Advertisements

Пропафенон

Quick links to important sections

Пропафенон

Selected form

Advertisements

Medically reviewed

Marina Burgos

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.

Advertisements

Overview of Пропафенон

Property Description
Active ingredient Propafenone hydrochloride
Form Tablet (immediate-release), Extended-release capsule, Solution for injection
Pharmacological class Antiarrhythmic agent (Class 1C)
Common use Regulation of heart rhythm in specific patient groups
Origin Synthetic, Prescription-only

Propafenone: What Type of Medicine Is It?

Propafenone, identified by the International Nonproprietary Name (INN) propafenone hydrochloride (Propafenonum), is a synthetic, prescription-only pharmaceutical compound that functions as an antiarrhythmic agent in cardiology. Its specific designation places it within the Vaughan-Williams classification system as a Class 1C antiarrhythmic. This classification is clinically recognized for defining drugs that exert a profound effect on the heart's electrical system, with the core function being to control and stabilize cardiac electrical activity.

Composition and Differentiating Features

The medicinal preparation contains propafenone hydrochloride as the sole active ingredient, which is administered as a racemic mixture of enantiomers, making it a single-ingredient product. Propafenone is structurally unique among some Class 1C agents because it also possesses weak beta-adrenergic blocker properties in addition to its primary sodium channel blocker effect. The drug is available primarily in immediate-release tablets and specialized extended-release capsules designed for oral administration, with a solution form reserved for intravenous administration.

General Purpose: What Does Propafenone Help To Achieve?

The general therapeutic purpose of Propafenone is to regulate and maintain a normal, steady heart rhythm in individuals experiencing electrical instability. It achieves this by reducing the heart's excitability to control excessively rapid heart beat or various forms of irregular heartbeats. This stabilization is often utilized in patients without underlying structural heart disease, and the drug is effective in stabilizing the heart's electrical conduction system.

Advertisements

What side effects are possible with Пропафенон?

Propafenone: Possible Side Effects and Safety Information

Propafenone's safety profile is formally classified by regulatory agencies, detailing potential adverse reactions across various body systems. The most frequently documented non-cardiac effects include dizziness and nausea, which are classified as Very Common (occurring in ge 1/10 patients) in official labeling. Effects listed as Common (ge 1/100 to <1/10 patients) include palpitations, bradycardia (slow heart rate), fatigue, and taste disturbance.


Systemic Adverse Reactions and Serious Concerns

The documented adverse effects are grouped by System-Organ Class (SOC), prominently featuring Cardiac Disorders, Nervous System Disorders, and Gastrointestinal Disorders. The most serious concerns highlighted in regulatory documents relate to the cardiac system:

  • Proarrhythmic Effects: Propafenone has a documented potential to cause new or worsen existing cardiac arrhythmias, including serious ventricular rhythms, which is a risk present particularly during dose initiation or escalation.
  • Other Serious Effects: The medication may provoke or exacerbate heart failure. Rare or post-marketing reports (Frequency Not Known) include severe blood disorders like agranulocytosis.

Population-Specific Safety Notes

Official labeling requires specific considerations for certain patient groups. Caution is required in individuals with impaired hepatic or renal function due to the potential for increased drug levels. Furthermore, Propafenone may alter the pacing and sensing thresholds of artificial pacemakers, necessitating monitoring.

The drug is associated with a negative inotropic effect (a weakening of heart muscle contraction), which is a general functional restriction noted in the regulatory documents.

Advertisements

Overdose and Emergency Response

Propafenone overdose is officially described in regulatory documents as severe, potentially fatal, and associated with life-threatening cardiac and neurological manifestations. Officially documented signs of acute intoxication include profound QRS widening, severe hypotension, and the occurrence of malignant ventricular arrhythmias such as ventricular fibrillation or ventricular tachycardia. Neurological symptoms may include dizziness, blurred vision, and escalating to severe complications like seizures, coma, and respiratory depression.

In any suspected overdose scenario, regulatory documents mandate that individuals must seek immediate medical attention. Emergency services must be contacted immediately if the affected person has collapsed, had a seizure, has trouble breathing, or cannot be awakened. There is no specific antidote known for Propafenone toxicity.

Treatment focuses on aggressive symptomatic and supportive measures. Officially described procedures may include prompt gastric lavage or administration of activated charcoal. Continuous cardiac monitoring is mandatory. Specific interventions, such as sodium bicarbonate administration, may be required to treat marked QRS widening. Furthermore, patients with impaired hepatic or renal function require careful monitoring due to potential accumulation risks.

Advertisements

Therapeutic Uses of Пропафенон

Propafenone (Пропафенон) is a specialized antiarrhythmic medicine used to address symptoms associated with a range of abnormal heart rhythms, known as arrhythmias. The medication is generally used to help manage an irregular heart rhythm. It is commonly applied in contexts marked by increased discomfort or tension caused by heart rhythm irregularities, and is relevant when supportive symptom management is appropriate.


