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amiodarone hydrochloride

Amyben (UK), Cordarone, Cordarone X (UK), Nexterone, Pacerone

Pharmacologic class: Benzofuran derivative

Therapeutic class: Antiarrhythmic (class III)

Pregnancy risk category D

FDA Box Warning

Oral products

• Because of substantial toxicity, drug is indicated only in patients with life-threatening arrhythmias.

• Drug may cause potentially fatal pulmonary toxicities, including hypersensitivity pneumonitis and interstitial/alveolar pneumonitis. Pulmonary toxicity is fatal about 10% of time.

• Hepatic injury is common but usually mild, manifesting only as abnormal liver enzyme levels. However, overt hepatic disease can occur and, in rare cases, is fatal.

• Drug may exacerbate arrhythmias by reducing tolerance for them or making them harder to reverse. Arrhythmias and significant heart block or sinus bradycardia occur in 2% to 5% of patients.

• Even in patients at high risk for arrhythmic death in whom toxicity is an acceptable risk, drug poses major management problems. Therefore, other agents should be tried first whenever possible.

• Difficulty of using drug effectively and safely poses significant risk. Patients with indicated arrhythmias must be hospitalized to receive loading dose; response generally takes at least 1 week, but usually 2 or more.


Prolongs duration and refractory period of action potential. Slows electrical conduction, electrical impulse generation from sinoatrial node, and conduction through accessory pathways. Also dilates blood vessels.


Injection: 50 mg/ml in 3-ml ampules

Injection, premixed in dextrose: 1.5 mg/ml (150 mg/100 ml), 1.8 mg/ml (360 mg/200 ml) in single-use plastic containers

Tablets: 100 mg, 200 mg, 400 mg

Indications and dosages

Life-threatening ventricular arrhythmias

Adults: 150 mg in 100 ml of dextrose 5% in water (D5W) by rapid I.V. infusion over 10 minutes; then dilute 900 mg in 500 ml of D5W and administer 360 mg by slow I.V. infusion over next 6 hours; then 540-mg I.V. maintenance infusion over next 18 hours. Or 800 to 1,600 mg P.O. daily in one to two doses for 1 to 3 weeks; then 600 to 800 mg P.O. daily in one to two doses for 1 month; then 400-mg P.O. daily as maintenance dosage. All dosages are titrated to individual patient's clinical needs.

Frequently recurring ventricular fibrillation (VF), hemodynamically unstable ventricular tachycardia (VT)

Adults: Initially, 1,000 mg I.V. infusion over first 24 hours, by following infusion regimen: 150 mg/100 ml (1.5 mg/ml) rapid I.V. infusion over 10 minutes, followed by 360 mg (1 mg/minute) by slow I.V. infusion over 6 hours; then 540 mg (0.5 mg/minute) by slow I.V. infusion over remaining 18 hours as maintenance infusion. For breakthrough episodes of VF or hemodynamically unstable VT, repeat initial loading dose of 150 mg/100 ml I.V. infusion over 10 minutes as needed. After first 24 hours, continue maintenance infusion of 720 mg/24 hours (0.5 mg/minute) for up to 3 weeks. Increase maintenance infusion rate to achieve effective arrhythmia suppression as needed.

Off-label uses

• Atrioventricular (AV) nodal reentry tachycardia (with parenteral use)

• Conversion of atrial fibrillation to normal sinus rhythm


• Hypersensitivity to drug or its components, including iodine

• Cardiogenic shock

• Second- or third-degree AV block

• Marked sinus bradycardia

• Breastfeeding

• Neonates


Use cautiously in:

• electrolyte imbalances, severe pulmonary or hepatic disease, thyroid disorders

• history of heart failure

• elderly patients

• pregnant patients

• children.


Know that I.V. amiodarone is a high-alert drug.

Give loading dose only in hospital setting with continuous ECG monitoring.

• Administer oral loading dose in two equal doses with meals. Give maintenance dose daily or in two divided doses to minimize GI upset.

• Don't give I.V. unless patient is on continuous ECG monitoring.

• Dilute I.V. drug (except premixed drug) with dextrose 5% in water and use an in-line filter. Drug isn't compatible with normal saline solution.

• Don't combine premixed drug with any other product in the same I.V. line or premixed container.

Don't use plastic containers in series connections because of risk of air embolism.

• Use central venous catheter when giving repeated doses. If possible, use dedicated catheter for drug.

Adverse reactions

CNS: dizziness, fatigue, headache, insomnia, paresthesia, peripheral neuropathy, poor coordination, involuntary movements, tremor, sleep disturbances

CV: hypotension, heart failure, worsening arrhythmia, AV block, sinoatrial node dysfunction, bradycardia, asystole, cardiac arrest, cardiogenic shock, electromechanical dissociation, ventricular tachycardia

EENT: corneal microdeposits, corneal or macular degeneration, visual disturbances, dry eyes, eye discomfort, optic neuritis or neuropathy, scotoma, lens opacities, photophobia, visual halos, papilledema

GI: nausea, vomiting, constipation, abdominal pain, abnormal salivation, anorexia

GU: decreased libido

Hematologic: coagulation abnormalities, thrombocytopenia

Hepatic: nonspecific hepatic disorders, hepatic dysfunction

Metabolic: hypothyroidism, hyperthyroidism

Respiratory: cough, adult respiratory distress syndrome, pulmonary inflammation or fibrosis, pulmonary edema

Skin: flushing, photosensitivity, toxic epidermal necrolysis

Other: abnormal taste and smell, edema, fever, Stevens-Johnson syndrome


Drug-drug. Anticoagulants: increased prothrombin time (PT)

Azole antifungals, fluoroquinolones, loratadine, macrolide antibiotics, trazodone: increased risk of life-threatening arrhythmias

Beta-adrenergic blockers: increased risk of bradycardia and hypotension

Calcium channel blockers: increased risk of AV block (with verapamil, diltiazem) or hypotension (with any calcium channel blocker)

Cholestyramine: decreased amiodarone blood level

Cimetidine, ritonavir: increased amiodarone blood level

Class I antiarrhythmics (disopyramide, flecainide, lidocaine, mexiletine, procainamide, quinidine): increased blood levels of these drugs, leading to toxicity

Cyclosporine: elevated cyclosporine and creatinine blood levels

Dextromethorphan: impaired dextromethorphan metabolism (with amiodarone therapy of 2 weeks or longer)

Digoxin: increased digoxin blood level, leading to toxicity

Fentanyl: increased bradycardia, hypotension

Methotrexate: impaired methotrexate metabolism, possibly causing toxicity (with amiodarone use longer than 2 weeks)

Phenytoin: decreased amiodarone blood level or increased phenytoin blood level (with amiodarone use longer than 2 weeks)

Protease inhibitors (atazanavir, indinavir, nelfinavir): possible increased amiodarone concentration

Rifampin: decreased amiodarone concentration

Theophylline: increased theophylline blood level (with amiodarone use longer than 1 week)

Drug-diagnostic tests. Kidney function tests: abnormal results

Drug-food. Grapefruit juice: increased drug concentration

Drug-herb. St. John's wort: decreased drug blood level

Patient monitoring

Monitor patient closely. Drug may cause serious or life-threatening adverse reactions.

Watch for slow onset of life-threatening arrhythmias, especially after giving loading dose.

Monitor ECG continuously during loading dose and when dosage is changed.

• Check patient's blood pressure, pulse, and heart rhythm regularly.

• Assess for signs and symptoms of lung inflammation.

• Monitor baseline and subsequent chest X-rays, as well as pulmonary, liver, and thyroid function test results.

• Closely monitor patient who's receiving other drugs concurrently because amiodarone can interact with many drugs. Check digoxin blood level if patient is receiving digoxin; monitor PT or International Normalized Ratio if patient is receiving anticoagulants.

Patient teaching

Inform patient that drug may cause serious adverse reactions. Instruct him to report these immediately.

• Tell patient to take oral doses with meals. Advise him to divide daily dose into two doses if drug causes GI upset.

• Tell patient that adverse reactions are most common with high doses and may become more frequent after 6 months of therapy.

• Inform patient that he'll undergo regular blood testing, eye examinations, chest X-rays, and pulmonary function tests during therapy.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved


A trademark for the drug amiodarone hydrochloride.
The American Heritage® Medical Dictionary Copyright © 2007, 2004 by Houghton Mifflin Company. Published by Houghton Mifflin Company. All rights reserved.


A brand name for AMIODARONE.
Collins Dictionary of Medicine © Robert M. Youngson 2004, 2005
References in periodicals archive ?
Following nearly nine months of shortage, the Ministry of Health said it distributed 113,000 packets of Cordarone to Egyptian pharmacies in October in a bid to overcome the shortage.
Cordarone was on their critical medicine list so it was essential to provide sufficient supplies."
The bag, last seen in the early hours of Saturday, contained: 28, 75mg tablets of Aspirin; 28, 20mg tablets of Frusemide; 28, 100mg tablets of Thiamine; 38, 125mg of Digoxin; 28, 200mg tablets of Cordarone and 28, 200mg tablets of Amiodarone.
The following drugs should not be combined with ritonavir: bepridil (Vascor), amiodarone (Cordarone), flecainide (Tambocor), propafenone (Rythmol), quinidine (Quinidex), simvastatin (Zocor), lovastatin (Mevacor), cisapride (Propulsid), clozapine (Clozaril), midazolam (Versed), triazolam (Halcion), dihydroergotamine (DHE 45) and ergotamine (Cafergot).
The Vaughan Williams classification of antiarrhythmics and examples of representative agents are as follows (although, as discussed elsewhere (5), this classification has certain limitations): class I, [Na.sup.+] -channel blockade (Harrison's modification (6) further divides this class of antiarrhythmics into three subclasses: IA (quinidine and procainamide), IB (lidocaine and phenytoin), and IC (flecainide)); class II, [beta]-adrenergic blockade, propranolol; class III, prolonged repolarization, amiodarone (Cordarone) or bretylium (Bretylol); class IV, [Ca.sup.2+]-channel blockade, verapamil or diltiazem; class V, altering cell membrane responsiveness, digoxin and atropine.
Drug Category Potential Alternatives Analgesic (pain reliever): meperidine (Demerol) acetaminophen (Tylenol, others) piroxicam (Feldene) aspirin (Bayer, others) propoxyphene (Darvon, others) oxycodone (Percocet, others) Cardiovascular (for the heart): amiodarone (Cordarone) flecainide (Tambocor) very limited clinical propafenone (Rythmol) experience quinidine (various) Antimycobacterial (Anti-TB or anti-MAC): clarithromycin (Biaxin) azithromycin (Zithromax) rifabutin (Mycobutin) ethambutol (Myambutol) Calcium Channel Blocker (for the heart): bepridil (Vascor) very limited clinical experience Ergot Alkaloid (vasoconstrictor): dihydroergotamine (D.H.E.
Among the more common antiarrhythmics are amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dronedarone (Multaq), flecainide (Tambocor) and sotalol (Betapace AF).
Amiodarone HCI injection, 50 Sicor Pharmaceuticals Cordarone IV
The parties' trial memoranda in a case holding that punitive damages were properly awarded where the manufacturer of Cordarone did not warn about the potential for permanent vision loss.
These drugs, known as anti-arrhythmics, include amiodarone (Cordarone, Pacerone) and dronedarone (Maltaq), among others.
One of Upsher-Smith's most recent successes dame with its class III antiarrhythmic Pacerone, which it launched in April 1998 as a generic alternative to Wyeth-Ayerst Laboratories' Cordarone. With a price pegged at only half of Gordarone's, Upsher-Smith set out to capture 25% of the market for the medication.
Ask your physician if you should be screened, especially if you have a family history of thyroid disease or you take medications that increase the risk of hypothyroidism, such as amiodarone (Cordarone) or lithium.