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Drugs reference index «Tambocor»

Tambocor

Generic Name: flecainide (Oral route)

FLEK-a-nide

Oral routeTablet

Flecainide acetate was included in the National Heart Lung and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicenter, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than six days but less than two years previously. An excessive mortality or non-fatal cardiac arrest rate was seen in patients treated with flecainide acetate compared with that seen in patients assigned to a carefully matched placebo-treated group. This rate was 16/315 (5.1%) for flecainide acetate and 7/309 (2.3%) for the matched placebo. The average duration of treatment with flecainide acetate in this study was ten months.

The applicability of the CAST results to other populations (eg, those without recent myocardial infarction) is uncertain, but at present, it is prudent to consider the risks of Class IC agents (including flecainide acetate), coupled with the lack of any evidence of improved survival, generally unacceptable in patients without life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs.

A review of the world literature revealed reports of 568 patients treated with oral flecainide acetate for paroxysmal atrial fibrillation/flutter (PAF). Ventricular tachycardia was experienced in 0.4% (2/568) of these patients. Of 19 patients in the literature with chronic atrial fibrillation (CAF), 10.5% (2) experienced VT or VF. Flecainide is not recommended for use in patients with chronic atrial fibrillation. Case reports of ventricular proarrhythmic effects in patients treated with flecainide for atrial fibrillation/flutter have included increased PVCs, VT, ventricular fibrillation (VF), and death.

As with other Class I agents, patients treated with flecainide acetate for atrial flutter have been reported with 1:1 atrioventricular conduction due to slowing the atrial rate. A paradoxical increase in the ventricular rate also may occur in patients with atrial fibrillation who receive flecainide acetate. Concomitant negative chronotropic therapy such as digoxin or beta-blockers may lower the risk of this complication .

An excessive mortality or non-fatal cardiac arrest rate was seen in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction treated with flecainide compared with that seen in patients assigned to a carefully matched placebo-treated group in the Cardiac Arrhythmia Suppression Trial (CAST). It is prudent to consider the risks of Class IC agents (including flecainide), coupled with the lack of any evidence of improved survival, generally unacceptable in patients without life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs. Flecainide is not recommended for use in patients with chronic atrial fibrillation. Case reports of ventricular proarrhythmic effects in patients treated with flecainide for atrial fibrillation/flutter have included increased PVCs, VT, ventricular fibrillation (VF), and death .

Commonly used brand name(s):

In the U.S.

  • Tambocor

Available Dosage Forms:

  • Capsule, Extended Release
  • Tablet

Therapeutic Class: Antiarrhythmic, Group IC

Chemical Class: Amino Amide

Uses For Tambocor

Flecainide belongs to the group of medicines known as antiarrhythmics. It is used to correct irregular heartbeats to a normal rhythm.

Flecainide produces its helpful effects by slowing nerve impulses in the heart and making the heart tissue less sensitive.

There is a chance that flecainide may cause new or make worse existing heart rhythm problems when it is used. Since it has been shown to cause severe problems in some patients, it is only used to treat serious heart rhythm problems. Discuss this possible effect with your doctor.

This medicine is available only with your doctor's prescription.

Before Using Tambocor

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of flecainide in children with use in other age groups.

