Pacerone Amiodarone Hydrochloride 200 mg Tablet, 100-count
Other active recalls for Amiodarone Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Antiarrhythmic class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Amiodarone is used to treat and prevent certain types of ventricular arrhythmias (a certain type of abnormal heart rhythm) and unstable tachycardia (fast hear rate). Amiodarone is in a class of medications called antiarrhythmics. It works by relaxing overactive heart muscles.
Read the full MedlinePlus article ↗- Amiodarone is reserved for serious, life-threatening heart rhythms — specifically the kind that can cause sudden cardiac arrest. Doctors only reach for it when other medications ha...
- Why is my doctor putting me on amiodarone instead of something simpler?
- The most important thing is to be consistent. Food significantly increases how much amiodarone your body absorbs, so your doctor will tell you to always take it with food or always...
- Should I take amiodarone with food or on an empty stomach?
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
8 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.125 | $12.49 / 100 tablet |
| Medicaid paysCMS SDUD · 12 mo | $1.10 | $109.53 / 100 tablet |
| Medicare drug plans payPart D · Q2 2026 | $0.1952 | $19.52 / 100 tablet |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Amiodarone Hydrochloride 200 mg 00904-6993-61 | Major | 100 tablets | $0.121 | AB | Availability likely | save 3% |
| Amiodarone Hydrochloride 200 mg 00904-7576-61 | Major | 100 tablets | $0.121 | AB | Availability likely | save 3% |
| Amiodarone Hydrochloride 200 mg 29300-0359-05 | Unichem | 500 tablets | $0.121 | AB | Availability likely | save 3% |
| Amiodarone Hydrochloride 200 mg 60687-0437-01 | American | 100 tablets | $0.121 | AB | Availability likely | save 3% |
| Amiodarone Hydrochloride 200 mg 62135-0577-60 | Chartwell | 60 tablets | $0.121 | AB | Availability likely | save 3% |
| amiodarone hydrochloride 200 mg 68382-0227-05 | Zydus | 500 tablets | $0.121 | AB | Availability likely | save 3% |
| Amiodarone Hydrochloride 200 mg 72888-0039-05 | Advagen | 500 tablets | $0.121 | AB | Availability likely | save 3% |
| Amiodarone Hydrochloride 200 mg 75907-0006-60 | Dr. | 60 tablets | $0.121 | AB | Availability likely | save 3% |
| Pacerone 200 mgthis 00245-0147-01 | Upsher-Smith | 100 tablets | $0.125 | AB | Availability likely | — |
| Amiodarone Hydrochloride 200 mg 00615-8258-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| amiodarone hydrochloride 200 mg 48433-0154-20 | Safecor | 100 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 50090-3015-01 | A-S | 30 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 50090-5766-01 | A-S | 30 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 51672-4025-03 | Sun | 1000 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 55154-3365-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 55154-8185-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Amiodarone hydrochloride 200 mg 65841-0631-05 | Zydus | 500 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 65862-0732-01 | Aurobindo | 100 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 70518-1939-01 | REMEDYREPACK | 90 tablets | — | AB | Discontinued | — |
| Amiodarone Hydrochloride 200 mg 70518-3246-00 | REMEDYREPACK | 30 tablets | — | AB | Discontinued | — |
| Amiodarone Hydrochloride 200 mg 70518-3439-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 71335-0881-01 | Bryant | 200 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 71335-1942-01 | Bryant | 200 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 71335-1985-01 | Bryant | 200 tablets | — | AB | FDA listed | — |
| Pacerone 200 mg 71610-0787-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Amiodarone Hydrochloride 200 mg 67296-2296-03 | Redpharm | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00245-0147-01 You're viewing this | 100 BLISTER PACK in 1 CARTON (0245-0147-01) / 1 TABLET in 1 BLISTER PACK (0245-0147-89) | $0.1249 / ea | $12.49 | 2011-01-19 | Active |
| 00245-0147-15 | 500 TABLET in 1 BOTTLE (0245-0147-15) | $0.1249 / ea | $62.44 | 2011-01-19 | Active |
| 00245-0147-60 | 60 TABLET in 1 BOTTLE (0245-0147-60) | $0.1249 / ea | $7.49 | 2011-01-19 | Active |
| 00245-0147-90 | 90 TABLET in 1 BOTTLE (0245-0147-90) | $0.1249 / ea | $11.24 | 2011-01-19 | Active |
This pack has the lowest per-ea cost of the 4 priced pack sizes ($0.1249 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 82% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00245-0147-01?
