Betapace AF

Generic Name: sotalol (Oral route)

SOE-ta-lol

Oral route(Tablet)

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 continuous cardiac resuscitation and ECG monitoring. Creatinine clearance should be calculated prior to dosing. Sotalol marketed under the brand name Betapace(R) is indicated for the treatment of documented life-threatening ventricular arrhythmias. Sotalol marketed under the brand name Betapace AF(R) is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial flutter (AFIB/AFL)) in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Betapace(R) and Betapace AF(R) cannot be substituted for each other because of significant differences in labeling (eg, indications, patient package insert, dosing administration, and safety information) .

Commonly used brand name(s)

In the U.S.

• Betapace


• Betapace AF


• Sorine

Available Dosage Forms:

• Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Beta-Adrenergic Blocker, Nonselective

Uses For Betapace AF

Sotalol is used to control rapid heartbeats and abnormal heart rhythms .

This medicine 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 Betapace AF

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.

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

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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.

Interactions with 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


• Grepafloxacin


• Levomethadyl


• Mesoridazine


• Pimozide


• Sparfloxacin


• Terfenadine


• Thioridazine


• 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


• Albuterol


• Amiloride


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Apomorphine


• Aprindine


• Arformoterol


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azimilide


• Azithromycin


• Azosemide


• Bambuterol


• Bemetizide


• Bendroflumethiazide


• Benzthiazide


• Bitolterol


• Bretylium


• Broxaterol


• Bumetanide


• Canrenoate


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Chlorthalidone


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clenbuterol


• Clomipramine


• Clonidine


• Clopamide


• Clozapine


• Colterol


• Crizotinib


• Cyclothiazide


• Dasatinib


• Desipramine


• Dibenzepin


• Diltiazem


• Disopyramide


• Dofetilide


• Dolasetron


• Doxepin


• Dronedarone


• Droperidol


• Enflurane


• Epinephrine


• Erythromycin


• Ethacrynic Acid


• Etozolin


• Fenoldopam


• Fenoterol


• Fenquizone


• Fingolimod


• Flecainide


• Fluconazole


• Fluoxetine


• Formoterol


• Foscarnet


• Furosemide


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Halothane


• Hexoprenaline


• Hydrochlorothiazide


• Hydroflumethiazide


• Ibutilide


• Iloperidone


• Imipramine


• Indacaterol


• Indapamide


• Isoetharine


• Isoflurane


• Isradipine


• Itraconazole


• Ketoconazole


• Lapatinib


• Levalbuterol


• Levofloxacin


• Lidocaine


• Lidoflazine


• Lopinavir


• Lorcainide


• Lumefantrine


• Mannitol


• Mefloquine


• Metaproterenol


• Methadone


• Metolazone


• Moricizine


• Moxifloxacin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Paliperidone


• Pazopanib


• Pentamidine


• Perflutren Lipid Microsphere


• Pirbuterol


• Piretanide


• Polythiazide


• Posaconazole


• Prilocaine


• Probucol


• Procainamide


• Procaterol


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinethazone


• Quinidine


• Quinine


• Ranolazine


• Reproterol


• Rimiterol


• Risperidone


• Ritodrine


• Salmeterol


• Saquinavir


• Sematilide


• Sertindole


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Spiramycin


• Spironolactone


• Sulfamethoxazole


• Sultopride


• Sunitinib


• Tedisamil


• Telavancin


• Telithromycin


• Terbutaline


• Tetrabenazine


• Ticrynafen


• Toremifene


• Torsemide


• Trazodone


• Tretoquinol


• Triamterene


• Trichlormethiazide


• Trifluoperazine


• Trimethoprim


• Trimipramine


• Tulobuterol


• Vandetanib


• Vardenafil


• Vasopressin


• Vemurafenib


• Verapamil


• Voriconazole


• Xipamide


• Zolmitriptan


• Zotepine

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


• Acetohexamide


• Alclofenac


• Alfuzosin


• Amlodipine


• Apazone


• Arbutamine


• Benfluorex


• Benoxaprofen


• Bromfenac


• Bufexamac


• Bunazosin


• Carprofen


• Chlorpropamide


• Clometacin


• Clonixin


• Dexketoprofen


• Diclofenac


• Diflunisal


• Digoxin


• Dipyrone


• Doxazosin


• Droxicam


• Etodolac


• Etofenamate


• Felbinac


• Felodipine


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Guar Gum


• Ibuprofen


• Indomethacin


• Indoprofen


• Insulin


• Insulin Aspart, Recombinant


• Insulin Glulisine


• Insulin Lispro, Recombinant


• Isoxicam


• Ketoprofen


• Ketorolac


• Lacidipine


• Lercanidipine


• Lornoxicam


• Manidipine


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Metformin


• Methyldopa


• Mibefradil


• Miglitol


• Moxisylyte


• Nabumetone


• Naproxen


• Nicardipine


• Nifedipine


• Niflumic Acid


• Nilvadipine


• Nimesulide


• Nimodipine


• Nisoldipine


• Nitrendipine


• Oxaprozin


• Oxyphenbutazone


• Phenoxybenzamine


• Phentolamine


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Pranidipine


