August 1, 2014
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Apo-Sotalol

(sotalol)

DIN (Drug Identification Number)

02167794 APO-SOTALOL 160MG TABLET
02210428 APO-SOTALOL 80MG TABLET

What side effects are possible with Apo-Sotalol?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • anxiety
  • decreased sexual ability
  • diarrhea
  • difficulty sleeping
  • dizziness or lightheadedness
  • itching of skin
  • loss of appetite
  • nausea or vomiting
  • nervousness
  • numbness or tingling of fingers or toes
  • unusual tiredness or weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • back or joint pain
  • breathing difficulty or wheezing
  • depression
  • fainting
  • fever and sore throat
  • low blood pressure
  • shortness of breath
  • skin rash
  • slow heartbeat (especially less than 50 beats per minute)
  • swelling of ankles, feet, or lower legs
  • unusual bleeding or bruising
  • vision problems

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • chest pain
  • fast or irregular heartbeat
  • signs of a severe allergic reaction, e.g.:
    • hives
    • shortness of breath
    • swelling of the lips, tongue, or throat

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Apo-Sotalol?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Abnormal heart rhythm: Sotalol may cause a heart rhythm disturbance called QT prolongation. It can also worsen or trigger an irregular heart beat (arrhythmia). You doctor will monitor your heart rhythm regularly while you are taking this medication with a test called an electrocardiogram (ECG).

Congestive heart failure: If you have congestive heart failure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Diabetes: The signs of low blood sugar may not be as noticeable when taking sotalol. If you have diabetes and take insulin or other medications that work by reducing blood sugar levels, you should monitor blood sugar carefully while taking this medication. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Electrolyte levels: People with low potassium or magnesium levels should not use sotalol until these imbalances are corrected, as these conditions can create higher risk for abnormal heart rhythms with the use of this medication.

Hyperthyroidism (high level of thyroid hormones): Sotalol may reduce the symptoms of hyperthyroidism, giving a false impression of improvement. Stopping the medication suddenly could worsen hyperthyroidism. If you have hyperthyroidism, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: Sotalol passes from the body via the kidneys. If you have reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Lung problems: People with asthma and certain other lung problems (e.g., chronic bronchitis, emphysema) should not take sotalol.

Severe allergies: If you have allergies severe enough to cause anaphylaxis (a severe allergic reaction where swelling of the face, lips, and throat make it difficult to breathe), you should talk to your doctor about what to do if you have an allergic reaction. Sotalol may make it more difficult to treat your allergic reaction with epinephrine.

Stopping the medication: Stopping this medication suddenly can cause abnormal heart rhythms, chest pain (angina), and even heart attack. Do not suddenly stop taking this medication. Consult your doctor about how to safely stop taking this medication.

Surgery: If you are scheduled for surgery, inform all doctors involved in your care that you are taking sotalol.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking sotalol, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children and adolescents: The safety and effectiveness of using sotalol have not been established for children and adolescents under 18 years of age.

What other drugs could interact with Apo-Sotalol?

There may be an interaction between sotalol and any of the following:

  • aluminum salts (e.g., aluminum hydroxide, attapulgite, kaolin)
  • amiodarone
  • anti-arrythmics (e.g., disopyramide, flecainide, procainamide, quinidine)
  • antidiabetes medications (e.g., glyburide, insulin)
  • astemizole
  • beta-blockers (e.g., metoprolol, propranolol)
  • calcium channel blockers (e.g., diltiazem, verapamil)
  • clonidine
  • digoxin
  • diuretics (water pills) that cause potassium loss (e.g., hydrochlorothiazide)
  • erythromycin
  • guanethidine
  • lidocaine
  • lithium
  • phenothiazines (e.g., chlorpromazine, perphenazine)
  • prazosin
  • quinolone antibiotics (e.g., ciprofloxacin, levofloxacin)
  • reserpine
  • salbutamol
  • terbutaline
  • terfenadine
  • tricyclic antidepressants (e.g., amitriptyline, desipramine)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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