Amiodarone Intravenous, Oral

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For amiodarone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to amiodarone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of amiodarone in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amiodarone in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving amiodarone.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking amiodarone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using amiodarone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Bepridil
• Cisapride
• Colchicine
• Dronedarone
• Fingolimod
• Fluconazole
• Grepafloxacin
• Indinavir
• Ketoconazole
• Levomethadyl
• Mesoridazine
• Nelfinavir
• Pimozide
• Piperaquine
• Posaconazole
• Ritonavir
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Tipranavir
• Vernakalant
• Ziprasidone

Using amiodarone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone
• Acecainide
• Afatinib
• Agalsidase Alfa
• Alfuzosin
• Amiodarone
• Amitriptyline
• Amlodipine
• Amprenavir
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Astemizole
• Atazanavir
• Azimilide
• Azithromycin
• Bedaquiline
• Betrixaban
• Bicalutamide
• Boceprevir
• Bretylium
• Buserelin
• Ceritinib
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Cilostazol
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabigatran Etexilate
• Dabrafenib
• Daclatasvir
• Dasabuvir
• Dasatinib
• Degarelix
• Delamanid
• Delavirdine
• Desipramine
• Deslorelin
• Deutetrabenazine
• Digoxin
• Diltiazem
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Ebastine
• Efavirenz
• Eliglustat
• Encainide
• Enflurane
• Eribulin
• Erythromycin
• Escitalopram
• Etravirine
• Famotidine
• Felbamate
• Felodipine
• Fentanyl
• Flecainide
• Flunarizine
• Fluoxetine
• Fluvoxamine
• Formoterol
• Fosamprenavir
• Foscarnet
• Fosphenytoin
• Galantamine
• Gallopamil
• Gatifloxacin
• Gemifloxacin
• Ginkgo Biloba
• Goldenseal
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indecainide
• Iohexol
• Isoflurane
• Isoniazid
• Isradipine
• Itraconazole
• Ivabradine
• Lacidipine
• Lapatinib
• Ledipasvir
• Lercanidipine
• Leuprolide
• Levofloxacin
• Lidocaine
• Lidoflazine
• Lopinavir
• Loratadine
• Lovastatin
• Lumefantrine
• Manidipine
• Mefloquine
• Methadone
• Methotrimeprazine
• Metronidazole
• Mexiletine
• Mibefradil
• Miconazole
• Mifepristone
• Mizolastine
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nefazodone
• Nicardipine
• Nifedipine
• Nilotinib
• Nilvadipine
• Nisoldipine
• Nitrendipine
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ombitasvir
• Ondansetron
• Ospemifene
• Oxycodone
• Paliperidone
• Panobinostat
• Papaverine
• Paritaprevir
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perhexiline
• Perphenazine
• Pimavanserin
• Pipamperone
• Pitolisant
• Pixantrone
• Pranidipine
• Prilocaine
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranitidine
• Ranolazine
• Regorafenib
• Ribociclib
• Rifampin
• Risperidone
• Salmeterol
• Sematilide
• Sertindole
• Sevoflurane
• Simeprevir
• Simvastatin
• Sirolimus
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sofosbuvir
• Solifenacin
• Sorafenib
• Sotalol
• Spiramycin
• St John's Wort
• Sulfamethoxazole
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tedisamil
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Ticagrelor
• Tizanidine
• Tocainide
• Tolterodine
• Topotecan
• Toremifene
• Trazodone
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vasopressin
• Vemurafenib
• Venetoclax
• Venlafaxine
• Verapamil
• Vilanterol
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Voriconazole
• Vorinostat
• Warfarin
• Zileuton
• Zolmitriptan
• Zotepine
• Zuclopenthixol

Using amiodarone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abarelix
• Acebutolol
• Acenocoumarol
• Alprenolol
• Atenolol
• Atorvastatin
• Betaxolol
• Bevantolol
• Bisoprolol
• Bucindolol
• Carteolol
• Carvedilol
• Celiprolol
• Cholestyramine
• Clonazepam
• Cyclosporine
• Dicumarol
• Digitoxin
• Dilevalol
• Esmolol
• Labetalol
• Levobunolol
• Mepindolol
• Methotrexate
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Nevirapine
• Oxprenolol
• Penbutolol
• Phenytoin
• Pindolol
• Propranolol
• Rifapentine
• Rosuvastatin
• Talinolol
• Tertatolol
• Theophylline
• Timolol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using amiodarone with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use amiodarone, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of amiodarone. Make sure you tell your doctor if you have any other medical problems, especially:

• AV block (type of abnormal heart rhythm), with no pacemaker or
• Bradycardia (slow heartbeat) or
• Cardiogenic shock or
• Sick sinus syndrome (type of abnormal heart rhythm), with no pacemaker—Should not be used in patients with these conditions.

