Flecaine LP

Quick links to important sections

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 Flecaine LP

Quick Facts

Property Description
Active Ingredient Flecainide Acetate
Form Prolonged-Release Capsule
Pharmacological Class Vaughan Williams Class Ic Antiarrhythmic
Common Use Heart Rhythm Stabilization
Origin Synthetic Compound (Benzamide derivative)

What Type of Medicine is Flecaine LP?

Flecaine LP is a prescription-only medicine that contains the active ingredient Flecainide Acetate, and is classified as a Vaughan Williams Class Ic antiarrhythmic drug. This medication is utilized in cardiovascular therapy to manage electrical disturbances in the heart. Flecainide Acetate is a synthetic compound derived from benzamide and is clinically recognized for its potent mechanism.

The drug acts as a powerful and selective voltage-gated sodium channel blocker. This classification means the medicine is specifically designed to interact with the heart's primary electrical pathways.


What Does the LP Formulation Mean?

The designation LP in Flecaine LP stands for Libération Prolongée, indicating that the medicine is formulated as a prolonged-release capsule. This specific sustained-release capsule is designed for oral administration, ensuring the Flecainide Acetate is delivered slowly and consistently into the bloodstream over an extended time period.

The benefit of this specific design is to maintain a stable, uniform therapeutic level of the active ingredient throughout the day, which supports consistent electrical control.


What is the General Purpose of Flecainide Acetate?

The general purpose of Flecainide Acetate is to stabilize the heart's electrical system by regulating the speed and path of electrical signals. It achieves this through a pronounced membrane stabilizing action, which reduces the excitability of the heart muscle and slows the rate of electrical conduction.

Antiarrhythmic agents are crucial for controlling underlying electrical instability in cardiac tissue. This mechanism supports the maintenance of a regular and steady heart rhythm, often used in situations where the heart is beating too fast or irregularly.

What side effects are possible with Flecaine LP?

Possible Side Effects and Safety Information

Flecaine LP (flecainide) is a Class Ic antiarrhythmic agent with a narrow therapeutic index, meaning that the difference between an effective dose and a toxic dose is small. Its use is associated with serious cardiac risks and requires careful patient selection and monitoring.

Serious and Clinically Significant Adverse Reactions

The most significant risk is proarrhythmia, the potential for the drug to cause new or worsened heart rhythm abnormalities, including fatal ventricular arrhythmias. This risk is notably increased in patients with structural heart disease (e.g., severe heart failure, history of myocardial infarction, or left ventricular dysfunction). Regulatory documents explicitly contraindicate the use of this medication in patients with a history of heart attack and non-life-threatening ventricular arrhythmias. Other serious cardiac events include new onset or worsening heart failure and conduction defects (e.g., second- or third-degree atrioventricular block, bundle branch block) without a pacemaker.

Common Side Effects

Common adverse reactions, typically observed early in treatment, involve the nervous system and vision. These include dizziness, headache, fatigue, and visual disturbances (e.g., blurred vision or difficulty focusing). Gastrointestinal side effects like nausea and constipation have also been reported.

Population-Specific Safety Notes

  • Structural Heart Disease: Use is generally restricted to patients without structural heart disease due to the elevated risk of mortality demonstrated in clinical studies.
  • Renal/Hepatic Impairment: Clearance is affected by kidney and liver function; plasma level monitoring and dosage adjustments are necessary in patients with significant impairment to maintain the drug concentration within the safe therapeutic range.
  • Electrolyte Imbalances: Abnormal potassium levels, such as hypokalemia, must be corrected prior to therapy, as they can exacerbate the risk of proarrhythmia.

Monitoring and Limitations

Close cardiac monitoring, including regular electrocardiograms (ECGs), is required to detect signs of proarrhythmia or significant QRS widening (which may necessitate a dose reduction). The drug is formally contraindicated in conditions such as cardiogenic shock, sick sinus syndrome (without a pacemaker), and certain pre-existing heart blocks.