• Prazosin


• Propyphenazone


• Proquazone


• Repaglinide


• St John's Wort


• Sulindac


• Suprofen


• Tamsulosin


• Tenidap


• Tenoxicam


• Terazosin


• Tiaprofenic Acid


• Tolazamide


• Tolbutamide


• Tolmetin


• Trimazosin


• Troglitazone


• Urapidil


• Zomepirac

Interactions with Food/Tobacco/Alcohol

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:

• Asthma or


• Bradycardia (slow heartbeat) or


• Heart block or


• Heart failure or


• Long QT syndrome (heart rhythm problem)—Should not use 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 (e.g., bronchitis, emphysema)—May cause difficulty with breathing in patients with this condition .

• Sick sinus syndrome (heart rhythm problem)—Use with caution. May make this condition worse .

Proper Use of sotalol

This section provides information on the proper use of a number of products that contain sotalol. It may not be specific to Betapace AF. Please read with care.

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

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 .

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 oral dosage form (tablets):
  
  • For abnormal heart rhythms:
    
    • Adults—At first, 80 milligrams (mg) two times a day. Your doctor may increase your dose if needed.
    
    
    • Children—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 Betapace AF

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

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; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing .

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, 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 .

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests .

Betapace AF Side Effects

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 or discomfort


• confusion


• diarrhea


• difficult or labored breathing


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• fast, slow, irregular, pounding, or racing heartbeat or pulse


• lightheadedness, dizziness, or fainting


• nausea and vomiting


• shortness of breath


• sweating


• swelling of face, fingers, feet, or lower legs


• tightness in chest


• unusual tiredness or weakness


• wheezing

Less common

• Abdominal pain or swelling


• back pain


• black, tarry stools


• blood in eyes


• blood in urine


• body aches or pain


• bruising or purple areas on skin


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• change in consciousness


• cold hands and feet


• cough or hoarseness


• coughing up blood


• decreased alertness


• decreased urine output


• difficulty in speaking


• dilated neck veins


• double vision


• ear congestion


• extreme fatigue


• feeling of warmth or heat


• fever or chills


• flushing or redness of skin, especially on face and neck


• headache


• inability to move arms, legs, or facial muscles


• inability to speak


• irregular breathing


• joint pain or swelling


• loss of voice


• lower back or side pain


• nasal congestion


• nervousness


• noisy breathing


• nosebleeds


• painful, burning, or difficult urination


• pounding in the ears


• runny nose


• slow speech


• sneezing


• sore throat


• troubled breathing


• weight gain

Rare

• Bleeding gums


• fast breathing, sometimes with wheezing


• large amount of fat in the blood


• not able to move


• pinpoint red spots on skin


• sores, ulcers, or white spots on lips or in mouth


• swollen glands


• unusual bleeding or bruising

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

Symptoms of overdose

• Anxiety


• cold sweats


• coma


• cool, pale skin


• depression


• increased hunger


• nightmares


• no heartbeat


• seizures


• shakiness


• slurred speech

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


• belching


• difficulty in sleeping


• heartburn


• indigestion


• lack or loss of strength


• pain in arms or legs


• stomach discomfort or upset

Less common

• Abnormal ejaculation


• bloated


• decreased sexual performance or desire


• disturbed color perception


• double vision


• excess air or gas in stomach or intestines


• full feeling


• halos around lights


• loss of appetite


• loss of vision


• mood changes


• night blindness


• overbright appearance of lights


• passing gas


• skin rash


• tunnel vision


• weight changes

Rare

• Crying


• depersonalization


• difficulty in moving


• dysphoria


• euphoria


• feeling of constant movement of self or surroundings


• hair loss, thinning of hair


• increased sensitivity of skin to sunlight


• itching skin


• lack of coordination


• mental depression


• muscle aching or cramping


• muscle pains or stiffness


• paranoia


• quick to react or overreact emotionally


• rapidly changing moods


• redness or other discoloration of skin


• 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.

See also: Betapace AF side effects (in more detail)

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More Betapace AF resources

• Betapace AF Side Effects (in more detail)
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• Drug Images
• Betapace AF Drug Interactions
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