PRESCRIPTION PREPARATIONS 10TH SCHEDULE, (P.P.10) Zimbabwe · MCAZ

CADENCE 100

FLECAINIDE ACETATE

2026/12.2/7430 TABLET; ORAL 100MG cardiovascular system INN generic

What it does

Flecainide is a medication used to help manage certain heart rhythm problems.

Commonly used for: irregular heartbeat (arrhythmia), atrial fibrillation, ventricular tachycardia

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
2026/12.2/7430
Registration date
2026-05-11
Expiry date
2031-05-10
Status
PRESCRIPTION PREPARATIONS 10TH SCHEDULE, (P.P.10)
Active ingredient
FLECAINIDE ACETATE
Dosage form
TABLET; ORAL
Strength
100MG
Pack size
-
Therapeutic class
-
ATC class (WHO)
C01BC - Antiarrhythmics, class Ic
RxNorm RxCUI
4441
Manufacturer / MAH
Emcure Pharmaceuticals
Applicant / LTR
EMCURE PHARMACEUTICALS LTD
Country of origin
-
Manufacturer location
Plot No. P-1 & P-2, IT-BT Park, Phase-II, D.C, M.I, Hinjawadi, Pune, Man, Maharashtra 411057, India

Source: Medicines Control Authority of Zimbabwe · fetched 2026-06-04 06:39:48 · updated 2026-10-18 04:30:04

Drug Interactions

6
Check interactions

Pharmacodynamic Warnings

Flecainide appears in TABLE 6: Drugs that cause bradycardia

Flecainide appears in TABLE 9: Drugs that prolong the QT interval

Moderate (3)

Flecainide - increases exposure

NSAIDs (celecoxib) are predicted to increase the exposure to antiarrhythmics (flecainide, propafenone). Monitor and adjust dose.

Moderate Theoretical

Flecainide - increases exposure

Cimetidine slightly increases the exposure to antiarrhythmics (flecainide). Monitor and adjust dose.

Moderate Study

Flecainide - increases exposure

Celecoxib is predicted to increase the exposure to antiarrhythmics (flecainide, propafenone). Monitor and adjust dose.

Moderate Theoretical

Unknown (3)

Flecainide - increases concentration

Cobicistat potentially increases the concentration of antiarrhythmics (amiodarone, disopyramide, flecainide, lidocaine).

Unknown Theoretical

Flecainide - increases concentration

Darifenacinispredictedtoincreasetheconcentrationof flecainide.oTheoretical

Unknown Theoretical

Flecainide - increases exposure

Ritonavir is predicted to increase the exposure to antiarrhythmics (flecainide). Avoid or monitor adverse effects.

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Medicines Control Authority of Zimbabwe (Zimbabwe). Always consult a qualified healthcare professional before using any medication.

About this medicine

Flecainide is a medication used to help manage certain heart rhythm problems.

What it treats

  • irregular heartbeat (arrhythmia)
  • atrial fibrillation
  • ventricular tachycardia

How it works

Flecainide helps to stabilize the electrical signals in the heart, which can prevent or reduce abnormal heart rhythms.

Who it's for

This medicine is for adults who have been diagnosed with specific heart rhythm disorders.

Cautions

  • • Be careful if you are taking other medications that slow down your heart rate.
  • • Avoid medications that may extend the time it takes for your heart to recharge between beats.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: flecainide

BNF-referenced

Flecainide is a class IC antiarrhythmic agent primarily used to treat various types of cardiac arrhythmias, including atrial fibrillation and ventricular tachycardia. It functions by blocking fast inward sodium channels in cardiac myocytes, which helps to stabilize the cardiac membrane and restore normal rhythm. While effective, flecainide's use is limited by its potential to exacerbate existing structural heart disease and its narrow therapeutic index.

Indications

  • Atrial fibrillation
  • Atrial flutter
  • Ventricular tachycardia
  • Paroxysmal supraventricular tachycardia

Dosage

Children: Refer to the BNF for Children for specific dosing information tailored to paediatric patients.

Adults: The usual initial oral dose is 50 mg every 12 hours, which may be increased to 100 mg every 12 hours based on clinical response and tolerability.

Mechanism of action

Flecainide blocks fast inward sodium channels and slowly unbinds during diastole, prolonging the refractory period of the heart. This blockade also shortens the duration of action potentials through the Purkinje fibers. Additionally, flecainide prevents delayed rectifier potassium channels from opening, lengthening the action potential in ventricular and atrial muscle fibers. It also blocks ryanodine receptor opening, reducing calcium release from the sarcoplasmic reticulum, which in turn decreases depolarization of cardiac cells.

Pharmacodynamics

Flecainide inhibits the action of sodium and potassium ion channels in the heart, raising the threshold for depolarization and correcting arrhythmias. It has a long duration of action, which allows for once daily dosing. However, due to its narrow therapeutic index, careful monitoring is required, particularly in patients with pre-existing cardiac conditions such as structural heart disease or left ventricular systolic dysfunction.

Pharmacokinetics

Flecainide is absorbed well from the gastrointestinal tract with a bioavailability of approximately 90%. It undergoes hepatic metabolism, primarily by cytochrome P450 enzymes, with a half-life ranging from 12 to 27 hours. The drug is excreted mainly in urine as metabolites, and renal function can significantly affect its clearance. Dose adjustments may be necessary in patients with impaired renal function.

