Tambocor

DRUG DESCRIPTION

TAMBOCOR™ (flecainide acetate) is an antiarrhythmic drug available in tablets of 50, 100, or 150 mg for oral administration. Flecainide acetate is benzamide, N-(2-piperidinylmethyl)-2,5-bis (2,2,2-trifluoroethoxy)-monoacetate. The structural formula is given below.

 TAMBOCOR (flecainide acetate) Structural Formula Illustration

Flecainide acetate is a white crystalline substance with a pKa of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C. TAMBOCOR (flecainide) tablets also contain: croscarmellose sodium, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose and starch.

What are the possible side effects of flecainide (Tambocor)?

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:

  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
  • dizziness, fainting, fast or pounding heartbeat;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • low potassium (confusion, uneven heart rate,...

Read All Potential Side Effects and See Pictures of Tambocor »

What are the precautions when taking flecainide (Tambocor)?

Before taking flecainide, 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 problems, other heart problems (such as previous heart attack, heart pacemaker).

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.

Flecainide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result...

Read All Potential Precautions of Tambocor »


Tambocor Consumer (continued)

SIDE EFFECTS: See also Warning section.

Dizziness, vision problems (such as blurred vision, problems focusing, seeing spots), shortness of breath, headache, nausea, shaking, tiredness, or weakness 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: new or worsening symptoms of heart failure (such as ankle/leg swelling, increased tiredness, increased shortness of breath when lying down).

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

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 flecainide, 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 problems, other heart problems (such as previous heart attack, heart pacemaker).

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.

Flecainide 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 flecainide, 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 flecainide safely.

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

This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Tambocor Patient Information Including Side Effects

Brand Names: Tambocor

Generic Name: flecainide (Pronunciation: FLEK a nide)

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

What is flecainide (Tambocor)?

Flecainide is in a group of drugs called Class IC anti-arrhythmics. It affects the way your heart beats.

Flecainide is used in certain situations to prevent serious heart rhythm disorders.

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

What are the possible side effects of flecainide (Tambocor)?

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:

  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
  • dizziness, fainting, fast or pounding heartbeat;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
  • pale skin, easy bruising or bleeding, unusual weakness; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • dizziness;
  • tremor or shaking;
  • headache;
  • anxiety or depression;
  • vision problems;
  • nausea, vomiting, stomach pain;
  • diarrhea, constipation; or
  • numbness or tingling.

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 flecainide (Tambocor)?

You should not use this medication if you are allergic to flecainide, or if you have certain heart conditions, especially "AV block" (unless you have a pacemaker).

Before using flecainide, tell your doctor if you have congestive heart failure, a heart condition called "sick sinus syndrome," an electrolyte imbalance, liver disease, kidney disease, if you have a pacemaker, or if you have had a heart attack within the past 2 years.

You will need to receive your first few doses of flecainide in a hospital setting in case the medication causes serious side effects. Your heart rate will be constantly monitored using an electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart.

Call your doctor at once if you have a serious side effect such as weak pulse, slow breathing, fast or uneven heartbeat, feeling like you might pass out, feeling short of breath, swelling, rapid weight gain, confusion, extreme thirst, increased urination, muscle weakness, or jaundice (yellowing of the skin or eyes).

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