Amiodacore

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Medically reviewed

Laura Arias

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 Amiodacore

Property Description
Active Ingredient Amiodarone Hydrochloride
Pharmacological Class Class III Antiarrhythmic Agent
Primary Forms Oral Tablet and Intravenous Solution
General Purpose Electrical Stabilization of the Heart
Origin Synthetic Organic Compound

What Type of Medicine is Amiodarone Hydrochloride?

Amiodacore is a preparation whose active ingredient is Amiodarone Hydrochloride, which is principally classified as an antiarrhythmic agent used to manage severe electrical disturbances in the heart. This medicinal substance is a synthetic organic compound, specifically a benzofuran derivative, and is designated as a Class III Antiarrhythmic within the Vaughan Williams classification system. Amiodarone is unique among Class III agents because it exhibits properties from all four antiarrhythmic classes, targeting potassium, sodium, and calcium channels simultaneously. The drug's distinctive chemical structure, which incorporates two atoms of iodine, contributes to its prolonged duration of action and efficacy in rhythm control. Amiodarone is used for maintaining sinus rhythm in patients with atrial fibrillation, helping the heart maintain a regular, steady beat.

Composition and Available Pharmaceutical Forms

The core composition is the single active ingredient, Amiodarone Hydrochloride, which confirms its status as a single-ingredient product entirely manufactured through chemical synthesis. Amiodacore is available in two key dosage forms for different routes of administration: an oral tablet form and a sterile solution for intravenous (IV) use. The intravenous solution requires the active ingredient to be dissolved in an aqueous base using specialized substances to maintain its solubility for critical parenteral delivery, providing flexibility in managing a patient's transition from acute rhythm instability to long-term maintenance.

The General Purpose of Amiodarone: Electrical Stabilization

The essential function of Amiodacore is to achieve electrical stabilization within the myocardium. The medicine assists the heart by extending the effective refractory period and action potential duration of heart muscle cells. This action helps to suppress or prevent rapid, chaotic, or disorganized electrical activity, ensuring the heart can maintain a more regulated and steady rhythm. Amiodarone is used in the management of severe ventricular and supraventricular tachyarrhythmias, serving as a tool for restoring order to heart rhythm irregularities.

What side effects are possible with Amiodacore?

Officially Documented Side Effects and Safety Profile

The safety profile for Amiodacore (Amiodarone Hydrochloride) is extensive, covering adverse reactions across multiple organ systems and classifying them by their official frequency of occurrence as documented in government regulatory sources (e.g., EMA SmPC, FDA Label).

Frequency-Classified Adverse Reactions

Frequency Category Examples of Associated Effects (by System-Organ Class)
Very Common (ge 1/10) Corneal microdeposits (Eye Disorders); Nausea, vomiting (Gastrointestinal); Increased transaminases (Hepato-biliary)
Common (< 1/10 and ge 1/100) Bradycardia (Cardiac); Hypothyroidism, Hyperthyroidism (Endocrine); Pulmonary inflammation/fibrosis (Respiratory); Acute liver disorders (Hepato-biliary)
Uncommon/Very Rare Peripheral neuropathy (Nervous System); Optic neuropathy/neuritis (Eye Disorders); Chronic liver disease (Hepato-biliary)

Serious Adverse Reactions

The most clinically significant adverse reactions explicitly documented by regulatory agencies involve high-risk, potentially fatal conditions:

  • Pulmonary Toxicity: Serious risks include pulmonary inflammation and fibrosis, which have been associated with respiratory failure.
  • Hepatic Toxicity: Acute or chronic liver disorders, including hepatic failure, are reported.
  • Proarrhythmia: The onset or worsening of existing arrhythmias, including life-threatening rhythms such as Torsade de Pointes.

