Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Cordarone
  2. Pacerone

Descriptions


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

Amiodarone 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 available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

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.

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.

Pregnancy

Information about this amiodarone-oral-route
Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

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.

Drug Interactions

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 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.

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

  • Abiraterone Acetate
  • Acebutolol
  • Acecainide
  • Afatinib
  • Alprenolol
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amlodipine
  • Amoxapine
  • Amprenavir
  • Apomorphine
  • Aprepitant
  • Aprindine
  • Arsenic Trioxide
  • Artemether
  • Asenapine
  • Astemizole
  • Atazanavir
  • Atenolol
  • Azimilide
  • Azithromycin
  • Bedaquiline
  • Betaxolol
  • Bevantolol
  • Bicalutamide
  • Bisoprolol
  • Boceprevir
  • Bosutinib
  • Bretylium
  • Bucindolol
  • Carbamazepine
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Ceritinib
  • Chloral Hydrate
  • Chloroquine
  • Chlorpromazine
  • Cilostazol
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Cyclobenzaprine
  • Dabigatran Etexilate
  • Dabrafenib
  • Darunavir
  • Dasatinib
  • Deferasirox
  • Delavirdine
  • Desipramine
  • Dibenzepin
  • Digoxin
  • Dilevalol
  • Diltiazem
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Doxepin
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Droperidol
  • Ebastine
  • Eletriptan
  • Enflurane
  • Erythromycin
  • Escitalopram
  • Eslicarbazepine Acetate
  • Esmolol
  • Etravirine
  • Everolimus
  • Felodipine
  • Fentanyl
  • Flecainide
  • Flunarizine
  • Fluoxetine
  • Fluvoxamine
  • Formoterol
  • Fosamprenavir
  • Fosaprepitant
  • Foscarnet
  • Gallopamil
  • Gatifloxacin
  • Gemifloxacin
  • Ginkgo Biloba
  • Goldenseal
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Halothane
  • Hydroquinidine
  • Ibutilide
  • Iloperidone
  • Imatinib
  • Imipramine
  • Iohexol
  • Isoflurane
  • Isoniazid
  • Isradipine
  • Itraconazole
  • Ivabradine
  • Labetalol
  • Lacidipine
  • Lapatinib
  • Lercanidipine
  • Levobunolol
  • Levofloxacin
  • Lidocaine
  • Lidoflazine
  • Lopinavir
  • Loratadine
  • Lorcainide
  • Lovastatin
  • Lumefantrine
  • Manidipine
  • Mefloquine
  • Mepindolol
  • Methadone
  • Metipranolol
  • Metoprolol
  • Metronidazole
  • Mibefradil
  • Miconazole
  • Mifepristone
  • Mitotane
  • Mizolastine
  • Moricizine
  • Moxifloxacin
  • Nadolol
  • Nebivolol
  • Nefazodone
  • Nicardipine
  • Nifedipine
  • Nilotinib
  • Nilvadipine
  • Nisoldipine
  • Nitrendipine
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Ospemifene
  • Oxprenolol
  • Oxycodone
  • Paliperidone
  • Pasireotide
  • Pazopanib
  • Penbutolol
  • Pentamidine
  • Perflutren Lipid Microsphere
  • Perhexiline
  • Perphenazine
  • Pindolol
  • Pixantrone
  • Pomalidomide
  • Pranidipine
  • Prilocaine
  • Primidone
  • Probucol
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Propranolol
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranitidine
  • Ranolazine
  • Regorafenib
  • Rifampin
  • Risperidone
  • Romidepsin
  • Salmeterol
  • Sematilide
  • Sertindole
  • Sevoflurane
  • Siltuximab
  • Simeprevir
  • Simvastatin
  • Sirolimus
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Spiramycin
  • St John's Wort
  • Sulfamethoxazole
  • Sultopride
  • Sunitinib
  • Tacrolimus
  • Talinolol
  • Tedisamil
  • Telaprevir
  • Telithromycin
  • Tertatolol
  • Tetrabenazine
  • Ticagrelor
  • Timolol
  • Tizanidine
  • Toremifene
  • Trabectedin
  • Trazodone
  • Trifluoperazine
  • Trimethoprim
  • Trimipramine
  • Vandetanib
  • Vardenafil
  • Vasopressin
  • Vemurafenib
  • Verapamil
  • Vilanterol
  • Vincristine
  • Vincristine Sulfate Liposome
  • Vinflunine
  • Voriconazole
  • Warfarin
  • Zileuton
  • Ziprasidone
  • Zolmitriptan
  • Zotepine

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
  • Cholestyramine
  • Clonazepam
  • Clopidogrel
  • Cyclosporine
  • Dicumarol
  • Digitoxin
  • Flecainide
  • Fosphenytoin
  • Methotrexate
  • Nevirapine
  • Phenytoin
  • Procainamide
  • Rifapentine
  • Rosuvastatin
  • Theophylline
  • Tolterodine

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 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 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:

  • 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.

