Flecainide Teva

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Flecainide Teva

Quick Facts

Property Description
Active ingredient Flecainide Acetate
Form Tablet (Oral preparation)
Pharmacological class Class Ic Antiarrhythmic Agent
Common use Management of abnormal heart rhythms
Origin Synthetic compound

What is Flecainide Teva and Its Composition?

Flecainide Teva is a prescription-only medicine provided as an oral tablet used for regulating the heart's electrical function. The therapeutic effectiveness of this medication rests entirely on the active ingredient, Flecainide Acetate, which is a synthetic compound. The specific brand formulation, Flecainide Teva, is an established generic alternative manufactured by Teva Pharmaceuticals, ensuring a consistent and controlled substance for therapeutic use.

The preparation is chemically defined by the purified Flecainide Acetate combined with necessary solid excipients to form the tablet matrix. The pharmacological efficacy of this compound has been clinically recognized for decades within cardiology, supporting its continuous role as an essential rhythm-stabilizing agent for managing electrical disturbances of the heart.

Flecainide's Pharmacological Class and General Purpose

The medication is formally classified as a Class Ic antiarrhythmic agent, which places it within the broader group of medicines used for managing abnormal heart rhythms, known as arrhythmias. The medication serves a specific role as a potent antiarrhythmic compound. This means the drug's core purpose is to help the heart maintain a coordinated and stable rhythm.

The drug operates by acting as a sodium channel blocker, slowing the conduction of electrical impulses through the heart muscle. This action results in conduction slowing. The overall therapeutic function is to stabilize the heart's electrical system, which is typically used for patients who require rhythm control to maintain a stable heart rate.

What side effects are possible with Flecainide Teva?

Possible side effects and safety information

Flecainide Acetate's safety profile is defined by governmental regulatory documents, which classify adverse reactions by frequency and affected body system.

Classification Details Based on Regulatory Documents
Frequency Categories Very Common (geq1/10): Dizziness (usually transient) and visual impairment. Common (geq1/100 to <1/10): Proarrhythmia, shortness of breath (dyspnoea), fatigue, and asthenia. Uncommon (geq1/1,000 to <1/100): Decreased blood cell count, nausea, vomiting, and rash. Reactions with a Frequency Not Known include cardiac arrest and pulmonary fibrosis.
Serious Adverse Reactions The label highlights the risk of proarrhythmia (new or worsened heart rhythm problems) and the risk of death or nonfatal cardiac arrest in patients treated for non-life-threatening ventricular arrhythmias following myocardial infarction. The drug may also cause or worsen cardiac failure or precipitate severe conduction blocks.
System-Organ Classes Adverse events are documented across various systems, most notably the Cardiac Disorders (e.g., AV block, cardiac failure) and Nervous System Disorders (e.g., headache, syncope, paresthesia). Other systems include Gastrointestinal, Hepatobiliary (increased liver enzymes), and Eye Disorders (e.g., corneal deposits).
Population Safety Notes Safety constraints are noted for specific populations: Severe Renal Impairment and Hepatic Impairment slow drug elimination, increasing the risk of toxicity. The safety and efficacy have not been established in the pediatric population (under 12 years).
Restrictions Use is formally contraindicated in patients with pre-existing second- or third-degree AV block, unless a pacemaker is present. It is also contraindicated in cardiogenic shock and is generally not recommended for use in chronic atrial fibrillation when structural heart disease is present.

The official safety information structures the understanding of the medicine's risks by distinguishing common, often transient effects from serious, life-threatening events. This regulatory framework emphasizes that the most significant safety concerns are related to the potential for new or worsened cardiac rhythm issues and use in patients with pre-existing conduction problems.

Overdose and Emergency Response

Overdose and When to Seek Help

Flecainide is an antiarrhythmic medication with a narrow therapeutic window, meaning that an overdose can lead to severe, life-threatening effects. Due to its action as a potent sodium channel blocker, an excessive amount of the drug primarily and critically impacts the heart's electrical conduction system.

Documented Overdose Manifestations

Symptoms officially documented in regulatory information that may signal an overdose include:

  • Cardiac: Markedly slow heart rate, first- to third-degree AV block, sinus arrest, or severe conduction delay seen as prolonged PR, QRS, and QT intervals. These conduction disturbances can rapidly progress to malignant and fatal ventricular arrhythmias.
  • Systemic: Nausea, vomiting, fainting (syncope), and seizures (convulsions).