Managing Episodic Fast Heart Rhythms

This therapeutic domain is used for managing symptoms related to sudden, fast heart rhythms that interfere with daily functioning. Propafenone is commonly used to help with conditions involving episodic or fluctuating manifestations, such as paroxysmal atrial fibrillation (AF) and paroxysmal supraventricular tachycardia (PSVT), and is applied in addressing these symptoms. It helps address symptom clusters that may appear suddenly, providing support that helps ease the overall symptom burden.

Addressing Symptoms Related to Ventricular Activity

This is applied in clinical settings that involve acute or unstable symptom patterns arising from the heart's lower chambers. The medicine is considered relevant for managing conditions associated with acute or disruptive episodes. When symptoms create noticeable physiological strain, this treatment offers symptomatic relief that helps patients cope more steadily and assists with maintaining functional stability.

Quick Fact: Supportive Management (The medicine is commonly used when symptoms create noticeable physiological strain, and additional symptomatic support is needed.)

Regulatory References

  1. NIH MedlinePlus Drug Information
Advertisements

Eligibility and Restrictions for Use

The eligibility for Propafenone is strictly determined by pre-existing cardiac function and specific comorbidities, as defined by regulatory authorities.

Absolute Contraindications

Propafenone is prohibited for patients with formal absolute contraindications, including:

  • Structural Heart Disease: Uncontrolled congestive heart failure, severe left ventricular output issues, or cardiogenic shock.
  • Conduction Defects: Severe sinoatrial, atrioventricular, or intraventricular conduction disorders, unless a functioning artificial pacemaker is present.
  • Other Conditions: Known Brugada Syndrome, severe obstructive pulmonary disease, marked hypotension, manifest electrolyte imbalances, and known hypersensitivity to the drug.

Population Restrictions and Limitations

  • Age: Use is not established and not recommended in the pediatric population (under 18 years). Older adults require cautious initiation.
  • Organ Function: Patients with impaired hepatic or renal function are classified for restricted use and must be carefully monitored due to the potential for drug accumulation.
  • Pregnancy/Lactation: Use during pregnancy is restricted, recommended only if the potential benefit justifies the potential risk to the fetus. Caution is advised during lactation.
Advertisements

What should I know about interactions with other medicines?

Interactions with other medicines and products

Propafenone's interaction profile is significantly influenced by its role as a substrate and inhibitor of the CYP450 enzyme system.

Propafenone is metabolized by CYP2D6, CYP3A4, and CYP1A2 enzymes. Co-administration with strong inhibitors of these enzymes, such as Quinidine (CYP2D6 inhibitor), increases propafenone plasma concentrations substantially. The combination of both a strong CYP2D6 inhibitor and a CYP3A4 inhibitor simultaneously is restricted by regulatory authorities due to the heightened risk of adverse cardiac events. Conversely, co-administration with strong inducers like Rifampin can lead to significantly reduced propafenone exposure.

As an inhibitor of CYP2D6 and the P-glycoprotein (P-gp) transporter, Propafenone can increase the plasma concentrations of co-administered medicines, including Digoxin and Warfarin. This effect necessitates careful monitoring when combined.

Other Documented Restrictions

  • Pharmacodynamic Effects: Propafenone has weak beta-blocking properties, leading to warnings against simultaneous use with other antiarrhythmic agents or drugs that prolong the QT interval, due to the risk of additive cardiac effects.
  • Food/Substance Interactions: Consumption of Grapefruit Juice must be avoided as it inhibits CYP3A4, resulting in an increase in propafenone blood levels. Drinking alcohol may increase the risk of dizziness.
  • Population-Specific Note: Patients who are genetically CYP2D6 Poor Metabolizers are at higher risk of interaction-related effects, mimicking strong CYP2D6 inhibition, necessitating specific restrictions.
Advertisements

Mechanism of Action

Propafenone is a multi-faceted agent classified pharmacologically as a Class 1C drug. Its primary mechanism involves blocking voltage-gated sodium channels in myocardial cells. By engaging these channels, the drug reduces the fast inward sodium current during the initial phase of the cardiac action potential (Phase 0). This interaction modulates the propagation velocity of electrical impulses through the myocardium, thereby reducing the excitability of the cardiac tissue.

Additionally, Propafenone engages mechanisms involving beta-adrenergic receptors. It exhibits weak beta-blocking properties, which affects systems where sympathetic neurotransmitters dominate. This action modulates the influence of sympathetic mediators on heart rate and myocardial contractility.

Propafenone also influences specific potassium channels. Although a secondary effect, the blockade of certain outward potassium currents can prolong the effective refractory period of the cardiac cells.

