Sotalol (Betapace Af) Risks, Warnings, and Complications
| Sotalol can cause or worsen health problems in some people. Talk with your doctor about other treatment options for an irregular heartbeat if you are at a high risk of complications from this medication. Some of the risks of sotalol use include: QT PROLONGATION AND PROARRHYTHMIA: Sotalol can be used to treat an abnormal heartbeat but can also cause serious life-threatening ventricular arrhythmias such as sustained ventricular tachycardia and ventricular fibrillation, Torsade de Pointes, and tachycardia associated with QT interval prolongation. These are called proarrhythmias, which are new arrhythmias or aggravation of pre-existing arrhythmias at doses of drugs that are not typically toxic. Risk factors include decreased creatinine clearance, female gender, higher doses of sotalol, slow heartbeat, and a history of sustained VT/VF or heart failure. Your doctor will adjust your sotalol dose based on your kidney function. They will also monitor ECG for increases in the QT interval. Sotalol is not prescribed to people with a QT interval of more than 450 msec. In addition, your doctor will check for and correct hypokalemia (low potassium) and hypomagnesemia (low magnesium) before starting sotalol because these electrolyte imbalances can worsen QT prolongation and increase the risk of Torsade de Pointes. Tell your doctor if you develop severe or prolonged diarrhea while on sotalol, which can affect electrolyte levels. Also, tell your healthcare provider if you take concomitant diuretic drugs (water pills). Give your doctor a complete list of your medications. The use of sotalol is not recommended with other drugs that can also cause QT prolongation. BRADYCARDIA, HEART BLOCK, SICK SINUS SYNDROME: Sinus bradycardia (slow heartbeat with a rate of less than 50 beats per minute) can occur in patients receiving sotalol. Bradycardia is a risk factor for serious complications such as Torsade de Pointes, which is a type of ventricular tachycardia. Other potential symptoms of beta-blockade, such as sinus pause, sinus arrest, and sinus node dysfunction occur in some patients, as do second or third-degree AV block. Your doctor will not prescribe sotalol to you if you have a history of sick sinus syndrome and are at a high risk of heart rhythm complications. HYPOTENSION: Sotalol, like other beta blockers, can lead to a decrease in both systolic and diastolic blood pressure, resulting in hypotension (low blood pressure). Your healthcare provider will monitor your blood pressure regularly. Tell your doctor if you have low blood pressure on checking at home or signs and symptoms such as lightheadedness, dizziness, or fainting. HEART FAILURE: People receiving sotalol can develop new or worsening heart failure because of its beta-blocking effects. Your health care provider will monitor you for signs and symptoms of heart failure such as swelling of the legs and feet and sudden weight gain. You may need to discontinue sotalol if this complication develops. CARDIAC ISCHEMIA WITH SUDDEN DISCONTINUATION: Suddenly stopping sotalol can lead to cardiac ischemia (reduced blood supply to the heart), causing angina pectoris (chest pain) or myocardial infarction (heart attack). If you are stopping sotalol therapy, your doctor will tell you how to gradually reduce the dose over 1-2 weeks. You will need to avoid strenuous physical activity during this time. If you develop new or worsening chest pain, you may need to take an alternative beta blocker. BRONCHOSPASM: People with bronchospastic diseases such as chronic bronchitis and emphysema should not take beta blockers. If such patients with lung conditions need to be on sotalol, their doctor will prescribe the smallest effective dose to lower the risk of bronchospasm (tightening of the airways). EFFECTS ON BLOOD GLUCOSE: Beta-blockers, including sotalol, can mask the early warning signs of hypoglycemia (low blood sugar), such as fast heart rate. This can increase the risk of severe or prolonged hypoglycemia, especially in people with diabetes mellitus and those who are not eating regularly, vomiting, or have upcoming surgery. You should know how to recognize hypoglycemia and what to do if it occurs. You may need to seek emergency treatment for low blood sugar. In addition, elevated blood glucose levels and increased insulin requirements may occur in people with diabetes. THYROID ABNORMALITIES: Sudden discontinuation of beta-blockade in people with thyroid disease can lead to worsening symptoms of hyperthyroidism (overactive thyroid gland), including thyroid storm. The use of beta-blockers can mask some of the clinical signs of hyperthyroidism, such as tachycardia (fast heart rate). SEVERE ALLERGIC REACTIONS: People with a history of anaphylactic reaction (severe allergic reaction) to drugs, foods, and other allergens may have a more severe reaction while they are on beta-blockers. Such individuals may not respond to the usual doses of epinephrine to treat allergic reactions. MAJOR SURGERY: Long-term treatment with beta-blockers does not usually need to be stopped before major surgery. However, beta blockers can affect the ability of the heart to respond to certain stimuli and increase the risks associated with general anesthesia. Tell your doctors you are taking sotalol for an abnormal heartbeat before any surgical procedure.
