Sotalol (Oral)

Sotalol is used to treat a serious heart rhythm problem called ventricular arrhythmia. It is also used to treat heart rhythm problems known as atrial fibrillation or atrial flutter.

Sotalol is a beta-blocker. It works by changing how nerve signals affect certain areas of the body, including the heart. As a result, the heart beats more slowly and maintains a regular rhythm.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks 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 notice any changes in your heart rhythm. You might feel dizzy or faint, or you might experience 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 feel 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 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 worsen if 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 experience 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. Additionally, this medicine may hide signs of low blood sugar in patients with diabetes or those who are fasting (e.g., surgery, not eating regularly, vomiting), such as a rapid pulse rate. Check with your doctor if you have these issues 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, inform 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 a 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 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.

In deciding to use a drug, the risks of using the drug must be weighed against the good it will do. This is a decision you and your physician will make. For this medication, 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 drugs. As well inform 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.

Pediatric

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues 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 issues, which may require caution and an adjustment in the dose for patients receiving this medication.

No guidance 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 medicine during breastfeeding. Weigh the potential benefits against the potential chances before taking this medication while breastfeeding.

Interactions with Drugs

Although certain drugs should not be used together at all, in other cases two different medications 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 using this medication, it is especially critical that your healthcare professional know if you are using any of the drugs 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 drugs is not advised. 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 medication with any of the following medications is normally not advised, but may be required in some cases. If both medicines are prescribed together, your physician may change the dose or how frequently 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
• Etrasimod
• 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 therapy for you. If both medicines are prescribed together, your physician may change the dose or how frequently 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

Interactions with Food/Tobacco/Alcohol

Certain medications 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 medications may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Issues

The presence of other medical issues 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 issue (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 issue (eg, long QT syndrome) or
• Hypokalemia (low potassium levels in the blood) or
• Kidney disease, serious 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 medication from the body.

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

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.

In the U.S.

• Betapace
• Betapace AF
• Sorine
• Sotylize

Available Dosage Forms:

• Tablet
• Solution

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Beta-Adrenergic Blocker, Nonselective

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.

• What's the difference between Sotalol and Sotalol AF?