Safety Restrictions and Limitations

Regulatory documents establish specific constraints on the use of Amiodacore:

  • Contraindications: The medicine is contraindicated in individuals with known hypersensitivity to the drug or iodine, pre-existing thyroid dysfunction, or severe conduction disturbances (unless a functioning pacemaker is present).
  • Time-Related Effects: Certain gastrointestinal effects and transaminase increases are noted as occurring commonly during the initial loading dosage, while serious effects like pulmonary fibrosis or blue-gray skin discoloration are associated with long-term exposure.
  • Population Notes: The intravenous form is contraindicated for neonates, and elderly patients require close monitoring for severe cardiac disturbances.

Overdose and Emergency Response

Overdose of Amiodarone Hydrochloride is officially documented to present primarily with signs of severe cardiovascular instability. These manifestations include profound bradycardia (slow heartbeat), severe hypotension, and heart conduction disturbances such as AV block. Systemic symptoms may also be observed, including nausea, blurred vision, lightheadedness, and fainting.

Regulatory documents state that an overdose carries the risk of life-threatening outcomes, including shock, further worsened arrhythmia, acute hepatocellular necrosis, and acute renal failure, which can result in a fatal outcome.

Emergency medical attention is required immediately for any suspected overdose. Due to the drug’s long elimination half-life, the resulting adverse effects may persist after withdrawal. Management is strictly supportive, as no specific antidote is known, and the substance is not removable by dialysis. Treatment focuses on initiating symptomatic support, which may involve temporary cardiac pacing or administering vasopressors and fluids. Continuous monitoring of liver function is required due to the documented risk of hepatic injury.

Therapeutic Uses of Amiodacore

What Amiodacore Treats: Main Uses and Benefits

The primary purpose of Amiodacore is to assist with managing symptoms related to heightened physiological activity and rhythm disorders. The medication is used to help manage these conditions as part of a therapeutic approach.

Clinical Focus and Symptom Relief

Amiodacore is considered relevant in clinical settings that involve acute or unstable symptom patterns. It is used across conditions presenting with acute episodes, including recurrent ventricular fibrillation, unstable ventricular tachycardia, and complex supraventricular tachyarrhythmias. This supportive function is applied across domains where additional symptomatic support is needed to help manage symptoms associated with recurrent episodes.

“It is commonly used when symptoms become more noticeable and supportive rhythm management is appropriate.”

The medication helps address symptom clusters that may become intense or disruptive, supporting patients during difficult episodes by easing distress. The medication may assist with easing the overall symptom load of palpitations and light-headedness, supporting the patient during difficult episodes.


Quick Fact: Symptomatic Support for Rhythm Disorders Amiodacore provides supportive relief when symptoms create noticeable physiological strain and interfere with daily functioning.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Amiodacore (amiodarone) is an antiarrhythmic medication generally reserved for managing life-threatening recurrent ventricular fibrillation or hemodynamically unstable ventricular tachycardia when other treatments have failed or are not tolerated.


Who Can Use Amiodacore?

This medication is primarily indicated for patients with serious, life-threatening ventricular arrhythmias who have not responded adequately to alternative agents.


Who Cannot Use Amiodacore?

Due to its potential for serious side effects, Amiodacore is contraindicated in several patient populations. It should not be used in individuals with:

  • Hypersensitivity (allergy) to amiodarone, iodine, or any component of the formulation.
  • Severe conduction disturbances such as marked sinus bradycardia, sino-atrial block, or second- or third-degree atrioventricular (AV) block, unless the patient has a functioning pacemaker.
  • Cardiogenic shock or severe arterial hypotension (very low blood pressure).
  • Thyroid dysfunction (evidence or history of hypo- or hyperthyroidism) due to the drug's effect on thyroid function.
  • Pregnancy and breastfeeding due to potential harm to the fetus or infant.

Caution is also advised in patients with pre-existing lung or liver disease, and those taking other medications that prolong the QT interval on an electrocardiogram.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Amiodacore’s official interaction profile, documented in government regulatory labeling, is defined by its role as a potent inhibitor of metabolic pathways and its effects on the heart's electrical system.