Immediate Emergency Action

Immediate medical attention is required in all cases of suspected overdose. The most urgent concern is the potential for profound cardiotoxicity, including cardiac arrest, particularly in vulnerable groups like pediatric patients with underlying structural heart disease. If an overdose is suspected, or if symptoms such as severe bradycardia, fainting, or seizures occur, contact emergency medical services immediately.

Overdose risk is heightened in the presence of electrolyte imbalances, such as high or low potassium levels, and caution is warranted for individuals with Sick Sinus Syndrome or pre-existing second- or third-degree heart block, unless a pacemaker is present.

Therapeutic Uses of Flecainide Teva

Flecainide Teva is used to help with symptoms related to heightened physiological activity and is applied across domains where additional symptomatic support for heart rhythm is needed. It is generally reserved for patients in whom treatment is deemed appropriate, focusing on conditions that create noticeable physiological strain.

Management of Disabling Supraventricular Tachycardias

This domain covers the primary use of the medication in addressing rapid, abnormal rhythms originating above the ventricles, such as Paroxysmal Atrial Fibrillation/Flutter and recurrent Supraventricular Tachycardia (PSVT). It is used across conditions presenting with episodic or fluctuating symptom patterns. The primary therapeutic benefit may be the support it provides during acute or episodic changes, helping to stabilize the manifestations of rapid heart rates.

Flecainide is also applied when appropriate for the management of certain severe ventricular rhythm disturbances like sustained Ventricular Tachycardia (VT), used across domains where additional symptomatic support is needed. The primary benefit is the support it provides that may assist with maintaining functional stability.

“Flecainide assists with maintaining functional stability and supports the patient during difficult episodes by easing distress.”

Quick Fact: Support for Recurrent Symptomatic Palpitations

Therapeutic Goal Primary Conditions Patient Benefit
Rhythm Maintenance Paroxysmal Atrial Fibrillation, PSVT, Sustained VT Contributes to improved day-to-day comfort
Prophylaxis Recurrent Episodic Symptoms Helps reduce the overall symptom burden

Regulatory References

  1. National Institutes of Health (NIH) DailyMed overview

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

The eligibility profile for Flecainide Teva is strictly defined by regulatory authorities based on cardiac status and organ function. The medicine is contraindicated for several populations, meaning it must not be used in these groups.

Absolute Exclusions (Contraindicated Populations):

  • Patients with pre-existing second- or third-degree AV block, or bifascicular block, unless a functional pacemaker is present.
  • Individuals with structural heart disease, impaired ventricular function (e.g., cardiac failure), or cardiogenic shock.
  • Patients with a history of myocardial infarction who have asymptomatic, non-life-threatening ventricular arrhythmias.
  • Individuals with known Brugada syndrome or long-standing atrial fibrillation where conversion to sinus rhythm has not been attempted.

Restricted and Conditional Use:

  • Use is generally not recommended in children under 12 years of age due to insufficient safety and efficacy data.
  • Extreme caution is required for use in patients with impaired renal or significant hepatic function, as drug clearance may be markedly reduced.
  • Use during pregnancy or lactation should be avoided unless deemed essential, and any significant electrolyte imbalances must be corrected prior to initiation.

What should I know about interactions with other medicines?

Flecainide Teva can interact with certain other medicines, which may affect its safety and effectiveness. It is essential to inform your doctor and pharmacist of all medications, including prescription and non-prescription drugs, vitamins, and herbal supplements you are taking.

Potential Drug Interactions

Category or Specific Medicine Interaction Effect and Requirement
Amiodarone (another antiarrhythmic) May significantly increase flecainide levels, requiring a reduction in the flecainide dose and close monitoring.
Digoxin (for heart failure/rhythm) Flecainide can increase the blood level of Digoxin; close monitoring of Digoxin levels is recommended.
Beta-blockers (e.g., Propranolol) Combining these may lead to additive negative effects on the heart and requires caution. Levels of both drugs may increase.
Cimetidine (for stomach acid) May cause an increase in flecainide blood levels by affecting its breakdown in the body.
Verapamil or Disopyramide Concurrent use is generally not recommended due to potential for additive effects on the heart's function.
QTc-prolonging medicines Increased risk of serious heart rhythm problems (prolonged QTc interval); use together requires careful risk assessment and monitoring.
Enzyme Inducers (e.g., Phenytoin, Phenobarbital) Can increase the rate at which flecainide is removed from the body.

Important Precaution

Electrolyte imbalances (such as low or high potassium) must be corrected before starting and checked during flecainide therapy, especially if you are taking medications like diuretics that can affect electrolyte levels. Flecainide can also increase the pacing threshold in patients with pacemakers, which requires careful follow-up.

Mechanism of Action

Flecainide Teva's mechanism is centered on the targeted blockade of fast voltage-gated sodium channels ( Na^+ channels), specifically the Na v1.5 subtype, which is crucial for initiating the heart's electrical pulse (Phase 0). This direct inhibition of sodium influx contributes to a slowing of the electrical conduction velocity (negative dromotropy) within the heart muscle and the His-Purkinje system.

The drug's effect is characterized as use-dependent, meaning its blocking action increases when sodium channels are cycling rapidly. The slow dissociation kinetics reinforce this channel suppression over successive cycles. This mechanism facilitates the interruption of reentry circuits by preferentially targeting the most rapidly activated tissue, altering the conditions necessary for the propagation of disorganized electrical loops.

Beyond the primary target, the molecule also modulates secondary processes, including I Kr potassium channels and potential inhibition of the RyR2 calcium channel. However, the strength of the sodium channel blockade presents an inherent physiological boundary: the mechanism that alters electrical function to disrupt reentry circuits can also exert a negative inotropic effect, potentially compromising the heart muscle's contractile force.

Dosage and Administration Information

How Flecainide Teva is used

Flecainide Teva is a medication provided as an oral tablet and is typically taken in a twice-daily (BID) schedule. The administration is generally flexible and can be taken with or without food.

Official Labeled Dosing Regimens

The dosage initiation and maximum daily limit are determined by the arrhythmia being managed:

Indication Standard Starting Dose Maximum Recommended Daily Dose
Supraventricular Arrhythmias 50 mg every 12 hours 300 mg per day
Sustained Ventricular Tachycardia 100 mg every 12 hours 400 mg per day

Increases to the dose should only be made in increments of 50 mg twice daily, with a mandatory minimum interval of four days between adjustments. This delay is required to allow the medicine's concentration in the blood to stabilize.

Use Conditions and Special Populations

Treatment initiation for sustained ventricular tachycardia is required to occur in a hospital setting under continuous cardiac monitoring.

For patients with severe kidney impairment (creatinine clearance less than or equal to 35 mL/min), the initial dosage is restricted to 100 mg once daily (or 50 mg twice daily), and frequent monitoring of plasma levels is necessary to guide therapy.

If a dose is missed, the standard procedure is to skip the missed dose if it is almost time for the next scheduled dose, and not to double doses.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Flecainide Teva

The research on Flecainide Teva provides context by describing how the medicine was observed in specific, controlled environments and patient groups. Research generally focuses on adults who experience abnormal heart rhythms but do not have underlying structural heart disease, as this is a key distinction across the evidence base. The following summary outlines the types of studies conducted and the remaining uncertainties, using only neutral, descriptive language.


Evidence Base for Paroxysmal Supraventricular Tachycardias (PSVT) and Atrial Fibrillation/Flutter (AF/AFL)

The evidence for Flecainide Teva was studied for rapid heart rhythms originating in the upper chambers of the heart (supraventricular tachycardias) and comes primarily from randomized controlled trials (RCTs). These studies research examined patterns in the rate of electrical rhythm conversion or stability over defined time intervals. Outcomes related to physical discomfort, such as palpitations, were also measured, describing how symptoms evolved in the observed populations. Some trials described patterns where the measured rate of rhythm stability differed between the observed groups compared to baseline periods or placebo groups. Uncertainty remains regarding the applicability of findings beyond the specific populations studied.


Evidence Base for Sustained Ventricular Tachycardia (VT) and Specialized Arrhythmias

Research for sustained VT is currently focused on unique and specific patient groups who do not have structural heart disease. For instance, research examined the use of the medicine in specific rare, inherited electrical disorders (channelopathies). Studies monitored outcomes such as the prevention of serious arrhythmic episodes, and data show patterns related to a measured difference in the frequency of these episodes in this very select population. The historical Cardiac Arrhythmia Suppression Trial (CAST) finding—where increased mortality was reported in post-heart attack patients compared to the placebo group—defines the focus of subsequent research for ventricular arrhythmias.


Research Gaps and Areas of Scientific Uncertainty

The core uncertainty is the limited applicability of the data beyond the tightly controlled study populations, as the strict exclusion of patients with any structural heart damage means the results apply only to the populations studied. Furthermore, comparative evidence is lacking for many new treatment approaches. The existing research provides context but does not determine whether an individual will respond similarly outside of the controlled conditions under which the studies were conducted. Long-term effects are not fully established regarding the stability of measured patterns over decades.

Key Studies & References

  1. Preliminary Report: Effect of Encainide and Flecainide on Mortality in a Randomized Trial of Arrhythmia Suppression after Myocardial Infarction (CAST Trial)
  2. Atrial fibrillation: diagnosis and management (NICE Guideline NG196) - Recommendations

Frequently Asked Questions (FAQ)

Common questions about Flecainide Teva (FAQ)


Q: How quickly does Flecainide Teva start to affect heart rate?

A: Official information regarding how the drug acts in the body shows that peak blood levels are typically reached about three hours after a dose. However, to achieve a stable concentration in the bloodstream (known as steady-state), the medicine is taken consistently over approximately three to five days.


Q: What kind of monitoring is typically done when taking Flecainide Teva?

A: Regulatory documents state that monitoring commonly includes regular electrocardiogram (ECG) checks, especially when starting the medication or changing the dose. Monitoring of blood levels (plasma concentrations) is also generally performed, particularly for patients with known kidney or liver impairment, as part of managing potential risks.


Q: Can Flecainide Teva cause fatigue or tiredness during the day?

A: Official documents classify fatigue (tiredness or lack of energy) and asthenia (physical weakness) as Common side effects. This means that these effects may occur in up to 1 in 10 people who take the medicine, according to the regulatory safety profile.


Q: Is it common to feel dizzy when first starting Flecainide Teva?

A: Yes, regulatory documents list dizziness as a Very Common side effect, meaning it may affect more than 1 in 10 people. Official information further describes this effect as usually transient, or temporary.


Q: Does Flecainide Teva have a risk of causing new heart rhythm issues?

A: Official regulatory documents include a Boxed Warning that flecainide can potentially cause new or worsened heart rhythm problems (known as proarrhythmia). This potential risk is a key factor in the regulatory caution that reserves the medication for specific patient groups where its use is warranted.


Q: How often do people usually experience vision changes while on Flecainide Teva?

A: Visual disturbances or visual impairment are listed in official documents as Very Common side effects, meaning they may affect more than 1 in 10 people. These effects can include blurred vision or difficulty focusing, and are classified in the drug's safety profile.


Q: Is it possible for Flecainide Teva to stop working over time?

A: Regulatory documents do not state that the drug loses its effectiveness, but they note that long-term research is limited. Specifically, the stability and measured effectiveness of flecainide over decades are not fully established by controlled studies, which is noted as an area of scientific uncertainty.


Q: What information is available about taking Flecainide Teva while pregnant or breastfeeding?

A: Regulatory sources state that flecainide should only be used during pregnancy or lactation if the benefit to the mother outweighs the potential risk to the fetus or infant. Official reports indicate that flecainide crosses the placenta and has been detected in breast milk.


Q: How long does Flecainide Teva stay in the system after the last dose?

A: For individuals with normal kidney function, the time it takes for half the medicine to be cleared (the elimination half-life) averages about 20 hours. This time is significantly prolonged—meaning it takes much longer—in patients who have severe kidney or liver impairment.


Q: Is Flecainide Teva safe to use if I have kidney problems?

A: Regulatory documents indicate that kidney function is important, as the drug is primarily cleared by the kidneys. For patients with severe kidney impairment, official regulatory information states that the initial dose is restricted to a lower amount, and drug levels are subject to close monitoring.


Q: What is the main purpose of the research studies mentioned for Flecainide Teva?

A: Research summarized in official documents focuses on establishing the effectiveness of the drug in groups of adults who do not have underlying structural heart disease. Studies examine the ability of the drug to achieve and maintain electrical rhythm conversion or stability over defined study periods.


Q: What is the difference between Flecainide Teva and other anti-arrhythmic drugs?

A: Flecainide is formally classified as a Class Ic antiarrhythmic agent because its primary action is to block fast voltage-gated sodium channels in the heart. This specific mechanism of slowing electrical conduction velocity distinguishes it from other anti-arrhythmic drug classes, such as Beta-blockers or Class III agents.


Q: Does Flecainide Teva cure atrial fibrillation or just manage the symptoms?