Overdose and Emergency Response

Overdose and when to seek help for Flecaine LP

Overdose with Flecaine LP (Flecainide Acetate) is officially documented as a severe medical emergency requiring urgent attention due to the high potential for life-threatening hemodynamic deterioration and cardiac toxicity.

Domain Official Regulatory Statements
Documented Overdose Manifestations Overdose may present with systemic non-cardiac effects such as nausea, vomiting, seizures (convulsions), and loss of consciousness. Cardiovascular signs include hypotension (low blood pressure) and rhythm disturbances like tachyarrhythmias or bradycardia.
Severe Outcomes & ECG Toxicity is associated with the onset of malignant ventricular arrhythmias and the potential for Cardiogenic shock or Cardiac arrest. ECG abnormalities consistently noted include significant QRS complex widening and PR interval prolongation.
Population Notes Official documents note a risk of increased toxicity in patients with pre-existing Kidney disease or Liver disease due to impaired clearance. Individuals with structural heart disease also carry an elevated risk for severe proarrhythmic effects.
Emergency Response Seek immediate medical attention for any suspected overdose. Call emergency services (e.g., 911) if the victim has collapsed, had a seizure, has trouble breathing, or cannot be awakened.

Regulatory documents emphasize that no specific antidote is known for Flecainide Acetate. Management requires intensive care monitoring (telemetry) and aggressive supportive measures. These procedures include the administration of activated charcoal and the use of high-dose hypertonic Sodium Bicarbonate to counteract severe cardiac conduction toxicity. Hemodialysis is not expected to be useful for drug removal.

Therapeutic Uses of Flecaine LP

What Flecaine LP Treats: Main Uses and Benefits

This medicine is commonly used to support the management of symptomatic heart rhythm disorders. Flecainide is used to help prevent or treat serious irregular heartbeats, generally when they may not be effectively managed by other forms of therapy.

Flecaine LP is applied in conditions involving episodic or fluctuating manifestations of rapid, irregular heart rhythms in the upper chambers, such as Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter, and certain Supraventricular Tachycardias (SVTs). It is also relevant in managing certain severe Ventricular Tachycardias in highly specific clinical settings. This supportive approach is used to maintain a more consistent heart rhythm, which may assist in managing the disorganized activity.

The medication is relevant for easing symptom clusters that may become intense or disruptive, specifically addressing palpitations (a racing or pounding pulse) and associated symptoms of systemic imbalance like dizziness and lightheadedness. It is often used as long-term prophylactic support for managing recurrence of symptomatic rhythm disorders after the heart has achieved stability. This supportive role contributes to maintaining functional stability by reducing the likelihood of sudden, disruptive events.


Quick Fact: Therapeutic Support

Category Therapeutic Goal
Primary Use Applied in conditions involving episodic or fluctuating manifestations of rapid heart rhythms.
Symptom Management Helps address palpitations and lightheadedness.
Context of Use Long-term prophylactic support for managing recurrence.
Patient Benefit Helps maintain a sense of stability when symptoms become more noticeable.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Flecaine LP?

The population eligibility for Flecaine LP (Flecainide Acetate) is strictly defined by regulatory authorities based on underlying cardiac health and age. The medicine is primarily approved for adults managing specific documented supraventricular arrhythmias, provided they do not have structural heart disease.

Contraindications and Restrictions

Classification Rule
Absolute Contraindication Contraindicated in patients with structural heart disease (including prior myocardial infarction or significant LV dysfunction), Cardiogenic Shock, or known hypersensitivity to the drug.
Conduction System Restriction Must not be used in patients with pre-existing Second- or Third-Degree Atrioventricular Block or Bifascicular/Trifascicular Bundle Branch Block unless a permanent pacemaker is present.
Pediatric Eligibility Use is not recommended for children under 12 years as safety and efficacy have not been established.
Conditional Use Requires caution and monitoring in patients with severe renal impairment or impaired liver function, and in older adults due to slower elimination.

