Concomitant Drug Class/Name | Examples | Clinical Comment |
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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. |
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CYP450 Inhibitors | grapefruit juice, certain fluoroquinolone and macrolide antibiotics, azole antifungals, cimetidine, certain protease inhibitors | Increased exposure of amiodarone. Avoid concomitant use. |
CYP450 Inducers | St. John's Wort | Reduced amiodarone serum levels. |
Cyclosporine | Increased plasma levels of cyclosporine have been reported resulting in elevated creatinine, despite reduction of cyclosporine dose. Monitor cyclosporine drug levels and renal function with concomitant use. | |
Cholestyramine | Reduced amiodarone serum levels. | |
Antiarrhythmics | quinidine, procainamide, flecainide | Reserve concomitant use for patients who are unresponsive to a single agent. Antiarrhythmic metabolism inhibited by amiodarone. Initiate antiarrhythmic at a lower than usual dose and monitor patient carefully. Reduce dose levels of previously administered antiarrhythmic by 30 to 50% for several days after transitioning to oral amiodarone. Evaluate continued need for antiarrhythmic. |
Digoxin | Increased digoxin concentration. Reduce digoxin by half or discontinue. If continued, monitor for evidence of toxicity. | |
HMG-CoA Reductase Inhibitors | simvastatin, lovastatin, atorvastatin | Increased plasma concentration of HMG- CoA reductase inhibitor. Limit the dose of lovastatin to 40 mg. Limit the coadministered dose of simvastatin to 20 mg. Lower starting dose of other CYP3A4 substrates may be required. |
Warfarin | Potentiates anticoagulant response and can result in serious or fatal bleeding. Coadministration increases prothrombin time by 100% after 3 to 4 days. Reduce warfarin dose by one-third to one-half and monitor prothrombin times. | |
Phenytoin | Increased steady-state levels of phenytoin. Monitor phenytoin levels. | |
Hepatitis C Direct Acting Antiviral | sofosbuvir | Cases of symptomatic bradyarrhythmia requiring pacemaker insertion have been reported in patients on oral maintenance amiodarone who initiated therapy with sofosbuvir. |
CYP3A Substrate | lidocaine | Sinus bradycardia has been reported with oral amiodarone in combination with lidocaine given for local anesthesia. Monitor heart rate. A lower starting dose of lidocaine may be required. |
CYP3A Substrate | fentanyl | Fentanyl in combination with amiodarone may cause hypotension, bradycardia, and decreased cardiac output. |
This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: September 2020 | ||
Amiodarone Hydrochloride (A-mee-OH-da-rone HYE-droe-KLOR-ide) Tablets, USP |
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Amiodarone hydrochloride tablets should be started in a hospital so that your medical condition can be carefully monitored. | |||
Amiodarone hydrochloride tablets should only be used to treat people who have been diagnosed with life-threatening heartbeat problems called ventricular arrhythmias, when other treatments did not work or you cannot tolerate them. | |||
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You may still have side effects after stopping amiodarone hydrochloride tablets because the medicine stays in your body for months after treatment is stopped. | |||
You should have regular check-ups, blood tests, chest x-rays before and during treatment with amiodarone hydrochloride tablets to check for serious side effects. You should also have lung function tests before starting treatment with amiodarone hydrochloride tablets. | |||
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Amiodarone hydrochloride tablets are a prescription medicine used to treat people who have been diagnosed with life-threatening heartbeat problems called ventricular arrhythmias, when other treatments did not work or you cannot tolerate them. | |||
It is not known if amiodarone hydrochloride tablets are safe and effective in children. | |||
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Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Amiodarone hydrochloride tablets and certain other medicines can affect with each other and cause serious side effects. You can ask your pharmacist for a list of medicines that interact with amiodarone hydrochloride tablets. | |||
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The most common side effects of amiodarone hydrochloride tablets include: | |||
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Amiodarone hydrochloride tablets may affect fertility in males and females. It is not known if the effects are reversible. Talk to your healthcare provider if you have concerns about fertility. | |||
These are not all the possible side effects of amiodarone hydrochloride tablets. For more information, ask your healthcare provider or pharmacist. | |||
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |||
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Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use amiodarone hydrochloride tablets for a condition for which it was not prescribed. Do not give amiodarone hydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about amiodarone hydrochloride tablets that is written for health professionals. | |||
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Medication Guides available at www.northstarrxllc.com/products or call 1-800-206-7821. | |||
Manufactured for: Northstar Rx LLC Memphis, TN 38141. |
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Manufactured by: Mayne Pharma Greenville, NC 27834. |
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