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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Sotalol
Generic Name
Sotalol Hydrochloride
Active Ingredient
SotalolCategory
Other
Salt Form
Hydrochloride
Variants
7
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 120 mg/1 | TABLET | ORAL | 72162-2522 |
| 120 mg/1 | TABLET | ORAL | 76385-115 |
| 80 mg/1 | TABLET | ORAL | 71335-1189 |
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Sotalol, you must consult a qualified healthcare professional.
| 160 mg/1 | TABLET | ORAL | 72162-2523 |
| 80 mg/1 | TABLET | ORAL | 76385-114 |
| 80 mg/1 | TABLET | ORAL | 72162-2524 |
| 160 mg/1 | TABLET | ORAL | 76385-116 |
Detailed information about Sotalol
Sotalol is a unique antiarrhythmic medication with both Class II (beta-adrenoceptor blocking) and Class III (cardiac action potential duration prolongation) properties, primarily used to manage life-threatening ventricular arrhythmias and maintain sinus rhythm in patients with atrial fibrillation.
Dosage for Sotalol is highly individualized based on the patient's renal function and the specific arrhythmia being treated.
Sotalol is approved for use in children for certain arrhythmias. Dosing in pediatrics is strictly based on Body Surface Area (BSA) and age. For children aged 2 years or older, the dose is generally calculated to be equivalent to the adult dose adjusted for BSA. For infants under 2 years of age, the dosage must be further reduced because the renal clearance mechanisms in infants are not fully developed. Pediatric treatment must only be managed by a pediatric cardiologist.
Because Sotalol is cleared entirely by the kidneys, dosage adjustments are mandatory for patients with decreased renal function.
Since Sotalol is not metabolized by the liver, no dosage adjustment is typically required for patients with liver disease. However, overall clinical status should still be monitored.
Older adults are more likely to have reduced renal function. Healthcare providers will typically perform a creatinine clearance test before starting Sotalol and monitor kidney function regularly to prevent drug accumulation and toxicity.
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and return to your regular schedule. Never double the dose to catch up, as this significantly increases the risk of a dangerous heart rhythm abnormality (Torsades de Pointes).
Signs of Sotalol overdose include extreme bradycardia (very slow heart rate), congestive heart failure, hypotension (very low blood pressure), bronchospasm (wheezing), and hypoglycemia (low blood sugar). In severe cases, it can lead to prolonged QT intervals and life-threatening ventricular tachyarrhythmias.
Emergency Measures: If an overdose is suspected, seek emergency medical attention immediately. Treatment usually involves gastric lavage, administration of activated charcoal, and intensive supportive care, including the use of a pacemaker or intravenous medications like isoproterenol or dopamine to support heart rate and blood pressure.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking Sotalol without medical guidance, as abrupt discontinuation can lead to severe heart complications.
Most patients taking Sotalol will experience some mild to moderate side effects as their body adjusts to the medication. Common side effects include:
Sotalol is a high-alert medication that requires strict adherence to safety protocols. Patients must be aware that Sotalol is not a 'start and forget' medication; it requires active participation in monitoring and reporting symptoms to a cardiology team.
The FDA has issued a Black Box Warning for Sotalol (Betapace and Betapace AF). The primary warning states that Sotalol can cause life-threatening ventricular arrhythmias, specifically Torsades de Pointes (TdP). To reduce this risk, patients must be placed in a facility for at least three days that provides continuous electrocardiographic (EKG) monitoring and has specialized staff available to perform cardiac resuscitation. This applies to both the initiation of the drug and any subsequent dose increases. Furthermore, Sotalol must not be substituted for Sotalol AF (and vice-versa) without consulting the specific prescribing information for each, as they have different labeling requirements.
Certain drugs must never be used with Sotalol because the risk of a fatal interaction is too high.
There are several conditions where Sotalol must NEVER be used because the risks far outweigh any potential benefit:
Sotalol is classified as FDA Pregnancy Category B (under the old system). Animal studies have not shown evidence of harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Sotalol does cross the placenta and can be found in amniotic fluid.
Sotalol is excreted in human milk in high concentrations. Studies have shown that the amount of Sotalol in breast milk can be 3 to 5 times higher than the amount in the mother's blood.
Sotalol is a unique 'hybrid' antiarrhythmic. It is a non-selective beta-adrenergic receptor antagonist (Class II) and a potassium channel blocker (Class III).