For pregnancy, use is acceptable only if the potential benefit outweighs the potential risk. Regulatory data suggests a minimal risk when used during breastfeeding.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Interactions with Flecaine LP are determined by its primary metabolic pathway and its effects on cardiac function. Co-administration with other Class I antiarrhythmic drugs is generally contraindicated in regulatory labeling. The label also advises against or restricts use with certain substances, including Pimozide, Ritonavir, and Dronedarone.

Pharmacokinetic and Exposure-Modifying Interactions

Flecainide Acetate is primarily cleared via the CYP2D6 enzyme. Co-administration with CYP2D6 inhibitors (e.g., Amiodarone, Quinidine, Cimetidine) is officially documented to increase the plasma concentration of Flecainide. Amiodarone, specifically, can cause an increase of two-fold or more. Conversely, some enzyme inducers (e.g., Phenytoin) are associated with an increased rate of Flecainide elimination.

Pharmacodynamic Effects and Restrictions

Additive negative inotropic effects are a documented risk when combining Flecaine LP with medicines like beta-blockers (Class II antiarrhythmics). Co-administration with Digoxin is documented to raise Digoxin plasma levels by 13% to 19%. Diuretics carry a documented risk of inducing hypokalaemia, which can heighten cardiotoxicity. Regulatory constraints mandate a 50% Flecainide dose reduction when co-administration with Amiodarone is initiated.

Substance and Population-Specific Notes

Tobacco/Smoking is associated with decreased Flecainide trough concentrations. Alcohol may increase the risk of certain central nervous system effects. For infants, milk may inhibit oral absorption. Population-specific cautions apply to patients with impaired hepatic or renal function, where slower clearance increases the potential for adverse interaction effects.

Mechanism of Action

Targeted Blockade of Cardiac Sodium Channels

This mechanism addresses the core action of Flecainide by inhibiting the fast inward sodium channels ( Nav1.5), which are responsible for the initial electrical surge. This molecular blockade significantly slows the conduction velocity of the heart's electrical signals, directly influencing the speed of impulse propagation across the myocardial tissue.


⏳ Rate-Selective Kinetics and Refractory Period Prolongation

Flecainide's action is defined by use-dependent blockade, a selective mechanism where the inhibitory effect on Nav1.5 channels intensifies when the channels are frequently active. By slowing conduction and exhibiting slow unbinding, the drug markedly prolongs the tissue's Effective Refractory Period ( ERP), which determines the necessary recovery time before a cell can be electrically excited again.


Modulation of Triggered Activity

The drug also exerts a secondary action by modulating the Ryanodine Receptor ( RyR2), which controls internal calcium ion ( Ca^2+) release. By influencing calcium dynamics, Flecainide suppresses erratic electrical activity known as delayed afterdepolarizations.

Dosage and Administration Information

Administration Scope

Parameter Instruction
Route of Administration The prolonged-release capsule (LP) is for oral administration. The immediate-release form is also for intravenous (IV) use in acute, supervised settings.
Dosing Schedule Initial Daily Dose: Typically 100 mg per day for supraventricular arrhythmias (50 mg twice daily) or 200 mg per day for ventricular arrhythmias. Maintenance Range: Generally 100 mg to 400 mg total daily dose.
Timing in Relation to Meals The medication can be taken with or without food.
Preparation Requirements The prolonged-release capsule must be swallowed whole to maintain its sustained-release mechanism and must not be crushed or chewed.
Age-Group Administration Rules Older Adults: The maximum initial daily dose is generally restricted to 100 mg per day due to potentially slower drug elimination. Renal/Hepatic Impairment: The maximum initial dose is similarly restricted to 100 mg per day, with frequent plasma level monitoring recommended.
Missed-Dose Rules If a dose is missed, it is advised to skip the missed dose and take the next dose at the regularly scheduled time; a double dose should not be taken.
Special Procedural Conditions The initiation of therapy, particularly for certain indications, is recommended or required to take place in a hospital setting under specialized cardiac monitoring.

