Pronunciation:

a-mee-OH-da-rone

Brand Names:

• Cordarone IV

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antiarrhythmic, Group III

Chemical—

Benzofuran

Uses of This Medicine:

Amiodarone injection is used to treat life-threatening heart rhythm problems called ventricular arrhythmias. It is used in patients who have already been treated with other medicines that did not work well.

Amiodarone injection belongs to the group of medicines known as antiarrhythmics. It works directly on the heart tissue and will slow the nerve impulses in the heart. This helps keep the heart rhythm normal.

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

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

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amiodarone injection 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 injection.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other 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 receiving this medicine, 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 this medicine 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.

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

Using this medicine 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.

• Abametapir
• Abiraterone Acetate
• Acecainide
• Adagrasib
• Afatinib
• Agalsidase Alfa
• Alfentanil
• Alfuzosin
• Alprazolam
• Amisulpride
• Amitriptyline
• Amprenavir
• Anagrelide
• Apalutamide
• Apixaban
• Apomorphine
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Armodafinil
• Arsenic Trioxide
• Artemether
• Asenapine
• Astemizole
• Azimilide
• Azithromycin
• Bedaquiline
• Bendamustine
• Benzhydrocodone
• Berotralstat
• Betrixaban
• Boceprevir
• Bretylium
• Buprenorphine
• Buserelin
• Carbamazepine
• Carvedilol
• Cenobamate
• Ceritinib
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Cilostazol
• Cimetidine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clopidogrel
• Clothiapine
• Clozapine
• Cobicistat
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabigatran Etexilate
• Dabrafenib
• Daclatasvir
• Darunavir
• Dasabuvir
• Dasatinib
• Deferasirox
• Degarelix
• Delamanid
• Delavirdine
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexamethasone
• Dexmedetomidine
• Digoxin
• Dihydrocodeine
• Diltiazem
• Disopyramide
• Docetaxel
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Ebastine
• Efavirenz
• Elagolix
• Eliglustat
• Encainide
• Encorafenib
• Enflurane
• Entrectinib
• Enzalutamide
• Eribulin
• Erlotinib
• Erythromycin
• Escitalopram
• Eslicarbazepine Acetate
• Etravirine
• Famotidine
• Fedratinib
• Felbamate
• Fentanyl
• Fexinidazole
• Finerenone
• Flecainide
• Fluoxetine
• Fluvoxamine
• Formoterol
• Fosamprenavir
• Fosaprepitant
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemfibrozil
• Gemifloxacin
• Gepirone
• Ginkgo Biloba
• Glasdegib
• Goldenseal
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydrocodone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Imatinib
• Imipramine
• Indecainide
• Inotuzumab Ozogamicin
• Iohexol
• Isoflurane
• Isradipine
• Itraconazole
• Ivabradine
• Ivacaftor
• Ivosidenib
• Lacosamide
• Lapatinib
• Larotrectinib
• Ledipasvir
• Lefamulin
• Lemborexant
• Lenvatinib
• Letermovir
• Leuprolide
• Levofloxacin
• Lidocaine
• Lofexidine
• Lomitapide
• Lopinavir
• Loratadine
• Lorlatinib
• Lovastatin
• Lumacaftor
• Lumefantrine
• Macimorelin
• Macitentan
• Mavacamten
• Mefloquine
• Meperidine
• Methadone
• Methotrexate
• Methotrimeprazine
• Metronidazole
• Mexiletine
• Mibefradil
• Miconazole
• Mifepristone
• Mirtazapine
• Mitotane
• Mizolastine
• Mobocertinib
• Modafinil
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nafcillin
• Nefazodone
• Netupitant
• Nevirapine
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Omaveloxolone
• Ombitasvir
• Ondansetron
• Osilodrostat
• Osimertinib
• Ospemifene
• Oxaliplatin
• Oxcarbazepine
• Oxycodone
• Ozanimod
• Paclitaxel
• Pacritinib
• Palbociclib
• Paliperidone
• Panobinostat
• Papaverine
• Paritaprevir
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Pentazocine
• Perphenazine
• Pexidartinib
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pipamperone
• Pitolisant
• Pixantrone
• Ponesimod
• Pralsetinib
• Prednisone
• Prilocaine
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranitidine
• Ranolazine
• Regorafenib
• Relugolix
• Ribociclib
• Rifabutin
• Rifampin
• Rimegepant
• Risperidone
• Selpercatinib
• Sematilide
• Sertindole
• Sertraline
• Sevoflurane
• Simeprevir
• Simvastatin
• Siponimod
• Sirolimus
• Sirolimus Protein-Bound
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sofosbuvir
• Solifenacin
• Sorafenib
• Sotalol
• Spiramycin
• St John's Wort
• Sufentanil
• Sulfamethoxazole
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Talazoparib
• Tamoxifen
• Tedisamil
• Telaprevir
• Telavancin
• Telithromycin
• Tenofovir Alafenamide
• Teriflunomide
• Tetrabenazine
• Ticagrelor
• Tocainide
• Tolterodine
• Topotecan
• Toremifene
• Tramadol
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Ubrogepant
• Vandetanib
• Vardenafil
• Vemurafenib
• Venetoclax
• Venlafaxine
• Verapamil
• Vilanterol
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Voxelotor
• Warfarin
• Zileuton
• Zolmitriptan
• Zolpidem
• Zotepine
• Zuclopenthixol