A: Flecainide is indicated for the management and prevention of recurrence of certain abnormal heart rhythms, including atrial fibrillation. The drug’s core purpose, as defined in regulatory texts, is to help control the rate and rhythm, not to provide a cure for the underlying heart condition.


Q: Are there any common over-the-counter medicines that interact with Flecainide Teva?

A: One over-the-counter medicine listed in regulatory information as potentially interacting is Cimetidine (a stomach acid reducer). The combination is noted because it may cause an increase in flecainide blood levels by affecting how the body breaks down the medicine.


Q: Does Flecainide Teva interact with common supplements like magnesium or potassium?

A: Regulatory documents state that imbalances in electrolytes (like low or high potassium or magnesium) must be corrected before starting flecainide therapy. This is because these mineral imbalances can negatively affect the drug's safety and increase the risk of serious side effects.


Q: Can alcohol consumption be a problem while taking Flecainide Teva?

A: Regulatory information indicates that consuming alcohol while taking flecainide may increase the risk of certain side effects, such as dizziness or fainting spells. In some circumstances, alcohol may also cause the drug to take longer to leave the body.


Q: Does Flecainide Teva interact with medications for depression or anxiety?

A: Regulatory documents list a potential interaction risk between flecainide and certain types of antidepressants or antipsychotic medications. These combinations are noted because they may increase the risk of electrical changes in the heart (such as a prolonged QT interval).


Q: Are there any specific dietary restrictions that apply to Flecainide Teva?

A: Official documents specify that milk and milk-containing products may reduce the absorption of flecainide in infants and children. For adults, food generally does not affect the absorption of the medicine, and it is usually taken with or without food.


Q: Is Flecainide Teva commonly used as a 'pill-in-the-pocket' treatment?

A: While regulatory sources do not use the specific term 'pill-in-the-pocket,' the drug's official labeling for treating paroxysmal atrial fibrillation (PAF), and the fact that regulatory documents describe the necessity of closely monitoring the patient when initiation or conversion is attempted, provides the context for this specific administration strategy.


Q: What are the potential interactions between Flecainide Teva and herbal remedies?

A: Regulatory information advises patients to inform their healthcare provider about all herbal products they are taking, as these products may interact with flecainide. However, specific interactions with common herbal remedies are generally not listed in official drug labels.


Q: Does Flecainide Teva affect sleep patterns or cause insomnia?

A: Regulatory documents list insomnia (difficulty sleeping) as a Rare side effect, meaning it may affect up to 1 in 1,000 people. Other rare nervous system effects are also included in the official safety documents.


Q: Can Flecainide Teva cause mental fog or concentration issues?

A: Adverse events reported in regulatory documents include neurological symptoms such as confusion, forgetfulness, and issues with coordination or unsteadiness. These effects are classified as Rare in the official safety profile, meaning they affect up to 1 in 1,000 people.


Q: What should be done if an adverse reaction is suspected while taking Flecainide Teva?

A: Official drug information notes that serious side effects should be reported to a healthcare provider promptly, such as symptoms of a new or worsened irregular heartbeat or signs of heart failure. Patients should discuss all symptoms causing concern with their healthcare provider for appropriate assessment.


Q: Is it important to check my pulse while taking Flecainide Teva?

A: While drug labels do not directly instruct self-checking of pulse, the serious warnings regarding the risk of slow heart rate (bradycardia) and the potential for new or worsened heart rhythm problems are noted. Unexpected changes in heart rate are important to discuss with a healthcare provider.


Q: What is the general expectation for effectiveness when taking Flecainide Teva for Afib?

A: Research evidence summarized in regulatory documents describes patterns related to the drug's role in achieving and maintaining electrical rhythm conversion or stability in the upper chambers of the heart. These studies focused on observed rates of rhythm control over defined time intervals in specific patient groups.

How should Flecainide Teva be stored and disposed of?

Storage and Disposal Instructions for Flecainide Teva


Storage Requirements

Flecainide Teva tablets must be stored at Controlled Room Temperature, which is defined as 20 C to 25 C (68 F to 77 F). It is a mandatory requirement to protect the tablets from light and keep them in a tight, light-resistant container. Always keep this medicine out of the sight and out of the reach of children and pets.

Disposal Requirements

Unused or expired Flecainide Teva must not be thrown away via wastewater or household trash. Disposal must be handled by returning the medicine to a pharmacist or a designated drug take-back program. This ensures the product is discarded in accordance with local regulations for pharmaceutical waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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