Instruction Classifications (High-Level)

Classification Parameter
Administration Method Type Oral / Intravenous
Frequency Pattern Once daily for the prolonged-release capsule; twice daily for immediate-release tablets.
Use-Context Constraints Dose adjustments must not be made more often than every four days due to the time required to reach a new steady-state plasma level.

Connection to the overall use protocol:

These instructions establish the parameters for the drug's administration, defining the oral route, the required once-daily frequency for the LP formulation, and standard time intervals for dose changes. The instructions also set dose limitations for specific patient populations and require specialized monitoring during the initiation of therapy, ensuring the drug is used within defined parameters.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Flecaine LP

This overview describes the types of clinical research that have been conducted on Flecainide Acetate (the active ingredient in Flecaine LP). It explains the study designs, the outcomes that researchers measured, and where evidence may be limited or still developing. This information provides context but does not constitute medical advice or predict individual patient outcomes.


Evidence for Rhythm Maintenance in Atrial Fibrillation (AF) and Atrial Flutter

The evidence base for Flecainide Acetate is largely derived from Randomized Controlled Trials (RCTs), where participants are randomly assigned to receive the medicine, a placebo, or an alternative antiarrhythmic drug. These trials were used in research exploring how symptoms change over time and the outcomes related to episodic or acute changes in heart rhythm.

Research focused primarily on two outcomes: first, studies examined the rate of restoration of a normal, steady rhythm (conversion); and second, studies explored rhythm maintenance outcomes, including the duration of normal sinus rhythm, and examined the rate of AF or Atrial Flutter recurrence over time. Findings describe patterns observed in the studies related to physical discomfort and outcomes reflecting daily functioning.


Study Populations and Defining Trial Inclusion

The research base has specific requirements for the patients included. A key research limitation is the restricted applicability of the primary evidence: results apply only to the populations studied, which were mainly patients without structural heart disease. This group includes individuals with significant heart damage, such as certain types of heart failure or those who have had a prior heart attack.

Because of this necessary exclusion, data for certain groups remain insufficient. The evidence highlights what is known, but it also clearly indicates that the research does not determine whether an individual with a pre-existing structural heart condition will respond similarly.


What Remains Uncertain About the Research Base

A key research limitation is the restricted applicability of the primary evidence: results apply mainly to patients without structural heart disease. Furthermore, long-term outcomes are not well characterized in large-scale RCTs, meaning long-term effects are not fully established. Follow-up durations were limited in many studies, contributing to the understanding of short-term patterns but leaving the full picture of extended-duration use still emerging.

Key Studies & References

  1. Cardiac Arrhythmia Suppression Trial (CAST)
  2. Label: FLECAINIDE ACETATE- flecainide tablet (NIH DailyMed)
  3. PUBLIC ASSESSMENT REPORT of the Medicines Evaluation Board in the Netherlands Flecaïnideacetaat retard (Prolonged-release formulation evidence)
  4. Atrial Fibrillation and Flecainide - Safety, Effectiveness and Quality of Life Outcomes (Review article covering key trials and structural heart exclusion)

Frequently Asked Questions (FAQ)

Common questions about Flecaine LP (FAQ)


Q: What is the main difference between Flecaine LP and standard Flecaine tablets?

A: The primary difference lies in the formulation and dosing schedule. Flecaine LP is a prolonged-release capsule designed to be taken once daily to maintain consistent levels of the medicine. The standard Flecaine tablet is an immediate-release formulation, which typically requires patients to take a dose twice daily.

Q: How long does it usually take to feel the full effect of Flecaine LP after starting treatment?

A: According to official product information, the full effects relate to the time it takes to achieve a steady-state plasma level, meaning a stable concentration of the medicine in the blood. Because Flecainide takes time to accumulate, regulatory guidance describes that dosage adjustments are generally made no more often than every four days.

Q: Can Flecaine LP cause any long-term problems with the heart rhythm or structure?

A: Official warnings note a risk of proarrhythmia, which is the potential for the medicine to cause new or worsened heart rhythm disturbances. While this risk is well-documented, regulatory-cited research indicates that the long-term effects of Flecainide on the heart are not fully established in large-scale studies.

