Amiodarone (Oral route)
Amiodarone oral tablet is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity. Amiodarone can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients. Pulmonary toxicity has been fatal about 10% of the time. Obtain a baseline chest X-ray and pulmonary-function tests, including diffusion capacity, when therapy is initiated. Repeat history, physical exam, and chest X-ray every 3 to 6 months. Amiodarone can cause hepatoxicity, which can be fatal. Obtain baseline and periodic liver transaminases and discontinue or reduce dose if the increase exceeds three times normal, or doubles in a patient with an elevated baseline. Discontinue if the patient experiences signs or symptoms of clinical liver injury. Amiodarone can exacerbate arrhythmias. Initiate in a clinical setting where continuous electrocardiograms and cardiac resuscitation are available .
Antiarrhythmic, Group III
Uses of This Medicine:
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 well.
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 your heart rhythm normal.
This medicine is available only with your doctor's prescription.
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:
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.
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.
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.
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.
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.
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
- Agalsidase Alfa
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Chloral Hydrate
- Dabigatran Etexilate
- Doxorubicin Hydrochloride Liposome
- Ginkgo Biloba
- Inotuzumab Ozogamicin
- Morphine Sulfate Liposome
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- St John's Wort
- Vincristine Sulfate Liposome
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.
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:
- 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 (eg, congestive heart failure) or
- Heart rhythm problems (eg, 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 (eg, interstitial pneumonitis) or
- Thyroid problems—Use with caution. May make these conditions worse.
Proper Use of This Medicine:
You will receive your first dose of this medicine in the hospital. Your doctor will watch you closely after you take this medicine to make sure you do not have any serious side effects.
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not miss any doses. It may also take 1 to 3 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 it the same way each time.
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.
- For ventricular arrhythmias:
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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 While Using This Medicine:
It is very 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 difficulty breathing, chest tightness, 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 a fast, pounding, or irregular heartbeat.
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 immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).
Check with your doctor right away if you have 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 using 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 using 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.
Grapefruit and grapefruit juice may increase the side effects of 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 (eg, St. John's wort) or vitamin supplements.
Side Effects of This Medicine:
- More common
- dizziness, lightheadedness, or fainting
- fever (slight)
- numbness or tingling in the fingers or toes
- painful breathing
- sensitivity of the skin to sunlight
- trembling or shaking of the hands
- trouble with walking
- unusual and uncontrolled movements of the body
- weakness of the arms or legs
- Less common
- Blue-gray coloring of the skin on the face, neck, and arms
- blurred vision or blue-green halos seen around objects
- dry eyes
- dry, puffy skin
- fast or irregular heartbeat
- pain and swelling in the scrotum
- sensitivity of the eyes to light
- sensitivity to heat
- slow heartbeat
- swelling of the feet or lower legs
- trouble with sleeping
- unusual tiredness
- weight gain or loss
- Skin rash
- yellow eyes or skin
- Incidence not known
- back, leg, or stomach pains
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine
- bloody, black, or tarry stools
- blue lips, fingernails, or skin
- blurred or double vision
- chest pain
- clay-colored stools
- confusion as to time, place, or person
- coughing or spitting up blood
- cracks in the skin
- dark urine
- decreased awareness or responsiveness
- decreased urine output
- difficult or labored breathing
- difficult urination
- dry cough
- eye pain
- fast heartbeat
- general body swelling
- high fever
- holding false beliefs that cannot be change by facts
- inability to have or keep an erection
- irregular, fast or slow, or shallow breathing
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss in sexual ability, desire, drive, or performance
- loss of consciousness
- loss of heat from the body
- lower back or side pain
- mood or mental change
- muscle cramps, spasms, twitching, pain, or stiffness
- no breathing
- noisy breathing
- pain in the abdomen, groin, or scrotum
- pain or burning with urination
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- pinpoint red spots on the skin
- rapid weight gain
- red skin lesions, often with a purple center
- red, irritated eyes
- red, swollen skin
- scaly skin
- seeing, hearing, or feeling things that are not there
- severe headache
- severe sleepiness
- sore throat
- sores, ulcers, or white spots on the lips or in mouth
- stomach pain
- swelling of the face, ankles, or hands
- swelling of the scrotum
- swollen or painful glands
- tightness in the chest
- troubled breathing
- unpleasant breath odor
- unusual bleeding or bruising
- unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
- unusual excitement, nervousness, or restlessness
- vomiting of blood
- More common
- loss of appetite
- Less common
- Bitter or metallic taste
- decrease in sexual interest
- decreased sexual ability in males
- feeling of warmth
- redness of the face, neck, arms and occasionally, upper chest
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:
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:
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.
Last Updated: 9/5/2019