Contra-indications

  • Structural heart disease
  • Left ventricular systolic dysfunction
  • Previous hypersensitivity to flecainide

Adverse effects

  • Dizziness
  • Visual disturbances
  • Palpitations
  • Heart block
  • Heart failure
  • Torsades de pointes
  • Seizures

Interactions

  • NSAIDs: Moderate (increases exposure)
  • Cimetidine: Moderate (increases exposure)
  • Celecoxib: Moderate (increases exposure)
  • Cobicistat: Unknown (increases concentration)
  • Darifenacin: Unknown (increases concentration)
  • Ritonavir: Unknown (increases exposure)

Precautions

  • Monitor cardiac function regularly
  • Use with caution in patients with renal impairment
  • Evaluate electrolyte levels, especially potassium
  • Consider potential drug interactions

Pregnancy

Flecainide should only be used if the potential benefit justifies the potential risk to the fetus. Consult relevant guidelines for more detailed information.

Breast-feeding

Flecainide is excreted in breast milk. Caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Tablets: 50 mg, 100 mg, 150 mg

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: Flecainideacetate

BNF-referenced

Flecainide acetate is a Class IC antiarrhythmic agent used primarily for the management of supraventricular and ventricular arrhythmias. It works by blocking sodium channels, thereby stabilizing cardiac cell membranes and reducing excitability in cardiac tissues. This drug is generally initiated under the supervision of a specialist due to potential risks and the need for careful monitoring.

Indications

  • Supraventricular arrhythmias
  • Ventricular arrhythmias
  • Paroxysmal supraventricular tachycardias including paroxysmal atrial flutter or fibrillation
  • Re-entrant tachycardias involving the AV node or accessory pathway

Dosage

Adults: Initially, 100 mg twice daily for 3-5 days, with a maximum of 400 mg daily for rapid control or in heavily built patients; maintenance dose should be reduced to the lowest effective dose. For ventricular arrhythmias, initiate at

Mechanism of action

Flecainide acetate primarily acts as a sodium channel blocker, inhibiting the influx of sodium ions during depolarization of cardiac cells. This reduces the conduction velocity in the myocardium and prolongs the refractory period, effectively suppressing abnormal electrical activity in the heart. Its antiarrhythmic effects are particularly useful in conditions such as paroxysmal atrial fibrillation and ventricular tachycardia.

Pharmacodynamics

Flecainide demonstrates a dose-dependent effect on cardiac action potentials, notably prolonging the QRS duration on the electrocardiogram (ECG). It has a rapid onset of action and can be used for both acute and chronic management of arrhythmias. The drug's efficacy is enhanced when used in patients with structurally normal hearts; however, its use in patients with underlying heart disease carries a risk of proarrhythmia.

Pharmacokinetics

Flecainide acetate is well-absorbed from the gastrointestinal tract, with peak plasma concentrations typically occurring within 1-3 hours after oral administration. It has a high protein binding rate (approximately 95%) and is extensively metabolized in the liver, primarily by CYP2D6. The elimination half-life ranges from 12 to 27 hours, depending on individual patient factors, including hepatic function. Renal impairment may lead to increased drug accumulation, necessitating dosage adjustments.

Contra-indications

  • Abnormal left ventricular function
  • Atrial conduction defects (unless pacing rescue available)
  • Bundle branch block (unless pacing rescue available)
  • Sinus node dysfunction (unless pacing rescue available)
  • History of myocardial infarction with asymptomatic ventricular ectopics
  • Severe hepatic impairment

Adverse effects

  • Dizziness
  • Visual disturbances
  • Nausea
  • Ventricular tachycardia
  • Heart failure
  • QT interval prolongation
  • Torsades de pointes
  • Hypotension

Interactions

  • Concurrent use of amiodarone may require dose reduction by half
  • Caution with lidocaine due to possible accumulation in renal impairment

Precautions

  • Monitor ECG and blood pressure regularly
  • Caution in patients with a history of heart failure
  • Use with caution in elderly patients (risk of accumulation)

Pregnancy

Crosses the placenta but not known to be harmful in animal studies-use if benefit outweighs risk.

Breast-feeding

Present in milk but amount too small to be harmful.

Storage

Store in a cool, dry place, away from light.

Formulations

  • 50 mg tablets
  • 100 mg tablets
BNF 85 (British National Formulary) p.132 BNF for Children 2019-2020 p.100 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: flecainide

PubChem CID 3356

Molecular formula: C17H20F6N2O3

Mechanism of action

Flecainide blocks fast inward sodium channels and slowly unbinds during diastole, prolonging the refractory period of the heart. This blockade also shortens the duration of action potentials through the Purkinjie fibers. Flecainide also prevents delayed rectifier potassium channels from opening, lengthening the action potential through ventricular and atrial muscle fibers. Finally, flecainide also blocks ryanodine receptor opening, reducing calcium release from sarcoplasmic reticulum, which reduces depolarization of cells.

Pharmacodynamics

Flecainide inhibits the action of sodium and potassium ion channels in the heart, raising the threshold for depolarization and correcting arrhythmias. Flecainide has a long duration of action, allowing for once daily dosing. The therapeutic index is narrow. Patients should not take this medication if there is already structural heart disease or left ventricular systolic dysfunction.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: Flecainideacetate

PubChem CID 41022

Molecular formula: C19H24F6N2O5

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.