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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Nexterone (amiodarone Hci)
Generic Name
Nexterone (amiodarone Hci)
Active Ingredient
AmiodaroneCategory
Other
Salt Form
Hydrochloride
Variants
2
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 1.8 mg/mL | INJECTION, SOLUTION | INTRAVENOUS | 51662-1481 |
| 1.5 mg/mL | INJECTION, SOLUTION | INTRAVENOUS | 51662-1480 |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Nexterone (amiodarone Hci), you must consult a qualified healthcare professional.
Detailed information about Nexterone (amiodarone Hci)
Amiodarone is a potent Class III antiarrhythmic medication used to treat life-threatening heart rhythm disorders. It works by stabilizing the heart's electrical activity but requires careful monitoring due to its long half-life and potential for serious side effects.
Dosing for amiodarone is highly individualized and typically involves a 'loading phase' followed by a 'maintenance phase.' The goal of the loading phase is to saturate the body's tissues quickly so the drug can begin working.
Amiodarone is not FDA-approved for use in pediatric patients, and its safety and effectiveness in children have not been formally established in large-scale clinical trials. However, pediatric cardiologists may use it off-label for refractory arrhythmias in children. Dosing is strictly weight-based (e.g., 5 mg/kg to 10 mg/kg for loading). Parents must ensure the child is monitored by a specialist in pediatric electrophysiology.
Because amiodarone is not significantly excreted by the kidneys, dosage adjustments are generally not required for patients with kidney disease or those on dialysis. However, these patients should still be monitored closely for overall tolerance.
Amiodarone is extensively metabolized by the liver. Patients with significant liver disease (e.g., cirrhosis) may require lower doses or more frequent monitoring of liver function tests (LFTs). If liver enzymes increase to three times the normal limit, the drug may need to be discontinued.
Older adults often have a lower body mass and reduced organ function. Healthcare providers typically start elderly patients at the lower end of the dosing range to minimize the risk of ataxia (lack of muscle coordination), bradycardia (slow heart rate), and thyroid dysfunction.
If you miss a dose, do not double the next dose to catch up. Because amiodarone stays in your system for so long, a single missed dose is rarely an emergency, but consistency is key for heart rhythm control. Take the missed dose as soon as you remember, unless it is almost time for your next scheduled dose. If you are unsure, contact your healthcare provider.
An overdose of amiodarone can be life-threatening. Symptoms may include severe bradycardia (very slow heart rate), feeling lightheaded or fainting, and signs of liver distress. Because of the drug's long half-life, the effects of an overdose can last for a long time. In case of a suspected overdose, call 911 or your local poison control center immediately. Emergency treatment may include gastric lavage (stomach pumping) and cardiac monitoring.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking this medication without medical guidance, as stopping suddenly can cause your heart rhythm disorder to return.
Due to its accumulation in various tissues, side effects are common with amiodarone, especially during long-term therapy. Up to 75% of patients taking the drug for a year or more may experience some form of adverse effect.
Amiodarone is a high-alert medication. Because it can affect almost every organ system in the body, it requires a level of vigilance higher than most other heart medications. Patients must be committed to regular blood work and diagnostic testing. It is also important to note that because amiodarone has a very long half-life, warnings and precautions apply for several months even after you stop taking the drug.
The FDA-approved labeling for amiodarone contains the following boxed warnings:
Certain medications should never be taken with amiodarone because the risk of a fatal interaction is too high.
Amiodarone is a potent inhibitor of several liver enzymes (CYP2C9, CYP2D6, and P-glycoprotein). This means it increases the levels of many other drugs in your system.
There are specific medical conditions where the risk of using amiodarone is so high that it must never be used. These include:
Amiodarone is classified as FDA Pregnancy Category D. This means there is clear evidence of human fetal risk based on adverse reaction data from investigational or marketing experience.
Amiodarone and its metabolite, DEA, are excreted into breast milk in significant quantities.
Amiodarone is a complex electrophysiological agent. Its primary mechanism is the blockade of the rapid delayed rectifier potassium current ($I_{Kr}$), which prolongs the cardiac action potential (Phase 3). This increases the refractory period in all cardiac tissues, including the atria, ventricles, and the bypass tracts.
