Warnings & Recalls for Cordarone
Black Box Warning
The black box warning indicates that Cordarone is
recommended for use ONLY in those with life-threatening arrhythmias as the health risks associated with the drug can provide fatal toxicities, especially in the lungs.
Other warnings
Patients who have
had a history of liver complications, lung complications, thyroid problems, blood pressure problems, any heart conditions, second or third degree AV blocks, hepatitis, low levels of potassium and magnesium levels, low heart rates, or those who have had recent surgery
should consult a physician before taking Cordarone.
The efficacy and
health risks in children have not yet been established, therefore caution should be exerted when administering Cordarone in children.
Those who are
allergic to cordarone or any of its ingredients (amiodarone HCl, iodine, amiodarone hydrochloride, colloidal silicon dioxide, cornstarch, FD&C Red No. 40 Lake, lactose, magnesium stearate, povidone and starch) should not take this drug.
Cordarone may make patients dizzy, therefore extreme caution, if avoidance, should be exerted when
operating heavy machinery until the patient is aware of how the drug will affect them.
This drug causes
sensitivity to the sun, therefore patients should avoid long exposure to the sun, as well as tanning booths and sunlamps. These patients should wear sunscreen and protective clothing when in the sunlight.
Cordarone may
stay within the body for months after discontinuation, therefore some patients may experience side effects even after they have stopped taking the drug.
Those who are taking Cordarone
CANNOT take the drug with grapefruit juice because of its affect on absorption of the drug in the stomach.
Cordarone may cause a condition that
can cause long QT syndrome that may require medical attention. This syndrome can cause fast/irregular heartbeats that may be more exaggerated than before. Testing can be done for susceptibility for the syndrome before taking Cordarone.
Contraindications:
Contraindications for Cordarone include:
- atenolol, propranolol, metoprolol, quinidine, fentanyl
- verapamil, diltiazem, digoxin, flecainide, procainamide, certain anesthetics
- phenytoin, ritonavir, amitriptyline, chlorpromazine, warfarin, fluoroquinolone antibiotics,
- simvastatin, atrovastatin, lovastatin, dextromethorphan, grapefruit juice
- fingolimod, dofetilide, pimozide, clarithromycin, erythromycin, cholestyramine
- levofloxacin, azole antifungals, cimetidine, protease inhibitors, rifamycins, St. John's wort
- lidocaine, clopidogrel, cyclosporine, digoxin, trazodone, antibiotics, macrolide antibiotics, methotrexate,
- depression medications, blood thinners, HIV/AIDS medications, seizure medications, diabetes medications
- loratadine, diuretics, heart/circulation/blood pressure medications, cholesterol medications, narcotic pain medications
- sildenafil, theophylline, rifabutin and rifampin
Family Planning:
Cordarone should
not be used during pregnancy as it has been listed by the FDA in pregnancy category D, meaning there has been previous fetal harm in those taking the drug while pregnant. Patients should seek medical attention if they discover they are pregnant to discuss the benefits and the risks of continuing the drug while pregnant.
Nursing mothers should be advised that Cordarone passes into breast milk, however no fetal harm has been reported. Those breastfeeding while on Cordarone should discuss the potential risk of fetal harm with their physician.
Cordarone Treatment and Use
What is Cordarone?
Cordarone is an antiarrhythmic used to treat abnormal hearth rhythms known as arrhythmias. It will help to treat life-threatening chronic arrhythmias as well as supraventricular arrhythmias and ventricular arrhythmias where other medications have failed.
How does Cordarone work?
Cordarone works by changing the electrical impulses that make the heart beat regularly. Among these changes are a delay in the rate the heart recharges after a contraction, heart muscle cell stimulation prolongation, decrease in the speed of the electrical impulses that go through a heart’s electrical pathways and a reduction in the pace of the firing of the heart’s natural pacemaker.
Cordarone can also enlargen the blood vessels which can help those with congestive heart failure.
Dosage Information
Cordarone is available in 200 mg and 400 mg tablet form, as well as liquid form that is normally administered by a physician.
The benefits of the medication can be seen as early as 3 days after taking the medication, but may take up to 3 weeks before the full benefits can be felt.
The recommended dosage for Cordarone is initially 800-1600 mg daily (in divided doses) for 1-3 weeks, then a dose of 600-800 mg per day for 4 weeks, followed by 400 mg a day for routine maintenance. All administrations of the drug should be taken with meals to minimize upset stomach.
Dosages can be changed depending on the patient’s personal conditions, and Cordarone can stay in the body for weeks, and even months, after discontinuation.
