DrugindexOnline^{2nd edition}

Generic Name: Amiodarone Injection Solution (a-MEE-oh-duh-rone)
Brand Name: Generic only. No brands available.

Amiodarone Solution is used for:

Treating and preventing certain kinds of life-threatening heart rhythm disturbances in patients who cannot take the oral form of Amiodarone Solution or alternative medicines. It may also be used for other conditions as determined by your doctor.

Amiodarone Solution is an antiarrhythmic. It works by stabilizing the heart rhythm in conditions in which the heart is beating too fast or in an irregular rhythm. It is usually used in situations in which the abnormal heart rhythms, if not treated, could cause death.

Do NOT use Amiodarone Solution if:

• you are allergic to any ingredient in Amiodarone Solution, including iodine
• you have complete, second degree, third degree, or severe sinoatrial heart block; an abnormally slow heartbeat; or shock due to serious heart problems
• you are taking cisapride, dofetilide, an H₁ antagonist (eg, astemizole, loratadine, terfenadine), an HIV protease inhibitor (eg, ritonavir), a phosphodiesterase type 5 inhibitor (eg, vardenafil), or a streptogramin (eg, dalfopristin, quinupristin)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Amiodarone Solution:

Some medical conditions may interact with Amiodarone Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of liver problems, lung disease, heart problems, low blood pressure, thyroid problems, electrolyte problems (eg, low blood potassium or magnesium), eye problems, or sinoatrial heart block
• if you will be having surgery
• if you take medicine for diabetes (eg, glyburide)

Some MEDICINES MAY INTERACT with Amiodarone Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Cholestyramine, hydantoins (eg, phenytoin), rifampin, or St. John's wort because they may decrease Amiodarone Solution's effectiveness
• Antiarrhythmics (eg, flecainide), arsenic, azole antifungals (eg, ketoconazole), cimetidine, cisapride, diuretics (eg, furosemide, hydrochlorothiazide), dofetilide, droperidol, H₁ antagonists (eg, astemizole, loratadine, terfenadine), HIV protease inhibitors (eg, ritonavir), ketolides (eg, telithromycin), macrolide antibiotics (eg, erythromycin), phenothiazines (eg, thioridazine), phosphodiesterase type 5 inhibitors (eg, vardenafil), pimozide, quinolones (eg, ciprofloxacin), serotonin receptor antagonists (eg, dolasetron), streptogramins (eg, dalfopristin, quinupristin), trazodone, or ziprasidone because side effects, such as heart rhythm problems or seizures, may occur
• Narcotic pain relievers (eg, fentanyl) because low blood pressure, slow heartbeat, and other heart problems may occur
• Anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), calcium channel blockers (eg, verapamil, diltiazem), cyclosporine, dextromethorphan, digoxin, HMG-CoA reductase inhibitors (eg, simvastatin), lidocaine, or methotrexate because the risk of their side effects may be increased by Amiodarone Solution
• Thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased or the risk of their side effects may be increased by Amiodarone Solution
• Clopidogrel because its effectiveness may be decreased by Amiodarone Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Amiodarone Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Amiodarone Solution:

Use Amiodarone Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Amiodarone Solution will be given by a qualified health care provider who is experienced in treating life-threatening irregular heartbeats.
• Amiodarone Solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Amiodarone Solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Amiodarone Solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Amiodarone Solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Follow all instructions for proper mixing and dilution with the correct intravenous (IV) fluids. Do not exceed the recommended rate of infusion.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Amiodarone Solution, contact your doctor right away. Do not increase the rate of infusion above the recommended rate to catch up.

Ask your health care provider any questions you may have about how to use Amiodarone Solution.

Important safety information:

• Amiodarone Solution may cause dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Amiodarone Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• A response may not been seen for up to 3 weeks after the medicine is started.
• Amiodarone stays in your body for weeks or months, even after you are no longer taking it. Caution is advised not only during treatment, but also for several months after amiodarone treatment has stopped, if you are taking any medicines that may interact with it.
• Limit alcoholic beverages while taking Amiodarone Solution.
• Infrequently with long-term treatment, you may develop blue-gray discoloring of the skin, particularly of the face and hands. This effect is not harmful and usually reverses, sometimes incompletely, after the medicine is stopped. Avoiding prolonged exposure to the sun may help to prevent this effect.
• Worsening of irregular heartbeat, life-threatening lung disease, and serious liver problems may occur with Amiodarone Solution. Therefore, it should only be given to patients with life-threatening heartbeats who cannot tolerate other medicines.
• Your doctor may want you to check your pulse rate every day while you take Amiodarone Solution. Learn how to monitor your pulse.
• Carry an ID card at all times that says you use Amiodarone Solution.
• A chemical, DEHP, found in plastic IV tubing might harm young children (male reproductive system effects). Amiodarone Solution can cause DEHP to leach out of the tubing. Therefore caution is advised when using Amiodarone Solution in CHILDREN. Special administration guidelines should be followed (eg, multiple bolus dosing) to minimize exposure to DEHP.
• Amiodarone Solution has benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.
• LAB TESTS, including electrocardiogram (ECG), chest x-rays, lung tests, liver tests, thyroid tests, and eye exams, may be performed while you use Amiodarone Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Amiodarone Solution with caution in the ELDERLY; they may be more sensitive to its effects, especially slowing of the heartbeat.
• Amiodarone Solution should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Amiodarone Solution has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Amiodarone Solution while you are pregnant. Amiodarone Solution is found in breast milk. Do not breast-feed while taking Amiodarone Solution.

Possible side effects of Amiodarone Solution:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blue-green discoloring of skin (especially hands or feet); constipation; decreased sexual interest; diarrhea; dizziness; flushing of the face; headache; loss of appetite; nausea; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; chills, coldness; cough; coughing up blood; dark urine; decreased urination; easy bruising or bleeding; enlarged thyroid gland; eye discomfort; fatigue; fever; irregular pulse; loss of coordination; menstrual changes; muscle pain, tenderness, or weakness (especially with fever or unusual tiredness); nervousness; persistent sore throat; severe dizziness; severe stomach pain; shortness of breath; skin reaction similar to serious sunburn; slow heartbeat; sluggishness; sweating; tingling or numbness of hands or feet; uncontrolled shaking or tremor; unexplained weight change; vision changes (seeing halos, blurred vision, loss of vision); wheezing; worsening of irregular heartbeat; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include fainting; lightheadedness, especially upon standing; severe dizziness; slow heartbeat; weakness; yellowing of the skin or eyes.

Proper storage of Amiodarone Solution:

Amiodarone Solution is usually handled and stored by a health care provider. If you are using Amiodarone Solution at home, store Amiodarone Solution as directed by your pharmacist or health care provider. Keep Amiodarone Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Amiodarone Solution, please talk with your doctor, pharmacist, or other health care provider.
• Amiodarone Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Amiodarone Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.