SOTALOL

COMMON BRAND NAME(S): Betapace, Betapace AF

GENERIC NAME(S): SOTALOL HCL

 

Description: Sotalol is a non-cardioselective β-blocker, and antiarrhythmic. It helps the heart beat regularly for a longer period of time.

Onset: 1-2 hr (oral); approx 5-10 min (IV).

Duration: 8-16 hr.

Pharmacokinetics:

Absorption: Almost completely absorbed from the GI tract. Absorption may decrease by 20-30% w/ food. Bioavailability: 90-100% (oral). Time to peak plasma concentration: Approx 2-4 hr.

Distribution: Crosses placenta and blood brain barrier (small amounts); enters breast milk and CSF (small amounts). Plasma protein binding: Low.

Metabolism: Minimal metabolism.

Excretion: Via urine (as unchanged drug). Elimination half-life: 10-20 hr.

Indications:

This medication is used to treat a serious (possibly life-threatening) type of fast heartbeat called sustained ventricular tachycardia. It is also used to treat certain fast/irregular heartbeats (atrial fibrillation/flutter) in patients with severe symptoms such as weakness and shortness of breath.

Contraindications:

Should not be given to patients with bronchial asthma, sinus bradycardia, second and third degree AV block, congenital or acquired long QT syndromes, cardiogenic shock, uncontrolled congestive heart failure, and previous evidence of hypersensitivity to Sotalol.

How to use sotalol

See also Warning section.

  • Take this medication by mouth as directed by your doctor, usually once or twice a day. You may take it with or without food, but it is important to choose one way and take it the same way with each dose.
  • If you use antacids containing aluminum or magnesium, do not take them at the same time as sotalol, as these may decrease its absorption and effectiveness. Separate doses of these antacids and sotalol by at least 2 hours to reduce this interaction.
  • Do not take more of this drug than prescribed because you may increase your risk of side effects, including a new serious abnormal heartbeat.
  • Do not take less of this medication or skip doses unless directed by your doctor.
  • Your fast/irregular heartbeat is more likely to return if you do not take sotalol properly. Also, do not run out of this medication. Order your refills several days early to avoid running out of pills.

Availability:  This is a prescription only drug.

QT prolongation: Although sotalol is effective for treating certain types of fast/irregular heartbeats, it can cause a new serious abnormal heart rhythm (QT prolongation in the EKG). This problem can lead to an abnormal heartbeat, known as torsade de pointes. If this new serious heart rhythm occurs, it is usually when sotalol treatment is first started or when the dose is increased. Therefore, to reduce the risk of this side effect, you should begin sotalol treatment in a hospital so your doctor can monitor your heart rhythm for several days and treat the problems if they occur.

Congestive heart failure (CHF): There are findings that may increase the risk of developing new or worsening the already present CHF.

Do not stop taking this medication without consulting your doctor. If your doctor decides you should no longer use this drug, he or she may direct you to gradually decrease your dose over 1 to 2 weeks.

When gradually stopping this medication, it is recommended that you temporarily limit physical activity to decrease strain on the heart. Seek immediate medical attention if you develop: chest pain/tightness/pressure, chest pain spreading to the jaw/neck/arm, unusual sweating, trouble breathing, fast/irregular heartbeat.

See also Warning section.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Common side effects:

  • Tiredness,
  • slow heartbeat, and
  • dizziness (get up slowly when rising from a sitting or lying position)

 Less common side effects include:

  • headache,
  • diarrhea, and
  • decreased sexual ability

Tell your doctor immediately if any of these unlikely but serious side effects occur: new or worsening symptoms of heart failure (such as swelling ankles/feet, severe tiredness, shortness of breath, unexplained/sudden weight gain).

Seek immediate medical attention if any of these unlikely but serious side effects occur: severe dizziness, fainting, sudden change in heartbeat (unusually faster/slower/more irregular), chest/jaw/left arm pain.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions:

See also Warning section.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Older adults may be more sensitive to the side effects of this drug, especially dizziness, tiredness, and QT prolongation.

  • Allergy: Before taking sotalol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.
  • Medical Condition: Before using this medicine, consult your doctor or pharmacist if you have: certain heart rhythm problems (such as a slow heartbeat, second- or third-degree atrioventricular block unless you have a heart pacemaker), severe heart failure, breathing problems (such as asthma, chronic bronchitis, emphysema).
  • Medical history: Before using this medication, tell your doctor or pharmacist if you had: kidney problems, treated stable heart failure, very recent heart attack (within 2 weeks), other irregular heartbeat problems (such as sick sinus syndrome), overactive thyroid disease (hyperthyroidism), serious allergic reactions needing treatment with epinephrine.
  • QT prolongationg: Sotalol may cause a condition that affects the heart rhythm (QT prolongation in the EKG). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
  • Diabetes: If you have diabetes, this product may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). This product may also make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst/urination. Your diabetes medication or diet may need to be adjusted.

Pregnancy Risk: Category B- During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

Breastfeeding: This medication passes into breast milk and may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.

Interactions:

  • A product that may interact with this drug is: fingolimod.
  • Many drugs besides sotalol may affect the heart rhythm (QT prolongation in the EKG), including amiodarone, disopyramide, dofetilide, pimozide, procainamide, quinidine, macrolide antibiotics (such as clarithromycin, erythromycin), among others.

This medication may interfere with certain medical/laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose:

If overdose is suspected, contact a poison control center or emergency room immediately.

Symptoms of overdose may include:

  • severe dizziness,
  • fainting,
  • unusually slower/faster/more irregular heartbeat,
  • shortness of breath

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as EKG, kidney function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Brands:

There are no brands containing this molecule.

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