Amiodarone is an antiarrhythmic indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. MedsAcross supplies Amiodarone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
NEXTERONE is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. NEXTERONE is an antiarrhythmic agent indicated for treatment and prophylaxis of ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy.
Source: US FDA prescribing information
Amiodarone is considered a class III antiarrhythmic drug, but it possesses electrophysiologic characteristics of all four Vaughan Williams classes. Like class I drugs, amiodarone blocks sodium channels at rapid pacing frequencies, and like class II drugs, amiodarone exerts a noncompetitive antisympathetic action. One of its main effects, with prolonged administration, is to lengthen the cardiac action potential, a class III effect. The negative chronotropic effect of amiodarone in nodal tissues is similar to the effect of class IV drugs. In addition to blocking sodium channels, amiodarone blocks myocardial potassium channels, which contributes to slowing of conduction and prolongation of refractoriness.
Source: US FDA prescribing information
• The recommended starting dosing regimen is: o Initial Load: 150 mg in 100 mL infused over 10 minutes o Followed by: 1 mg/min for 6 hours o Followed by: 0.5 mg/min thereafter • For breakthrough episodes of VF or hemodynamically unstable VT, repeat the Initial Load
Source: US FDA prescribing information
NEXTERONE is contraindicated in patients with: • Known hypersensitivity to any of the components of NEXTERONE Premixed Injection, including iodine. • Cardiogenic shock. • Marked sinus bradycardia. • Second- or third-degree atrioventricular (AV) block unless a functioning pacemaker is available. NEXTERONE is contraindicated in patients with: • Known hypersensitivity to any of the components of NEXTERONE, including iodine • Cardiogenic shock • Marked sinus bradycardia • Second- or third-degree atrio-ventricular (AV) block unless a pacemaker is available.
Source: US FDA prescribing information
• Hypotension: Slow the infusion, as needed, add vasopressor drugs, positive inotropic agents, and volume expansion. • Bradycardia and AV block: Slow the infusion or discontinue.
Source: US FDA prescribing information
The following adverse reactions are described elsewhere in labeling: • Hypotension • Hepatic injury • Proarrhythmia • Pulmonary injury • Thyroid injury • Hypersensitivity • The most common adverse reactions (1-2%) leading to discontinuation of intravenous amiodarone therapy are hypotension, asystole/cardiac arrest/pulseless electrical activity, VT, and cardiogenic shock. • Other important adverse reactions are torsade de pointes, congestive heart failure, and liver function test abnormalities.
Source: US FDA prescribing information
Drug interactions with amiodarone are described in Table 5 below. Table 5: Amiodarone Drug Interactions Concomitant Drug Class/Name Examples Clinical Comment QT Prolonging Drugs class I and III antiarrhythmics, lithium, certain phenothiazines, tricyclic antidepressants, certain fluoroquinolone and macrolide antibiotics, azole antifungals, halogenated inhalation anesthetic agents Increased risk of Torsade de Pointes. Avoid concomitant use. Negative Chronotropes digoxin, beta blockers, verapamil, diltiazem, clonidine, ivabradine Potentiates the electrophysiologic and hemodynamic effects of amiodarone, resulting in bradycardia, sinus arrest and AV block. Monitor heart rate. CYP450 Inhibitors Grapefruit juice, certain fluoroquinolone and macrolide antibiotics, azole antifungals, cimetidine Increased exposure of amiodarone.
Source: US FDA prescribing information
Store at 20° - 25°C (68° - 77°F), excursions permitted to 15° - 30°C (59° - 86°F). See USP Controlled Room Temperature. Protect from freezing. Protect from light and excessive heat.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
15 presentations of Amiodarone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Amiodarone 200 mg tabletOralGeneric name | — | US FDA | Available on request |
| Amiodarone 150 mg/3 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Amiodarone 100 mg tabletOralGeneric name | — | US FDA | Available on request |
| Amiodarone 450 mg/9 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Amiodarone 900 mg/18 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Amiodarone 400 mg tabletOralGeneric name | — | US FDA | Available on request |
| Pacerone 200 mg tabletOral | Upsher-Smith Laboratories | US FDA | Available on request |
| Pacerone 100 mg tabletOral | Upsher-Smith Laboratories | US FDA | Available on request |
| Amiodarone 300 mg tabletOralGeneric name | — | US FDA | Available on request |
| Pacerone 400 mg tabletOral | Upsher-Smith Laboratories | US FDA | Available on request |
| Amiodarone 150 mg/100 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Amiodarone 360 mg/200 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Amiodarone 50 mg/1 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Nexterone 150 mg/100 mL injectionIntravenous | Baxter Healthcare | US FDA | Available on request |
| Nexterone 360 mg/200 mL injectionIntravenous | Baxter Healthcare | US FDA | Available on request |
2 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 24 December 1985 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Amiodarone in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 15 presentations of Amiodarone and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Amiodarone, including Nexterone, Pacerone.
Yes. The US FDA first approved Amiodarone on 24 December 1985, according to Drugs@FDA.
No listed presentation of Amiodarone is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Amiodarone is classified under ATC code C01BD01 (Amiodarone).
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