Amiodarone Hydrochloride (Monograph)

Brand names: Cordarone, Pacerone
Drug class: Class III Antiarrhythmics

Medically reviewed by Drugs.com on Jun 10, 2024. Written by ASHP.

Introduction

Class III antiarrhythmic agent;¹ ² ⁴ ⁵ ⁸ ¹² ¹⁷ ¹⁸ ²¹ ²⁴ ²⁵ ²⁶ ²⁸ ³¹ ³⁸ ³⁵⁵ also exhibits activity in each of the 4 Vaughn-Williams antiarrhythmic classes, including some class I (membrane-stabilizing) antiarrhythmic action.⁵ ⁷ ⁸ ²¹ ²⁵ ³² ³⁵ ⁴⁴ ⁴⁶ ³⁵⁵ ³⁶⁴

Uses for Amiodarone Hydrochloride

Ventricular Arrhythmias

Treatment to suppress or prevent the recurrence of documented life-threatening ventricular arrhythmias (e.g., recurrent VF; recurrent, hemodynamically unstable VT) that do not respond to documented adequate dosages of other currently available antiarrhythmic agents or when alternative antiarrhythmic agents are not tolerated.¹ ³ ³⁵⁵ ³⁶⁴

Used during cardiac arrest for treatment of refractory (i.e., unresponsive to CPR, defibrillation, and a vasopressor [e.g., epinephrine]) VF or pulseless VT.⁵⁰⁰ ⁵⁰¹ Considered the preferred antiarrhythmic drug for this use in current ACLS guidelines in adults; lidocaine may be used as an alternative.⁵⁰⁰ ⁵⁰¹ In pediatric patients, current evidence supports use of either amiodarone or lidocaine.⁵⁰²

Also may be used for treatment of wide-complex tachycardias during periarrest period; included in current ACLS guidelines for both adult and pediatric tachycardia.⁵⁰⁰ ⁵⁰¹ ⁵⁰³

Treatment of sustained monomorphic VT not associated with angina, pulmonary edema, or hypotension^{† [off-label]},³⁶⁴ ⁴⁴² or hemodynamically stable monomorphic VT^{† [off-label]} .⁵⁰¹

Treatment of polymorphic (irregular) VT^{† [off-label]} associated with myocardial ischemia in the absence of QT interval prolongation.⁵⁰¹

Has been used for primary prevention^{† [off-label]} of sustained VT (i.e., VT lasting >30 seconds and/or associated with hemodynamic compromise),³⁶⁴ VF, or sudden cardiac death in patients with nonsustained ventricular arrhythmia following MI.³⁴⁴ ³⁶⁸ ³⁷⁰ ³⁸⁴ ³⁹⁴

Has been used in a limited number of patients for life-threatening ventricular arrhythmias associated with post-infarction aneurysm^{† [off-label]} or with chronic myocarditis induced by Chagas’ disease^† .²⁶ ⁷² ¹⁷²

Supraventricular Tachyarrhythmias

Used for suppression and prevention of various supraventricular tachycardias (SVTs)^†.³ ⁴ ⁵ ⁹ ¹⁰ ¹² ²⁵ ²⁶ ²⁷ ³⁵ ⁶² ⁶⁶ ⁷¹ ⁷² ⁹² ¹⁰⁹ ¹¹⁰ ¹¹¹ ¹¹³ ¹¹⁶ ¹¹⁹ ¹²⁰ ¹²² ¹²⁵ ¹²⁶ ⁴⁰² ⁵⁰¹ ⁷⁰¹

Because of higher risk of toxicity and proarrhythmic effects, antiarrhythmic agents generally reserved for patients who do not respond to or cannot be treated with AV nodal blocking agents (β-adrenergic blocking agents, diltiazem, verapamil).⁵⁰¹ ⁷⁰⁰

Some experts state amiodarone may be useful when ventricular rate control is needed but AV nodal blocking agents are contraindicated (e.g., patients with preexcited atrial arrhythmias associated with an accessory pathway^†).⁵⁰¹ ⁷⁰¹

May be effective for conversion of atrial fibrillation^† to normal sinus rhythm (i.e., rhythm control); however, other antiarrhythmic agents (e.g., flecainide, dofetilide, propafenone, ibutilide) are preferred.⁷⁰¹

Used to maintain sinus rhythm in patients with atrial fibrillation or flutter^†.⁴ ⁵ ⁹ ¹⁰ ¹² ²⁵ ²⁶ ²⁷ ³⁵ ⁶² ⁶⁶ ⁷¹ ⁷² ⁹² ¹⁰⁹ ¹¹⁰ ¹¹¹ ¹¹³ ¹¹⁶ ¹¹⁹ ¹²⁰ ¹²² ⁷⁰⁰ ⁷⁰¹

Termination of paroxysmal supraventricular tachycardia (PSVT)^†, including atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular reentrant tachycardia (AVRT) (e.g., Wolff-Parkinson-White syndrome); generally reserved for use when other therapies are ineffective or contraindicated.⁹ ³⁸ ⁴⁸ ⁵⁰¹ ⁷⁰⁰ Avoid IV use in patients with Wolff-Parkinson-White syndrome who have preexcited atrial fibrillation; may accelerate ventricular rate and potentially cause life-threatening ventricular arrhythmias.⁷⁰¹

Also used for long-term prevention of PSVT^†,⁴ ⁵ ⁸ ⁹ ²⁵ ²⁶ ²⁷ ²⁸ ²⁹ ³⁷ ³⁹ ⁴¹ ⁴⁷ ⁴⁸ ⁶⁶ ⁷¹ ⁷² ¹⁰⁹ ¹¹⁰ ¹¹² ¹¹³ ¹²² ¹²⁸ ³¹⁸ including those refractory to other antiarrhythmic agents.⁵ ²⁶ ²⁷ ³⁹ ⁶⁶ ⁷¹ ¹¹⁰ ¹¹³ ¹²² ¹²⁸ ³¹⁸

Has been used in the treatment of atrial tachycardia^†.⁷⁰⁰

Has been effective in the prevention of supraventricular arrhythmias associated with bradycardia-tachycardia syndrome^†.⁴ ⁹ ²⁵ ¹¹⁰ ¹²⁹ ¹³⁰ ¹³¹

Angina

Has been used in treatment of chronic stable angina pectoris^† and Prinzmetal variant angina^†; because of potential toxicity, generally not considered a first-line agent but may have beneficial antianginal effect in patients receiving the drug for the management of arrhythmias.¹⁷ ⁵⁰ ¹³³ ¹³⁴ ²²⁹

Hypertrophic Cardiomyopathy

Has been used in the management of ventricular and supraventricular arrhythmias associated with hypertrophic cardiomyopathy^†.²⁵ ²⁵⁸ ²⁵⁹ ²⁷⁸ ²⁹²

Amiodarone Hydrochloride Dosage and Administration

General

Administer lowest effective dosage to minimize the risk and occurrence of adverse effects.¹
Adjust dosage carefully according to individual requirements and response and the general condition and cardiovascular status of the patient.¹ ³⁵⁵ Adjustment of maintenance dosage is difficult due to variable absorption and elimination of amiodarone; dosage reduction or temporary withdrawal or discontinuance of the drug may be required.¹ ²⁸⁴
When dosage adjustment is necessary, close monitoring for an extended period of time is recommended.¹ ³⁵⁵
Clinical and ECG monitoring of cardiac function, including appropriate ambulatory ECG monitoring (e.g., Holter monitoring) and/or programmed electrical stimulation (PES), as appropriate, is recommended.¹
Monitor plasma amiodarone concentrations if patient does not respond or experiences unexpectedly severe toxicity.¹ ² ³ ⁵ ²⁵ ³⁵ ⁶² ⁶³ ⁶⁴ ⁷⁰ ⁷¹ ⁷⁵ ⁸¹
When initiating therapy in patients receiving other antiarrhythmic agents, attempt to gradually discontinue the other antiarrhythmic agents.¹

Administration

Administer orally or by IV infusion.¹ ³ ⁹ ¹⁰ ²⁵ ³⁵ ³⁵⁵

Also has been administered via intraosseous (IO) injection^† during cardiac resuscitation.⁵⁰¹

Oral Administration

Usually administered once daily.¹ ³ Administer in divided doses (e.g., twice daily) with meals when dosages ≥1 g daily are administered (e.g., during the loading-dose phase of therapy) or when intolerable adverse GI effects occur.¹ ³

Administer in a consistent manner relative to food intake.¹

Administration of a loading-dose phase of therapy is required for the management of life-threatening ventricular arrhythmias;¹ ² ³ ⁵ ²³ ²⁵ ³⁵ ⁴² ⁵⁹ ⁶⁴ ⁶⁸ ⁷² ⁷³ administer oral loading dose in hospital setting and monitor closely until risk of recurrent VT or VF has abated.¹ ³⁵

Extemporaneous Oral Suspension

Extemporaneous oral suspensions of amiodarone have been prepared using the tablets and a commercially available vehicle.⁴⁶³ ⁴⁶⁴

Standardize 4 Safety

Standardized concentrations for an extemporaneously prepared oral suspension of amiodarone have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care.⁴⁶² Because recommendations from the S4S panels may differ from the manufacturer’s prescribing information, caution is advised when using concentrations that differ from labeling, particularly when using rate information from the label.⁴⁶² For additional information on S4S (including updates that may be available), see [Web]

Table 1: Standardize 4 Safety Compounded Oral Liquid Standards for Amiodarone462
Concentration Standards
5 mg/mL 20 mg/mL for doses of 75 mg or greater

Amiodarone needs to have a pH very close to 8 to assure particle consistency

IV Administration

IV therapy may be used for acute antiarrhythmic therapy until cardiac rhythm is stabilized and oral therapy can be initiated.³⁵⁵ IV therapy may be required for 48–96 hours, but may be administered safely for longer periods.³⁵⁵ Experience with IV administration of amiodarone exceeding 3 weeks is limited.³⁵⁵

Administer in 3-phase sequence: rapid loading phase, slow loading phase, and maintenance infusion phase.³⁵⁵

Dilute amiodarone hydrochloride concentrate prior to administration by IV infusion.³⁵⁵