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Precautions Before Starting Sotalol (Betapace Af)
Tell your doctor if you have ever had allergic reactions to sotalol, any of the active or inactive ingredients in sotalol formulations, other antiarrhythmic drugs, or any other medications. Your pharmacy can give you a list of ingredients.
Give your doctor and pharmacist a complete list of all your medications, including prescription drugs, over-the-counter medicines, dietary supplements, and herbal products. This can help prevent possible interactions between sotalol and your other medicines.
Give your doctor a complete medical history. Sotalol may not be safe for people with certain medical conditions, such as lung disease, heart disease (coronary artery disease, congestive heart failure), diabetes, low potassium, low magnesium, hyperthyroidism (overactive thyroid), or serious allergic reactions in the past.
Tell your doctor if you are pregnant, could be pregnant, are planning a pregnancy, or are breastfeeding.
Precautions During Use of Sotalol (Betapace Af)
Keep all your medical and laboratory appointments during treatment with sotalol. Your doctor may want to adjust your dose, order certain laboratory tests, and monitor your heart rhythm.
Take aluminum- and magnesium-containing medicines such as antacids (Mylanta, Maalox) at least two hours away from your sotalol dose.
Sotalol can cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how this medicine affects you.
Treatment with sotalol for an abnormal heart rhythm can mask symptoms such as fast heartbeat which are signs of health complications such as hypoglycemia (low blood sugar) or hyperthyroidism (overactive thyroid). You should know how to recognize hypoglycemia (hunger, shakiness, sweating, confusion, dizziness) and seek medical care if you develop low blood glucose. Tell your doctor if you are not eating or drinking normally or have vomiting while on sotalol.
If you have a history of serious allergic reactions and carry epinephrine, you should know that you may not respond to the usual doses of epinephrine while on treatment with sotalol.
Tell all your healthcare professionals you are taking sotalol, especially before surgical procedures, including dental treatment.
Tell your doctor if you become pregnant while on this medicine.
Sotalol (Betapace Af) Drug Interactions
Taking sotalol with certain other drugs can affect how it works. Possible drug interactions between sotalol and your other medications can increase the risk of potentially serious adverse reactions. Your doctor may change the dose of your medications, switch you to a different medication, and/or monitor you carefully for serious side effects if there are known interactions between sotalol and your other medicines. Sotalol can have interactions with the following medications:
- Calcium channel blockers such as bepridil
- Anti-ulcer drugs such as cisapride
- Other antiarrhythmics such as dronedarone and vernakalant
- Medications prescribed for multiple sclerosis, such as fingolimod
- Certain antibiotics such as grepafloxacin and sparfloxacin
- Cortisol synthesis inhibitors such as levoketoconazole
- Medications used to manage opiate dependence, such as levomethadyl
- Antipsychotic medications such as mesoridazine, thioridazine, pimozide, and ziprasidone
- Antimalarials such as piperaquine
- HIV medications such as saquinavir
- Antihistamines such as terfenadine
The above list may not include all the possible interactions of sotalol. Give your doctor or pharmacist a complete list of your medications, including prescription drugs, over-the-counter medicines, dietary supplements, and herbal remedies. Also, tell your healthcare provider if you smoke, drink alcohol, or use recreational drugs because some of these substances can cause serious health complications when used with prescription and over-the-counter medicines.
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