• Eye or vision problems or
• Heart disease (e.g., congestive heart failure) or
• Heart rhythm problems (e.g., QT prolongation) or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Hypotension (low blood pressure) or
• Lung disease or other breathing problems (e.g., interstitial pneumonitis) or
• Thyroid problems—Use with caution. May make these conditions worse.

It is important that your doctor check your progress at regular visits to make sure that amiodarone is working properly. Blood tests may be needed to check for unwanted effects.

Using amiodarone while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Tell your doctor right away if you are having shortness of breath, chest tightness, wheezing, or any type of breathing problem while using amiodarone.

amiodarone can cause changes in your heart rhythm, such as a condition called QT prolongation. It may cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Liver problems may occur while you are using amiodarone. Stop using amiodarone and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

You may need to carry a medical identification card or bracelet showing that you are taking amiodarone. Ask your doctor about this.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking amiodarone. You may need to stop using amiodarone several days before having surgery or medical tests.

Amiodarone increases the sensitivity of your skin to sunlight; too much sun exposure could cause a serious sunburn. Your skin may continue to be sensitive to sunlight for several months after treatment is stopped. Use a sunscreen when you are outdoors. Wear protective clothing and hats. Avoid sunlamps and tanning beds.

After you have taken amiodarone for a long time, it may cause a blue-gray color to appear on your skin, especially in areas exposed to the sun, such as your face, neck, and arms. This color will usually fade after treatment with amiodarone has ended, although it may take several months. Check with your doctor if this color change occurs.

Grapefruits and grapefruit juice may increase the side effects from amiodarone by increasing the amount of amiodarone in your body. You should not eat grapefruit or drink grapefruit juice while you are using amiodarone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Usual Adult Dose for Arrhythmias:

IV:
Initial dose: 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen:
-Loading infusions: 150 mg over the first 10 minutes (15 mg/min), followed by 360 mg over the next 6 hours (1 mg/min)
-Maintenance infusion: 540 mg over the remaining 18 hours (0.5 mg/min)

Maintenance dose: After the first 24 hours, continue the maintenance infusion rate of 0.5 mg/min; may increase infusion rate to achieve effective arrhythmia suppression.
-Supplemental infusions: 150 mg over 10 minutes (15 mg/min) for breakthrough episodes of ventricular fibrillation (VF) or hemodynamically unstable ventricular tachycardia (VT)

Maximum dose: Initial infusion rate: 30 mg/min

Duration of therapy: Until ventricular arrhythmias stabilize (most patients require 48 to 96 hours); maintenance infusion of up to 0.5 mg/min can be continued for up to 3 weeks.

Comments: Mean daily doses greater than 2100 mg for the first 24 hours were associated with increased risk of hypotension.

Use: Initiation of treatment and prophylaxis of frequently recurring VF and hemodynamically unstable VT in patients refractory to other therapy.


ORAL:
Loading dose: 800 to 1600 mg orally per day for 1 to 3 weeks (occasionally longer) until adequate arrhythmia control is achieved or if side effects become prominent, then switch to adjustment dose
Adjustment dose: 600 to 800 mg orally per day for 1 month, then switch to maintenance dose
Maintenance dose: 400 mg orally per day

Comments:
-May be administered once a day; twice a day dosing is recommended for total daily doses of 1000 mg or more or in patients who experience gastrointestinal tolerance.
-Close monitoring is indicated during the loading phase and surrounding any dose adjustments.
-Maintenance dose should be determined according to antiarrhythmic effect as assessed by patient tolerance as well as symptoms, Holter recordings, and/or programmed electrical stimulation; some patients may require up to 600 mg/day while some can be controlled on lower doses.

Use: Treatment of life-threatening recurrent VF or life-threatening recurrent hemodynamically unstable VT in patients refractory to adequate doses of other antiarrhythmics or those intolerant of alternative agents.

