FDA and Wyeth notified pharmacists and physicians of a new Medication Guide for amiodarone hydrochloride tablets (Cordarone, Pacerone). The FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern. The Medication Guide and current Prescribing Information for amiodarone hydrochloride and its generic equivalents are also provided below. For more information visit the FDA website at: [Web] and [Web].
AMIODARONE (a MEE oh da rone) is an antiarrhythmic drug. It helps make your heart beat regularly. Because of the side effects caused by this medicine, it is only used when other medicines have not worked.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
This does not apply.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Your condition will be monitored closely when you first begin therapy. This drug is first started in a hospital or other monitored health care setting. Once you are on maintenance therapy, visit your doctor or health care professional for regular checks on your progress. Because your condition and use of this medicine carry some risk, it is a good idea to carry an identification card, necklace or bracelet with details of your condition, medications, and doctor or health care professional.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.
This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.
Your eyes may get dry while you are using this medicine. It may be helpful to use a lubricating eye solution or artificial tears solution. Check with your doctor or health care professional for regular eye examinations.
If you are going to have surgery or a procedure that requires contrast dyes, tell your doctor or health care professional that you are taking this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
blue-gray coloring of the skin
blurred vision, seeing blue-green halos, increased sensitivity of the eyes to light
change in sex drive or performance
constipation
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
This drug is given in a hospital or clinic and will not be stored at home.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