Additionally, it exhibits:
Common questions about Nexterone (amiodarone Hci)
Amiodarone is a potent antiarrhythmic medication primarily used to treat life-threatening heart rhythm disorders of the ventricles, such as recurrent ventricular fibrillation and unstable ventricular tachycardia. It is often reserved for patients who have not responded to other treatments due to its potential for serious side effects. Doctors may also use it 'off-label' to manage atrial fibrillation in patients with complex heart disease. It works by stabilizing the electrical activity in the heart to maintain a steady, normal rhythm. Because of its strength, it is considered a critical tool in cardiac medicine.
The most common side effects include nausea, vomiting, and constipation, which often occur during the initial high-dose loading phase. Many patients also experience neurological symptoms like tremors, lack of coordination, or a bitter/metallic taste in the mouth. A unique side effect is photosensitivity, where the skin becomes extremely sensitive to sunlight, sometimes leading to a blue-gray skin discoloration in sun-exposed areas. Nearly all long-term users develop tiny deposits on the surface of the eye called corneal microdeposits, though these rarely interfere with vision. Because the drug accumulates in tissues, these effects can persist long after the medication is stopped.
While there is no direct chemical reaction between amiodarone and alcohol, it is generally recommended to avoid or strictly limit alcohol consumption. Alcohol can act as a trigger for the very arrhythmias that amiodarone is trying to prevent, potentially making the treatment less effective. Additionally, both alcohol and amiodarone are processed by the liver, and combining them can increase the risk of liver irritation or damage. Since amiodarone already carries a 'Black Box' warning for liver toxicity, adding alcohol increases unnecessary risk. Always consult your cardiologist before consuming alcohol while on this medication.
Amiodarone is generally not considered safe during pregnancy and is classified as FDA Category D. It is known to cross the placenta and can cause significant harm to the developing fetus, most notably affecting the fetal thyroid gland. This can lead to congenital hypothyroidism or goiter in the newborn. It has also been linked to slow heart rates in the fetus and potential developmental delays. Healthcare providers only prescribe amiodarone to pregnant women in extreme, life-threatening situations where no other safer options are available. Women of childbearing age should use effective contraception while taking this drug.
Amiodarone does not work immediately when taken in tablet form because it must first build up in the body's tissues, a process called saturation. Even with high 'loading doses,' it typically takes between 2 days and 3 weeks to see the full antiarrhythmic effect. In emergency hospital settings, the intravenous (IV) form works much faster, often within hours, but the oral transition still requires time for long-term stability. Patients should not be discouraged if their heart rhythm doesn't stabilize on the first day of oral treatment. Consistent dosing as prescribed by your doctor is necessary to reach therapeutic levels.
You should never stop taking amiodarone suddenly without the direct supervision of your cardiologist. Stopping the medication abruptly can cause your life-threatening heart rhythm disorder to return, potentially leading to a cardiac emergency. Furthermore, because amiodarone stays in your body's tissues for a very long time (months), the 'withdrawal' of the drug's effect is naturally slow, but the underlying heart condition can destabilize quickly. If the drug needs to be stopped due to side effects, your doctor will provide a specific tapering schedule and likely start an alternative medication to protect your heart.
If you miss a dose of amiodarone, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and return to your regular schedule. Never take two doses at once to make up for a missed one. Because amiodarone has an exceptionally long half-life, missing a single dose is unlikely to cause an immediate return of your arrhythmia, but maintaining consistent blood levels is vital for long-term success. If you find yourself missing doses frequently, talk to your doctor about using a pill organizer or alarm system.
Amiodarone is not typically associated with direct weight gain as a primary side effect. However, it can cause hypothyroidism (an underactive thyroid) in up to 10% of patients. A common symptom of hypothyroidism is unexplained weight gain, along with fatigue, cold intolerance, and dry skin. If you notice you are gaining weight rapidly or feeling unusually sluggish while taking amiodarone, it may be a sign that the medication is affecting your thyroid gland. Your doctor will monitor your thyroid hormone levels (TSH) regularly to detect and treat this side effect if it occurs.
Amiodarone has a very high potential for drug interactions and can be dangerous when combined with certain other medicines. It significantly increases the levels of common drugs like warfarin (a blood thinner), digoxin, and certain cholesterol-lowering statins, which can lead to toxicity or bleeding. It also interacts with many antibiotics and anti-fungal medications. Because of these risks, you must provide your healthcare provider and pharmacist with a complete list of every medication, supplement, and herbal product you take. Your doctor will often need to adjust the doses of your other medications when you start or stop amiodarone.