No adjustment recommended

US BOXED WARNINGS (TABLET): These effects may also be seen with IV administration.
-FATAL TOXICITY: This drug is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity. Even in patients at high risk of arrhythmic death, in whom the toxicity of this drug is an acceptable risk, this drug poses major management problems that could be life-threatening in a population at risk of sudden death, so that every effort should be made to utilize alternative agents first. The difficulty of using this drug safely and effectively itself poses a significant risk to patients. Patients with the indicated arrhythmias must be hospitalized while the loading dose is given, and a response generally requires at least one week, usually two or more. Because absorption and elimination are variable, maintenance-dose selection is difficult, and it is not unusual to require dosage decrease or discontinuation of treatment. In a retrospective survey of 192 patients with ventricular tachyarrhythmias, 84 required dose reduction and 18 required at least temporary discontinuation because of adverse effects, and several series have reported 15% to 20% overall frequencies of discontinuation due to adverse reactions. The time at which a previously controlled life-threatening arrhythmia will recur after discontinuation or dose adjustment is unpredictable, ranging from weeks to months. The patient is obviously at great risk during this time and may need prolonged hospitalization. Attempts to substitute other antiarrhythmic agents when this drug must be stopped will be made difficult by the gradually, but unpredictably, changing body burden of this drug. A similar problem exists when this drug is not effective; it still poses the risk of an interaction with whatever subsequent treatment is tried.
-HEPATOTOXICITY: Liver injury is common with this drug, but is usually mild and evidenced only by abnormal liver enzymes. Overt liver disease can occur, however, and has been fatal in a few cases.
-PROARRHYTHMIC EFFECTS: Like other antiarrhythmics, this drug can exacerbate the arrhythmia, e.g., by making the arrhythmia less well tolerated or more difficult to reverse. This has occurred in 2% to 5% of patients in various series, and significant heart block or sinus bradycardia has been seen in 2% to 5%. All of these events should be manageable in the proper clinical setting in most cases. Although the frequency of such proarrhythmic events does not appear greater with this drug than with many other agents used in this population, the effects are prolonged when they occur.
-PULMONARY TOXICITY: This drug has several potentially fatal toxicities, the most important of which is pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 10% to 17% in some series of patients with ventricular arrhythmias given doses around 400 mg/day, and as abnormal diffusion capacity without symptoms in a much higher percentage of patients. Pulmonary toxicity has been fatal about 10% of the time.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

• Amiodarone is used to treat and prevent abnormal rhythms of the heart (arrhythmias).
• Experts are not sure exactly how amiodarone works but believe it either affects receptors involved in electrical conduction or the length of time between electrical impulses in a cell.
• Amiodarone belongs to the class of medicines known as antiarrhythmics.

• Recommended ONLY for the treatment of life-threatening recurrent ventricular fibrillation and recurrent hemodynamically unstable ventricular tachycardia in people who have not responded to or are intolerant of other antiarrhythmics.
• Available as an oral tablet and in an injectable form.
• Generic amiodarone is available.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Tiredness, tremor and involuntary movements, poor coordination and gait, nausea, vomiting, constipation, and weight loss, elevation of liver enzymes and abnormalities in thyroid function tests, eye conditions that impair vision, peripheral neuropathy (pins and needles in the hands and feet), hyper or hypothyroidism (always suspect hyperthyroidism if a new arrhythmia occurs). Some side effects such as pulmonary fibrosis, liver-enzyme elevations, corneal deposits and facial pigmentation, peripheral neuropathy, gastrointestinal and central nervous system effects are more likely at higher dosages.
• Amiodarone can significantly reduce a person's heart rate and may cause heart block (a slowing of electrical impulses within the heart). On rare occasions (2-5% of patients), amiodarone may worsen the arrhythmia being treated.
• Amiodarone is usually initiated in a hospital because it has been associated with life-threatening side effects. There is no evidence that treatment with amiodarone favorably influences survival.
• There is a wide variation in the way people eliminate amiodarone from their bodies and finding the right dosage of amiodarone for each individual may take some time. Some people may require blood level monitoring. It may be difficult to assess the effectiveness of amiodarone without further medical testing.
• Significant, potentially fatal toxicities and side effects associated with amiodarone usage include pneumonitis (inflammation of the alveoli in the lungs). In one study, this affected 10-17% of participants prescribed 400 mg/day of amiodarone. Reports indicate that pulmonary (lung) toxicity is fatal in 1 in 10 people.
• May also cause liver damage. This is usually mild but occasionally may be fatal.
• Not suitable for people with certain heart conditions (cardiogenic shock, AV block) and several other medical conditions. Avoid in pregnancy.
• May interact with numerous drugs including antivirals, antidepressants, other heart medications, and warfarin. For a full list of interactions see here.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

• Amiodarone is absorbed slowly and maximum concentrations are reached three to seven hours after oral administration. Some effects may be seen after two to three days; however, it normally takes between one and three weeks of regular dosing for the full effects of amiodarone to be seen, even with a loading dose.
• The effects of amiodarone may continue to increase for several weeks until a plateau is reached.
• The relationship between the concentration of amiodarone and the resulting effects is not well established, although generally 1 to 2.5 mg/L is suggested as the ideal range for amiodarone blood levels. Levels below this range are more likely to be associated with ineffectiveness, and levels above this range are likely to be associated with toxicity and increased side effects.
• Side effects may persist for a while even after stopping amiodarone because it takes several months for amiodarone to be totally cleared from the body.

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