Q: Is Flecaine LP considered a safe option for older adults (seniors)?

A: Use in older adults is subject to specific caution and monitoring requirements. Due to potentially slower elimination of the medicine in this population, regulatory guidance describes that the maximum initial dose is typically restricted compared to younger adults.

Q: Can Flecaine LP be taken at the same time as blood pressure medication?

A: Regulatory documents describe potential issues when Flecaine LP is used alongside certain heart medications, such as beta-blockers, which are common for high blood pressure. This combination carries a documented risk of additive negative effects on the heart's pumping function, meaning close monitoring is indicated if used together.

Q: Can patients with kidney issues use Flecaine LP safely?

A: Use in patients with kidney impairment is subject to caution and monitoring requirements. For individuals with significant kidney impairment, official guidelines describe a lower maximum initial dose and recommend frequent plasma level monitoring (checking the drug concentration in the blood).

Q: How is the effectiveness of Flecaine LP typically monitored by a healthcare provider?

A: Effectiveness and safety are monitored through various means. This includes regular Electrocardiograms (ECGs) to check the heart's electrical activity. Healthcare providers may also measure flecainide plasma concentrations via blood tests to ensure the level of the medicine is within the appropriate therapeutic range.

Q: Are there any genetic factors that influence how Flecaine LP works for someone?

A: Official product information notes that Flecainide is cleared from the body primarily by the CYP2D6 enzyme. Variations in this enzyme's activity are known to occur in the population, and these genetic differences are described as influencing the plasma concentration of the medicine a person experiences.

Q: Do people typically stay on Flecaine LP for a short time or for many years?

A: Flecaine LP is prescribed for the maintenance of a regular heart rhythm, which often requires long-term therapy. However, regulatory overviews of clinical studies indicate that definitive evidence on the patterns and outcomes of extended-duration use is not fully established.

Q: Is it necessary to have blood tests done while taking Flecaine LP?

A: Regulatory documents indicate that blood tests are typically necessary. Prior to and throughout therapy, levels of electrolytes like potassium are required to be checked and corrected, as imbalances can increase serious cardiac risks. Additionally, flecainide plasma levels are often measured, especially for patients with impaired kidney or liver function.

Q: Can patients with liver problems take Flecaine LP?

A: Use in patients with impaired liver function is subject to specific caution and monitoring requirements. For these patients, official guidelines advise a restricted initial daily dose. Frequent plasma level monitoring is strongly recommended to safely manage the medicine’s clearance from the body.

Q: Does taking Flecaine LP affect the results of a standard ECG test?

A: Yes, the medication is expected to alter the heart's electrical pattern recorded on an ECG. Official documents indicate that the drug prolongs the PR and QRS intervals. Significant QRS widening seen on an ECG is a common signal that may prompt a dose review.

Q: Does Flecaine LP interact with any antidepressant or anti-anxiety medications?

A: Flecainide is metabolized (broken down) by the CYP2D6 enzyme. Certain drugs, including some antidepressants, are known to inhibit this enzyme. Co-administration with such inhibitors is described as leading to increased concentrations of Flecainide in the blood and potentially necessitating a dose adjustment.

Q: What is the shelf life of Flecaine LP?

A: The shelf life is determined by the manufacturer and is indicated as the expiry date printed on the package. Official instructions specify that the medicine is not to be used past this labeled date.

Q: Does Flecaine LP cure the heart condition it treats, or only manage the symptoms?

A: According to general medical information, Flecainide is used to help control or prevent the recurrence of an abnormal heart rhythm. It is a maintenance medication that manages electrical instability; it cannot cure the underlying cardiac condition.

Q: Does taking Flecaine LP affect your ability to drive or operate machinery?

A: Side effects of Flecaine LP, such as dizziness and visual disturbances, may affect a patient’s concentration and ability to operate vehicles or machinery safely. Official regulatory guidance describes how patients' ability to perform these activities may be affected by the medicine.

Q: Are there specific foods or drinks that should be avoided while on Flecaine LP?

