Description
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.
This product is available in the following dosage forms:
- Solution
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 injection 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 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.
Breastfeeding
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.
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 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
- Deuruxolitinib
- 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
- Abiraterone Acetate, Micronized
- Acecainide
- Adagrasib
- Afatinib
- Agalsidase Alfa
- Alfentanil
- Alfuzosin
- Alprazolam
- Amisulpride
- Amitriptyline
- Amprenavir
- Anagrelide
- Apalutamide
- Apixaban
- Apomorphine
- Aprepitant
- Aripiprazole
- Armodafinil
- Arsenic Trioxide
- Artemether
- Asenapine
- Astemizole
- Avacopan
- Azathioprine
- Azimilide
- Azithromycin
- Bedaquiline
- Bendamustine
- Benzhydrocodone
- Betrixaban
- Boceprevir
- Bretylium
- Budesonide
- Buprenorphine
- Buserelin
- Carbamazepine
- Carvedilol
- Celecoxib
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
- Levothyroxine
- Mavacamten
- 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
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
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
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.
DRG-20073219
