Betapace AF (Oral)
Generic Name: sotalol (Oral route)
To minimize the risk of induced arrhythmia, patients initiated or reinitiated on sotalol or converted from IV to oral therapy should be placed for a minimum of 3 days (on maintenance dose) in a facility that can provide continuous cardiac resuscitation and ECG monitoring. CrCl should be calculated prior to dosing . May cause life-threatening ventricular tachycardia associated with QT interval prolongation has been reported. Do not initiate sotalol therapy if the baseline QTc is longer than 450 milliseconds. If the QT interval prolongs to 500 milliseconds or greater, dose reduction, dosing interval prolongation, or therapy discontinuation is necessary. Adjust dosing interval based on CrCl .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 fibrillation or atrial flutter) in patients with symptomatic atrial fibrillation or atrial flutter 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 AF
Available Dosage Forms:
Therapeutic Class: Cardiovascular Agent
Pharmacologic Class: Beta-Adrenergic Blocker, Nonselective
Uses For Betapace AF
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 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:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sotalol oral solution 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.
|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.|
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.
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.
- Arsenic Trioxide
- Chloral Hydrate
- Ethacrynic Acid
- Perflutren Lipid Microsphere
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
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.
- Amtolmetin Guacil
- Choline Salicylate
- Flufenamic Acid
- Ibuprofen Lysine
- 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
- Mefenamic Acid
- Niflumic Acid
- Propionic Acid
- Salicylic Acid
- Sodium Salicylate
- St John's Wort
- Tiaprofenic Acid
- Tolfenamic Acid
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:
- 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 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.
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.
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.
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 forms (solution or tablets):
- For abnormal heart rhythms:
- Adults—At first, 80 milligrams (mg) one or two 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 abnormal heart rhythms:
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.
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. 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, 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. Do not stop taking this medicine before surgery without your doctor's approval.
This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis 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.
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
- 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
- swelling of the face, fingers, feet, or lower legs
- tightness in the chest
- unusual tiredness or weakness
- Abdominal or stomach pain or swelling
- 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
- extreme fatigue
- feeling of warmth or heat
- fever or chills
- flushing or redness of the skin, especially on the face and neck
- 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
- noisy breathing
- painful, burning, or difficult urination
- pounding in the ears
- slow speech
- weight gain
- Fast breathing
- pinpoint red spots on the skin
Get emergency help immediately if any of the following symptoms of overdose occur:Symptoms of overdose
- cold sweats
- cool, pale skin
- increased hunger
- 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
- difficulty with sleeping
- heartburn or indigestion
- pain in the arms or legs
- Changes in vision
- decreased sexual performance or desire
- loss of appetite
- mood changes
- night blindness
- passing gas
- skin rash
- weight changes
- Feeling of constant movement of self or surroundings
- hair loss or thinning of the hair
- itching skin
- muscle aching or cramping
- muscle 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.
See also: Side effects (in more detail)
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