitored.

Your pharmacist may prepare the tablets to make an oral liquid. Talk with your doctor or pharmacist if you have any concerns about this.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

If you are also taking an antacid aluminum or magnesium hydroxide, take it 2 hours before or 2 hours after taking sotalol.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For abnormal heart rhythms:
- For oral dosage forms (solution or tablets):
  - Adults—At first, 80 milligrams (mg) once or 2 times a day. Your doctor may adjust your dose every 3 days as needed.
  - Children—Use and dose must be determined by your doctor.
- For oral dosage forms (Betapace® and Betapace® AF tablets):
  - Adults—At first, 80 milligrams (mg) 2 times a day. Your doctor may adjust your dose every 3 days as needed.
  - Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. At first, the dose is usually 1.2 mg per kilogram (kg) of body weight 3 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 2.4 mg per kg of body weight 3 times a day.
  - Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood, urine, and ECG tests will be needed to check for unwanted effects.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

This medicine may make you dizzy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Stand up slowly if you feel dizzy or lightheaded.

Do not interrupt or stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous.

Sotalol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort, dilated neck veins, extreme fatigue, irregular breathing, an irregular heartbeat, swelling of the face, fingers, feet, or lower legs, or weight gain.

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar in patients who have diabetes or are fasting (eg, surgery, not eating regularly, vomiting), such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

This medicine may cause serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common: Blurred vision; chest pain, tightness, or discomfort; confusion; difficult or labored breathing; dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position; fast, slow, irregular, pounding, or racing heartbeat or pulse; lightheadedness, dizziness, or fainting; nausea and vomiting; sweating; swelling of the face, fingers, feet, or lower legs; unusual tiredness or weakness

Less common: Body aches or pain; burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings; cough or hoarseness; decreased alertness; difficulty with speaking; dilated neck veins; double vision; feeling of warmth or heat; fever or chills; flushing or redness of the skin, especially on the face and neck; headache; inability to move the arms, legs, or facial muscles; inability to speak; irregular breathing; joint pain or swelling; loss of voice; lower back or side pain; nervousness; noisy breathing; painful, burning, or difficult urination; pounding in the ears; slow speech; stomach pain or swelling; weight gain

Rare: Fast breathing; pinpoint red spots on the skin

Incidence not known: Black, tarry stools; bleeding gums; blood in the urine or stools; blue lips and fingernails; coughing that sometimes produces a pink frothy sputum; crying; delusions of persecution, mistrust, suspiciousness, or combativeness; false or unusual sense of well-being; feeling of unreality; mental depression; not able to move; pale skin; pinpoint red spots on the skin; quick to react or overreact emotionally; rapidly changing moods; sense of detachment from self or body; sore throat; sores, ulcers, or white spots on the lips or in the mouth; swelling in the legs and ankles; swollen glands; unusual bleeding or bruising

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose: Anxiety; blurred vision; chest pain or discomfort; cold sweats; confusion; cool, pale skin; dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position; depression; fast, pounding, or irregular heartbeat or pulse; increased hunger; nightmares; seizures; shakiness; slow or irregular heartbeat; slurred speech; sweating; unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common: Acid or sour stomach; difficulty with sleeping; heartburn or indigestion; pain in the arms or legs

Less common: Changes in vision; decreased sexual performance or desire; loss of appetite; mood changes; night blindness; passing gas; skin rash; weight changes

Rare: Feeling of constant movement of self or surroundings; hair loss or thinning of the hair; itching skin; muscle aches, cramps, pains, or stiffness; quick to react or overreact emotionally; sensation of spinning; severe sunburn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Last Updated: 11/16/2023

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