Administer solutions containing an amiodarone hydrochloride concentration >2 mg/mL via central venous catheter.³⁵⁵

Use in-line filter.³⁵⁵

Amiodarone hydrochloride infusions exceeding 2 hours should be administered in 5% dextrose in glass or polyolefin containers .³⁵⁵ Manufacturer recommends using PVC tubing (used in clinical studies).³⁵⁵ Leaching of plasticizer diethylhexylphthalate (DEHP) from IV tubing may occur.³⁵⁵

Standardize 4 Safety

Standardized concentrations for IV amiodarone have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care.⁴⁶⁰ ⁴⁶¹ Multidisciplinary expert panels were convened to determine recommended standard concentrations.⁴⁶⁰ ⁴⁶¹ Because recommendations from the S4S panels may differ from the manufacturer’s prescribing information, caution is advised when using concentrations that differ from labeling, particularly when using rate information from the label.⁴⁶⁰ ⁴⁶¹ For additional information on S4S (including updates that may be available), see [Web].⁴⁶⁰ ⁴⁶¹

Dosing units differ from concentration units

Table 2: Standardize 4 Safety Continuous IV Infusion Standard Concentrations for Amiodarone460461
Patient Population	Concentration Standards	Dosing Units
Adults	1.8 mg/mL	mg/min
Pediatric patients (<50 kg)	1.8 mg/mL	mcg/kg/min
	3.6 mg/mL

Dilution

For the first rapid loading infusion or for supplemental infusions, add 3 mL of amiodarone hydrochloride concentrate to 100 mL of 5% dextrose, resulting in a final concentration of 1.5 mg/mL.³⁵⁵

For the slow loading infusion and maintenance infusion, add 18 mL of amiodarone hydrochloride concentrate to 500 mL of 5% dextrose, resulting in a final concentration of 1.8 mg/mL.³⁵⁵ For subsequent maintenance infusions, solutions containing a final amiodarone hydrochloride concentration of 1–6 mg/mL may be used.³⁵⁵

Rate of Administration

For treatment of ventricular arrhythmias in adults, 15 mg/minute for 10 minutes (rapid loading phase), then 1 mg/minute for 6 hours (slow loading phase), then 0.5 mg/minute (initial maintenance phase) for 18 hours;³⁵⁵ infuse supplemental doses of 150 mg over 10 minutes (at a rate of 15 mg/minute).³⁵⁵ ³⁶⁴ Initial (rapid) loading infusion rate should not exceed 30 mg/minute.³⁵⁵ ³⁶⁴ ³⁹⁷ Monitor initial rate of infusion closely; do not exceed recommended rate.³⁵⁵

Use volumetric infusion pump.³⁵⁵ Do not use drop-counter infusion sets; may result in underdosage.³⁵⁵

Dosage

Available as amiodarone hydrochloride; dosage expressed in terms of the salt.¹ ³⁵⁵

Pediatric Patients

Ventricular Arrhythmias†

Oral

Pediatric dosage has not been established; dosage may vary considerably.²⁰¹ ²⁸⁰ ²⁸¹ Some clinicians have recommended loading dosages of 10–15 mg/kg daily⁴⁰ ²⁴² or 600–800 mg/1.73 m² daily⁹ ⁶⁹ ¹⁸⁹ ²⁴² for approximately 4–14 days⁴⁰ ⁶⁹ ¹⁸⁹ ²⁴² and/or until adequate control of cardiac arrhythmias is achieved or adverse effects become prominent.⁴⁰ ²⁴² Subsequently, reduce dosage to 5 mg/kg daily⁴⁰ ²⁴² or 200–400 mg/1.73 m² daily⁹ ⁶⁹ ¹⁸⁹ ²⁴² for several weeks; if possible, reduce dosage to the lowest effective level.⁶⁹ ¹⁸⁹ ²⁴²

Children <1 year of age may require higher oral loading and maintenance dosages than older children when dosage is calculated on the basis of body weight, but not on the basis of body surface area^†.²⁸⁰ ²⁸²

Pediatric Resuscitation

IV or IO^†

Refractory VF or pulseless VT: 5 mg/kg as a rapid bolus.⁵⁰² ⁵⁰³ May repeat twice up to 15 mg/kg (maximum single dose of 300 mg).⁵⁰² ⁵⁰³

To minimize pediatric exposure to DEHP,⁴⁰⁸ may infuse a loading dose of 5 mg/kg given in 5 divided doses of 1 mg/kg (each dose infused over 5–10 minutes).⁴¹⁶

Wide-complex Tachycardias in Patients Not in Cardiac Arrest

5 mg/kg over 20–60 minutes (depending on urgency).⁵⁰³

To minimize pediatric exposure to DEHP,⁴⁰⁸ may infuse a loading dose of 5 mg/kg given in 5 divided doses of 1 mg/kg (each dose infused over 5–10 minutes).⁴¹⁶

Supraventricular Arrhythmias†

Oral

Pediatric dosage has not been established; dosage may vary considerably.²⁰¹ ²⁸⁰ ²⁸¹ Some clinicians have recommended loading dosages of 10–15 mg/kg daily⁴⁰ ²⁴² or 600–800 mg/1.73m² daily⁹ ⁶⁹ ¹⁸⁹ ²⁴² for approximately 4–14 days⁴⁰ ⁶⁹ ¹⁸⁹ ²⁴² and/or until adequate control of cardiac arrhythmias is achieved or adverse effects become prominent.⁴⁰ ²⁴² Subsequently, reduce dosage to 5 mg/kg daily⁴⁰ ²⁴² or 200–400 mg/1.73 m² daily⁹ ⁶⁹ ¹⁸⁹ ²⁴² for several weeks; if possible, reduce dosage to the lowest effective level.⁶⁹ ¹⁸⁹ ²⁴²

IV

5 mg/kg over 20–60 minutes depending on urgency.⁵⁰³

To minimize pediatric exposure to DEHP,⁴⁰⁸ may infuse a loading dose of 5 mg/kg given in 5 divided doses of 1 mg/kg (each dose infused over 5–10 minutes).⁴¹⁶

Adults

Ventricular Arrhythmias

Oral

Table 3. Oral Loading and Maintenance Dosages
Loading Dose	800–1600 mg daily for 1–3 weeks or until initial therapeutic response occurs¹
Dosage Adjustment	When adequate control of ventricular arrhythmias is achieved or adverse effects become prominent, decrease dosage to 600–800 mg daily for about 1 month¹ ³ ²⁸⁴
Maintenance Dosage	400–600 mg daily;¹ ³ ²⁸⁴ if possible, cautiously reduce dosage to 200 mg daily⁷⁰ ²⁸⁴

Consult published protocols for specific information about oral loading doses >1600 mg daily³⁵ ⁶⁴ ⁷³ ³⁰¹ or IV loading-dose regimens^† ⁶⁴ ²⁵⁰ followed by oral therapy.³⁰¹ If an IV loading-dose regimen is used, initiate oral therapy as soon as possible after an adequate response is obtained and gradually eliminate IV amiodarone.³⁰¹

IV

Total initial dosage during first 24 hours is approximately 1000 mg.³⁵⁵

Table 4. IV Dosage Over First 24 Hours
Loading Phase	Initial rapid loading phase: 150 mg administered at rate of 15 mg/minute (i.e., over 10 minutes) ³⁵⁵ ³⁶⁴
	Followed by slow loading phase: 360 mg administered at rate of 1 mg/minute (i.e., over 6 hours)³⁵⁵ ³⁶⁴ ³⁹⁷
Maintenance Phase	First maintenance phase: 540 mg administered at rate of 0.5 mg/minute (i.e., over 18 hours)³⁵⁵ ³⁶⁴ ³⁹⁷

Table 5. IV Dosage After First 24 Hours
Maintenance Phase	0.5 mg/minute (i.e., 720 mg over 24 hours); can be administered for 2–3 weeks ³⁵⁵
Breakthrough Episodes of VF or Hemodynamically Unstable VT	Supplemental infusion of 150 mg administered at rate of 15 mg/minute (i.e., over 10 minutes)³⁵⁵

IV/Oral

When switching from IV to oral therapy, oral dosage depends on dose and duration of IV therapy, as well as bioavailability of oral drug.³⁵⁵ When switching from IV to oral therapy, clinical monitoring is recommended, particularly for geriatric patients.³⁵⁵

Assuming 720-mg/day infusion (0.5 mg/minute)

IV amiodarone not intended for maintenance treatment

Table 6. Switching to Oral Therapy Following IV Therapy355
Duration of IV Therapy	Initial Oral Daily Dosage
<1 week	800–1600 mg
1–3 weeks	600–800 mg
>3 weeks	400 mg

ACLS

IV or IO^†

Refractory VF or pulseless VT: 300 mg by rapid IV/IO injection; may consider an additional dose of 150 mg.⁵⁰⁰ ⁵⁰¹

Supraventricular Arrhythmias†

IV

For acute treatment of SVT, 150 mg over 10 minutes.⁷⁰⁰ Follow with 1 mg/minute for 6 hours, then 0.5 mg/minute for remaining 18 hours or initiate oral dosing.⁷⁰⁰

Oral

For ongoing management of SVT, some experts recommend 400–600 mg daily (in divided doses) in adults for approximately 2–4 weeks, followed by a maintenance dosage of 100–200 mg daily.⁷⁰⁰

Consult published protocols for specific information about oral loading-dose regimens using higher dosages.

Atrial Fibrillation†

IV

When used for rate control in patients with atrial fibrillation, some experts recommend an initial IV dose of 300 mg over 1 hour, followed by 10–50 mg/hr over 24 hours.⁷⁰¹

Oral

Usual maintenance dose is 100–200 mg daily.⁷⁰¹

Long-term Management of Recurrent Atrial Fibrillation†

Oral

Initially, 10 mg/kg daily for 14 days, followed by 300 mg daily for 4 weeks, and then 200 mg daily.⁴⁰²

Prescribing Limits

Pediatric Patients

Ventricular Arrhythmias†

IV

Maximum single dose: 300 mg,⁵⁰² ⁵⁰³ up to a total dose of 15 mg/kg.^h ⁵⁰² ⁵⁰³

Adults

Ventricular Arrhythmias

IV

Mean daily doses >2.1 g are associated with an increased risk of hypotension.³⁵⁵

Limited experience with IV administration of amiodarone for >3 weeks.³⁵⁵

Special Populations

Hepatic Impairment

Dosage reduction recommended in patients with substantial hepatic impairment.³⁵ ²⁸³ ²⁸⁴

Renal Impairment

Routine dosage reduction not required.¹ ³⁵

Geriatric Patients

Select dosage with caution, usually starting at low end of dosage range, because of possible age-related decrease in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy; however, dosage requirements generally similar in geriatric and younger adults.¹ ³⁵⁵

Use caution with high dosages due to increased susceptibility to drug-induced bradycardia and conduction disturbances.³⁰¹

Cautions for Amiodarone Hydrochloride

Contraindications

Cardiogenic shock.¹ ³⁵⁵
Severe sinus node dysfunction resulting in marked sinus bradycardia (unless a functioning pacemaker is present).¹ ³⁵⁵
Second- or third-degree AV block (unless a functioning pacemaker is present).¹ ³⁵⁵
Bradycardia that has caused syncope (unless a functioning pacemaker is present).¹
Known hypersensitivity to amiodarone or any ingredient in the formulation, including iodine.¹ ³⁵⁵

Warnings/Precautions

Warnings

Mortality

Potentially fatal toxicities and severe adverse effects;¹ ¹⁰⁶ ³⁵⁵ use principally for documented life-threatening ventricular arrhythmias.¹

Amiodarone therapy should be administered only by physicians experienced in the management of life-threatening arrhythmias who have access to laboratory facilities necessary to adequately monitor efficacy and adverse effects, including continuous ECG monitoring and electrophysiologic techniques for evaluating the patient in both ambulatory and hospital settings.¹ ¹⁰⁶ ³⁵⁵

Pulmonary Effects

Possible acute-onset (days to weeks) pulmonary injury; findings may include pulmonary infiltrates and/or mass on radiograph, pulmonary alveolar hemorrhage, bronchospasm, wheezing, fever, dyspnea, cough, hemoptysis, or hypoxia, sometimes leading to respiratory failure and/or death.¹ ³⁵⁵

Potentially fatal pulmonary toxicity¹ ³ ⁹ ²⁵ ¹³⁶ ³²⁴ ³²⁵ ³²⁶ ³²⁷ ³³³ ³³⁸ ³⁷⁰ may result from pulmonary interstitial pneumonitis (or alveolitis) or hypersensitivity pneumonitis.¹ ³²⁵ ³²⁶ ³³⁸ ³³⁹ ³⁴⁵ ³⁴⁶ Toxicity is usually reversible following discontinuance of the drug (with or without corticosteroid therapy).¹ ³ ⁷⁵ ¹³⁶ ¹³⁸ ¹³⁹ ¹⁴⁰ ¹⁴² ²⁷² ³⁰⁸ ³²⁷ ³²⁹ ³³³ ³³⁶ ³³⁷ ³³⁸ ³⁵⁰

Baseline pulmonary function testing (prior to initiating therapy)¹ ²⁵ ³²⁵ ³²⁶ ³²⁷ ³²⁸ ³³⁵ ³³⁸ and periodic (e.g., every 3–6 months) chest radiographs, clinical evaluation, and pulmonary function testing recommended.¹ ²⁵ ¹⁴⁸ ²⁸⁴ ³²⁵ ³²⁷ ³³⁸

If hypersensitivity pneumonitis occurs, discontinue amiodarone and initiate corticosteroid therapy.¹ ³⁵⁰

If interstitial pneumonitis occurs, reduce dosage or discontinue therapy, especially if other acceptable antiarrhythmic therapies are available.¹ ³²⁶ ³²⁷ ³²⁸ ³³³ ³³⁸ Supportive treatment, including mechanical ventilation, may be required.¹³⁶ ¹⁴⁰ ¹⁴²

Use with caution, if at all, in patients with preexisting pulmonary disease³⁵ (e.g., chronic obstructive disease,²⁵² reduced pulmonary diffusion capacity³⁵ ¹³⁸ ³²⁴ ); poorer prognosis if pulmonary toxicity develops in such patients.¹

If new respiratory symptoms develop, consider the possibility of amiodarone-induced pulmonary toxicity; ¹ ¹³⁶ ¹⁴⁰ ³²⁶ ³²⁷ clinical and radiographic evaluation, as well as scintigraphic and pulmonary function testing (including diffusion capacity), if necessary, are recommended.¹ ¹³⁸ ¹⁵¹ ³²⁴ ³²⁶ ³²⁷ ³²⁸ ³³³ ³³⁶ ³³⁷ ³³⁸ Carefully assess respiratory symptoms and rule out other causes of respiratory impairment (e.g., CHF, pulmonary embolism, malignancy, infectious causes) before discontinuing therapy.¹ ¹³⁶ ¹³⁸ ¹⁴⁰ ³²⁷ ³²⁸ ³³⁸

Bronchiolitis obliterans organizing pneumonia (possibly fatal) and pleuritis reported during postmarketing experience.¹

Hepatic Effects

Possible liver function test abnormalities;¹ ³ ⁹ ¹⁰ ²⁵ ³⁰ ⁷⁵ ⁸³ ¹⁰⁸ ¹⁴¹ ¹⁵³ ¹⁵⁴ ¹⁵⁷ ¹⁵⁸ ¹⁵⁹ ¹⁶³ ³⁵⁵ abnormalities are usually minor,¹ ²⁵ ⁷⁵ not accompanied by clinical symptoms,¹ ³ ⁹ ¹⁰ ⁷⁰ ⁷² ⁷⁵ ¹⁵³ ¹⁵⁸ ¹⁵⁹ ¹⁶¹ and generally return to normal following dosage reduction or discontinuance of the drug.⁹ ⁷² ⁷⁵ ¹⁴¹ ¹⁵⁴ ¹⁵⁹

Rarely, potentially fatal hepatic injury (i.e., clinical hepatitis, cholestatic hepatitis, hepatocellular necrosis, cirrhosis) ¹ ³ ³⁵ ¹⁵⁵ ¹⁵⁶ ¹⁶⁰ ¹⁶² ³⁴¹ ³⁴² ³⁵⁵ has occurred.¹ ³ ²⁵ ³⁵ ¹⁵⁵ ¹⁵⁶ ¹⁵⁸ ¹⁶⁰ ¹⁶¹ ¹⁶² ¹⁶³ ¹⁶⁴ ³⁵⁵

Monitor serum hepatic enzyme concentrations at regular intervals.¹ ¹⁵³ ¹⁵⁷ ¹⁶⁰ ¹⁶⁴ ³⁵⁵ Reduce oral dosage, decrease IV infusion rate, or discontinue therapy if enzyme concentrations are >3 times normal values in patients with normal pretreatment values or twice baseline pretreatment values in patients with elevated pretreatment values or if hepatomegaly or progressive hepatic injury occurs.¹ ¹⁵⁶ ¹⁶² ¹⁶³ ¹⁶⁴ ³⁵⁵

Possible acute centrolobular confluent hepatic necrosis during IV therapy; may be related to a much higher loading dose concentration and more rapid infusion rate than recommended.³⁵⁵ Closely monitor initial concentration and rate of IV infusion; do not exceed recommended initial drug concentration and infusion rate.³⁵⁵

Arrhythmogenic Effects

Possible worsening of existing arrhythmias¹ ³ ⁹ ¹⁰ ²⁵ ³⁵ ⁷⁵ ¹³² ¹⁴¹ ¹⁷⁵ ²⁸⁷ ³⁵⁵ or occurrence of new arrhythmias.¹ ³⁵ ¹⁶⁶ ¹⁶⁷ ¹⁶⁸ ¹⁷⁵ ¹⁷⁶ ³⁵⁵ Arrhythmogenic effects include progression of VT to VF,¹ ¹³² ³⁵⁵ sustained VT,¹ ²⁵ ¹⁴¹ ¹⁷⁵ ¹⁷⁶ ³⁵⁵ increased resistance to cardioversion,¹ ²⁵ ¹²² ¹⁷⁵ ³⁰⁴ atrial fibrillation,³⁵⁵ nodal arrhythmia,³⁵⁵ and atypical VT (torsades de pointes).¹ ³ ⁹ ²⁵ ⁷⁵ ¹³² ¹⁷¹ ¹⁷³ ²⁶⁵ ³⁵⁵

Monitor for QT_c prolongation during IV infusion of amiodarone.³⁵⁵

If new signs of arrhythmia appear, consider possibility of hyperthyroidism.¹ ³⁵⁵

Chronic administration of antiarrhythmic drugs (e.g., amiodarone) in patients with an implanted cardiac device (e.g., defibrillator, pacemaker) may change electrical conduction properties of the heart and potentially affect pacing and/or defibrillating thresholds.¹ Therefore, manufacturer recommends assessment to ensure appropriate device parameters before and during amiodarone therapy.¹

Electrolyte Abnormalities

Electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia) may increase arrhythmogenic effects.¹ ³ ⁴¹ Evaluate patient for potassium or magnesium deficiency; if present, correct deficiency prior to initiation of therapy.¹ ²⁴⁹

Monitor electrolyte and acid-base balance in patients with severe or prolonged diarrhea and in patients receiving diuretics concomitantly.⁴⁵ ⁴⁷ ⁵⁰ ³⁵⁵

Effects on Cardiac Conduction

Possible AV, intraventricular,¹ ³ ⁴ ²⁵ ²⁶ ³⁰ ³⁵ ³⁵⁵ or SA block;¹⁶⁸ SA node dysfunction (e.g., symptomatic sinus bradycardia),¹ ³ ⁴ ⁹ ¹⁰ ²⁵ ²⁶ ³⁰ ³⁵ ⁵⁰ ⁷⁵ ¹⁵⁴ ¹⁶⁹ ¹⁷⁵ ³⁵⁵ ³⁹³ sinus arrest with suppression of escape foci);¹ ¹⁴¹ ¹⁶⁶ ¹⁶⁷ ¹⁶⁸ ¹⁶⁹ or bradycardia (usually associated with IV therapy).³⁵⁵

Administer IV amiodarone in a setting where a temporary pacemaker is available for patients with known predisposition to bradycardia or AV block.³⁵⁵

Ocular Effects

Optic neuropathy¹ ²⁵ ¹⁵³ ¹⁵⁴ ¹⁸⁴ ¹⁸⁵ ¹⁸⁶ ¹⁸⁷ ³⁵⁵ and/or optic neuritis may occur at any time during amiodarone therapy; usually results in visual impairment¹ ²⁹⁴ ³¹¹ ³⁵⁵ ³⁵⁷ and may progress to permanent blindness.¹ ³⁵⁵ ³⁵⁷

Baseline and routine (e.g., after the first 6 months and then annually and/or as necessary) ophthalmologic examinations recommended, including slit-lamp and funduscopic tests.¹ ²⁵ ³¹ ³⁵⁵ ⁴³¹

Careful monitoring recommended for patients experiencing visual disturbances or those receiving long-term therapy.¹ ¹⁸⁶ ¹⁸⁸ If visual impairment occurs (e.g., changes in visual acuity, decreases in peripheral vision), prompt ophthalmologic examination recommended.¹ ³⁵⁵ ³⁵⁷

If optic neuropathy and/or optic neuritis develops, reevaluate therapy; consider risks and complications against the possible benefits of antiarrhythmic therapy.¹ ³⁵⁵

Thyroid Effects

Thyroid nodules or thyroid cancer reported during postmarketing experience, sometimes accompanied by hyperthyroidism.¹ ³⁵⁵

Possible altered thyroid function test results:¹ ⁴ ⁹ ¹⁰ ²⁵ ³⁵ ⁸³ ¹⁵³ ¹⁵⁴ ²³⁰ ²³¹ ²³² ²³³ ²³⁴ ²³⁵ ²³⁶ ²³⁷ ²³⁸ ²³⁹ ²⁴⁰ ²⁵³ ³⁵⁵ ³⁷⁴ ³⁸⁵ increased serum thyroxine (T₄) and reverse triiodothyronine (rT₃) concentrations, decreased serum T₃ concentrations.¹ ⁴ ⁹ ¹⁰ ²⁵ ³⁵ ⁸³ ¹⁵³ ²³⁰ ²³¹ ²³² ²³³ ²³⁴ ²³⁵ ²³⁷ ²⁵³ ²⁸³ ³⁵⁵ ³⁹³

Possible hypothyroidism or hyperthyroidism.¹ ³ ⁴ ⁹ ¹⁰ ²⁵ ²⁶ ⁷⁰ ⁸³ ¹⁵³ ¹⁵⁴ ²³⁰ ²³¹ ²³³ ²³⁴ ²³⁵ ²³⁶ ²³⁷ ²³⁸ ²³⁹ ²⁴⁰ ²⁵³ ³⁷⁰ ³⁷⁴ ³⁵⁵ ³⁹³ Amiodarone-induced hyperthyroidism may result in thyrotoxicosis and/or arrhythmia breakthrough or aggravation; fatalities have occurred.¹ ³⁵⁵

Thyroid function tests recommended prior to initiating therapy and at periodic intervals (approximately every 3–6 months) thereafter,¹ ²⁵ ³⁵ ²³¹ ²³⁴ ²³⁵ ²³⁶ ²³⁷ ²⁵³ ³⁵⁵ particularly in geriatric patients¹ ²⁸³ ³⁵⁵ and/or in patients with a history of thyroid nodules, goiter, or other thyroid dysfunction.¹ ⁴ ²³⁴ ²³⁷ ²⁸³ ³⁵⁵

If hypothyroidism occurs, reduce amiodarone dosage¹ ²⁵ ¹⁵⁴ ²⁸³ ³⁵⁵ and/or carefully supplement with thyroid agents if necessary;¹ ²⁵ ⁷² ⁸³ ¹⁵³ ¹⁵⁴ ²³⁰ ²³¹ ²³⁵ ²⁸³ ³⁵⁵ ³⁷⁴ discontinuance of amiodarone may be required.¹ ²³¹ ²⁸³ ³⁴⁴ ³⁵⁵ ³⁶⁸ ³⁷⁴

If hyperthyroidism occurs, aggressive therapy (including dosage reduction or discontinuance of amiodarone) is indicated, since clinical manifestations (i.e., cardiac arrhythmias) may be potentially serious and may be fatal.¹ ⁷² ¹⁵³ ¹⁵⁴ ²³⁰ ²⁵³ ²⁸³ ³⁴⁴ ³⁵⁵ ³⁶⁸ ³⁷⁴ Antithyroid drugs, adrenergic blockers, and/or temporary corticosteroid therapy may be necessary.¹ ³⁵⁵ However, antithyroid agents appear to be of limited benefit when used alone, since high intrathyroidal iodine stores (typically observed in patients receiving long-term amiodarone therapy)¹ ²³⁸ ²³⁹ ³⁵⁵ ⁴⁴⁵ antagonize the inhibitory effects of antithyroid drugs on thyroidal iodine utilization.⁴⁴⁶ Radioactive iodine treatment contraindicated because of low radioiodine uptake in amiodarone-associated hyperthyroidism.¹ ³⁵⁵ In patients in whom aggressive treatment of amiodarone-induced toxicity has failed or the drug cannot be discontinued because it is the only drug effective against the resistant arrhythmia, thyroidectomy may be an option.¹ ³⁵⁵ However, experience with surgical management is limited and such treatment could induce thyroid storm; therefore, careful surgical and anesthetic management is required.¹ ³⁵⁵

Fetal/Neonatal Morbidity

Possible adverse effects on fetal thyroid function and overall development.²⁵ ³⁵ ⁸⁹ ⁹¹ Possible congenital goiter/hypothyroidism and hyperthyroidism.¹ ³³⁰ ³⁵⁴ ³⁵⁵ Women should avoid becoming pregnant during amiodarone therapy.⁴³¹ Use during pregnancy only when the potential benefits justify the possible risks to the fetus.¹ ⁸⁸ ⁸⁹ ³⁵⁵ If amiodarone is used during pregnancy or the patient becomes pregnant while taking the drug, apprise patient of potential hazard to fetus.¹ ³⁵⁵

Hypotension

Hypotension associated with IV therapy;³⁵⁵ mean daily IV dosages >2.1 g associated with increased risk of hypotension.³⁵⁵ Hypotension may be refractory in some cases, resulting in death.¹ ³⁵⁵ Monitor initial rate of infusion closely; do not exceed recommended rate. ³⁵⁵

Hypotension (possibly severe) reported during open-heart surgery (during and/or following cardiopulmonary bypass) in amiodarone-treated patients.¹ ¹⁷⁰ ²¹⁶ ²⁶⁷

Arrhythmia Recurrence

Possible recurrence of life-threatening arrhythmias after dosage reduction or discontinuance of therapy; time to recurrence may range from weeks to months.¹ Prolonged hospitalization¹ ³⁵ or intensive ambulatory monitoring (e.g., via telemetric ECG),²⁸⁴ possibly with periodic determination of plasma amiodarone concentrations, may be required.³⁵

Sensitivity Reactions

Hypersensitivity Reactions

Possible hypersensitivity pneumonitis.¹ ³²⁶ ³³⁰ ³³⁸ ³⁴⁶ If hypersensitivity pneumonitis occurs, initiate corticosteroid therapy and discontinue amiodarone.¹ ³⁵⁰ Rechallenge may result in more rapid and more severe adverse effects than rechallenge with amiodarone in patients with interstitial pneumonitis.¹

Anaphylactic/anaphylactoid reaction (including shock) and angioedema reported during postmarketing experience.¹ ³⁵⁵

Dermatologic Reactions

Possible photosensitivity.¹ ⁷⁰ ⁷² ¹⁵³ ³⁷³ Reactions generally begin within 2 hours of exposure to sunlight ⁹ ¹⁵³ ¹⁹⁰ ¹⁹⁵ and last for 1–3 days;¹⁹⁰ ¹⁹⁵ may last a week in severe cases.¹⁹⁰ Reactions may occur up to 4 months following discontinuance of the drug.⁹ ¹⁴⁰

Possible pigmentary changes (blue-gray discoloration) to exposed areas of the body (e.g., face, hands) in patients receiving long-term therapy,¹ ³ ⁹ ²⁵ ³⁰ ³⁵ ¹⁰⁸ ¹⁵³ ¹⁵⁴ ¹⁹⁰ ¹⁹¹ ¹⁹² ¹⁹³ ¹⁹⁶ ³⁸⁵ in patients with fair complexions,¹ or following excessive exposure to sunlight.¹ ⁹ ²⁵ ³⁵ ¹⁵³ ¹⁹¹ ¹⁹³ Usually slowly reversible following discontinuance of the drug.¹ ¹⁹¹

Sunscreen agents,¹ ²⁵ ³⁵ ⁷² ¹⁵³ ¹⁹⁰ ¹⁹⁵ ²⁸³ protective clothing,¹ ³⁵ ¹⁹⁰ ¹⁹⁵ and avoidance of excessive exposure to sunlight²⁵ ³⁵ ¹⁹⁰ are recommended.¹ ²⁵ ³⁵ ¹⁹⁰ ¹⁹⁵

Toxic epidermal necrolysis (sometimes fatal), erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, skin cancer, and pruritus reported during postmarketing experience.¹ ³⁵⁵

General Precautions

Ocular Effects

Corneal microdeposits occur in almost all patients.¹ ³ ⁹ ²⁵ ³⁵ ⁷⁰ ⁷² ⁷⁵ ¹⁴¹ ¹⁵³ ¹⁷⁶ ¹⁸⁵ ¹⁸⁶ ¹⁸⁷ ³⁹³ Usually not associated with visual disturbances;¹ ⁹ ³⁵ ¹⁸⁵ however, halo vision,¹ ²⁵ ⁷⁰ ⁷³ ⁷⁵ ¹⁴¹ ¹⁵³ ¹⁵⁴ ¹⁷⁵ ¹⁷⁶ ¹⁸⁴ ¹⁸⁷ ¹⁸⁸ blurred vision,¹ ³ ¹⁰ ²⁵ ¹⁵⁴ ¹⁸⁵ ¹⁸⁸ photophobia,¹ ²⁵ ⁷⁵ ¹⁷⁶ ¹⁸⁴ ¹⁸⁷ and dry eyes may occur.¹ ¹⁷⁵ ¹⁷⁶

