Tikosyn

DRUG DESCRIPTION

TIKOSYN® (dofetilide) is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C19H27N3O5S2 and it has a molecular weight of 441.6. The structural formula is

TIKOSYN® (dofetilide) Structural Formula Illustration

The chemical name for dofetilide is:

N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]- methanesulfonamide.

Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan-2-ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid.

TIKOSYN capsules contain the following inactive ingredients: microcrystalline cellulose, corn starch, colloidal silicon dioxide and magnesium stearate. TIKOSYN is supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules.

What are the possible side effects of dofetilide (Tikosyn)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fast or pounding heartbeat, chest pain, shortness of breath; or
  • feeling like you might pass out.

Less serious side effects may include:

  • headache or back pain;
  • dizziness;
  • nausea, diarrhea, stomach pain;
  • sleep problems...

Read All Potential Side Effects and See Pictures of Tikosyn »

What are the precautions when taking dofetilide (Tikosyn)?

Before taking dofetilide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver disease.

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.

Dofetilide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms...

Read All Potential Precautions of Tikosyn »


Tikosyn Consumer (continued)

SIDE EFFECTS: Headache, dizziness, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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.

Seek immediate medical attention if any of these rare but serious side effects occur: chest pain, fainting, faster/more irregular heartbeat, severe dizziness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

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

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking dofetilide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver disease.

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.

Dofetilide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using dofetilide, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using dofetilide safely.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Tikosyn Patient Information Including Side Effects

Brand Names: Tikosyn

Generic Name: dofetilide (Pronunciation: doe FET i lide)

  • What is dofetilide (Tikosyn)?
  • What are the possible side effects of dofetilide (Tikosyn)?
  • What is the most important information I should know about dofetilide (Tikosyn)?
  • What should I discuss with my health care provider before taking dofetilide (Tikosyn)?
  • How should I take dofetilide (Tikosyn)?
  • What happens if I miss a dose (Tikosyn)?
  • What happens if I overdose (Tikosyn)?
  • What should I avoid while taking dofetilide (Tikosyn)?
  • What other drugs will affect dofetilide (Tikosyn)?
  • Where can I get more information?

What is dofetilide (Tikosyn)?

Dofetilide is a heart rhythm medication, also called an antiarrhythmic.

Dofetilide is used to help keep the heart beating normally in people with certain heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart). Dofetilide is used in people with atrial fibrillation or atrial flutter.

Dofetilide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of dofetilide (Tikosyn)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fast or pounding heartbeat, chest pain, shortness of breath; or
  • feeling like you might pass out.

Less serious side effects may include:

  • headache or back pain;
  • dizziness;
  • nausea, diarrhea, stomach pain;
  • sleep problems (insomnia);
  • stuffy or runny nose, cough, sore throat; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about dofetilide (Tikosyn)?

You should not use this medication if you have severe kidney disease or a history of "Long QT syndrome."

There are many other medicines that can cause serious medical problems if you take them together with dofetilide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

You may need to spend at least 3 days in a hospital setting when you first start taking dofetilide. This is so your heart rhythm and kidney function can be monitored in case the medication causes serious side effects.

Tell your doctor if you have an illness that involves diarrhea or vomiting lasting more than a few hours. Prolonged diarrhea or vomiting can lower your potassium levels, making it dangerous for you to use dofetilide.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Your heart and kidney function will also need to be tested. Do not miss any scheduled visits to your doctor.

Dofetilide may be available only from a hospital or specialty pharmacy.

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