Yes, amiodarone is available as a generic medication in both tablet and injectable forms. The generic versions are bioequivalent to the original brand-name versions, such as Cordarone or Pacerone. Generic amiodarone is typically much more affordable and is covered by most insurance plans. When switching between different manufacturers or between brand and generic, it is important to stay consistent and keep your doctor informed, although the FDA ensures that generic versions meet the same high standards for safety and effectiveness as the brand-name drug.
Other drugs with the same active ingredient (Amiodarone)
> Warning: Stop taking Amiodarone and call your doctor immediately if you experience any of these serious symptoms.
Long-term use of amiodarone requires a 'monitoring roadmap.' Because the drug accumulates, side effects can appear months or even years after starting treatment. Chronic use is associated with a higher risk of lung scarring and thyroid issues. Regular chest X-rays, liver function tests, and thyroid panels are mandatory for as long as you are on the medication.
The FDA has issued several 'Black Box' warnings for amiodarone, the most serious type of warning. These include:
Report any unusual symptoms to your healthcare provider immediately. Early detection of side effects is the best way to prevent permanent organ damage.
To ensure safety, the following monitoring schedule is typically recommended by the American Heart Association (AHA) and the Heart Rhythm Society (HRS):
Amiodarone may cause dizziness, tremors, or blurred vision. Do not drive or operate heavy machinery until you know how the medication affects you. If you experience halos or blurred vision at night, avoid driving after dark.
While there is no direct chemical interaction between amiodarone and alcohol, alcohol can irritate the heart and trigger arrhythmias, potentially counteracting the medication's effects. Furthermore, both alcohol and amiodarone are processed by the liver; combining them may increase the risk of liver strain. It is best to limit or avoid alcohol.
Never stop taking amiodarone abruptly. If you stop suddenly, your life-threatening arrhythmia could return. Furthermore, because the drug stays in your system for months, side effects may continue or even appear for the first time after you have stopped the medication. Any tapering must be done under the strict supervision of a cardiologist.
> Important: Discuss all your medical conditions, especially lung, liver, or thyroid disease, with your healthcare provider before starting Amiodarone.
Amiodarone contains iodine and can interfere with radioactive iodine uptake tests used to evaluate thyroid function. It can also cause false elevations in certain liver enzymes. Always inform lab technicians that you are taking amiodarone before having blood work or diagnostic imaging.
For each major interaction, your doctor will likely:
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking. Even 'natural' products can have dangerous interactions with amiodarone.
In these cases, a healthcare provider must perform a careful risk-benefit analysis. The drug is usually avoided unless no other options exist:
Patients who have had a severe reaction to other iodine-containing substances (like certain IV contrast dyes used in CT scans) should be monitored with extreme caution. While a 'shellfish allergy' is often thought to be an iodine allergy, it is usually an allergy to proteins in the fish; however, you should still disclose all allergies to your doctor.
> Important: Your healthcare provider will evaluate your complete medical history, including all allergies and previous reactions to medications, before prescribing Amiodarone.
As noted previously, amiodarone is not FDA-approved for children. However, it is used in pediatric cardiology for complex arrhythmias.
Clinical studies of amiodarone did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects.
Renal impairment does not significantly influence the pharmacokinetics of amiodarone. The drug is not dialyzable, meaning hemodialysis will not remove it from the system in the event of an overdose. No specific dose adjustment is required for patients with kidney disease, but they should be monitored for fluid balance, especially if receiving IV formulations which contain certain excipients.
Because amiodarone is primarily metabolized by the liver, patients with hepatic impairment (Child-Pugh Class B or C) are at higher risk for toxicity.
> Important: Special populations require individualized medical assessment. Always inform your specialist if you are pregnant, planning to become pregnant, or have underlying organ disease.
| Parameter | Value |
|---|---|
| Bioavailability | 35% - 65% |
| Protein Binding | ~96% (primarily to albumin) |
| Half-life | 15 - 142 days (Average 58 days) |
| Tmax | 3 - 7 hours (Oral) |
| Metabolism | Hepatic (CYP3A4, CYP2C8) to Desethylamiodarone |
| Excretion | Biliary/Fecal (>90%), Renal (<1%) |
Amiodarone belongs to the Class III Antiarrhythmic therapeutic area. Related medications include Sotalol, Dofetilide, and Ibutilide, though amiodarone is unique due to its multi-channel effects and significantly longer half-life.