Common questions about Sotalol
Sotalol is primarily used to treat and prevent serious, life-threatening heart rhythm disorders. It is FDA-approved for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, and for the maintenance of normal sinus rhythm in patients with atrial fibrillation or atrial flutter. Because it has both beta-blocking and potassium-channel-blocking properties, it helps stabilize the heart's electrical activity. It is usually reserved for patients whose symptoms are severe or whose arrhythmias are life-threatening. Your cardiologist will determine if Sotalol is appropriate based on the specific type of irregular heartbeat you have.
The most common side effects of Sotalol include fatigue, slow heart rate (bradycardia), dizziness, and shortness of breath. Many patients also report headaches, a general feeling of weakness, or lightheadedness when standing up. These symptoms occur because the medication slows down the heart and reduces the effects of adrenaline on the body. While many of these side effects are mild and may improve over time, a very slow heart rate can sometimes lead to fainting. It is important to monitor your pulse and report any significant changes or extreme tiredness to your healthcare provider.
Drinking alcohol while taking Sotalol is generally discouraged or should be done with extreme caution. Alcohol can enhance the blood-pressure-lowering effects of Sotalol, which may lead to severe dizziness, lightheadedness, or fainting. Additionally, alcohol is a known 'trigger' for atrial fibrillation in many people, which can counteract the benefits of the medication. Excessive alcohol consumption can also lead to dehydration and electrolyte imbalances, such as low potassium, which significantly increases the risk of dangerous heart rhythm side effects from Sotalol. Always consult your doctor before consuming alcohol while on this medication.
Sotalol is considered a Category B medication, meaning animal studies haven't shown harm, but there isn't enough data in humans to guarantee safety. The drug does cross the placenta and can reach the developing fetus, potentially causing the baby to have a slow heart rate or low blood sugar after birth. Sotalol is also found in high concentrations in breast milk, which could affect a nursing infant. Therefore, it is only prescribed during pregnancy or breastfeeding if the benefit to the mother's heart health clearly outweighs the risks to the baby. If you are pregnant or planning to become pregnant, you must discuss alternative treatments with your cardiologist.
Sotalol begins to have a beta-blocking effect (slowing the heart rate) within about 1 to 2 hours after the first dose. However, its full antiarrhythmic effect—the ability to keep the heart in a stable, normal rhythm—usually takes about 2 to 3 days of consistent dosing. This is because it takes several doses for the medication to reach a 'steady state' concentration in your bloodstream. For this reason, doctors usually require patients to stay in the hospital for the first three days of treatment to monitor the heart's response as the drug levels build up. Do not expect an immediate complete resolution of rhythm issues on day one.
No, you should never stop taking Sotalol suddenly. Abruptly discontinuing any beta-blocker can cause a dangerous 'rebound' effect where your heart rate and blood pressure spike rapidly. This can lead to severe chest pain (angina), a heart attack, or new, dangerous heart arrhythmias. If your doctor decides you should no longer take Sotalol, they will provide a specific schedule to gradually taper your dose over one to two weeks. This allows your heart to slowly readjust to the absence of the medication. Always follow your doctor’s specific instructions for stopping the drug.
If you miss a dose of Sotalol, take it as soon as you remember. However, if it is almost time for your next scheduled dose (usually within a few hours), you should skip the missed dose and simply take the next one at the regular time. You should never take two doses at once to make up for a missed one. Taking a double dose significantly increases the risk of toxicity and dangerous heart rhythm abnormalities like Torsades de Pointes. If you miss more than one dose, contact your healthcare provider for specific instructions on how to restart your schedule safely.
Weight gain is not a common direct side effect of Sotalol, but it can occur indirectly. Like other beta-blockers, Sotalol can cause fatigue and decreased exercise tolerance, which might lead to a less active lifestyle and subsequent weight gain. However, a more serious concern is sudden weight gain (e.g., 3 pounds in a day or 5 pounds in a week), which can be a sign of worsening heart failure or fluid retention. If you notice rapid weight gain accompanied by swelling in your ankles or shortness of breath, you should contact your doctor immediately, as this requires urgent medical evaluation.
Sotalol has many significant drug interactions, so it must be used cautiously with other medications. It should not be taken with other drugs that prolong the QT interval, such as certain antibiotics (erythromycin), antipsychotics, or other antiarrhythmics. It also interacts with blood pressure medications like Digoxin, Verapamil, and Diltiazem, which can dangerously slow the heart rate. Even over-the-counter antacids can interfere with how Sotalol is absorbed. It is vital to provide your doctor and pharmacist with a complete list of all prescriptions, over-the-counter drugs, and herbal supplements you are taking to avoid dangerous interactions.