Corneal deposits are related to dosage and duration of therapy.⁹ ²⁵ ⁷² ¹⁵³ ¹⁸³ ¹⁸⁵ ¹⁸⁶ Reversible following dosage reduction or discontinuance of therapy.¹ ⁹ ²⁵ ⁵⁶ ⁷⁰ ⁷² ¹⁵³ ¹⁵⁴ ¹⁸⁵ ¹⁸⁶ ¹⁸⁷ Asymptomatic, nonprogressive deposits do not necessitate dosage reduction or drug discontinuance.¹ ²⁸⁴

Routine ophthalmologic examinations, including slit-lamp and funduscopic tests, recommended.¹ ³⁵⁵

Most manufacturers of corneal refractive laser surgery devices consider the procedure to be contraindicated in patients receiving amiodarone.¹ ³⁵⁵

Nervous System Effects

Possible peripheral neuropathy ¹ ³ ⁹ ²⁵ ³⁵ ⁷² ⁷⁵ ¹⁶² ¹⁷⁶ ¹⁷⁷ ¹⁷⁸ ¹⁷⁹ ¹⁸⁰ ²⁶⁸ and proximal myopathy.³ ⁹ ²⁵ ⁷⁵ ¹⁵³ ¹⁶² ¹⁷⁶ ¹⁷⁷ ²⁶⁸

Delirium, hallucination, confusional state, pseudotumor cerebri, disorientation, and parkinsonian symptoms (e.g., akinesia, bradykinesia) reported during postmarketing experience.¹

Cardiac Failure

Possible new or worsened heart failure;¹ ⁹ ²⁵ ³⁵ ⁷⁰ ⁷⁵ ¹⁰⁸ ²⁹⁹ ³⁵⁵ rarely requires discontinuance of the drug.¹

Pulmonary Precautions

Possible ARDS following cardiothoracic or other surgery.¹ ³⁰⁹ ³³⁴ ³⁵⁵ Closely monitor forced inspiratory oxygen and tissue oxygenation.¹ ³⁵⁵ Preoperative pulmonary function testing recommended for patients undergoing cardiothoracic surgery.³⁰⁹

Symptomatic Bradycardia in Patients Receiving HCV Treatment

Symptomatic bradycardia, including cases requiring pacemaker intervention, reported in patients receiving amiodarone concomitantly with an HCV treatment regimen containing sofosbuvir in conjunction with another HCV direct-acting antiviral (DAA), including ledipasvir, simeprevir, or daclatasvir.⁴⁵³ ⁴⁵⁴ ⁴⁵⁵ ⁴⁵⁶ ⁴⁵⁷ Fatal cardiac arrest reported in a patient receiving amiodarone concomitantly with fixed combination of ledipasvir and sofosbuvir (ledipasvir/sofosbuvir).⁴⁵³ ⁴⁵⁴ ⁴⁵⁵ ⁴⁵⁶ ⁴⁵⁷

In most reported cases, bradycardia occurred within hours to days after HCV treatment initiated in patients receiving amiodarone (also has been observed up to 2 weeks after initiation of HCV treatment) and resolved after HCV treatment discontinued.⁴⁵⁴ ⁴⁵⁵ ⁴⁵⁶ ⁴⁵⁷ Mechanism for this adverse cardiovascular effect unknown.⁴⁵³ ⁴⁵⁴ ⁴⁵⁵ ⁴⁵⁶ ⁴⁵⁷

Patients who may be at increased risk for symptomatic bradycardia if amiodarone used concomitantly with HCV treatment regimen containing sofosbuvir with another DAA include those also receiving a β-adrenergic blocking agent, those with underlying cardiac comorbidities, and/or those with advanced liver disease.⁴⁵⁴ ⁴⁵⁵ ⁴⁵⁶ ⁴⁵⁷

Concomitant use of amiodarone with HCV treatment regimen containing sofosbuvir with another DAA not recommended.⁴⁵⁴ ⁴⁵⁵ ⁴⁵⁶ ⁴⁵⁷

If there are no alternative HCV treatment options and regimen of sofosbuvir with another DAA must be used in a patient receiving amiodarone, advise patient about the risk of serious symptomatic bradycardia before initiating HCV treatment.⁴⁵⁴ ⁴⁵⁵ ⁴⁵⁶ ⁴⁵⁷ Perform cardiac monitoring in an inpatient setting during first 48 hours of concomitant use of amiodarone and regimen of sofosbuvir with another DAA;⁴⁵⁴ ⁴⁵⁵ ⁴⁵⁶ ⁴⁵⁷ subsequently, perform heart rate monitoring daily (outpatient or self-monitoring) through at least the first 2 weeks of concomitant use.⁴⁵⁴ ⁴⁵⁵ ⁴⁵⁶ ⁴⁵⁷ Similar cardiac monitoring recommended in patients who discontinued amiodarone just prior to initiation of regimen of sofosbuvir with another DAA or if alternative antiarrhythmic agent cannot be used and amiodarone must be initiated in a patient already receiving regimen of sofosbuvir with another DAA.⁴⁵⁴ ⁴⁵⁵ ⁴⁵⁶ ⁴⁵⁷

Advise patients receiving amiodarone concomitantly with regimen of sofosbuvir with another DAA to immediately contact a clinician if signs or symptoms of bradycardia (e.g., near-fainting or fainting, dizziness or lightheadedness, malaise, weakness, excessive tiredness, shortness of breath, chest pain, confusion, memory problems) develop.⁴⁵⁴ ⁴⁵⁵ ⁴⁵⁶ ⁴⁵⁷

Specific Populations

Pregnancy

Category D.¹ ¹²⁸ ³⁵⁵

Lactation

Amiodarone and desethylamiodarone are distributed into milk.¹ ² ⁷⁸ ⁸⁹ ⁹¹ ³⁵⁵ Discontinue nursing.¹ ⁹¹ ³⁵⁵

Pediatric Use

Safety and efficacy not established;¹ ³⁵⁵ however, amiodarone has been used in children.³⁵ ⁴⁰ ⁶⁹ ¹⁸⁹ ²⁸⁰ ²⁸¹ ²⁸² ⁵⁰² ⁵⁰³

Large amounts of benzyl alcohol (e.g., 100–400 mg/kg daily) have been associated with toxicity in neonates;³⁵⁵ ⁴⁰⁸ ⁴⁰⁹ ⁴¹⁰ ⁴¹¹ ⁴¹² ⁴¹³ ⁴¹⁴ each mL of amiodarone hydrochloride injection contains 20.2 mg of benzyl alcohol.³⁵⁵

Amiodarone hydrochloride injection leaches DEHP plasticizer from IV tubing;³⁵⁵ ⁴⁰⁸ exposure to DEHP may adversely affect male reproductive tract development during fetal, infant, and toddler stages of development.⁴⁰⁸ ⁴¹⁵ Consider dosing methods to reduce potential exposure to DEHP.⁴⁰⁸

Geriatric Use

Response similar to that in younger adults.¹ ³⁵⁵

Possible increased susceptibility to bradycardia and conduction disturbances.³⁰¹

Possible thyroid effects.²⁸³

Select dosage with caution, usually starting at low end of dosage range, because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹ ³⁵⁵

Hepatic Impairment

Effects of hepatic impairment on amiodarone elimination have not been evaluated;¹ ² ³⁵ however, amiodarone is extensively metabolized,⁹ ²⁵ ⁷⁶ ⁸⁰ ¹⁰¹ probably in the liver.⁹ ³⁵ ⁶⁴ ⁷⁶ ⁸¹ Consider dosage reduction in patients with substantial hepatic impairment.³⁵ ²⁸³ ²⁸⁴

Renal Impairment

Possible excessive accumulation of iodine and possible resultant thyroid effects.²⁸⁴ ³¹⁴ ³¹⁵

Common Adverse Effects

IV administration: hypotension.³⁵⁵

Oral therapy: adverse nervous system (e.g., malaise and fatigue,¹ tremor and/or involuntary movements,¹ ³ ⁹ ¹⁰ ²⁵ ⁷⁰ ⁷⁵ ¹⁵³ ¹⁷⁵ ¹⁷⁸ ¹⁸⁰ ²⁶⁸ lack of coordination,¹ abnormal gait and/or ataxia,¹ ³ ⁹ ⁷⁵ ¹⁵⁴ ¹⁷⁵ ¹⁷⁶ ¹⁷⁸ ¹⁸⁰ ²⁶⁸ dizziness,¹ ³ ¹⁰ paresthesia¹ ⁹ ¹⁰ ⁷⁰ ⁷⁵ ¹⁷⁵ ¹⁷⁶ ¹⁷⁷ ¹⁷⁸ ¹⁷⁹ ) and GI (e.g., nausea,¹ ³ ⁹ ²⁵ ⁷⁰ ⁷⁵ ¹⁴¹ ¹⁵³ ¹⁵⁴ ¹⁷⁵ ¹⁷⁶ vomiting,¹ ³ ¹⁷⁵ constipation,¹ ⁹ ²⁵ ⁷⁰ ⁷⁵ ¹⁴¹ ¹⁵³ ¹⁵⁴ ¹⁷⁵ ¹⁷⁶ anorexia¹ ³ ⁹ ²⁵ ⁷⁰ ⁷⁵ ¹⁴¹ ¹⁵³ ¹⁷⁶ ) effects.

Drug Interactions

Metabolized by CYP3A4 and CYP2C8.¹ ³⁵⁵

Elimination half-life of amiodarone is long and variable; potential for interactions exists with drugs administered after discontinuance of amiodarone therapy.¹ ³⁵ ²⁰⁸ ²¹⁵ ³⁵⁵

Drugs, Foods, and Dietary or Herbal Supplements Affecting or Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions with substrates, inhibitors, or inducers of CYP3A4 are likely.¹ ³⁵⁵ Inhibits CYP isoenzymes 1A2, 2C9, 2D6, and 3A4;¹ ³⁵⁵ potential pharmacokinetic interaction with drugs metabolized by these isoenzymes (increased plasma concentrations).¹ ³⁵⁵ Amiodarone is a substrate for CYP3A4 and CYP2C8; drugs and other substances that inhibit these isoenzymes may decrease metabolism and increase serum concentrations of amiodarone.¹ ³⁵⁵

Drugs with P-Glycoprotein-Mediated Clearance

Amiodarone inhibits the P-glycoprotein transport system, which may result in unexpectedly high plasma concentrations of drugs that are substrates for this transport system.¹ ³⁵⁵

Drugs Affecting QT Interval

Potential pharmacodynamic interaction (additive effects on the QT_c interval).¹ ³⁵⁵ ⁴³³

Antiarrhythmic Agents

Cautious use and close monitoring for possible adverse effects recommended if amiodarone is used concomitantly with other antiarrhythmic agents,¹ ³⁵⁵ particularly class IA antiarrhythmic agents.²⁰⁷ ²²⁸ ²⁵⁵ ²⁶⁴ ²⁶⁵ ²⁶⁶

Reserve concomitant use for the management of life-threatening arrhythmias unresponsive to monotherapy.¹ ³⁵⁵

In general, reduce dosage of other antiarrhythmic agent(s) by 30–50% several days after initiating amiodarone therapy;¹ ³⁵⁵ assess necessity of continuing the other antiarrhythmic agent(s) after antiarrhythmic effect of amiodarone has been established.¹ ³⁵⁵

In patients already receiving amiodarone, reduce initial dosage of other antiarrhythmic agent(s) by approximately 50%.¹ ³⁵⁵

Specific Drugs, Foods, and Dietary or Herbal Supplements

Drug, Food, or Supplement	Interaction	Comments
Agalsidase beta	Theoretical risk of inhibited intracellular α-galactosidase activity⁴³⁹	Some clinicians recommend avoidance of concurrent use of biosynthetic forms of α-galactosidase and amiodarone⁴³⁹
Anesthetics, general	Potential serious cardiovascular (e.g., hypotension) and cardiac (e.g., sinus bradyarrhythmias, AV block) effects¹ ¹⁶⁷ ¹⁷⁰ ²¹⁶ ²⁶⁷	Close perioperative monitoring is recommended¹ ³⁵⁵
Anticoagulants, oral	Decreased warfarin clearance; ²⁰³ ²⁰⁴ ²⁰⁷ ²⁰⁸ ³¹⁶ increased PT in almost all patients.¹ ²⁰³ ²⁰⁸ ²¹⁰ ³⁰¹ ³¹⁶ ³⁵⁵ ³⁹⁰ Can result in serious or fatal hemorrhage¹ ²⁰³ ²⁰⁴ ²⁰⁷ ²⁰⁸ ²⁰⁹ ²¹¹ ²¹² ²¹⁴ ³¹⁶ ³⁵⁵	Reduce anticoagulant dosage by 33–50% when initiating amiodarone¹ ²⁰⁴ ²⁰⁷ ²⁰⁹ ²¹⁴ ²⁸³ ³⁵⁵ Frequent PT determinations and close observation for adverse effects recommended; adjust anticoagulant dosage as necessary¹ ²⁰³ ²⁰⁴ ²⁰⁷ ²⁰⁹ ³¹⁶ ³⁹⁰ ³⁵⁵ PT may not return to normal for 1–4 months following discontinuance of amiodarone²⁰³ ²⁰⁴ ²⁰⁷ ²⁰⁹ ²¹⁰ ³¹⁶ ³⁹⁰
Azole antifungals	Additive effects in prolonging QT_c interval; serious cardiac arrhythmias (e.g., torsades de pointes) reported¹ ³⁵⁵ ⁴³²	Assess risks versus benefits¹ ³⁵⁵
β-adrenergic blocking agents (e.g., propranolol)	Possible potentiation of sinus bradycardia, sinus arrest, and AV block¹ ²⁵ ²⁶³ ³⁵⁵	Concomitant therapy may be considered in patients with severe sinus bradycardia or sinus arrest following insertion of artificial pacemaker;¹ ³⁵⁵ monitor cardiac function⁴³²
Calcium-channel blocking agents (e.g., diltiazem, verapamil)	Possible potentiation of sinus bradycardia, sinus arrest, and AV block¹ ³⁵ ²⁵⁶ ³⁰¹ ³⁵⁵	Concomitant therapy may be considered in patients with severe sinus bradycardia or sinus arrest following insertion of artificial pacemaker¹ ³⁵⁵
Cardiac glycosides	Increased serum digoxin concentrations and digoxin toxicity¹ ⁹ ²⁵ ³⁵ ²⁰³ ²⁰⁴ ²⁰⁷ ²¹⁷ ²¹⁸ ²¹⁹ ²²⁰ ²²¹ ²²² ²²³ ³⁰¹ ³⁵⁵	When initiating amiodarone therapy, reassess need for continued cardiac glycoside therapy; discontinue digoxin or reduce digoxin dosage by 50%¹ ²⁵ ³⁵ ²⁰⁷ ²¹⁷ ²²³ ³⁵⁵ Monitor serum digoxin concentrations carefully and reduce digoxin dosage as necessary¹ ⁹ ³⁵ ²⁰⁴ ²¹⁸ ²¹⁹ ²²² ²²³ ³⁵⁵ ⁴³² Close observation for signs of cardiac glycoside toxicity recommended ¹ ⁹ ²⁰⁴ ²¹⁸ ³⁵⁵ Monitor thyroid function carefully due to potential for altered cardiac glycoside sensitivity in patients with amiodarone-induced changes in thyroid function²¹⁸ ²²⁴ ²²⁵
Cholestyramine	Decreased plasma amiodarone concentrations and half-life¹ ²⁰³ ²⁶² ³⁵⁵
Cimetidine	Increased plasma amiodarone concentrations¹ ³⁵⁵
Cisapride (no longer commercially available in the US)	Additive effects in prolonging QT_c interval; serious cardiac arrhythmias (e.g., torsades de pointes) reported⁴³²	Concurrent use contraindicated⁴³²
Clopidogrel	Potential interaction resulting in ineffective inhibition of platelet aggregation by clopidogrel¹ ³⁵⁵
Cyclosporine	Increased plasma cyclosporine concentrations resulting in elevated serum creatinine concentrations¹ ³⁵⁵
Dextromethorphan	Possible inhibition of dextromethorphan metabolism with prolonged administration (>2 weeks) of oral amiodarone¹ ³⁵⁵
Disopyramide	Additive effects in prolonging QT_c interval; possible serious cardiac arrhythmias (e.g., torsades de pointes)¹ ³⁵⁵
Dolasetron	Possible additive effects in prolonging QT_c interval⁴³² ⁴³⁸	Use concomitantly with caution; monitor cardiac function⁴³² ⁴³⁸
Fentanyl	Possible hypotension, bradycardia, and decreased cardiac output¹ ³⁵⁵
Flecainide	Decreased flecainide clearance²²⁶	Reduce flecainide dosage by 30–50% several days after initiating amiodarone therapy¹ ²²⁶ ³⁵⁵ Monitor patient and plasma flecainide concentrations closely; adjust flecainide dosage as necessary¹ ²²⁶ ³²⁰ ³⁵⁵
Fluoroquinolone anti-infectives (e.g., ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin)	Additive effects in prolonging QT_c interval; possible serious cardiac arrhythmias (e.g., torsades de pointes)¹ ³⁵⁵ ⁴³²	Avoid concomitant use ³⁶⁶ ⁴³² ⁴³⁴ ⁴³⁵ ⁴³⁶
Grapefruit juice	Increased amiodarone concentrations.¹ ³⁵⁵	Avoid concomitant use.¹ ³⁵⁵
Halofantrine (no longer commercially available in the US)	Additive effects in prolonging QT_c interval; possible serious cardiac arrhythmias (e.g., torsades de pointes)⁴⁴⁴	Avoid concomitant use⁴⁴⁴
HCV antivirals	Regimen containing sofosbuvir with another DAA (e.g., ledipasvir, simeprevir, daclatasvir): May result in serious symptomatic bradycardia (mechanism unknown);⁴⁵³ ⁴⁵⁴ ⁴⁵⁵ ⁴⁵⁶ ⁴⁵⁷ effect on plasma concentrations of the drugs is unknown⁴⁵⁴ ⁴⁵⁵ ⁴⁵⁶ ⁴⁵⁷ Simeprevir-containing regimen that does not include sofosbuvir: Modestly increased plasma concentrations of oral amiodarone due to intestinal CYP3A4 inhibition by simeprevir⁴⁵⁶ Fixed combination of ombitasvir, paritaprevir, and ritonavir (ombitasvir/paritaprevir/ritonavir) with dasabuvir: Increased plasma concentrations of amiodarone⁴⁵⁸	Regimen containing sofosbuvir with another DAA: Concomitant use not recommended;⁴⁵⁴ ⁴⁵⁵ ⁴⁵⁶ ⁴⁵⁷ if concomitant use necessary, patient counseling and cardiac monitoring required⁴⁵⁴ ⁴⁵⁵ ⁴⁵⁶ ⁴⁵⁷ Simeprevir-containing regimen that does not include sofosbuvir: Use concomitantly with caution;⁴⁵⁶ amiodarone therapeutic drug monitoring recommended, if available⁴⁵⁶ Ombitasvir/paritaprevir/ritonavir with dasabuvir: Use concomitantly with caution;⁴⁵⁸ amiodarone therapeutic drug monitoring recommended, if available⁴⁵⁸
HIV protease inhibitors	HIV protease inhibitors used with low-dose ritonavir (ritonavir-boosted) or without low-dose ritonavir (unboosted): Possible increased plasma concentrations of amiodarone and the HIV protease inhibitor¹ ²⁰⁰ ³⁵⁵	Ritonavir-boosted saquinavir or ritonavir-boosted tipranavir: Concomitant use not recommended²⁰⁰ Other ritonavir-boosted HIV protease inhibitors or unboosted HIV protease inhibitors: Use concomitantly with caution;²⁰⁰ monitor for amiodarone toxicity;²⁰⁰ consider monitoring ECG and amiodarone plasma concentrations²⁰⁰
HMG-CoA reductase inhibitors (statins)	Increased risk of myopathy and/or rhabdomyolysis, particularly when used with higher dosages of certain statins (e.g., simvastatin)¹ ³⁵⁵ ³⁷¹ ⁴¹⁷ ⁴⁴⁸ ⁴⁴⁹ ⁴⁵⁰ ⁴⁵¹	Reduce dosage of lovastatin (to ≤40 mg daily) or simvastatin (to ≤20 mg daily) during concomitant therapy with amiodarone³⁷¹ ⁴¹⁷ ⁴⁴⁸
Lidocaine	Increased serum lidocaine concentrations; potential increase in adverse effects (e.g., sinus bradycardia, seizures)¹ ³⁵⁵
Loratadine	Additive effects in prolonging QT_c interval; serious cardiac arrhythmias (e.g., torsades de pointes)¹ ³⁵⁵
Macrolide antibiotics	Additive effects in prolonging QT_c interval; serious cardiac arrhythmias (e.g., torsades de pointes)¹ ³⁵⁵	Assess risks versus benefits¹ ³⁵⁵
Methotrexate	Possible inhibition of methotrexate metabolism with prolonged administration (>2 weeks) of oral amiodarone¹ ³⁵⁵
Phenytoin	Increased serum phenytoin concentrations;¹ ²⁰³ ²⁰⁵ ²⁰⁶ ³⁵⁵ possible phenytoin toxicity (e.g., nystagmus, ataxia, lethargy)¹ ²⁰³ ²⁰⁵ ²⁰⁶ Possible decreased plasma amiodarone concentrations¹ ³⁵⁵	Monitor serum phenytoin concentrations and closely observe patient for signs of phenytoin toxicity; reduce phenytoin dosage as necessary¹ ²⁰⁵
Pimozide	Additive effects in prolonging QT_c interval; possible serious cardiac arrhythmias (e.g., torsades de pointes)⁴³³	Concomitant use contraindicated⁴³³
Procainamide	Increased plasma procainamide and N-acetylprocainamide (NAPA) concentrations;¹ ²⁰³ ²²⁷ possible increases in QT_c and QRS intervals and acceleration of ventricular tachycardia³¹³	Reduce procainamide dosage by 20–33% when amiodarone therapy is initiated or discontinue procainamide therapy¹ ²²⁷ ³¹³ ³⁵⁵
Quinidine	Increased serum quinidine concentrations;¹ ³⁵ ²²⁷ ²²⁸ ³⁵⁵ possible marked QT prolongation and torsades de pointes²⁰⁷ ²²⁸ ²⁶⁴	Reduce quinidine dosage by 33–50% when amiodarone therapy is initiated or discontinue quinidine therapy¹ ²²⁷ ³⁵⁵ Monitor serum quinidine concentrations carefully and reduce quinidine dosage as necessary; observe patient closely for signs of toxicity, including QT prolongation¹ ²²⁷ ²²⁸ ³⁵⁵
Rifampin	Decreased plasma amiodarone and desethylamiodarone concentrations¹ ³⁵⁵
St. John’s wort (Hypericum perforatum)	Potential decrease in amiodarone concentrations¹ ³⁵⁵
Trazodone	Additive effects in prolonging QT_c interval; serious cardiac arrhythmias (e.g., torsades de pointes)¹ ³⁵⁵
Ziprasidone	Possible additive effects in prolonging QT_c interval; possible serious cardiac arrhythmias (e.g., torsades de pointes)⁴³⁷	Avoid concomitant use⁴³⁷