Proper Use

You will receive your first dose of this medicine in a hospital. Your doctor will watch you closely after you take this medicine to make sure you do not have any serious side effects.

Take amiodarone exactly as directed by your doctor even though you may feel well. Do not take more medicine than your doctor ordered and do not miss any doses. It may take one or two weeks before your body responds to this medicine.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food, but take amiodarone the same way each time.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For ventricular arrhythmias:
      • Adults—At first, 800 to 1600 milligrams (mg) per day taken in divided doses. Your doctor may adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is important that your doctor check your progress at regular visits to make sure that this medicine 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.

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

This medicine 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 this medicine. Stop using this medicine 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 this medicine. 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 this medicine. You may need to stop using this medicine 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 this medicine 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 this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you are using this medicine.

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.

Side Effects

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 immediately if any of the following side effects occur:

More common

  1. Cough
  2. dizziness, lightheadedness, or fainting
  3. fever (slight)
  4. numbness or tingling in the fingers or toes
  5. painful breathing
  6. sensitivity of the skin to sunlight
  7. shortness of breath
  8. trembling or shaking of the hands
  9. trouble with walking
  10. unusual and uncontrolled movements of the body
  11. weakness of the arms or legs

Less common

  1. Blue-gray coloring of the skin on the face, neck, and arms
  2. blurred vision or blue-green halos seen around objects
  3. coldness
  4. dry eyes
  5. dry, puffy skin
  6. fast or irregular heartbeat
  7. nervousness
  8. pain and swelling in the scrotum
  9. sensitivity of the eyes to light
  10. sensitivity to heat
  11. slow heartbeat
  12. sweating
  13. swelling of the feet or lower legs
  14. trouble with sleeping
  15. unusual tiredness
  16. weight gain or loss

Rare

  1. Skin rash
  2. yellow eyes or skin

Incidence not known

  1. Abdominal or stomach pain
  2. agitation
  3. back, leg, or stomach pains
  4. bleeding gums
  5. blistering, peeling, or loosening of the skin
  6. bloating
  7. blood in the urine
  8. bloody, black, or tarry stools
  9. blue lips, fingernails, or skin
  10. blurred or double vision
  11. chest pain
  12. chills
  13. clay-colored stools
  14. coma
  15. confusion
  16. confusion as to time, place, or person
  17. coughing or spitting up blood
  18. cracks in the skin
  19. dark urine
  20. decreased urine output
  21. depression
  22. diarrhea
  23. difficult or labored breathing
  24. difficult urination
  25. dry cough
  26. eye pain
  27. fast heartbeat
  28. fatigue
  29. general body swelling
  30. high fever
  31. holding false beliefs that cannot be change by fact
  32. hostility
  33. inability to have or keep an erection
  34. indigestion
  35. irregular, fast or slow, or shallow breathing
  36. irritability
  37. itching
  38. joint or muscle pain
  39. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  40. lethargy
  41. loss in sexual ability, desire, drive, or performance
  42. loss of heat from the body
  43. lower back or side pain
  44. mood or mental change
  45. muscle cramps or spasms
  46. muscle pain or stiffness
  47. muscle twitching
  48. no breathing
  49. noisy breathing
  50. nosebleeds
  51. pain in the abdomen, groin, or scrotum
  52. pain or burning with urination
  53. pains in the stomach, side, or abdomen, possibly radiating to the back
  54. pale skin
  55. pinpoint red spots on the skin
  56. rapid weight gain
  57. rash
  58. red skin lesions, often with a purple center
  59. red, irritated eyes
  60. red, swollen skin
  61. scaly skin
  62. seeing, hearing, or feeling things that are not there
  63. seizures
  64. severe headache
  65. sneezing
  66. sore throat
  67. sores, ulcers, or white spots on the lips or in mouth
  68. stupor
  69. swelling of the face, ankles, or hands
  70. swelling of the scrotum
  71. swollen or painful glands
  72. tightness in the chest
  73. troubled breathing
  74. unpleasant breath odor
  75. unusual bleeding or bruising
  76. unusual excitement, nervousness, or restlessness
  77. unusual tiredness or weakness
  78. vomiting of blood
  79. wheezing

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:

More common

  1. Constipation
  2. headache
  3. loss of appetite
  4. nausea and vomiting

Less common

  1. Bitter or metallic taste
  2. decrease in sexual interest
  3. decreased sexual ability in males
  4. dizziness
  5. flushing of the face

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.