Interaction Scope Constraint or Regulatory Description
Formal Contraindicated Combinations The co-administration of Amiodacore with other medicines known to prolong the QTc interval (e.g., specific Class I and Class III antiarrhythmics) is formally prohibited due to the risk of Torsade de Pointes (TdP).
High-Risk Exposure Modification Amiodacore significantly increases the plasma concentration of co-administered medicines that are metabolized by CYP2C9 (e.g., Warfarin) or transported by P-glycoprotein (P-gp) (e.g., Digoxin). Co-administration with certain statins is also restricted due to increased exposure via CYP3A4 inhibition.

Pharmacodynamic and Environmental Interactions

Interaction Type Regulatory Finding
Additive Cardiac Effects Co-administration with Negative Chronotropes (e.g., certain Beta-blockers and Calcium Channel Blockers) or Sofosbuvir-containing regimens is associated with a risk of severe bradycardia, sinus arrest, and AV block.
Food and Herbal Influence Ingestion with Grapefruit Juice (a documented CYP3A4 inhibitor) is advised against, as it officially increases Amiodacore plasma concentrations. St. John’s Wort is documented to decrease plasma concentrations.
Interaction Persistence Due to the medicine's exceptionally long half-life, the risk of clinically significant interactions can persist for several weeks or months following the discontinuation of the medicine.
Administration Timing Official labeling notes that oral administration should be consistent with respect to meals to maintain stable absorption.

Mechanism of Action

Multi-Channel Modulation of Cardiac Electrical Currents

Amiodarone's primary action is the inhibition of multiple cardiac ion channels ( K^+, Na^+, and Ca^2+). This multi-target blockade significantly prolongs the heart cell’s recovery period (Effective Refractory Period, ERP) and slows conduction velocity. This action reduces the tissue's excitability to premature electrical stimuli, thereby impeding the propagation of re-entrant electrical circuits .

Modulation of Autonomic Signaling and Conduction Velocity

This mechanism involves the noncompetitive antagonism of beta-adrenergic receptors and a weak calcium channel block. This reduces the excitatory influence of the sympathetic nervous system on the heart and slows the rate at which electrical signals pass through the nodal tissues, contributing to a reduction in sinus node automaticity and conduction velocity.

Systemic Vascular and Endocrine Pathway Modulation

Amiodarone exerts an independent effect as a direct vasodilator, relaxing smooth muscle in blood vessel walls. Separately, the molecule inhibits key deiodinase enzymes and binds to thyroid hormone receptors. The vascular action leads to a reduction in systemic vascular resistance, resulting in reduced myocardial oxygen demand, while the endocrine interactions introduce a unique, non-cardiac molecular consequence.

Dosage and Administration Information

Administration Routes and Setting

Amiodacore is administered either as an oral tablet for long-term therapy or as a sterile solution for intravenous (IV) infusion for acute stabilization. The initiation of therapy, whether oral or intravenous, occurs within a hospital or specialist setting where continuous cardiac monitoring is available. IV administration is used for acute episodes, with a typical duration that does not exceed two to three weeks.

Phased Dosing Regimen

The medicine is used following a two-part procedural structure involving a loading phase and a maintenance phase. The oral loading regimen involves a high daily dose, typically ranging from 800 mg to 1600 mg, which is administered in divided doses for one to three weeks. Following this initial titration period, the dose is gradually reduced to a long-term maintenance dose, commonly 400 mg per day.

For acute IV use, the first 24 hours involve a sequence of infusion rates to deliver a total loading dose of approximately 1000 mg. Supplemental 150 mg infusions may be administered for breakthrough episodes.