What is the difference between NDC 00245-0147-01 and NDC 00245-0147-60?
What NDC number is used to bill for this package of Pacerone Amiodarone Hydrochloride 200 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: PULMONARY, HEPATIC and CARDIAC TOXICITY Pacerone 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) ] . Pacerone 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 Pacerone therapy is initiated. Repeat history, physical exam, and chest X-ray every 3 to 6 months [see Warnings and Precautions 5.2) ] . Pacerone 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 Pacerone if the patient experiences signs or symptoms of clinical liver injury [see Warnings and Precautions (5.3) ] . Pacerone 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 Pacerone for patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity, some also life-threatening.
Utilize alternative agents first. ( 1 ) Pacerone' s life-threatening toxicities include pulmonary ( 5.2 ), hepatic ( 5.3 ), and proarrhythmic ( 5.4 ). Initiate under hospital or specialist supervision.
( 5 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Pacerone is 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. Pacerone is an antiarrhythmic indicated for: Recurrent ventricular fibrillation. ( 1 ) Recurrent hemodynamically unstable ventricular tachycardia.
( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Dosage must be individualized based on severity of arrhythmia and response. Use the lowest effective dose. Obtain baseline chest x-ray, pulmonary function tests, thyroid function tests, and liver aminotransferases.
Correct hypokalemia, hypomagnesemia, and hypocalcemia before initiating treatment. Initiate treatment with a loading dose of 800 to 1600 mg/day until initial therapeutic response occurs (usually 1 to 3 weeks). Once adequate arrhythmia control is achieved, or if side effects become prominent, reduce Pacerone tablets dose to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day.
( 2 ) Recommended Dosage: Initiate treatment with a loading dose of 800 to 1600 mg/day until initial therapeutic response occurs (usually 1 to 3 weeks). Once adequate arrhythmia control is achieved, or if side effects become prominent, reduce Pacerone tablet dose to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day. Administration: Administer Pacerone tablets consistently with regard to meals [see Clinical Pharmacology (12.3) ] .
Administration of Pacerone tablets in divided doses with meals is suggested for total daily doses of 1000 mg or higher, or when gastrointestinal intolerance occurs.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Pacerone tablets, 100 mg, are peach, round, flat-faced, uncoated tablets, debossed with "P" on one side, and "U-S" above "144" on the other side. Pacerone tablets, 200 mg, are pink, round, flat-faced, scored, uncoated tablets, debossed with "P 200 " on the unscored side, and "U-S" above and "0147" below the score on the reverse side. Pacerone tablets, 400 mg, are white to off-white, round, uncoated, scored tablets, debossed with "U-S' above and "1645' below the score on one side and "P 400 " on the unscored side.
Tablets: 100 mg, 200 mg and 400 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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.
Pacerone 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.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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 )
5.1Persistence 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) ] .
5.2Pulmonary Toxicity Pacerone 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 Pacerone may result from either indirect or direct toxicity as represented by hypersensitivity pneumonitis (including eosinophilic pneumonia) or interstitial/alveolar pneumonitis, respectively. Rates of pulmonary toxicity have been reported to be as high as 17% and is fatal in about 10% of cases.
Obtain a baseline chest X-ray and pulmonary-function tests, including diffusion capacity, when Pacerone therapy is initiated. Repeat history, physical exam, and chest X-ray every 3 to 6 months or if symptoms occur. Consider alternative antiarrhythmic therapy if the 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. Adult Respiratory Distress Syndrome (ARDS) Postoperatively, occurrences of ARDS have been reported in patients receiving amiodarone hydrochloride 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.
5.3Hepatic Injury Asymptomatic elevations of hepatic enzyme levels are seen frequently, but Pacerone 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 of Pacerone, obtain follow-up tests and treat appropriately.
5.4Worsened Arrhythmia Pacerone can exacerbate the presenting arrhythmia in about 2% to 5% of patients or cause new ventricular fibrillation, incessant ventricular tachycardia, increased resistance to cardioversion, and polymorphic ventricular tachycardia associated with QTc prolongation (Torsade de Pointes [TdP]). Correct hypokalemia, hypomagnesemia, and hypocalcemia before initiating treatment with amiodarone hydrochloride, 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 receiving drugs affecting electrolyte levels, such as diuretics, laxatives, systemic corticosteroids, or amphotericin B.
