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Amiodarone affects the rhythm of your heartbeats. It is used to help keep the heart beating normally in people with life-threatening heart rhythm disorders of the ventricles (the lower chambers of the heart that allow blood to flow out of the heart).
Amiodarone is used to treat ventricular tachycardia or ventricular fibrillation.
Amiodarone is for use only in treating life-threatening heart rhythm disorders.
Amiodarone can cause dangerous side effects on your heart, liver, lungs, or vision.
You should not take this medicine if you are allergic to amiodarone or iodine, or if you have heart block, a history of slow heartbeats that have caused you to faint, or if your heart cannot pump blood properly.
Call your doctor or get medical help at once if you have: chest pain, fast or pounding heartbeats, trouble breathing, vision problems, upper stomach pain, vomiting, dark urine, jaundice (yellowing of the skin or eyes), or if you cough up blood.
Tell your doctor if you have signs of a thyroid problem, such as weight changes, extreme tiredness, dry skin, thinning hair, feeling too hot or too cold, irregular menstrual periods, or swelling in your neck (goiter).
You should not use amiodarone if you have:
a serious heart condition called "AV block" (2nd or 3rd degree), unless you have a pacemaker;
a history of slow heartbeats that have caused you to faint; or
if your heart cannot pump blood properly.
Amiodarone can cause dangerous side effects on your heart, liver, lungs, or thyroid.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
asthma or another lung disorder;
liver disease;
a thyroid disorder;
vision problems;
high or low blood pressure;
an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
if you have a pacemaker or defibrillator implanted in your chest.
Taking amiodarone during pregnancy may harm an unborn baby, or cause thyroid problems or abnormal heartbeats in the baby after it is born. Amiodarone may also affect the child's growth or development (speech, movement, academic skills) later in life. Tell your doctor if you are pregnant or if you become pregnant.
You should not breast-feed while taking this medicine, and for several months after stopping. Amiodarone takes a long time to clear from your body. Talk to your doctor about the best way to feed your baby during this time.
Take amiodarone exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
You will receive your first few doses in a hospital setting, where your heart rhythm can be monitored.
If you have been taking another heart rhythm medicine, you may need to gradually stop taking it when you start using amiodarone. Follow your doctor's dosing instructions very carefully.
You may take the tablets with or without food, but take it the same way each time.
It may take up to 3 weeks before your heart rhythm improves. Keep using the medicine as directed even if you feel well.
Amiodarone can have long lasting effects on your body. You may need frequent medical tests while using this medicine and for several months after your last dose.
If you need surgery (including laser eye surgery), tell the surgeon ahead of time that you are using amiodarone.
This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.
Store at room temperature away from moisture, heat, and light.
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.
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amiodarone can be fatal.
Overdose symptoms may include weakness, slow heart rate, feeling light-headed, or loss of consciousness.
Avoid driving or hazardous activity until you know how amiodarone will affect you. Your reactions could be impaired.
Grapefruit may interact with amiodarone and lead to unwanted side effects. Avoid the use of grapefruit products.
Avoid taking an herbal supplement containing St. John's wort.
Amiodarone could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Get emergency medical help if you have signs of an allergic reaction to amiodarone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Amiodarone takes a long time to completely clear from your body. You may continue to have side effects from this medicine after you stop using it.
Call your doctor at once if you have any of these side effects, even if they occur up to several months after you stop using this medicine:
wheezing, cough, chest pain, cough with bloody mucus, fever;
a new or a worsening irregular heartbeat pattern (fast, slow, or pounding heartbeats);
a light-headed feeling, like you might pass out;
blurred vision, seeing halos around lights (your eyes may be more sensitive to light);
liver problems - nausea, vomiting, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes);
nerve problems - loss of coordination, muscle weakness, uncontrolled muscle movement, or a prickly feeling in your hands or lower legs;
signs of overactive thyroid - weight loss, thinning hair, feeling hot, increased sweating, tremors, feeling nervous or irritable, irregular menstrual periods, swelling in your neck (goiter); or
signs of underactive thyroid - weight gain, tiredness, depression, trouble concentrating, feeling cold.