Contextual Use and Specifics

The oral tablets are taken consistently with respect to meals to help standardize the body's absorption of the medicine. The IV solution concentrate is diluted using 5% Dextrose solution, and infusions with high concentrations are preferably delivered via a central venous catheter. While no dose adjustment is required for patients with renal impairment, close monitoring and potentially a lower starting dose are appropriate for older adults.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Amiodacore


Evidence for Use in Life-Threatening Heart Rhythm Disorders

Amiodacore was studied for severe, life-threatening heart rhythm problems, specifically recurrent ventricular fibrillation (VF) and unstable ventricular tachycardia (VT). The research base for this use includes large, organized Randomized Controlled Trials (RCTs) and meta-analyses that observed patterns in many patients over time. Research examined how frequently these dangerous rhythm events returned after administration, and studies tracked measures of arrhythmic mortality and overall survival.

Findings from trials describe patterns observed in the short-term and intermediate periods. However, certain aspects remain uncertain. The long-term effects are not fully established regarding the overall survival advantage when compared to non-drug treatments, such as device therapy. Additionally, the results apply only to the populations studied, meaning the patterns may vary for individuals with different underlying heart conditions.


Evidence for Managing Atrial Fibrillation and Atrial Flutter

The role of Amiodacore in atrial fibrillation (AF) and atrial flutter (AFL) was evaluated in a significant number of Randomized Controlled Trials and large observational cohorts. Researchers designed studies to measure whether the drug was observed in helping the heart convert back to and maintain a normal sinus rhythm over time. Research examined patient-reported outcomes describing perceived discomfort.

Findings indicate data show patterns related to the maintenance of normal rhythm when compared to other rhythm control medicines. Follow-up durations in these AF studies were often long-term, extending from six months to two years, which provides context regarding the follow-up durations for these conditions. A primary limitation is the variability in patient characteristics (heterogeneity), which is described by researchers.


Understanding the Strength and Gaps in the Evidence

The evidence supporting the use of Amiodacore contributes to the broader evidence landscape for severe heart rhythm disturbances. It is important to understand that evidence quality varies across studies, ranging from High-level evidence (for core indications like AF rhythm maintenance) derived from RCTs, down to Low-level evidence for some complex supraventricular tachyarrhythmias (SVT) where only small case series exist.

Subgroup findings are uncertain due to limited patient numbers in specific categories. Evidence highlights what is known — and what is still uncertain. Research does not determine whether an individual will respond similarly; study results reflect the specific conditions under which they were conducted.

Key Studies & References

  1. Amiodarone Uses, Dosage & Side Effects - Drugs.com
  2. Amiodarone - Wikipedia (Reflecting general consensus and trial summaries)

Frequently Asked Questions (FAQ)

Common questions about Amiodacore (FAQ)


Q: Is Amiodacore considered a 'last resort' heart medication?

Official documents state that Amiodacore is generally reserved for treating severe, life-threatening ventricular arrhythmias (irregular heartbeats) when other treatments have not been effective or cannot be tolerated. This classification indicates that its use is carefully considered due to its risk profile.

Q: What is the risk of having lung problems (pulmonary toxicity) with Amiodacore?

The risk of serious lung problems, known as pulmonary toxicity (inflammation or scarring of the lung tissue), is an officially documented concern. Respiratory effects like pulmonary inflammation or fibrosis are classified as Common adverse reactions, meaning they are reported to occur in approximately 1 out of every 10 to 100 patients.

Q: What are the signs of liver problems I should watch for while taking Amiodacore?

Signs described in official regulatory warnings include unusual tiredness or weakness, dark urine, or yellowing of the skin or the whites of the eyes (jaundice). These symptoms may suggest a need for medical assessment.

Q: Will Amiodacore make my skin more sensitive to the sun?

Yes, official labeling states that Amiodarone has been observed to cause photosensitivity (increased sensitivity to sunlight or UV light) in about 10% of patients. Regulatory information indicates that protective measures, such as covering up or using sunscreens, are often mentioned in the context of managing photosensitivity.

Q: Can Amiodacore cause a blue-gray discoloration of the skin?