Advertisements

Dosage and Administration Information

Propafenone is an antiarrhythmic medication and should be used exactly as prescribed by your healthcare provider. The dose is individually titrated based on your response and tolerance, and it is crucial not to take more or less than instructed.

Administration Guidelines

  • Initial Treatment: Therapy is often initiated in a monitored hospital setting to safely evaluate your body's response, especially for potential new or worsened arrhythmias, and to establish a stable, effective dose.
  • Dosing Schedule: Propafenone immediate-release tablets are typically taken three times a day, approximately every 8 hours. The extended-release capsules are usually taken twice a day, about every 12 hours. Taking the doses at evenly spaced times helps maintain a steady level of medication in the blood.
  • Tablets/Capsules: Tablets can generally be taken with or without food. Extended-release capsules must be swallowed whole and should not be crushed, broken, or chewed.

What to Do About Missed Doses

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose (e.g., if more than four hours have passed for a three-times-daily schedule), skip the missed dose and continue with your regular schedule. Never take a double dose to make up for a missed one, as this can increase the risk of side effects.

Important Safety Points

  • Do not stop taking propafenone suddenly. Abrupt discontinuation can lead to an irregular heartbeat. Consult your doctor before making any changes.
  • Monitoring: Regular follow-up appointments, including electrocardiograms (ECGs) and potentially blood tests, are required before and during therapy to monitor heart function and adjust the dose as needed.
  • Interactions: Inform your doctor about all prescription, over-the-counter, vitamin, and herbal supplements you are taking. Avoid consuming grapefruit or grapefruit juice, as this may increase the amount of propafenone in your body and increase side effects.
Propafenone Formulation Typical Frequency Administration Note
Immediate-Release Tablets Three times a day Can be taken with or without food.
Extended-Release Capsules Two times a day Swallow whole; do not crush or chew.
Advertisements

Recent Clinical Evidence

Research Evidence / Overview of Studies for Propafenone

Propafenone was evaluated in research exploring heart rhythm patterns through formal clinical trials and systematic research. The available research is primarily derived from studies that include Randomized Controlled Trials (RCTs), which provide a standardized way to compare the medicine against other treatments or a placebo, and meta-analyses, which pool data from multiple trials.


Evidence for use in Preventing Atrial Fibrillation Recurrence

Research exploring Propafenone's role in preventing the return of Atrial Fibrillation (AF) or Atrial Flutter episodes primarily involves RCTs and meta-analyses. These studies focused on patients with conditions characterized by fluctuating or episodic manifestations. The research typically monitored outcomes related to the time until the next arrhythmia recurrence and the proportion of patients who were able to maintain a normal rhythm over defined time intervals.

Studies reported measurements that suggested a difference in the periods observed before the return of a symptomatic AF episode between groups, compared to control groups, within the trial observation periods. It is important to note that the results apply only to the populations studied, which were restricted to adults who did not have underlying structural heart conditions.


Evidence for use in Acute Heart Rhythm Conversion

Propafenone was evaluated in research scenarios focusing on the acute restoration of a normal heart rhythm. These studies were typically short-term, acute intervention trials that researched temporary physiological imbalance, specifically recent-onset AF. Researchers monitored outcomes describing episodic or acute changes by measuring the rate and speed at which the abnormal rhythm was converted to a normal sinus rhythm.

Reported results indicated a difference in the measured conversion times between Propafenone groups and control groups used for acute rhythm control. The findings are specific to AF that is recent-onset (lasting less than 48 hours in many trials) and do not reflect outcomes for long-standing AF.


Research Gaps and Unanswered Questions

While the data show patterns related to rhythm maintenance, long-term effects are not fully established for periods extending beyond the trial duration. Furthermore, a core area of uncertainty relates to the evidence for patients with structural heart disease; due to historical safety concerns, the certainty remains low for its use in this group, and these patients were generally excluded from primary efficacy trials.

Advertisements

Frequently Asked Questions (FAQ)

Common questions about Пропафенон (FAQ)


Q: What sensations might a patient feel when starting Propafenone?

Official product information indicates that very common side effects when starting this medication include dizziness and nausea (occurring in ge 1/10 patients). Other effects commonly reported are fatigue and a change in the sense of taste. These effects relate to how the body adjusts to the medication, according to official regulatory data.

Q: Is Propafenone the same as Anaprilin (Propranolol)?

No, they are different medicines. Propafenone is primarily classified as a Class 1C antiarrhythmic, meaning its main action is on the heart's sodium channels. While it also exhibits weak beta-blocking properties, Propranolol is a classic Class II antiarrhythmic (a pure beta-blocker) with a different primary mechanism of action.

Q: Does Propafenone affect blood pressure?

Yes, regulatory documents describe that Propafenone can cause hypotension (lowering of blood pressure) as a potential adverse reaction. Furthermore, pre-existing marked hypotension (very low blood pressure) is listed as a contraindication for using the medication.