A: Official labeling notes that alcohol may increase the risk of certain central nervous system side effects. Though Flecaine LP can generally be taken with or without food, some regulatory sources advise informing a healthcare provider about consumption of grapefruit products, due to the narrow therapeutic window of the medicine.

Q: Is a metallic or strange taste in the mouth a known side effect of Flecaine LP?

A: While the most common side effects involve the nervous system and vision, official documents do report a rare occurrence of a change in taste among patients taking this medicine.

Q: What is the risk of drug dependency or withdrawal symptoms with Flecaine LP?

A: There is no regulatory mention of dependency or addiction associated with Flecainide LP. However, official guidance describes that the medicine should not be stopped suddenly, as this action can lead to a worsening of the underlying heart condition.

Q: Is Flecaine LP known to interact with grapefruit or grapefruit juice?

A: Flecainide is metabolized by the CYP2D6 enzyme—which is not typically affected by grapefruit. However, due to the narrow therapeutic window, regulatory sources advise informing a healthcare provider about consumption of grapefruit products.

Q: What makes Flecaine LP a prescription-only medicine?

A: Flecaine LP is designated as prescription-only due to the specialized nature of its use. It is a narrow therapeutic index agent that requires careful patient selection, specialized cardiac monitoring when therapy is initiated, and ongoing supervision due to the serious risk of proarrhythmia.

Q: What should be done if an allergic reaction to Flecaine LP is suspected?

A: In the event of a suspected serious allergic reaction, official regulatory guidance indicates that immediate medical help or notifying a doctor straight away is required. Signs of a serious reaction include swelling of the face, lips, throat, or difficulty breathing.

Q: Why is Flecaine LP generally reserved for certain types of heart rhythm issues?

A: Flecaine LP is reserved for specific supraventricular arrhythmias because clinical studies have shown it carries an increased rate of death or nonfatal cardiac arrest when used in patients with underlying structural heart disease (such as a prior heart attack or significant heart failure). Its use is therefore limited to patients without these severe cardiac issues.

Q: Are there any reported interactions with herbal remedies?

A: While specific herbal products may not be listed, general patient information indicates that patients should inform their healthcare professional about all medications, supplements, and herbal remedies they are taking. This is necessary due to the potential for unknown interactions that could affect how Flecainide works or is cleared from the body.

Q: Is the dose of Flecaine LP adjusted based on a person's body weight?

A: For standard adult dosing, the schedule is based on fixed milligram increments. However, regulatory documents indicate that in the case of pediatric dosing, the amount of medicine to be administered is officially guided by the child’s body size, such as body weight or body surface area.

Q: What should a patient tell their dentist if they are taking Flecaine LP?

A: Official guidance indicates that patients should inform any healthcare professional, including a dentist, that they are taking Flecainide. This is important before any procedure due to the medicine's effects on cardiac function and the potential for drug interactions, especially with local anesthetics.

Q: What is the guidance on suddenly stopping Flecaine LP treatment?

A: Official patient information describes that the medicine should not be stopped suddenly. Consulting a doctor first is required to ensure the condition does not worsen or cause a serious event upon cessation.

How should Flecaine LP be stored and disposed of?

Storage and Protection Requirements

Flecainide acetate tablets and prolonged-release capsules must be stored at Controlled Room Temperature, typically defined as 20 C to 25 C (68 F to 77 F), with protection from light specified for certain container types.

Requirement Official Regulatory Statement
Temperature Range Store below 25 C or at Controlled Room Temperature.
Container Integrity Store in the original container; do not use the medicine after the labeled expiry date.
Child Protection Keep this medicine out of the sight and reach of children.

Disposal Instructions

Official labeling directs that the medicine must not be thrown away via wastewater or household waste to protect the environment. Users must ask their pharmacist how to properly discard any unused or expired product. If a drug take-back program is unavailable, non-flush list medicines may be mixed with an undesirable substance before disposal in the trash, provided all personal information is removed from the label.

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

Available in countries:

Equivalent of Flecaine LP found in:

A-Z Index: