Cordarone

(Amiodarone Hydrochloride)

The active ingredient in Cordarone is amiodarone hydrochloride.

Amiodarone works by slowing electrical signals in the heart that cause abnormal rhythms. It blocks certain potassium channels in the heart muscle, prolonging the electrical phase during which the heart refills with blood before beating again. This helps prevent rapid or irregular heartbeats.

In addition to potassium channel blockade, Cordarone also has effects similar to those of beta-blockers and calcium channel blockers, which help reduce heart rate and the heart’s workload.

Because of how it affects the heart’s electrical system, Cordarone can be used to treat a range of arrhythmias, including atrial fibrillation, ventricular tachycardia, and ventricular fibrillation.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Cordarone. However, the following is a synopsis of the general guidelines for the use of Cordarone:

• Cordarone is taken by mouth, usually once or twice daily, with or without food.
• Try to take it the same way each time (always with food or always without).
• Swallow tablets whole with a glass of water; do not crush or chew them.
• Your doctor may start you on a higher dose for several days or weeks before reducing it to a maintenance dose.
• Do not suddenly stop taking this medicine without medical advice.
• Avoid grapefruit and grapefruit juice while taking Cordarone, as it can increase the drug level in your bloodstream and raise the risk of side effects.
• Your doctor will regularly monitor your heart rhythm, blood pressure, liver function, lung function, and thyroid function through blood tests, chest X-rays, or ECGs while you are on this medication.

Some mild or common side effects of Cordarone seen in clinical trials as compared to placebo include:

• Nausea or vomiting.
• Constipation or stomach pain.
• Loss of appetite or weight changes.
• Fatigue or lightheadedness.
• Tremors.
• Blurred vision or seeing halos around lights.
• Changes in taste or a metallic taste in the mouth.

Some individuals may experience serious side effects while using Cordarone. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Shortness of breath, persistent cough, or chest pain (possible lung toxicity).
• Yellowing of the skin or eyes, dark urine, or severe fatigue (possible liver problems or jaundice).
• Vision problems or partial vision loss.
• Irregular heartbeat, slow heart rate (bradycardia), or fainting.

Numbness, tingling, or weakness in the hands or feet (peripheral neuropathy).

• Signs of thyroid problems include unexplained weight gain, weight loss, sensitivity to heat or cold, or swelling of the neck (thyroid dysfunction).
• Severe skin reactions or increased sensitivity to sunlight.

These are not all of the possible side effects of Cordarone. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Cordarone, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Heart failure or heart block.
• Low blood pressure or slow heart rate.
• Liver disease.
• Thyroid problems (either hypothyroidism or hyperthyroidism).
• Lung disease.
• A pacemaker or implanted defibrillator.
• Vision problems.
• Electrolyte imbalances (low potassium or magnesium).
• Amiodarone can increase your skin’s sensitivity to sunlight, so use sunscreen, wear protective clothing, and avoid sunlamps or tanning beds.
• Because of possible liver toxicity, your doctor will order blood tests to check liver function regularly.
• Tell your healthcare professional if you are taking any medications that may prolong the QT interval, as combining them with Cordarone may increase the risk of life-threatening arrhythmias.

Boxed Warning

Cordarone carries an FDA Boxed Warning for potential life-threatening pulmonary, hepatic, and proarrhythmic effects. It should only be used for treating serious, documented ventricular arrhythmias when other therapies are ineffective or not tolerated.

Patients must be closely monitored during treatment, including regular ECGs, liver and thyroid function tests, and chest X-rays.

Cordarone should not be used in patients who have:

• Severe sinus node dysfunction or heart block (without a pacemaker).
• Cardiogenic shock.
• Known hypersensitivity to amiodarone or iodine.
• Evidence of severe liver disease.
• Always review the full list of contraindications in the official product labeling before use.

Amiodarone has a long half-life and may take several days to weeks to reach full effect. Some improvement in heart rhythm may be seen after the loading dose period, but complete stabilisation may take up to a few weeks.

Because of its long action, Cordarone can remain in your system for weeks or months after stopping the medication.

When Cordarone is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Warfarin, digoxin, or beta-blockers.
• Antiarrhythmic drugs such as sotalol, quinidine, procainamide, or flecainide.
• Hepatitis C medications like ledipasvir or sofosbuvir.
• Cholesterol-lowering agents such as simvastatin, lovastatin, or atorvastatin.
• Phenytoin or cimetidine.
• Diuretics that may affect potassium or magnesium levels.
• St. John’s wort (may reduce the effects of Cordarone).
• Lidocaine or other drugs affecting heart rhythm.
• Avoid grapefruit juice and certain inhibitors that affect liver enzymes, as these can raise amiodarone levels in your blood.

Your healthcare provider may adjust dosages, monitor ECGs, or order blood tests to check for adverse reactions when using interacting medications.

Cordarone is available as oral tablets in the following strengths:

• 100 mg
• 200 mg
• 400 mg

The dose and treatment duration depend on your condition, age, response to therapy, and any coexisting health problems.

Store Cordarone tablets at room temperature, away from moisture, heat, and direct light.

Keep the medication in its original container and out of reach of children and pets.

Do not store it in the bathroom or near sources of humidity.

Cordarone is manufactured by Sanofi-Aventis. Generic amiodarone tablets are made by several other pharmaceutical companies and meet the same FDA standards for safety and effectiveness.

Yes. Cordarone’s generic name is amiodarone hydrochloride, and it is available in multiple strengths. Generic versions are typically less expensive and are considered equivalent in quality, safety, and efficacy to the brand-name medication.

Do not stop taking Cordarone suddenly without medical supervision. Because the drug stays in your system for a long time, stopping it abruptly may lead to a return of irregular heartbeat or other complications. Your doctor will guide you through a safe plan to taper or discontinue treatment.

Cordarone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Amiodarone crosses the placenta and may cause fetal thyroid dysfunction, bradycardia, growth retardation, or premature birth. If you are pregnant or planning to become pregnant, discuss the safest treatment options with your healthcare provider.

Amiodarone passes into breast milk and may cause adverse effects in a nursing infant, including thyroid changes or bradycardia. Breastfeeding is generally not recommended while taking Cordarone. If you plan to breastfeed, consult your doctor to determine the best course of action for you and your baby.