5.5Visual Impairment and Loss of Vision Optic Neuropathy and Optic Neuritis Cases of optic neuropathy and optic neuritis, usually resulting in visual impairment and sometimes permanent blindness, have been reported in patients treated with amiodarone and may occur at any time during therapy. If symptoms of visual impairment appear, such as changes in visual acuity and decreases in peripheral vision, consider discontinuing Pacerone and promptly refer for ophthalmic examination. Regular ophthalmic examination, including funduscopy and slit-lamp examination, is recommended during administration of Pacerone [see Adverse Reactions (6.1) ] .
Corneal Microdeposits Corneal microdeposits appear in the majority of adults treated with amiodarone hydrochloride. They are usually discernible only by slit-lamp examination but give rise…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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 include pulmonary toxicity, paroxysmal ventricular tachycardia, congestive heart failure, and elevation of liver enzymes.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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. At the usual maintenance dose (400 mg/day) and above, amiodarone hydrochloride causes adverse reactions in about three-fourths of all patients, resulting in discontinuation in 7% to 18%. In surveys of almost 5,000 patients treated in open U.S. studies and in published reports of treatment with amiodarone hydrochloride, the adverse reactions most frequently requiring discontinuation of amiodarone hydrochloride included pulmonary infiltrates or fibrosis, paroxysmal ventricular tachycardia, congestive heart failure, and elevation of liver enzymes.
Other symptoms causing discontinuations less often included visual disturbances, photosensitivity, blue skin discoloration, hyperthyroidism, and hypothyroidism. The following side-effect rates are based on a retrospective study of 241 patients treated for 2 to 1,515 days (mean 441.3 days): Thyroid Common: Hypothyroidism, hyperthyroidism. Cardiovascular Common: Congestive heart failure, cardiac arrhythmias, SA node dysfunction.
Gastrointestinal Very common: Nausea, vomiting. Common: Constipation, anorexia, abdominal pain. Dermatologic Common: Solar dermatitis/photosensitivity.
Neurologic Common: Malaise and fatigue, tremor/abnormal involuntary movements, lack of coordination, abnormal gait/ataxia, dizziness, paresthesias, decreased libido, insomnia, headache, sleep disturbances. Ophthalmic Common: Visual disturbances. Hepatic Common: Abnormal liver-function tests, nonspecific hepatic disorders.
Respiratory Common: Pulmonary inflammation or fibrosis. Other Common: Flushing, abnormal taste and smell, edema, abnormal salivation, coagulation abnormalities. Uncommon: Blue skin discoloration, rash, spontaneous ecchymosis, alopecia, hypotension, and cardiac conduction abnormalities.
6.2Post-marketing Experience The following adverse reactions have been identified during post-approval use of amiodarone hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hematologic: hemolytic anemia, aplastic anemia, pancytopenia, neutropenia, thrombocytopenia, agranulocytosis, granuloma.
Immune: anaphylactic/anaphylactoid reaction (including shock), angioedema. Neurologic: pseudotumor cerebri, parkinsonian symptoms such as akinesia and bradykinesia (sometimes reversible with discontinuation of therapy), demyelinating polyneuropathy. Psychiatric: hallucination, confusional state, disorientation, delirium.
Cardiac: hypotension (sometimes fatal), sinus arrest. Respiratory: eosinophilic pneumonia, acute respiratory distress syndrome in the post-operative setting, bronchospasm, bronchiolitis obliterans o…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS 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. Cyclosporine Increased plasma levels of cyclosporine have been reported resulting in elevated creatinine, despite reduction of cyclosporine dose. Monitor cyclosporine drug levels and renal function with concomitant use.
Cholestyramine Reduced amiodarone serum levels. Antiarrhythmics quinidine, procainamide, flecainide Reserve concomitant use for patients who are unresponsive to a single agent. Antiarrhythmic metabolism inhibited by amiodarone.
Initiate antiarrhythmic at a lower than usual dose and monitor patient carefully. Reduce dose levels of previously administered antiarrhythmic by 30% to 50% for several days after transitioning to oral amiodarone. Evaluate continued need for antiarrhythmic.