Amiodarone Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Slowly¹ ² ¹⁰ ²⁵ ³⁵ ⁴⁰ ⁴⁹ ⁵⁵ ⁵⁸ ⁵⁹ ⁶¹ ⁶² ⁶⁵ ⁷⁸ ⁷⁹ ⁸⁰ ⁸¹ ⁹⁹ and variably absorbed from the GI tract following oral administration;¹ ² ⁵ ²⁵ ²⁶ ³⁵ ⁴⁹ ⁵⁵ ⁵⁶ ⁵⁸ ⁵⁹ ⁶⁰ ⁶¹ ⁶² ⁶⁵ ⁷⁰ ⁷⁶ ⁷⁷ ⁷⁸ ⁷⁹ ⁸⁰ ⁸¹ ⁹⁹ absolute bioavailability averages 50%¹ ²⁵ ⁵⁵ ⁵⁸ ⁵⁹ ⁶⁰ ⁶¹ ⁷⁸ ⁷⁹ ⁸⁰ ³⁵⁵ (range: 22–86%).² ³ ²⁵ ⁵⁵ ⁵⁸ ⁵⁹ ⁶⁰ ⁷⁸ ⁹⁹ Considerable interindividual variation in plasma concentrations attained with a given dosage.¹ ⁵ ⁵⁶ ⁶⁰ ⁷⁰ ⁷⁵ Following oral administration, peak plasma concentrations usually occur within 3–7 hours.¹ ² ¹⁰ ²⁵ ³⁵ ⁵⁵ ⁵⁸ ⁵⁹ ⁶⁰ ⁶¹ ⁶² ⁶⁴ ⁶⁵ ⁷³ ⁷⁸ ⁷⁹ ⁸⁰ ⁸¹ ⁹⁹

Onset

Following oral administration, onset of antiarrhythmic activity is highly variable;¹ ² ³ ²³ ²⁵ ⁴² ⁵⁹ ⁶⁴ ⁶⁸ ⁷² however, a therapeutic response generally is not evident until 1–3 weeks after beginning therapy, even when loading doses are administered.¹ ² ³ ⁵ ²³ ²⁵ ⁴² ⁵⁹ ⁶⁴ ⁶⁸ ⁷²

Duration

Antiarrhythmic effects generally persist for 10–150 days following withdrawal of long-term therapy;¹ ² ³ ⁴ ⁵ ²³ ²⁴ ²⁶ ⁴⁹ ⁵⁶ ⁵⁹ ⁶⁷ ⁷² ⁷⁹ duration of antiarrhythmic activity is variable and unpredictable¹ and appears to depend on length of therapy² ²⁶ and type of arrhythmia.⁵ ²³

Food

Food increases rate and extent of absorption.¹ ²⁸³

Distribution

Extent

Following chronic oral administration, amiodarone and N-desethylamiodarone are distributed extensively into many body tissues and fluids.¹ ² ¹⁰ ²⁵ ³⁵ ⁵⁵ ⁵⁶ ⁶² ⁷⁸ ⁸¹ ⁸⁴ ⁸⁶ ⁹⁴ ⁹⁸ ⁹⁹ ²⁹⁰ Tissue concentrations generally exceed concurrent plasma concentrations of the drug.² ¹⁰ ³⁵ ⁵⁵ ⁶² ⁷⁸ ⁸² ⁸⁴ ⁸⁵ After long-term therapy, concentrations of the metabolite usually are substantially higher than concentrations of unchanged drug in almost all tissues, except adipose tissue.² ⁵ ³⁵ ⁵⁵ ⁷⁸ ⁸¹ ⁸² ⁸⁴ ⁸⁶ ⁹⁹

Following IV administration, amiodarone is rapidly and widely distributed.⁸⁵

Amiodarone and N-desethylamiodarone cross the placenta to a limited extent.¹ ² ⁷⁸ ⁸⁸ ⁸⁹ ⁹¹ ³⁵⁵ Amiodarone and N-desethylamiodarone are distributed into milk.¹ ² ⁷⁸ ⁸⁹ ⁹¹ ³⁵⁵

Plasma Protein Binding

Approximately 96%.¹ ² ⁸⁷ ⁹⁰ ³⁵⁵

Elimination

Metabolism

Extensively metabolized,⁹ ²⁵ ⁷⁶ ⁸⁰ ¹⁰¹ probably in the liver⁹ ³⁵ ⁶⁴ ⁷⁶ ⁸¹ and possibly in the intestinal lumen and/or GI mucosa,³⁵ ⁶⁴ ⁷⁶ to at least one major metabolite,¹ ² ²⁵ ³⁵ ⁷⁶ ⁷⁷ ⁷⁸ ⁸¹ ⁹⁶ ¹⁰¹ ³⁵⁵ N-desethylamiodarone. This metabolite appears to possess substantial electrophysiologic and antiarrhythmic activity similar to amiodarone’s.¹ ⁸⁶ ⁹⁹ ¹⁰⁰ ¹⁰¹ ²⁷³ ²⁸⁵ ³⁵⁵

Elimination Route

Excreted almost completely in feces as unchanged drug and N-desethylamiodarone, presumably via biliary elimination.¹ ³ ⁹ ²⁵ ³⁵ ⁵⁹ ⁷⁷ ⁷⁸ ⁸⁰ ⁹⁵ ⁹⁸ ³⁵⁵

Half-life

Half-life of amiodarone appears to be substantially more prolonged following multiple rather than single doses.² ⁴ ⁹ ²⁶ ⁵⁵ ⁵⁸ ⁵⁹ ⁶⁴ ⁶⁵ ⁷⁸ ⁸¹ ⁹⁹ ²⁹¹

Following a single IV dose, the terminal elimination phase half-life of amiodarone averages 25 days (range 9–47 days);² ⁵ ⁵⁵ ³⁵⁵ elimination half-life of N-desethylamiodarone equals or exceeds that of amiodarone.³⁵⁵

Following chronic oral administration, amiodarone has an initial elimination half-life of about 2.5–10 days, followed by a terminal elimination half-life averaging 53 days;¹ ⁵⁵ elimination half-life of N-desethylamiodarone averages 57–61 days.¹ ²⁵ ⁵⁵ ⁹³ ⁹⁷ ⁹⁹ ¹⁰¹

Clearance may be more rapid in pediatric patients.² ⁹ ⁴⁰ ⁶⁹

Clearance may be decreased in geriatric patients (>65 years of age).³⁵⁵

Stability

Storage

Oral

Tablets

Tightly sealed containers at 20–25°C; protect from light.¹ ⁴⁴³ The manufacturer of one commercially available amiodarone tablet preparation (Pacerone) states the tablets may be exposed to 15–30°C.⁴⁴³

Parenteral

Injection Concentrate

20–25°C; protect from light and excessive heat.³⁵⁵ Store ampuls in carton to protect from light until used.³⁵⁵ Light protection not necessary during administration.³⁵⁵ ^c

Compatibility

Parenteral

Do not use evacuated glass containers for amiodarone hydrochloride infusions (incompatibility with a buffer in the container may cause precipitation).^c Polysorbate 80, a component of IV amiodarone injection, can cause leaching of diethylhexyl phthalate (DEHP) from IV tubing, including PVC tubing; leaching increases at lower than recommended flow rates and at higher than recommended infusion concentrations.³⁵⁵

Solution Compatibilityc

Manufacturer states physically compatible in PVC container with amiodarone loss of <10% at 2 hours at room temperature and physically compatible in polyolefin or glass container with no amiodarone loss at 24 hours at room temperature.^c

Compatible
Dextrose 5% in water
Variable
Sodium chloride 0.9%

Drug Compatibility

Admixture Compatibilityc
Compatible
Dobutamine HCl
Lidocaine HCl
Potassium chloride
Procainamide HCl
Verapamil HCl
Variable
Furosemide
Quinidine gluconate

Y-Site Compatibility c
Compatible
Amikacin sulfate
Amphotericin B
Atracurium besylate
Atropine sulfate
Calcium chloride
Calcium gluconate
Caspofungin acetate
Ceftaroline fosamil
Ceftriaxone sodium
Cefuroxime sodium
Ciprofloxacin
Clindamycin phosphate
Dexmedetomidine HCl
Dobutamine HCl
Dopamine HCl
Doripenem
Doxycycline hyclate
Epinephrine HCl
Eptifibatide
Erythromycin lactobionate
Esmolol HCl
Famotidine
Fenoldopam mesylate
Fentanyl citrate
Fluconazole
Gentamicin sulfate
Hetastarch in lactated electrolyte injection (Hextend)
Insulin, regular
Isoproterenol HCl
Labetalol HCl
Lepirudin
Lidocaine HCl
Lorazepam
Methylprednisolone sodium succinate
Metoprolol tartrate
Midazolam HCl
Milrinone lactate
Morphine sulfate
Nesiritide
Nitroglycerin
Norepinephrine bitartrate
Penicillin G potassium
Phentolamine mesylate
Phenylephrine HCl
Potassium chloride
Procainamide HCl
Tirofiban HCl
Tobramycin sulfate
Vancomycin HCl
Vasopressin
Vecuronium bromide
Incompatible
Aminophylline
Ampicillin sodium-sulbactam sodium
Argatroban
Bivalirudin
Ceftazidime
Digoxin
Heparin sodium
Imipenem-cilastatin sodium
Micafungin sodium
Piperacillin sodium-tazobactam
Potassium phosphates
Sodium bicarbonate
Sodium phosphates
Variable
Cefazolin sodium
Furosemide
Magnesium sulfate
Sodium nitroprusside

Actions

Exhibits greater efficacy and a lower incidence of proarrhythmic effects than class I or other class III antiarrhythmic drugs. ⁴⁰⁶ ⁴⁰⁷
Delays repolarization by prolonging the action potential duration and effective refractory period in cardiac tissue.¹ ² ³ ⁴ ⁵ ⁶ ⁷ ¹² ¹³ ¹⁷ ¹⁸ ¹⁹ ²¹ ²² ²⁵ ²⁶ ³⁸ ³⁵⁵
Inhibits transmembrane influx of extracellular sodium ions via fast sodium channels.⁵ ¹³ ³² ³⁵ ⁴⁴ ³⁵⁵ Combines with fast sodium channels in their inactive state and inhibits recovery after repolarization in a time- and voltage-dependent manner.²¹ ²⁵ ³² ³⁵ ⁴⁴ ⁴⁶
Noncompetitively inhibits α- and β-adrenergic responses to sympathetic stimulation and catecholamine administration.¹ ³ ⁴ ⁵ ⁶ ⁹ ¹⁰ ¹¹ ¹³ ¹⁴ ¹⁵ ¹⁶ ¹⁹ ²¹ ²⁴ ²⁵ ³⁴ ³⁵ ⁵¹
Depresses sinus node function¹ ³ ⁴ ⁵ ⁶ ⁹ ¹⁰ ¹¹ ¹⁴ ¹⁵ ¹⁸ ²⁰ ²¹ ²⁵ ²⁶ ²⁸ ²⁹ ³⁰ ³³ ³⁴ ³⁵ ³⁹ ⁴⁹ ⁵⁰ and automaticity.¹ ⁵ ⁶ ⁹ ²⁵
Relaxes cardiac and vascular smooth muscle, thereby dilating both systemic and coronary arteries.¹ ³ ⁴ ⁹ ¹⁰ ¹³ ¹⁴ ¹⁷ ³⁵ ⁵³ ⁵⁴
Inhibits extrathyroidal deiodinases,²³¹ ²³⁷ ²⁶⁹ resulting in decreased peripheral conversion of thyroxine (T₄) to triiodothyronine (T₃).¹ ⁴ ⁹ ²⁵ ³⁵ ⁸³ ¹⁵⁴ ²³¹ ²³² ²³³ ²³⁴ ²³⁵ ²³⁷ ²⁵³ ²⁶⁹ ²⁹⁸ ³⁵⁵
Contains 37.3% iodine; each 200-mg tablet or each mL of the injection contains approximately 75 or 18.7 mg of iodine, respectively.¹ ² ¹³ ³⁵⁵
Inhibits phospholipase (e.g., phospholipase A₁, A₂, and C)¹⁵⁰ ²⁷⁰ activity in vitro;³⁵ ¹⁵⁰ ¹⁵⁷ ²⁷⁰ ³²⁶ ³³⁹ production of amiodarone-phospholipid complexes within certain organs may be involved in the development of adverse effects.⁹ ²⁵ ³⁵ ¹⁵⁰ ¹⁵⁶ ¹⁵⁷ ¹⁵⁸ ¹⁵⁹ ¹⁶¹ ¹⁶² ¹⁶³ ¹⁶⁴ ¹⁷⁷ ¹⁷⁹ ¹⁸³ ¹⁸⁵ ¹⁸⁶ ¹⁸⁷ ¹⁹¹ ¹⁹² ¹⁹³ ¹⁹⁶ ²⁷⁰
Inhibits α-galactosidase activity.⁴³⁹

Advice to Patients

Importance of patients taking medication exactly as prescribed.⁴³¹ Importance of not taking a double dose to make up for a missed dose but instead taking the next scheduled dose.⁴³¹
Importance of not interrupting or discontinuing therapy without consulting a clinician, even if improvement is evident, as condition may worsen.⁴³¹
Importance of seeking medical attention immediately or proceeding to a hospital emergency department if too many oral doses are ingested.⁴³¹
If serious adverse effects occur, importance of informing a clinician before discontinuing the drug.⁴³¹
Importance of patients informing clinician of history of BP abnormalities, lung, liver, or thyroid disorders prior to treatment initiation.⁴³¹
Importance of clinicians informing patients of potential toxicities (e.g., lung, liver) that may occur during therapy.³⁵⁵
Importance of patients informing clinician of any episodes of shortness of breath, wheezing, coughing, spitting up blood, chest pain, any other breathing disorders, or aggravation of cardiovascular disease.⁴ ⁴³¹
Importance of patients informing clinician of symptoms of thyroid dysfunction such as weakness, weight gain or loss, heat or cold intolerance, hair thinning, sweating, menstrual cycle changes, swelling of the neck (goiter), nervousness, irritability, restlessness, decreased concentration, depression in geriatric patients, or tremor.⁴³¹
Importance of patients contacting their clinician if nausea or vomiting, dark urine, fatigue, yellowing of the skin or whites of eyes, or stomach pain occurs.⁴³¹
Importance of patients contacting their clinician if heart pounding, irregular heart beat, rapid or slow heartbeat, lightheadedness, or faintness occurs.⁴³¹
Importance of patients contacting their clinician if visual disturbances (e.g., blurred vision, visual halos, ocular photosensitivity) occur.⁴³¹
Importance of advising patients that most manufacturers of corneal refractive laser surgery devices consider the procedure to be contraindicated in patients receiving amiodarone.¹ ³⁵⁵
Importance of regular laboratory monitoring (e.g., pulmonary, thyroid, and liver function) and clinical (e.g., cardiac, ophthalmologic) evaluation.¹ ³⁵⁵
Importance of patients informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, dietary supplements and/or herbal products, as well as any concomitant illnesses.¹ ³⁵⁵
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ ³⁵⁵ Importance of avoiding pregnancy during therapy.⁴³¹
Importance of using sunscreen agents¹ ²⁵ ³⁵ ⁷² ¹⁵³ ¹⁹⁰ ¹⁹⁵ ²⁸³ and protective clothing¹ ³⁵ ¹⁹⁰ ¹⁹⁵ ⁴³¹ and of avoiding excessive exposure to sunlight or sun lamps.²⁵ ³⁵ ¹⁹⁰ ⁴³¹
Importance of taking amiodarone in a consistent manner relative to food intake.¹ ⁴³¹
Importance of not consuming grapefruit juice during oral amiodarone therapy.¹ ³⁵⁵ ⁴³¹
Importance of advising patients of other important precautionary information.¹ ³⁵⁵

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Amiodarone Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	100 mg	Pacerone	Upsher-Smith
		200 mg*	Amiodarone Hydrochloride Tablets
			Cordarone (scored)	Wyeth
			Pacerone (scored)	Upsher-Smith
		400 mg*	Amiodarone Hydrochloride Tablets
			Pacerone (scored)	Upsher-Smith
Parenteral	Concentrate for injection, for IV infusion	50 mg/mL*	Amiodarone Hydrochloride Injection

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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Pill A 8 4 is Amiodarone Hydrochloride 200 mg — Amiodarone Hydrochloride 200 mg (A 8 4)

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