Common amiodarone side effects may include:
nausea, vomiting, loss of appetite; or
constipation.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Amiodarone takes a long time to completely clear from your body. Drug interactions are possible for up to several months after you stop using amiodarone. Talk to your doctor before taking any medication during this time. Keep track of how long it has been since your last dose of amiodarone.
Many drugs can interact with amiodarone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use amiodarone only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Amiodarone Hydrochloride (www.drugs.com/amiodarone.html).
Commonly reported side effects of amiodarone include: hypersensitivity pneumonitis, interstitial pneumonitis, pulmonary toxicity, pulmonary alveolitis, hypotension, corneal deposits, ataxia, blurred vision, decreased visual acuity, dermatological reaction, gastrointestinal signs and symptoms, peripheral neuropathy, photophobia, phototoxicity, skin photosensitivity, visual halos around lights, and xerophthalmia. Other side effects include: persistent ventricular tachycardia, pneumonitis, bradycardia, abnormal hepatic function tests, nausea, abnormal gait, asthenia, constipation, cough, dizziness, dyspnea, fatigue, heart block, involuntary body movements, neurotoxicity, paresthesia, solar dermatitis, tremor, visual disturbance, blue-gray skin pigmentation, anorexia, and malaise. See below for a comprehensive list of adverse effects.
Applies to amiodarone: oral tablet
Other dosage forms:
Oral route (Tablet)
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.
Along with its needed effects, amiodarone 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 while taking amiodarone:
More common
Less common
Rare
Incidence not known
Some side effects of amiodarone 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
Less common
Applies to amiodarone: compounding powder, intravenous solution, oral tablet
The most common adverse reactions were corneal microdeposits, hypotension, and photosensitivity.
Very common (10% or more): Hypotension (up to 20.2%)
Common (1% to 10%): Bradycardia, blood pressure decreased, congestive heart failure, heart arrest, ventricular tachycardia, cardiac arrhythmia, sinoatrial node dysfunction, flushing
Uncommon (0.1% to 1%): Conduction disturbances
Very rare (less than 0.01%): Marked bradycardia, sinus arrest, vasculitis, hot flushes
Frequency not reported: Torsade de pointes, collapse, atrial fibrillation, nodal arrhythmia, QT interval prolonged, sinus bradycardia, ventricular fibrillation, shock, asystole, pulseless electrical activity, cardiogenic shock, atrioventricular block, severe hypotension
Postmarketing reports: Sinoatrial block, intraventricular conduction disorders, bundle branch block, infra-His block, ventricular extrasystole, antegrade conduction via an accessory pathway
Common (1% to 10%): Acute liver disorders with high serum transaminases and/or jaundice including hepatic failure, liver function tests abnormal, nonspecific hepatic disorder
Very rare (less than 0.01%): Pseudo alcoholic hepatitis, cirrhosis, serum transaminases increased
Frequency not reported: ALT increased, AST increased
Postmarketing reports: Cholestatic hepatitis, cholestasis, jaundice, alkaline phosphatase increased, blood lactate dehydrogenase increased, hepatitis
Common (1% to 10%): Pulmonary toxicity, pulmonary inflammation or fibrosis, adult respiratory distress syndrome
Very rare (less than 0.01%): Bronchospasm, interstitial pneumonitis, severe respiratory complications, apnea
Frequency not reported: Pulmonary hemorrhage, lung edema, respiratory disorder, alveolar pneumonitis
