Amiodarone-New Medicating Guide Rules

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Ross

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA and Wyeth notified pharmacists and physicians of a new Medication Guide
for Cordarone (amiodarone hydrochloride tablets). 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. A list of currently approved Medication Guides are
available at http://www.fda.gov/cder/Offices/ODS/labeling.htm.

Read the 2005 safety summary, including links to the Dear Healthcare
Professional Letter, Dear Pharmacist Letter, current Prescribing
Information, and new Medication Guide:
http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Cordarone
 
Ross - my computer reader won't open it. I need to read the amiodarone one. Maybe somebody could cut/paste to a thread? We have lots of ?s about Cordarone in VR and it's a need to know subject.
 
well, okey dokey, Ross. Thanks. Wonder why Adobe comes out with a new one ever time I turn around. I have Adobe 6 - and 5 - and 4, etc......but I'll do 'er. Cause I have to read this.
 
Here it is. Very important info:

Here it is. Very important info:

Medication Guide
Cordarone® ´KOR-DU-RO¯ N Tablets
(amiodarone HCl)
Rx only
Read the Medication Guide that comes with Cordarone Tablets before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about Cordarone
Tablets?
Cordarone Tablets can cause serious side effects
that can lead to death including:
? lung damage
? liver damage
? worse heartbeat problems
Call your doctor or get medical help right away if you
have any symptoms such as the following:
? shortness of breath,
wheezing, or any other trouble breathing; coughing,
chest pain, or spitting up of blood
? nausea or vomiting; passing brown or dark-colored urine; feel more tired than usual; your skin and whites of your eyes get yellow; or have stomach
pain
? heart pounding, skipping a beat, beating very fast
or very slowly; feel lightheaded or faint
Because of these possible side effects, Cordarone Tablets should only be
used in adults with lifethreatening heartbeat problems called ventricular
arrhythmias, for which other treatments did not work or were not
tolerated.
Cordarone Tablets can cause other serious side effects. See ?What are the possible or reasonably likely side effects of Cordarone Tablets?? for more information.
If you get serious side effects during treatment with Cordarone Tablets you may need to stop Cordarone Tablets, have your dose changed, or get medical
treatment. Talk with your doctor before you stop taking Cordarone
Tablets.
You may still have side effects after stopping Cordarone Tablets because the
medicine stays in your body months after treatment is stopped.
Tell all your healthcare providers that you take or took Cordarone Tablets. This information is very important for other medical treatments or surgeries you may have.
What are Cordarone Tablets?
Cordarone is a medicine used in adults to treat life-threatening heartbeat problems called ventricular arrhythmias, for which other treatment did not work or was not tolerated.
Cordarone Tablets have not been shown to help people with life-threatening
heartbeat problems live longer. Treatment with Cordarone Tablets should be started in a hospital to monitor your condition. You should have regular check-ups, blood tests, chest x-rays, and eye exams before and during treatment with Cordarone Tablets to check for serious side effects.
Cordarone Tablets have not been studied in children.
Who should not take Cordarone Tablets?
Do not take Cordarone Tablets if you:
? have certain heart conditions (heart block, very slow heart rate, or slow heart rate with dizziness or lightheadedness)
? have an allergy to amiodarone, iodine, or any of the other ingredients in
Cordarone Tablets. See the end of this Medication Guide for a complete list of
ingredients in Cordarone Tablets.
What should I tell my doctor before starting Cordarone Tablets?
Tell your doctor about all of your medical conditions including if you:
? have lung or breathing problems
? have liver problems
? have or had thyroid problems
? have blood pressure problems
? are pregnant or planning to become pregnant. Cordarone can harm your unborn baby. Cordarone can stay in your body for months after treatment is stopped.
Therefore, talk with your doctor before you plan to get pregnant.
? are breastfeeding. Cordarone passes into your milk and can harm your baby. You should not breast feed while taking Cordarone. Also, Cordarone can stay in your body for months after treatment is stopped.
Tell your doctor about all the medicines you take including prescription and
nonprescription medicines, vitamins and herbal supplements. Cordarone Tablets and certain other medicines can interact with each other causing serious side effects.
Sometimes the dose of Cordarone Tablets or other medicines must be changed when they are used together. Especially, tell your doctor if you are taking:
? antibiotic medicines used to treat infections
? depression medicines
? blood thinner medicines
? HIV or AIDS medicines
? cimetidine (Tagamet®), a medicine for stomach ulcers or indigestion
? seizure medicines
? diabetes medicines
? cyclosporine, an immunosuppressive medicine
? dextromethorphan, a cough medicine
? medicines for your heart, circulation, or blood pressure
? water pills (diuretics)
? high cholesterol or bile medicines
? narcotic pain medicines
? St. John?s Wort
Know the medicines you take. Keep a list of them with you at all times and show it to your doctor and pharmacist each time you get a new medicine. Do not take any new medicines while you are taking Cordarone Tablets unless you have talked with your doctor.
How should I take Cordarone Tablets?
? Take Cordarone Tablets exactly as prescribed by your doctor.
 
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