Yes, Sotalol is widely available as a generic medication in several tablet strengths (80 mg, 120 mg, 160 mg, and 240 mg). Generic versions are typically much more affordable than the brand-name versions like Betapace or Betapace AF. However, it is important to note that even when using the generic, the specific labeling for 'AF' (atrial fibrillation) vs. 'non-AF' use still applies. Your pharmacist will ensure you receive the correct generic version that corresponds to your doctor's prescription. Generic Sotalol is required by the FDA to have the same active ingredient and effectiveness as the brand-name drug.
Other drugs with the same active ingredient (Sotalol)
> Warning: Stop taking Sotalol and call your doctor immediately or seek emergency care if you experience any of these symptoms.
Prolonged use of Sotalol may lead to a persistent decrease in exercise tolerance due to the chronic blockade of beta-receptors. Additionally, like other beta-blockers, Sotalol may mask the symptoms of hyperthyroidism (overactive thyroid) or hypoglycemia (low blood sugar in diabetics). Long-term monitoring of renal function is essential, as any decline in kidney health over the years will increase the concentration of Sotalol in the blood, raising the risk of toxicity.
Sotalol carries a prominent FDA Black Box Warning regarding the risk of proarrhythmia.
Report any unusual symptoms, especially fainting or severe dizziness, to your healthcare provider immediately.
While taking Sotalol, you will need regular medical tests:
Sotalol can cause dizziness, fatigue, and blurred vision, especially during the first few weeks of treatment or after a dose increase. Do not drive or operate heavy machinery until you know how this medication affects you.
Alcohol should be used with extreme caution. Alcohol can increase the blood-pressure-lowering effects of Sotalol, leading to severe dizziness or fainting. Furthermore, excessive alcohol use can trigger atrial fibrillation, the very condition Sotalol is meant to prevent.
Do not stop taking Sotalol suddenly. Abruptly stopping a beta-blocker can cause a 'rebound' effect, leading to severe chest pain (angina), heart attack (myocardial infarction), or dangerous spikes in blood pressure. If the drug must be stopped, your doctor will provide a tapering schedule to slowly decrease the dose over 1 to 2 weeks.
> Important: Discuss all your medical conditions, especially kidney disease and lung problems, with your healthcare provider before starting Sotalol.
Sotalol may interfere with certain lab tests. It can cause a false-positive result for urinary catecholamines when using certain testing methods (photometric methods). If you are being tested for an adrenal gland tumor (pheochromocytoma), ensure the lab knows you are taking Sotalol.
For each major interaction, the mechanism is usually pharmacodynamic (the drugs have additive effects on the heart's electrical system) rather than pharmacokinetic (interference with metabolism). The clinical consequence is typically an increased risk of heart failure, bradycardia, or sudden cardiac death.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter cold medicines which may contain stimulants.
These conditions require a careful risk-benefit analysis by a cardiologist:
Patients who have had a severe allergic reaction (anaphylaxis) to other beta-blockers (like Atenolol or Propranolol) should use Sotalol with extreme caution, although cross-reactivity is not always guaranteed. There is no known cross-sensitivity between Sotalol and sulfonamides, despite the structural similarity.
> Important: Your healthcare provider will evaluate your complete medical history, including EKG results and kidney function tests, before prescribing Sotalol.
Sotalol is approved for use in children from birth through adolescence for the treatment of supraventricular and ventricular arrhythmias.
Elderly patients (over age 65) are at the highest risk for side effects from Sotalol.
Renal impairment is the single most important factor in Sotalol toxicity.
Because Sotalol is not metabolized by the liver, patients with liver cirrhosis or hepatitis generally do not require dose adjustments. However, these patients often have complex fluid and electrolyte balances that must be monitored to prevent secondary cardiac issues.
> Important: Special populations require individualized medical assessment and frequent monitoring of heart rhythm and kidney function.
| Parameter | Value |
|---|---|
| Bioavailability | 90% - 100% |
| Protein Binding | 0% |
| Half-life | 12 hours (increases with renal impairment) |
| Tmax (Time to Peak) | 2.5 - 4 hours |
| Metabolism | None (Not metabolized by liver) |
| Excretion | Renal (90-100% unchanged in urine) |
Sotalol is classified as a Class II/III antiarrhythmic. While it shares the '-olol' suffix with beta-blockers, its Class III properties make it pharmacologically distinct from drugs like Metoprolol or Atenolol. It is more closely related in function (though not structure) to drugs like Amiodarone or Dofetilide.