Postmarketing reports: Possibly fatal respiratory disorder, bronchiolitis obliterans organizing pneumonia, dyspnea, cough, hemoptysis, wheezing, hypoxia, pulmonary infiltrates, pulmonary mass, pleuritis, pulmonary phospholipidosis, pleural effusion, eosinophilic pneumonia, acute respiratory distress syndrome
Very common (10% or more): Corneal microdeposits (up to 90% or more)
Common (1% to 10%): Visual disturbance
Very rare (less than 0.01%): Optic neuropathy/neuritis
Frequency not reported: Permanent blindness, papilledema, corneal degeneration, eye discomfort, scotoma, lens opacities, macular degeneration, keratopathy, gritty eyes, itching, burning
Postmarketing reports: Visual field defect, blurred vision
Very common (10% or more): Photosensitivity (up to 10%)
Common (1% to 10%): Slate-gray or bluish pigmentations of light-exposed skin
Very rare (less than 0.01%): Erythema, rash, exfoliative dermatitis, alopecia, sweating
Frequency not reported: Granuloma, angioedema, urticaria, Stevens-Johnson syndrome, spontaneous ecchymosis, pustular psoriasis enhanced
Postmarketing reports: Toxic epidermal necrolysis, erythema multiforme, skin cancer, pruritus, bullous dermatitis, drug rash with eosinophilia and systemic symptoms (DRESS), eczema
Common (1% to 10%): Extrapyramidal symptoms, extrapyramidal tremor, tremor/abnormal involuntary movement, lack of coordination, gait abnormal/ataxia, dizziness, paresthesia, headache, abnormal taste and smell
Uncommon (0.1% to 1%): Peripheral sensorimotor neuropathy
Very rare (less than 0.01%): Cerebellar ataxia, benign intracranial hypertension, vertigo
Frequency not reported: Peripheral neuropathy, demyelinating polyneuropathy, nerve conduction abnormal, neurolipidosis, neuromyopathy, parosmia
Postmarketing reports: Confusional state, disorientation, delirium, intracranial pressure increased, hypoesthesia, Parkinsonian symptoms
Common (1% to 10%): Nightmare, sleep disorders, libido decreased, insomnia, sleep disturbance
Frequency not reported: Vivid dreams, chronic anxiety
Postmarketing reports: Hallucination
Common (1% to 10%): Nausea, constipation, abdominal pain, salivation abnormal
Frequency not reported: Vomiting, dysgeusia, diarrhea
Postmarketing reports: Pancreatitis, acute pancreatitis, dry mouth
Common (1% to 10%): Fever, malaise, fatigue
Very common (10% or more): Hypothyroidism (up to 10%)
Common (1% to 10%): Hyperthyroidism
Very rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone secretion
Frequency not reported: Thyroid function tests abnormal
Postmarketing reports: Thyroid nodules/cancer
Common (1% to 10%): Anorexia, edema
Frequency not reported: Weight gain, symptomatic hypercalcemia, appetite decreased
Common (1% to 10%): Coagulation abnormalities
Very rare (less than 0.01%): Hemolytic anemia, aplastic anemia, thrombocytopenia
Frequency not reported: Bone marrow granuloma, bone marrow depression
Postmarketing reports: Pancytopenia, neutropenia, agranulocytosis, granulocytosis
Common (1% to 10%): Muscle weakness
Frequency not reported: Back pain
Postmarketing reports: Myopathy, rhabdomyolysis, muscle spasm, lupus-like syndrome
Common (1% to 10%): Injection site reactions
Very rare (less than 0.01%): Epididymo-orchitis, impotence
Postmarketing reports: Epididymitis
Very rare (less than 0.01%): Anaphylactic shock
Frequency not reported: Hypersensitivity reaction, positive antinuclear antibodies, immunoglobulin level increased
Postmarketing reports: Anaphylactic/anaphylactoid reaction
Very rare (less than 0.01%): Blood creatinine increased
Frequency not reported: Kidney function abnormal, chronic renal failure worsened
Postmarketing reports: Renal impairment, renal insufficiency, acute renal failure
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Amiodarone Hydrochloride (www.drugs.com/amiodarone.html).
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