Geriatric

Elderly people are especially sensitive to the effects of flecainide. Flecainide may be more likely to cause irregular heartbeat in the elderly.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Bepridil
  • Cisapride
  • Levomethadyl
  • Mesoridazine
  • Pimozide
  • Ritonavir
  • Saquinavir
  • Terfenadine
  • Thioridazine
  • Tipranavir
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acecainide
  • Ajmaline
  • Alatrofloxacin
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amoxapine
  • Aprindine
  • Arbutamine
  • Arsenic Trioxide
  • Astemizole
  • Azimilide
  • Balofloxacin
  • Bendroflumethiazide
  • Bretylium
  • Chloral Hydrate
  • Chloroquine
  • Chlorothiazide
  • Chlorpromazine
  • Chlorthalidone
  • Ciprofloxacin
  • Clarithromycin
  • Clinafloxacin
  • Darifenacin
  • Darunavir
  • Delavirdine
  • Desipramine
  • Dibenzepin
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Droperidol
  • Duloxetine
  • Enflurane
  • Enoxacin
  • Erythromycin
  • Etravirine
  • Flecainide
  • Fleroxacin
  • Fluconazole
  • Flumequine
  • Fluoxetine
  • Foscarnet
  • Gatifloxacin
  • Gemifloxacin
  • Grepafloxacin
  • Halofantrine
  • Haloperidol
  • Halothane
  • Hydrochlorothiazide
  • Hydroflumethiazide
  • Hydroquinidine
  • Ibutilide
  • Imipramine
  • Isoflurane
  • Isradipine
  • Levofloxacin
  • Lidocaine
  • Lidoflazine
  • Lomefloxacin
  • Lorcainide
  • Lumefantrine
  • Mefloquine
  • Metolazone
  • Moxifloxacin
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Pazopanib
  • Pefloxacin
  • Pentamidine
  • Pirmenol
  • Polythiazide
  • Prajmaline
  • Prilocaine
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Propafenone
  • Protriptyline
  • Prulifloxacin
  • Quetiapine
  • Quinidine
  • Risperidone
  • Rufloxacin
  • Sematilide
  • Sertindole
  • Sertraline
  • Sotalol
  • Sparfloxacin
  • Spiramycin
  • Sulfamethoxazole
  • Sultopride
  • Tedisamil
  • Telithromycin
  • Temafloxacin
  • Tosufloxacin
  • Trichlormethiazide
  • Trifluoperazine
  • Trimethoprim
  • Trimipramine
  • Vasopressin
  • Zolmitriptan
  • Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amiodarone
  • Bupropion
  • Cimetidine
  • Clozapine
  • Digoxin
  • Paroxetine
  • Propranolol
  • Protriptyline
  • Verapamil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Congestive heart failure—Flecainide may make this condition worse
  • Kidney disease or
  • Liver disease—Effects of flecainide may be increased because of slower removal from the body
  • Recent heart attack—Risk of irregular heartbeats may be increased
  • If you have a pacemaker—Flecainide may interfere with the pacemaker and require more careful follow-up by the doctor

Proper Use of Tambocor

Take flecainide exactly as directed by your doctor, even though you may feel well. Do not take more medicine than ordered.

This medicine works best when there is a constant amount in the blood. To help keep this amount constant, do not miss any doses. Also, it is best to take the doses 12 hours apart, in the morning and at night , unless otherwise directed by your doctor. If you need help in planning the best times to take your medicine, check with your health care professional.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For correcting irregular heartbeat:
      • Adults—50 to 150 milligrams (mg) every twelve hours.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Tambocor

It is important that your doctor check your progress at regular visits to make sure the medicine is working properly. This will allow for changes to be made in the amount of medicine you are taking, if necessary.

Your doctor may want you to carry a medical identification card or bracelet stating that you are using this medicine.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Flecainide may cause some people to become dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

If you have been using this medicine regularly for several weeks, do not suddenly stop using it. Check with your doctor for the best way to reduce gradually the amount you are taking before stopping completely.

Tambocor Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Less common
  • Chest pain
  • irregular heartbeat
  • shortness of breath
  • swelling of feet or lower legs
  • trembling or shaking
Rare
  • Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Blurred vision or seeing spots
  • dizziness or lightheadedness
Less common
  • Anxiety or mental depression
  • constipation
  • headache
  • nausea or vomiting
  • skin rash
  • stomach pain or loss of appetite
  • unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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  • Tambocor Prescribing Information (FDA)
  • Tambocor MedFacts Consumer Leaflet (Wolters Kluwer)
  • Tambocor Detailed Consumer Information (PDR)
  • Tambocor Concise Consumer Information (Cerner Multum)
  • Flecainide Prescribing Information (FDA)