Amiodarone — $0 with Membership

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What Amiodarone is approved for (FDA label)

Amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. Amiodarone hydrochloride tablets are an antiarrhythmic indicated for: Recurrent ventricular fibrillation. ( 1 ) Recurrent hemodynamically unstable ventricular tachycardia. ( 1 )

Source: Read the full FDA label on DailyMed. Label effective date: August 5, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Amiodarone (FDA label)

WARNING: PULMONARY, HEPATIC and CARDIAC TOXICITY Amiodarone hydrochloride is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity [see Indications and Usage ( 1 )]. Amiodarone hydrochloride can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients. Pulmonary toxicity has been fatal about 10% of the time . Obtain a baseline chest X-ray and pulmonary-function tests, including diffusion capacity, when amiodarone hydrochloride therapy is initiated. Repeat history, physical exam, and chest X-ray every 3 to 6 months [see Warnings and Precautions 5.2 )]. Amiodarone hydrochloride can cause hepatoxicity, which can be fatal. Obtain baseline and periodic liver transaminases and discontinue or reduce dose if the increase exceeds three times normal, or doubles in a patient with an elevated baseline. Discontinue amiodarone hydrochloride if the patient experiences signs or symptoms of clinical liver injury [see Warnings and Precautions ( 5.3 )]. Amiodarone hydrochloride can exacerbate arrhythmias. Initiate amiodarone hydrochloride in a clinical setting where continuous electrocardiograms and cardiac resuscitation are available [see Warnings and Precautions ( 5.4 )] WARNING: PULMONARY, HEPATIC, and CARDIAC TOXICITY See full prescribing information for complete boxed warning . Reserve amiodarone hydrochloride for patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity, some also life-threatening.

Source: FDA prescribing information (DailyMed). Set ID: 4c149392-a4f0-4e2d-a13f-2b94810005de. SPL document ID: 584f8c98-a7ba-67ac-e063-6294a90a56d6. Label effective date: August 5, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Amiodarone (FDA label)

Amiodarone Hydrochloride Tablets USP, 200 mg are white to off white round-shaped flat faced beveled edged tablets debossed with "U" over score on one side and "359" on other side. Tablets, 200 mg. ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 4c149392-a4f0-4e2d-a13f-2b94810005de. SPL document ID: 584f8c98-a7ba-67ac-e063-6294a90a56d6. Label effective date: August 5, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Amiodarone (FDA label)

The following serious adverse reactions are described in more detail in other sections of the prescribing information: Pulmonary Toxicity [see Warnings and Precautions ( 5.2 )] Hepatic Injury [see Warnings and Precautions ( 5.3 )] Worsened Arrhythmia [see Warnings and Precautions ( 5.4 )] Visual Impairment and Loss of Vision [see Warnings and Precautions ( 5.5 )] Thyroid Abnormalities [see Warnings and Precautions ( 5.6 )] Bradycardia [see Warnings and Precautions ( 5.7 )] Peripheral Neuropathy [see Warnings and Precautions ( 5.10 )] Photosensitivity and Skin Discoloration [see Warnings and Precautions ( 5.11 )] The most common reactions (>1%) leading to discontinuation of amiodarone hydrochloride tablets include pulmonary toxicity, paroxysmal ventricular tachycardia, congestive heart failure, and elevation of liver enzymes. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Unichem Pharmaceuticals (USA), Inc., at 1-866-562-4616 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Source: FDA prescribing information (DailyMed). Set ID: 4c149392-a4f0-4e2d-a13f-2b94810005de. SPL document ID: 584f8c98-a7ba-67ac-e063-6294a90a56d6. Label effective date: August 5, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Amiodarone (FDA label)

Cardiogenic shock. Sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia leading to syncope without a functioning pacemaker. Known hypersensitivity to the drug or to any of its components, including iodine. Amiodarone hydrochloride tablet is contraindicated in patients with ( 4 ): Cardiogenic shock. Sick sinus syndrome, second- or third-degree AV block, bradycardia leading to syncope without a functioning pacemaker. Known hypersensitivity to the drug or any of its components.

Source: FDA prescribing information (DailyMed). Set ID: 4c149392-a4f0-4e2d-a13f-2b94810005de. SPL document ID: 584f8c98-a7ba-67ac-e063-6294a90a56d6. Label effective date: August 5, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Amiodarone (FDA label)

Persistence of Adverse Effects: Adverse reactions and drug interaction can persist for several weeks following discontinuation. ( 5.1 ) Impaired Vision: Corneal microdeposits (common; reversible), optic neuropathy/neuritis (rare; may lead to blindness). ( 5.5 ) Thyroid Abnormalities: Hyperthyroidism or hypothyroidism. ( 5.6 ) 5.1 Persistence of Adverse Effects Because of the long half-life of amiodarone (15 to 142 days) and its active metabolite desethylamiodarone (14 to 75 days), adverse reactions and drug interactions can persist for several weeks following amiodarone discontinuation [see Clinical Pharmacology ( 12.3 )] . 5.2 Pulmonary Toxicity Amiodarone hydrochloride may cause a clinical syndrome of cough and progressive dyspnea accompanied by functional, radiographic, gallium-scan, and pathological data consistent with pulmonary toxicity. Pulmonary toxicity secondary to amiodarone hydrochloride may result from either indirect or direct toxicity as represented by hypersensitivity pneumonitis (including eosinophilic pneumonia) or interstitial/alveolar pneumonitis, respectively.

Source: FDA prescribing information (DailyMed). Set ID: 4c149392-a4f0-4e2d-a13f-2b94810005de. SPL document ID: 584f8c98-a7ba-67ac-e063-6294a90a56d6. Label effective date: August 5, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Amiodarone (FDA label)

Because of amiodarone's long half-life, expect drug interactions to persist for weeks to months after discontinuation of amiodarone. Drug interactions with amiodarone are described in Table 1 below. Table 1: Amiodarone Drug Interactions Concomitant Drug Class/Name Examples Clinical Comment Pharmacodynamic Interactions QT Prolonging Drugs class I and III antiarrhythmics, lithium, certain phenothiazines, tricyclic antidepressants, certain fluoroquinolone and macrolide antibiotics, azole antifungals, halogenated inhalation anesthetic agents Increased risk of Torsade de Pointes. Avoid concomitant use. Negative Chronotropes digoxin, beta blockers, verapamil, diltiazem, clonidine, ivabradine Potentiates the electrophysiologic and hemodynamic effects of amiodarone, resulting in bradycardia, sinus arrest, and AV block. Monitor heart rate. Pharmacokinetic Interactions CYP450 Inhibitors grapefruit juice, certain fluoroquinolone and macrolide antibiotics, azole antifungals, cimetidine, certain protease inhibitors Increased exposure of amiodarone. Avoid concomitant use. CYP450 Inducers St. John's Wort Reduced amiodarone serum levels.

Source: FDA prescribing information (DailyMed). Set ID: 4c149392-a4f0-4e2d-a13f-2b94810005de. SPL document ID: 584f8c98-a7ba-67ac-e063-6294a90a56d6. Label effective date: August 5, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.