Using this medicine 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
• Acenocoumarol
• Atorvastatin
• Clonazepam
• Cyclosporine
• Dicumarol
• Digitoxin
• Ibrutinib
• Rifapentine
• Rivaroxaban
• Rosuvastatin
• Theophylline

Other interactions—

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 this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bradycardia (slow heartbeat) or
• Cardiogenic shock (shock caused by heart attack) or
• Heart block, without a pacemaker—Should not be used in patients with these conditions.

• Eye or vision problems or
• Heart rhythm problems (eg, QT prolongation) or
• Hyperthyroidism (overactive thyroid) or
• Hypocalcemia (low calcium levels in the blood)
• Hypokalemia (low potassium levels in the blood) or
• Hypomagnesemia (low magnesium levels in the blood) or
• Hypotension (low blood pressure) or
• Liver disease or
• Lung or breathing problems (eg, bronchospasm)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. It is given through a needle placed into one of your veins.

Your doctor will give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you receive this medicine to make sure that it is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine 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.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin using this medicine, or when the dose is increased.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor right away if you have fainting, fast, pounding, or uneven heartbeat. These may be symptoms of a heart rhythm problem, including QT prolongation.

This medicine may cause lung or breathing problems. Check with your doctor right away if you have chest tightness, cough, difficulty breathing, fever, or noisy breathing.

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).

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Check with your doctor right away if you have bluish color, changes in skin color, pain, tenderness, or swelling at the injection site. These may be symptoms of infusion site reactions (eg, phlebitis).

Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

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 (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Blurred vision

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

sweating

unusual tiredness or weakness

Less common

Black, tarry stools

bleeding gums

blistering, peeling, or loosening of the skin

blood in the urine or stools

chest pain, tightness, or discomfort

chills

cold, clammy skin

cough

decreased urine output

diarrhea

difficulty with breathing

dilated neck veins

dizziness

fainting

fast, pounding, or irregular heartbeat or pulse

fast, weak pulse

fever

irregular heartbeat recurrent

itching

joint or muscle pain

lightheadedness, dizziness, or fainting

no blood pressure or pulse

pinpoint red spots on the skin

red, irritated eyes

red skin lesions, often with a purple center

slow or irregular heartbeat

sore throat

sores, ulcers, or white spots in the mouth or on the lips

stopping of the heart

swelling of the face, fingers, feet, or lower legs

trouble breathing

unconsciousness

unusual bleeding or bruising

weight gain

Incidence not known

Agitation

back, leg, or stomach pains

bleeding gums

bloating

blurred or double vision

clay-colored stools

coma

confusion about identity, place, and time

cough or hoarseness

coughing or spitting up blood

cracks in the skin

dark-colored urine

decreased frequency or amount of urine

decreased urine output

depression

difficulty swallowing

eye pain

fever with or without chills

general body swelling

headache

high fever

hives

holding false beliefs that cannot be changed by fact

hostility

increased blood pressure

increased thirst

indigestion

inflamed tissue from infection

irritability

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lethargy

light-colored stools

loss of appetite

loss of heat from the body

lower back or side pain

muscle pain, stiffness, cramps, spasms, twitching, tenderness, wasting, or weakness

noisy breathing

nosebleeds

painful or difficult urination

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

persistent non-healing sore

pink growth

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid weight gain

rash

red, swollen skin

reddish patch or irritated area

redness, soreness, or itching skin

scaly skin

seeing, hearing, or feeling things that are not there

seizures

severe headache

shiny bump

sores, welting, or blisters

stomach pain

stupor

swollen or painful glands

unexplained bleeding or bruising

unpleasant breath odor

unusual excitement, nervousness, or restlessness

upper right abdominal or stomach pain

vomiting

vomiting of blood

weakness

white, yellow, or waxy scar-like area

yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.