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Cordarone IV

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Cordarone IV

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Cordarone IV Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cordarone IV (amiodarone hydrochloride) Intravenous is an antiarrhythmic drug used to treat and prevent frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Cordarone I.V. also can be used to treat patients with VT/VF for whom oral Cordarone is indicated, but who are unable to take oral medication. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include low blood pressure, slow heart rate, heart arrest, nausea, fever, congestive heart failure, and abnormal heart rhythm.

The recommended starting dose of Cordarone I.V. is about 1000 mg over the first 24 hours of therapy. Cordarone IV may interact with protease inhibitors, loratadine, cimetidine, antidepressants, grapefruit juice, cyclosporine, simvastatin, digoxin, other antiarrhythmic drugs, beta-blockers, calcium channel antagonists, anticoagulants, clopidogrel, antibiotics, St. Johns Wort, fentanyl, lidocaine, dextromethorphan, cholestyramine, disopyramide, azole antifungals, propranolol, diltiazem, verapamil, phenytoin, dextromethorphan, methotrexate, and diuretics. Tell your doctor all medications and supplements you use. Cordarone IV may be harmful to a fetus if administered during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant before using Cordarone IV. This drug passes into breast milk. Breastfeeding while using this drug is not recommended.

Our Cordarone IV (amiodarone hydrochloride) Intravenous Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cordarone IV FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

In a total of 1836 patients in controlled and uncontrolled clinical trials, 14% of patients received Cordarone I.V. for at least 1 week, 5% received it for at least 2 weeks, 2% received it for at least 3 weeks, and 1% received it for more than 3 weeks, without an increased incidence of severe adverse reactions. The mean duration of therapy in these studies was 5.6 days; median exposure was 3.7 days.

The most important treatment-emergent adverse effects were hypotension, asystole/cardiac arrest/electromechanical dissociation (EMD), cardiogenic shock, congestive heart failure, bradycardia, liver function test abnormalities, VT, and AV block. Overall, treatment was discontinued for about 9% of the patients because of adverse effects. The most common adverse effects leading to discontinuation of Cordarone I.V. therapy were hypotension (1.6%), asystole/cardiac arrest/EMD (1.2%), VT (1.1%), and cardiogenic shock (1%).

The following table lists the most common (incidence 2%) treatment-emergent adverse events during Cordarone I.V. therapy considered at least possibly drug-related. These data were collected in clinical trials involving 1836 patients with life-threatening VT/VF. Data from all assigned treatment groups are pooled because none of the adverse events appeared to be dose-related.

SUMMARY TABULATION OF TREATMENT-EMERGENT DRUG-RELATED STUDY EVENTS IN PATIENTS RECEIVING CORDARONE I.V. IN CONTROLLED AND OPEN-LABEL STUDIES (≥ 2% INCIDENCE)

Study Event
Controlled Studies (n=814)
Open-Label Studies (n=1022)
Total (n=1836)
Body as a Whole
Fever
24 (2.9%)
13 (1.2%)
37 (2.0%)
Cardiovascular System
Bradycardia
49 (6.0%)
41 (4.0%)
90 (4.9%)
Congestive heart failure
18 (2.2%)
21 (2.0%)
39 (2.1%)
Heart arrest
29 (3.5%)
26 (2.5%)
55 (2.9%)
Hypotension
165 (20.2%)
123 (12.0%)
288 (15.6%)
Ventricular tachycardia
15 (1.8%)
30 (2.9%)
45 (2.4%)
Digestive System
Liver function tests abnormal
35 (4.2%)
29 (2.8%)
64 (3.4%)
Nausea
29 (3.5%)
43 (4.2%)
72 (3.9%)

Other treatment-emergent possibly drug-related adverse events reported in less than 2% of patients receiving Cordarone I.V. in Wyeth-Ayerst controlled and uncontrolled studies included the following: abnormal kidney function, atrial fibrillation, diarrhea, increased ALT, increased AST, lung edema, nodal arrhythmia, prolonged QT interval, respiratory disorder, shock, sinus bradycardia, Stevens-Johnson syndrome, thrombocytopenia, VF, and vomiting.

Postmarketing Reports

In postmarketing surveillance, hypotension (sometimes fatal), sinus arrest, anaphylactic/anaphylactoid reaction (including shock), angioedema, hepatitis, cholestatic hepatitis, cirrhosis, pancreatitis, renal impairment, renal insufficiency, acute renal failure, bronchospasm, possibly fatal respiratory disorders (including distress, failure, arrest, and ARDS), bronchiolitis obliterans organizing pneumonia (possibly fatal), fever, dyspnea, cough, hemoptysis, wheezing, hypoxia, pulmonary infiltrates and/or mass, pleuritis, pseudotumor cerebri, syndrome of inappropriate antidiuretic hormone secretion (SIADH), thyroid nodules/thyroid cancer, toxic epidermal necrolysis (sometimes fatal), erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, skin cancer, vasculitis, pruritus, hemolytic anemia, aplastic anemia, pancytopenia, neutropenia, thrombocytopenia, agranulocytosis, granuloma, myopathy, muscle weakness, rhabdomyolysis, hallucination, confusional state, disorientation, delirium, epididymitis, and impotence also have been reported with amiodarone therapy.

Also, in patients receiving recommended dosages of Cordarone I.V., there have been postmarketing reports of the following injection site reactions: pain, erythema, edema, pigment changes, venous thrombosis, phlebitis, thrombophlebitis, cellulitis, necrosis, and skin sloughing (see DOSAGE AND ADMINISTRATION).

Read the entire FDA prescribing information for Cordarone IV (Amiodarone Intravenous) »

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Additional Cordarone IV Information

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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