Official product information notes that a blue-gray discoloration of the skin exposed to the sun can occur. This cosmetic effect is associated with long-term treatment, and the risk may be higher for individuals with a fair complexion.

Q: Can taking Amiodacore affect my vision or cause issues with bright lights at night?

Yes, regulatory sources list corneal microdeposits (tiny deposits in the outer layer of the eye) as a very common side effect. Although often without symptoms, these deposits can be associated with visual symptoms such as seeing halos (circles around objects) or experiencing increased sensitivity to light.

Q: Can Amiodacore be taken with or without food?

Official documents advise taking the oral tablets consistently with respect to meals. This requirement means that consistency in taking the medicine—either always with food or always without food—is necessary to help ensure stable and uniform absorption.

Q: What is a 'loading dose' of Amiodacore?

A loading dose refers to an initial, higher daily dose administered when beginning therapy. The purpose of this short-term regimen is to quickly raise the level of the medicine in the body’s tissues to the concentration necessary to achieve its initial therapeutic effect.

Q: Can the drug deposits in the eyes (corneal deposits) affect daytime vision?

Corneal microdeposits are very common, and although many patients do not experience visual changes, the deposits have been associated with symptoms like eye discomfort, blurred vision, or halos around lights. These effects usually do not severely impact typical daytime vision, but they require ongoing monitoring.

Q: Does Amiodacore contain iodine?

Yes, the active ingredient in Amiodacore, Amiodarone, is chemically known as an iodine-containing compound. Its molecular structure incorporates two atoms of iodine, which contributes to its unique chemical and pharmacological properties.

Q: How long does it take for Amiodacore to start working?

The onset of the initial antiarrhythmic effect for the oral tablets can take anywhere from 2 to 3 days up to 1 to 3 weeks, even when a high loading dose is used. This is because the medicine takes time to accumulate in the body’s tissues.

Q: How long does Amiodacore stay in the body after stopping the medicine?

Amiodacore leaves the body very slowly due to its exceptionally long half-life, which regulatory documents state can range from 25 to 100 days. Because of this, its effects and the risk of interactions can persist for several weeks or months after treatment is stopped.

Q: Can Amiodacore cause thyroid issues like hyperthyroidism or hypothyroidism?

Yes, due to its structure containing iodine, both Hypothyroidism (an underactive thyroid) and Hyperthyroidism (an overactive thyroid) are explicitly documented as Common adverse reactions. Regulatory sources describe that close monitoring of thyroid function is a standard measure during treatment.

Q: Is it normal to experience a metallic taste or changes in smell with Amiodacore?

Changes in the ability to taste and smell are documented as side effects of Amiodacore. Patients have reported a metallic or unpleasant taste, which is categorized in official drug information.

Q: Is it true that Amiodacore can cause numbness or tingling in the hands and feet?

Yes, official labeling notes that chronic use may lead to the development of peripheral neuropathy, which is a nervous system disorder. This may include symptoms such as numbness, tingling, or pain in the hands and feet.

Q: Why are regular blood tests and eye exams needed while taking Amiodacore?

Regular testing is required by regulatory guidelines to monitor for organ toxicity. The tests, which include blood work and eye exams, help to detect potential adverse effects on the thyroid, liver, and eyes, all of which are documented as areas of concern.

Q: Is Amiodacore used for Atrial Fibrillation (AFib)?

While the medicine's primary approval is for life-threatening ventricular arrhythmias, official research indicates that it is also commonly used and studied for the treatment of Atrial Fibrillation (AFib). It is frequently employed for controlling heart rhythm in these patients.

Q: Does Amiodacore interact with common over-the-counter pain relievers?

Official drug interaction resources indicate potential for interaction with some common non-prescription medicines. This may include certain common non-prescription pain relievers.

Q: Is Amiodacore safe to use for children or in the elderly?