Q: Is it true that Propafenone has many side effects?

Official labeling uses frequency categories to describe potential adverse reactions. For instance, common effects like dizziness and nausea are classified as 'Very Common,' meaning they are expected to occur in ge 1/10 patients. The most frequently reported issues are typically not classified as serious cardiac events.

Q: How long can Propafenone be taken?

Propafenone is prescribed for the long-term prevention of arrhythmia recurrence in certain patient groups, according to official indications. Regulatory reviews indicate that while the medicine is prescribed long-term, long-term effects extending beyond the duration of clinical trials are not fully established.

Q: Why is Propafenone sometimes prescribed to younger adults?

The use of Propafenone is determined by the specific type of heart rhythm disorder being treated, such as ventricular or supraventricular tachyarrhythmias. The decision to prescribe is based on the specific cardiac indication and the patient's underlying cardiac health (specifically, the absence of structural heart disease), rather than age alone.

Q: How might Propafenone interact with cold medicine?

Propafenone interacts with the CYP450 enzyme system, which metabolizes many drugs, including those found in over-the-counter cold medicines. There is also a risk of additive cardiac effects with certain cold medicine ingredients. Regulatory labeling advises informing a healthcare provider about all medications, including non-prescription cold remedies.

Q: Is a dietary change required when taking Propafenone?

Official product information explicitly states that consumption of grapefruit or grapefruit juice is restricted. This is because grapefruit can increase the concentration of Propafenone in the blood, potentially increasing the risk of adverse effects.

Q: Are there any restrictions on driving a car while taking Propafenone?

This medication may cause side effects such as dizziness, fatigue, blurred vision, and changes in blood pressure. Regulatory documents state that caution is required regarding driving or operating machinery until an individual understands the medication's effect.

Q: Can Propafenone affect eyesight?

Yes, official product safety information lists blurred vision as a potential side effect. This has been noted, particularly following a higher initial dose.

Q: Does Propafenone affect body weight?

Official safety lists indicate that weight gain is a potential, though less frequent, reported side effect. It is also important to note that unexpected weight increase may be a documented sign of worsening heart failure, a serious condition that requires medical evaluation.

Q: Can one drink coffee while taking Propafenone?

Propafenone is known to affect the enzyme (CYP1A2) that processes caffeine in the body, which can slow down how quickly caffeine is eliminated. Information regarding concomitant use is intended for discussion with a healthcare provider, especially for individuals who are known poor metabolizers of the drug.

Q: What are the warning signs that Propafenone may not be suitable?

Official labeling suggests seeking medical evaluation for serious adverse effects, including the onset of chest pain, fainting (syncope), shortness of breath, or swelling of the hands or feet. Additionally, any significant changes to the heart rhythm, such as a severely fast, slow, or irregular heartbeat, are noted as requiring medical evaluation.

Q: How does Propafenone affect ECG results?

As expected with its mechanism of action, the medication causes a slight prolongation of the PR interval and widening of the QRS complex on an electrocardiogram (ECG). Significant lengthening of these intervals may be a sign that a dose reduction or discontinuation of the medicine is required.

Q: Are there special considerations for smokers taking Propafenone?

Official drug information indicates that cigarette smoking may reduce the effectiveness of Propafenone. Official documents describe the importance of informing the prescribing physician about the use of tobacco products.

Q: Can Propafenone interact with antidepressants?

Yes, Propafenone can interact with many antidepressants, such as SSRIs, because both types of drugs are often metabolized or inhibited by the same enzyme system (CYP2D6). This interaction may lead to increased Propafenone levels in the plasma, potentially necessitating a dose adjustment.

Q: What does 'extended-release' mean for Propafenone?

The extended-release formulation is designed to maintain a more consistent level of the medicine in the blood over a longer period. This formulation typically allows the drug to be taken less frequently, such as twice a day, compared to the immediate-release tablet.

Advertisements

How should Пропафенон be stored and disposed of?

How to Store and Dispose of Propafenone

The storage and disposal of Propafenone (propafenone hydrochloride) must strictly follow the requirements set forth in official prescribing information to ensure drug stability and public safety.

Storage Requirement Official Condition
Temperature Store at room temperature, generally not above 25 C or 30 C. Keep away from excessive heat and do not freeze.
Environment Protect from moisture and direct light. Keep the medicine in its original, tightly closed container and carton.
Safety Keep the medicine out of the sight and reach of children, securing it immediately with a locked safety cap.

For disposal, do not throw away Propafenone in household trash or pour it down a drain or toilet. Unused or expired medication must be handled in accordance with local requirements or through consultation with a healthcare professional.

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

Available in countries:

Equivalent of Пропафенон found in:

A-Z Index: