amiodarone (Rx)

Brand and Other Names:Pacerone, Cordarone, more...Nexterone
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Dosing & Uses


Dosage Forms & Strengths

injectable solution

  • 50mg/mL
  • 150mg/100mL (Nexterone)
  • 360mg/200mL (Nexterone)


  • 100mg
  • 200mg
  • 400mg

Stable Monomorphic or Polymorphic Ventricular Tachycardia (Off-label)

150 mg IV bolus in 10 minutes; may repeat q10min as necessary, THEN

1 mg/min IV for 6 hours, THEN

0.5 mg/min IV for 18 hours; not to exceed 2.2 g/24hr

For breakthrough episodes of VF or hemodynamically unstable VT , repeat the initial load

Dosing considerations

  • Initiate in hospital with experienced personnel

ACLS, Pulseless Ventricular Fibrillation/Ventricular Tachycardia (Off-label)

300 mg IV or intraosseous push after dose epinephrine if no initial response to defibrillation

May follow initial dose with 150 mg IV q3-5min

Dosing considerations

  • Rapid IV push if pulseless/no BP

Ventricular Arrhythmias


  • Load: 800-1600 mg PO qDay for 1-3 weeks until response; once adequate arrhythmia control achieved, reduce dose to 600-800 mg/day for 1 mo; THEN reduce to maintenance dose
  • Maintenance dose: 400 mg PO qDay


  • 150 mg over first 10 min (15mg/min), followed by 360 mg over next 6 hr (1 mg/min), THEN 540 mg over remaining 18 hr (0.5 mg/min), for a total of 1000 mg over 24 hr before administering maintenance infusion
  • Maintenance: 0.5 mg/min for a total 720 mg/24hr at a concentration of 1-6 mg/mL (360 mg/200mL), or 1.8 mg/mL Nexterone at rate of 278 mL/min
  • Duration of therapy: May continue to administer 0.5 mg/min for 2-3 weeks regardless of patient's age, renal function or ventricular function

Dosing considerations

Conventional IV preparation contains polysorbate 80 and benzyl alcohol

Newer IV formulation (Nexterone) does not contain polysorbate 80 or benzyl alcohol

Conversion to oral amiodarone after IV administration

<1 week IV infusion: 800-1600 mg/day

1-3 week IV infusion: 600-800 mg/day

>3 week IV infusion: 400 mg/day

Dosage Forms & Strengths

injectable solution

  • 50mg/mL
  • 150mg/100mL (Nexterone)
  • 360mg/200mL (Nexterone)


  • 100mg
  • 200mg
  • 400mg

Drug Resistant Refractory Cardiac Arrhythmias (Off-label)


  • Age <1 year: 600-800 mg/1.73 m² q24hr or divided q12hr; continue therapy for 4-14 days and/or until adequate control achieved; if initial treatment effective, decrease dosage to 200-400 mg/1.73 m² q24hr or divided q12hr  
  • Age >1 year: Until adequate control, 10-15 mg/kg/day PO qDay or divided q12hr; if effective, reduce to 5 mg/kg/day PO qDay or divided q12hr  


  • Loading dose (limited data): 5 mg/kg IV over 30-60 min
  • Maintenance dose: 0.005 mg/kg/min IV infusion; may increase to 20 mcg/kg/min per 24 hr; consider converting to oral therapy within 24-48 hr

Pulseless Ventricular Tachycardia or Ventricular Fibrillation (PALS dosing) (Off-label)

5 mg/kg IV/IO rapid bolus; not to exceed 300 mg/dose; may repeat twice to maximum 15 mg/kg during acute treatment  

Supraventricular Tachycardia (Off-label)

Infants/children/adolescents: 5 mg/kg IV over 1 hr initially; follow with 5 mg/kg/day for 47 hr  

Maintenance: 10-20 mg/kg/day for 7-10 days; follow with 3-20 mg/kg/day

Dosing Considerations

In a pediatric trial of 61 patients, aged 30 days to 15 years, hypotension (36%), bradycardia (20%), and atrioventricular block (15%) were common dose-related adverse events and were severe or life-threatening in some cases

Injection site reactions were seen in 5 (25%) of the 20 patients receiving amiodarone HCI injection through a peripheral vein, irrespective of dose regimen

Conventional IV amiodarone contains the preservative benzyl alcohol; there have been reports of fatal “gasping syndrome” in neonates (children aged less than 1 month) following the administration of IV solutions containing the preservative benzyl alcohol

Newer IV formulation (Nexterone) does not contain polysorbate 80 or benzyl alcohol

Recommended to start dosing at the lower end of the dosing range because elderly may be predisposed to toxicity



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            Adverse Effects


            Increased liver AST or ALT levels (3-20%; as high as 40-50% in some studies)

            Hypotension (16%)

            Dizziness (3-40%)

            Headache (3-40%)

            Malaise (3-40%)

            Abnormal gait/ataxia (3-40%)

            Fatigue (3-40%)

            Impaired memory (3-40%)

            Involuntary movement (3-40%)

            Sleep disturbances (3-40%)

            Photosensitivity (10-75%)

            Hypothyroidism (1-22%)

            Constipation (10-33%)

            Anorexia (10-33%)


            CHF (3%)

            Bradycardia or sinus arrest (3-5%)

            AV block (5%)

            SA node dysfunction (1-3%)

            Hyperthyroidism (3-10%)

            Hepatitis and cirrhosis (<3%)

            Visual disturbances (2-9%)

            Optic neuritis (1%)

            Frequency Not Defined

            Corneal microdeposits

            Demyelinating polyneuropathy

            Postmarketing Reports

            Hypersensitivity: Anaphylactic/anaphylactoid reaction (including shock), angioedema, urticaria

            Pulmonary: Eosinophilic pneumonia, ARDS (in postoperative setting), 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, pulmonary alveolar hemorrhage, pleural effusion, pleuritis

            Gastrointestinal: Hepatitis, cholestatic hepatitis, cirrhosis, pancreatitis, dry mouth

            Nephrology: Renal impairment, renal insufficiency, acute renal failure

            Neurology: Pseudotumor cerebri, parkinsonian symptoms, such as akinesia and bradykinesia (sometimes reversible with discontinuation of therapy)

            Endocrine: SIADH, thyroid nodules/thyroid cancer

            Dermatology: Toxic epidermal necrolysis (sometimes fatal), erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, drug rash with eosinophilia and systemic symptoms (DRESS), eczema, skin cancer, vasculitis, pruritus, bullous dermatitis

            Hematology: Hemolytic anemia, aplastic anemia, pancytopenia, neutropenia, thrombocytopenia, agranulocytosis, granuloma, lupus-like syndrome

            Musculoskeletal: Myopathy, muscle weakness, rhabdomyolysis, demyelinating polyneuropathy

            Psychiatric: Hallucination, confusional state, disorientation, delirium

            Genitourinary: Epididymitis, impotence



            Black Box Warnings

            Indicated only for life-threatening arrhythmias

            • Indicated only for life-threatening arrhythmias because of risk for substantial toxicity; poses major management problems that could be life-threatening in patients at risk of sudden death; therefore, make every effort to utilize alternative agents first
            • Difficulty of using amiodarone effectively and safely poses significant risk to patients
            • Patients must be hospitalized while IV loading dose administered; response generally requires at least 1 week
            • Absorption and elimination variable, maintenance dosing difficult, and often requires dosage decrease or temporary discontinuation
            • Retrospective survey of 192 patients with ventricular tachyarrhythmias showed 84 patients required dose reduction and 18 required at least temporary discontinuation (because of adverse reactions); several trials have reported 15-20% overall frequencies of discontinuation because of adverse reactions
            • Time to recurrence of previously controlled life-threatening arrhythmia after discontinuation or dose adjustment is unpredictable (ranges from weeks to months); patient is at great risk during this transition and may require hospitalization
            • Fatal toxicities: Fatal toxicities may be caused by pulmonary toxicity, hepatotoxicity, and proarrhythmic effect
            • Initiate therapy under hospital or specialist supervision

            Pulmonary toxicity

            • Presents as hypersensitivity pneumonitis or interstitial/alveolar pneumonitis (10-17% incidence with 400 mg/day)
            • May present without symptoms as abnormal diffusion capacity in a much higher percentage of patients
            • Fatal in ~10% of cases

            Liver injury

            • Common but usually mild and evidenced only by abnormal liver enzymes
            • Overt liver disease can occur and has been fatal in a few cases

            Proarrhythmic effect

            • Like other antiarrhythmics, can exacerbate the arrhythmia (eg, by making the arrhythmia less well tolerated or more difficult to reverse)
            • 2-5% incidence; includes significant heart block or sinus bradycardia
            • Manage arrhythmias in proper clinical setting
            • Effects are prolonged when they occur because of long drug half-life



            Severe sinus node dysfunction, 2°/3° AV block or bradycardia causing syncope (except with functioning artificial pacemaker), cardiogenic shock

            Avoid during breastfeeding


            To be administered only by physicians experienced in treatment of life-threatening arrhythmias, who are thoroughly familiar with risks and benefits of amiodarone therapy, and have access to facilities adequate for monitoring effectiveness and side effects of treatment; because of long half-life of amiodarone and its metabolite desethylamiodarone, the potential for adverse reactions or interactions, as well as observed adverse effects, can persist following amiodarone withdrawal

            Adjust dosage based on adverse reaction and therapeutic response

            Avoid excessive exposure to sunlight; may cause photosensitivity

            Attempts to substitute other antiarrhythmic agents when amiodarone must be stopped is difficult due to the complex pharmacokinetics of the drug, including prolonged duration of action and half-life and difficulties predicting them, which in turn increases risk for drug interactions

            Hypothyroidism has been reported in 2 to 10% of patients receiving amiodarone and may be primary or subsequent to resolution of preceding amiodarone-induced hyperthyroidism; manage hypothyroidism by reducing the dose of or discontinuing amiodarone and considering the need for thyroid hormone supplement

            Risks of acute MI, AV block, cardiomegaly; especially with IV administration

            Bradycardia and atrio-ventricular block reported; treat bradycardia by slowing infusion rate or discontinuing therapy; in some patients, inserting a pacemaker is required; treat patients with a known predisposition to bradycardia or AV block in a setting where a temporary pacemaker is available

            Hypotension is the most common adverse reaction; in some cases, hypotension may be refractory and result in a fatal outcome; treat hypotension initially by slowing the infusion; additional standard therapy may include vasopressor drugs, positive inotropic agents, and volume expansion; monitor initial rate of infusion closely, not to exceed recommended rate

            Chronic administration of antiarrhythmic drugs may affect defibrillation or pacing thresholds in patients with implanted defibrillators, pacemakers; assess when therapy is initiated and throughout

            Correct hypokalemia, hypomagnesemia or hypocalcemia before initiating treatment as these disorders can exaggerate the degree of QTc prolongation and increase the potential for TdP; give special attention to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhea or in patients receiving concomitant diuretics and laxatives, systemic corticosteroids, amphotericin B (IV) or other drugs affecting electrolyte levels

            May increase risks of pulmonary fibrosis; liver disease; hypotension, bradycardia, hyperthyroidism; optic neuropathy; pleural effusion; pneumonitis (including eosinophilic pneumonia); consider alternative antiarrhythmic therapy if patient experiences signs or symptoms of pulmonary toxicity; prednisone 40 to 60 mg/day tapered over several weeks may be helpful in treating pulmonary toxicity

            Acute-onset (days to weeks) pulmonary injury reported in patients treated with IV amiodarone; findings have included pulmonary infiltrates and masses on X-ray, bronchospasm, wheezing, fever, dyspnea, cough, hemoptysis, and hypoxia; some cases have progressed to respiratory failure or death

            Postoperatively, occurrences of adult respiratory distress syndrome reported in patients receiving amiodarone therapy who have undergone either cardiac or noncardiac surgery; although patients usually respond well to vigorous respiratory therapy, in rare instances the outcome has been fatal; until further studies performed, monitor FiO2 and determinants of oxygen delivery to tissues (e.g., SaO2, PaO2) while taking amiodarone

            Use caution when administering concomitantly with drugs that prolong QTc interval

            Corneal microdeposits appear in majority of adults treated; usually discernible only by slit-lamp examination, but give rise to symptoms such as visual halos or blurred vision up to 10% of patients; corneal microdeposits are reversible upon reduction of dose or termination of treatment; asymptomatic microdeposits alone are not reason to reduce dose or discontinue treatment

            Causes increased INR; use caution when initiating therapy in patients treated with warfarin

            Close perioperative monitoring is recommended in patients undergoing general anesthesia who are on amiodarone therapy as they may be more sensitive to myocardial depressant and conduction effects of halogenated inhalational anesthetics

            Fatal cutaneous reactions reported, including Stevens-Johnson syndrome and toxic epidermal necrolysis; discontinue therapy if symptoms of progressive skin rash occur

            Monitor hepatic enzymes regularly in patients receiving relatively high maintenance doses; asymptomatic elevations of hepatic enzyme levels seen frequently, but therapy can cause life-threatening hepatic injury; histology has resembled that of alcoholic hepatitis or cirrhosis; obtain baseline and periodic liver transaminases; if transaminases exceed three times normal, or doubles in a patient with an elevated baseline, discontinue or reduce dose, obtain follow-up tests and treat appropriately

            Peripheral neuropathy reported rarely with chronic administration; may resolve upon discontinuation of therapy

            Bradycardia, some requiring pacemaker insertion reported when ledipasvir/sofosbuvir or sofosbuvir with simeprevir initiated in patients on amiodarone; bradycardia generally occurred within hours to days, but in some cases up to 2 weeks after initiating antiviral treatment; monitor heart rate in patients taking or recently discontinuing amiodarone when starting antiviral treatment

            Drug interaction overview

            • Serious symptomatic bradycardia when co-administered with ledipasvir/sofosbuvir or with sofosbuvir with simeprevir; postmarketing cases of symptomatic bradycardia, some requiring pacemaker insertion and at least one fatal, have been reported when ledipasvir/sofosbuvir or sofosbuvir with simeprevir were initiated in patients on amiodarone; bradycardia generally occurred within hours to days, but in some cases up to 2 weeks after initiating antiviral treatment and resolved after discontinuation of antiviral treatment; monitor heart rate in patients taking or recently discontinuing amiodarone when starting antiviral treatment
            • Concomitant use of drugs with depressant effects on sinus and AV node (e.g., digoxin, beta blockers, verapamil, diltiazem, ivabradine, clonidine) can potentiate electrophysiologic and hemodynamic effects of amiodarone, resulting in bradycardia, sinus arrest, and AV block; monitor heart rate in patients on amiodarone and concomitant drugs that slow heart rate

            Pregnancy & Lactation


            Amiodarone can cause fetal harm when administered to a pregnant woman; fetal exposure may increase potential for adverse experiences including cardiac, thyroid, neurodevelopmental, neurological and growth effects in neonate; inform patient of potential hazard to fetus if amiodarone administered during pregnancy or if patient becomes pregnant while in therapy

            The incidence of ventricular tachycardia is increased and may be more symptomatic during pregnancy; ventricular arrhythmias most often occur in pregnant women with underlying cardiomyopathy, congenital heart disease, valvular heart disease, or mitral valve prolapse; most tachycardia episodes are initiated by ectopic beats and occurrence of arrhythmia episodes may therefore, increase during pregnancy due to increased propensity to ectopic activity; breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to increased volume of distribution and increased drug metabolism inherent in pregnant state

            Amiodarone and its metabolite have been shown to cross the placenta; adverse fetal effects associated with maternal amiodarone use during pregnancy may include neonatal bradycardia, QT prolongation, and periodic ventricular extrasystoles, neonatal hypothyroidism (with or without goiter) detected antenatally or in the newborn and reported even after a few days of exposure, neonatal hyperthyroxinemia, neurodevelopmental abnormalities independent of thyroid function, including speech delay and difficulties with written language and arithmetic, delayed motor development, and ataxia, jerk nystagmus with synchronous head titubation, fetal growth restriction, and premature birth; monitor newborn for signs and symptoms of thyroid disorder and cardiac arrhythmias

            Labor and delivery

            • Risk of arrhythmias may increase during labor and delivery; patients treated should be monitored continuously during labor and delivery


            • Based on animal fertility studies, drug may reduce female and male fertility; not known if this effect is reversible


            Amiodarone and one of its major metabolites, DEA, are excreted in human milk, suggesting that breast-feeding could expose the nursing infant to a significant dose of the drug; risk of exposing infant to amiodarone and DEA must be weighed against potential benefit of arrhythmia suppression in the mother; advise mother to discontinue nursing

            There are cases of hypothyroidism and bradycardia in breastfed infants, although it is unclear if these effects are due to amiodarone exposure in breastmilk; breastfeeding is not recommended during treatment

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.



            Mechanism of Action

            Class III antiarrhythmic agent, which inhibits adrenergic stimulation; affects sodium, potassium, and calcium channels; markedly prolongs action potential and repolarization; decreases AV conduction and sinus node function


            Bioavailability: 35-65%

            Onset (PO): Initial response 2 days to 3 wk; peak response takes 1 week to 5 months

            Duration (PO): Up to 50 days after discontinuation of therapy

            Peak serum time: 3-7 hr (PO)

            Therapeutic range: 0.8-2.8 mcg/mL

            Toxicity range: >2-2.5 mcg/mL


            Protein bound: 96%

            Vd: 66 L/kg


            Liver with enterohepatic recirculation; hepatic CYP2C8 and CYP3A3/4 isozymes

            Metabolites: N-desethylamiodarone (DEA) (active)

            Enzymes inhibited: CYP2C9, CYP2D6, CYP3A3/4


            Half-life: 26-107 days (parent drug); 61 days (DEA metabolite)

            Dialyzable: Not dialyzable by hemodialysis or peritoneal dialysis

            Excretion: Feces; urine



            IV Incompatibilities

            Additive: Floxacillin, quinidine

            Syringe: Heparin

            Y-site: Aminophylline, ampicillin/sulbactam, bivalirudin, cefamandole, cefazolin, ceftazidime, digoxin, furosemide(?), heparin, imipenem/cilastatin, mezlocillin, piperacillin, piperacillin/tazobactam, K phosphates, Na bicarb, Na nitroprusside(?), Na phosphates

            IV Compatibilities

            Solution: D5W (incomp in 24 hr), NS (incomp in 24 hr)

            Additive: dobutamine, furosemide (incomp at high conc), lidocaine, KCl, procainamide, propafenone, verapamil

            Y-site (partial list): amphotericin B, atracurium, atropine, CaCl2, ciprofloxacin, clarithromycin, dobutamine, dopamine, epinephrine, eptifibatide, erythromycin, esmolol, fentanyl, fluconazole, gentamicin, labetalol, lorazepam, lidocaine, Mg sulfate (incomp at high conc), milrinone, morphine sulfate, nitroglycerin, norepinephrine, KCl, vancomycin

            IV Preparation

            Loading IV infusion: Dilute 150 mg (3 mL) in 100 mL to form 1.5 mg/mL concentration

            Slow/maintenance infusion: Dilute 900 mg (18 mL) of amiodarone with 500 mL to form 1.8 mg/mL concentration

            Conventional amiodarone: Dilute only with D5W

            Nexterone: May dilute with either D5W or 0.9% NaCl

            For subsequent maintenance infusion, may use 1-6 mg/mL concentrations

            IV Administration

            Concentrations >2 mg mL associated with venous irritation

            If concentration >2 mg/mL, administer via central venous catheter; in-line filter should be used during administration

            Administer IV via volumetric infusion pump

            Do not use evacuated glass containers for admixing, as incompatibility with a buffer in the container may cause precipitation

            Does not need to be protected from light during administration

            See dosing for bolus/infusion times

            Conventional amiodarone

            • Administer in glass/polyolefin bottles for infusions >2 hr


            • First product to successfully overcome solubility issues of amiodarone by removing the original cosolvents polysorbate 80 and benzyl alcohol
            • As a result, Nexterone does not have many of the product administration limitations regarding compatibility and stability with plastics and ionic infusion fluids, which are included in the labeling of conventional IV amiodarone
            • May be diluted in D5W or 0.9% NaCl and administered in polyvinyl chloride (PVC), polyolefin, or glass containers


            Store at room temp; protect from light and excessive heat





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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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