Official product information states that safety and effectiveness have not been established for pediatric use (in children). For older adults (geriatric patients), official information indicates that a lower starting dose and close monitoring are often considered due to an increased risk of specific adverse effects.

Q: Can Amiodacore be used during pregnancy?

No, regulatory documents state that Amiodacore is contraindicated (should not be used) during pregnancy. This restriction is in place because the medicine carries a potential for harm to the fetus, particularly an impact on the developing fetal thyroid gland.

Q: Is it safe to breastfeed while taking Amiodacore?

No, regulatory documents state that Amiodacore is contraindicated (should not be used) while breastfeeding. This is due to the potential for the medicine to pass to the infant, where it may affect the baby’s heart or thyroid function.

Q: Are there different brand names for the medicine containing Amiodarone?

Yes, the active ingredient in Amiodacore is Amiodarone, and this chemical substance is sold under various different brand names. The names Cordarone and Pacerone are two common examples of other products containing amiodarone.

Q: How does Amiodacore compare to other medicines used for irregular heartbeats (in terms of drug class)?

Amiodacore is officially classified as a Class III Antiarrhythmic agent. It is considered unique within this group because it exhibits properties that affect the heart’s electrical system in ways similar to all four major antiarrhythmic classes.

Q: What should be done if I experience a persistent cough or shortness of breath while on this medicine?

The sudden onset of a new or worsening cough or shortness of breath is described in official warnings as a potential sign of serious lung toxicity. Official regulatory warnings describe these symptoms as requiring prompt medical assessment.

Q: Does Amiodacore interfere with the effects of general anesthesia during surgery?

Yes, regulatory information indicates that long-term treatment with Amiodacore may add to the hemodynamic risk inherent to general anesthesia. Because of this, informing the anesthetist prior to any surgery is described as necessary to manage the potential effects on heart conduction and blood pressure.

Q: How quickly do the blue-gray skin changes usually fade after stopping Amiodacore?

Clinical observations indicate that the blue-gray skin discoloration resolves very slowly after the medicine is stopped. The process may take several months or over a year for the pigmentation to completely fade.

Q: How is Amiodacore eliminated from the body?

Regulatory documents describe that Amiodacore is eliminated primarily through metabolism in the liver. The medicine and its breakdown products are then largely excreted through the bile. Only a very small amount is eliminated via the urine.

Q: Can Amiodacore cause anxiety or trouble sleeping?

Yes, official drug information documents list side effects related to the nervous system. Difficulty falling asleep or staying asleep (insomnia) is documented, and feelings of nervousness or restlessness may also occur.

Q: Are there specific symptoms that require immediate medical attention while taking Amiodacore?

Yes, the official warnings describe several symptoms that indicate serious adverse reactions. These include signs of liver injury, severe trouble breathing, or a noticeable worsening of heart rhythm, all of which are described as needing prompt assessment.

Q: How often are thyroid function tests usually required?

Monitoring guidelines supported by regulatory authorities recommend conducting thyroid function tests (specifically TSH) at baseline before starting treatment. Routine monitoring is typically recommended thereafter, approximately every 6 months during therapy.

Q: Can Amiodacore cause diarrhea or constipation?

While various gastrointestinal issues are documented, the side effect of constipation is specifically listed in official drug information. Other gastrointestinal effects like nausea and vomiting are also common.

How should Amiodacore be stored and disposed of?

How to Store and Dispose of Amiodarone Hydrochloride Tablets

Amiodarone hydrochloride tablets must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). The medication must be kept in its original package and stored in a tightly closed, light-resistant container.

Storage Requirements

  • Keep from freezing and do not store above 25 C.
  • Must be protected from light and moisture.
  • Store out of the reach of children and out of sight.

Disposal

Disposal should be via a community drug take-back program. If this is unavailable, the medication is not on the flush list and should not be poured down the sink or toilet. For household trash, mix the tablets with an undesirable substance (e.g., dirt) and seal the mixture in a container before discarding.

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

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