Digoxin Increased digoxin concentration. Reduce digoxin by half or discontinue. If continued, monitor for evidence of toxicity.
HMG-CoA Reductase Inhibitors simvastatin, lovastatin, atorvastatin Increased plasma concentration of HMG-CoA reductase inhibitor. Limit the dose of lovastatin to 40 mg. Limit the coadministered dose of simvastatin to 20 mg.
Lower starting dose of other CYP3A4 substrates may be required. Warfarin Potentiates anticoagulant response and can result in serious or fatal bleeding. Coadministration increases prothrombin time by 100% after 3 to 4 days.
Reduce warfarin dose by one-third to one-half and monitor prothrombin times. Phenytoin Increased steady-state levels of phenytoin. Monitor phenytoin levels.
Hepatitis C Direct Acting Antiviral sofosbuvir Cases of symptomatic bradyarrhythmia requiring pacemaker insertion have been reported in patients on oral maintenance amiodarone who initiated therapy with sofosbuvir. CYP3A Substrate lidocaine Sinus bradycardia has been reported with oral amiodarone in combination with lidocaine given for local anesthesia. Monitor heart rate.
A lower starting dose of lidocaine may be required. CYP3A Substrate fentanyl Fentanyl in combination with amiodarone may cause hypotension, bradycardia, and decreased cardiac output. Avoid coadministration of amiodarone with other antiarrhythmics and drugs known to prolong the QT interval.
( 7 ) Amiodarone is a substrate for CYP3A and CYP2C8, so inhibitors and inducers affect amiodarone exposure. ( 7 ) Amiodarone inhibits P-glycoprotein and CYP1A2, CYP2C9, CYP2D6, and CYP3A, increasing exposure to other drugs. ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. ( 8.1 ) Lactation: Breastfeeding not recommended. ( 8.2 )
8.1Pregnancy Risk Summary Available data from post-marketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. Amiodarone and its metabolite, desethylamiodarone (DEA), cross the placenta. Untreated underlying arrhythmias, including ventricular arrhythmias, during pregnancy pose a risk to the mother and fetus (see Clinical Considerations ) .
In animal studies, administration of amiodarone to rabbits, rats, and mice during organogenesis resulted in embryo-fetal toxicity at doses less than the maximum recommended human maintenance dose (see Data ) . Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk 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 the occurrence of arrhythmia episodes may, therefore, increase during pregnancy due to the increased propensity to ectopic activity. Breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to the increased volume of distribution and increased drug metabolism inherent in the pregnant state.
Fetal/Neonatal adverse reactions 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 the 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 with Pacerone should be monitored continuously during labor and delivery [see Warnings and Precautions (5.4) ] .
Data Animal Data In pregnant rats and rabbits during the period of organogenesis, amiodarone hydrochloride in doses of 25 mg/kg/day (approximately 0.4 and 0.9 times, respectively, the maximum recommended human maintenance dose 600 mg in a 60 kg patient (doses compared on a body surface area basis) ) had no adverse effects on the fetus. In the rabbit, 75 mg/kg/day (approximately 2.7 times the maximum recommended human maintenance dose ) caused abortions in greater than 90% of the animals. In the rat, doses of 50 mg/kg/day or more were associated with slight displacement of the testes and an increased incidence of incomplete ossification of some skull and digital bones; at 100 mg/kg/day or more, fetal body weights were reduced; at 200 mg/kg/day, there was an increased incidence of fetal resorption.
(These doses in the rat are approximately 0.8, 1.6 and 3.2 times the maximum recomm…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from post-marketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. Amiodarone and its metabolite, desethylamiodarone (DEA), cross the placenta. Untreated underlying arrhythmias, including ventricular arrhythmias, during pregnancy pose a risk to the mother and fetus (see Clinical Considerations ) .
In animal studies, administration of amiodarone to rabbits, rats, and mice during organogenesis resulted in embryo-fetal toxicity at doses less than the maximum recommended human maintenance dose (see Data ) . Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk 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 the occurrence of arrhythmia episodes may, therefore, increase during pregnancy due to the increased propensity to ectopic activity. Breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to the increased volume of distribution and increased drug metabolism inherent in the pregnant state.
Fetal/Neonatal adverse reactions 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 the 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 with Pacerone should be monitored continuously during labor and delivery [see Warnings and Precautions (5.4) ] .
Data Animal Data In pregnant rats and rabbits during the period of organogenesis, amiodarone hydrochloride in doses of 25 mg/kg/day (approximately 0.4 and 0.9 times, respectively, the maximum recommended human maintenance dose 600 mg in a 60 kg patient (doses compared on a body surface area basis) ) had no adverse effects on the fetus. In the rabbit, 75 mg/kg/day (approximately 2.7 times the maximum recommended human maintenance dose ) caused abortions in greater than 90% of the animals. In the rat, doses of 50 mg/kg/day or more were associated with slight displacement of the testes and an increased incidence of incomplete ossification of some skull and digital bones; at 100 mg/kg/day or more, fetal body weights were reduced; at 200 mg/kg/day, there was an increased incidence of fetal resorption.
(These doses in the rat are approximately 0.8, 1.6 and 3.2 times the maximum recommended human maintenance dose ) Adverse effects on fetal growth and survival also were noted in one of two strains of mice…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of Pacerone in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Normal subjects over 65 years of age show lower clearances and increased drug half-life than younger subjects [see Clinical Pharmacology (12.3) ] . In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE There have been cases, some fatal, of amiodarone hydrochloride overdose. Monitor the patient's cardiac rhythm and blood pressure, and, if bradycardia ensues, a β-adrenergic agonist or a pacemaker may be used. Treat hypotension with inadequate tissue perfusion with positive inotropic and vasopressor agents. Neither Pacerone nor its metabolite is dialyzable.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Amiodarone is considered a class III antiarrhythmic drug, but it possesses electrophysiologic characteristics of all four Vaughan Williams classes. Like class I drugs, amiodarone blocks sodium channels at rapid pacing frequencies, and like class II drugs, amiodarone exerts a noncompetitive antisympathetic action. One of its main effects, with prolonged administration, is to lengthen the cardiac action potential, a class III effect.
The negative chronotropic effect of amiodarone in nodal tissues is similar to the effect of class IV drugs. In addition to blocking sodium channels, amiodarone blocks myocardial potassium channels, which contributes to slowing of conduction and prolongation of refractoriness. The antisympathetic action and the block of calcium and potassium channels are responsible for the negative dromotropic effects on the sinus node and for the slowing of conduction and prolongation of refractoriness in the atrioventricular (AV) node.
Its vasodilatory action can decrease cardiac workload and consequently myocardial oxygen consumption. Pacerone prolongs the duration of the action potential of all cardiac fibers while causing minimal reduction of dV/dt (maximal upstroke velocity of the action potential). The refractory period is prolonged in all cardiac tissues.
Amiodarone hydrochloride increases the cardiac refractory period without influencing resting membrane potential, except in automatic cells where the slope of the prepotential is reduced, generally reducing automaticity. These electrophysiologic effects are reflected in a decreased sinus rate of 15% to 20%, increased PR and QT intervals of about 10%, the development of U-waves, and changes in T-wave contour. These changes should not require discontinuation of Pacerone as they are evidence of its pharmacological action, although Pacerone can cause marked sinus bradycardia or sinus arrest and heart block [see Warnings and Precautions (5.4) ] .
Hemodynamics In animal studies and after intravenous administration in man, amiodarone hydrochloride relaxes vascular smooth muscle, reduces peripheral vascular resistance (afterload), and slightly increases cardiac index. After oral dosing, however, amiodarone hydrochloride produces no significant change in left ventricular ejection fraction (LVEF), even in patients with depressed LVEF. After acute intravenous dosing in man, amiodarone hydrochloride may have a mild negative inotropic effect.
12.2Pharmacodynamics There is no well-established relationship between plasma concentration and effectiveness, but it does appear that concentrations much below 1 mg/L are often ineffective and that levels above 2.5 mg/L are generally not needed. Plasma-concentration measurements can be used to identify patients whose levels are unusually low, and who might benefit from a dose increase, or unusually high, and who might have dosage reduction in the hope of minimizing side effects. Effects on abnormal rhythms are not seen before 2 to 3 days and usually require 1 to 3 weeks, even when a loading dose is used.
There may be a continued increase in effect for longer periods still. There is evidence that the time to effect is shorter when a loading-dose regimen is used. Consistent with the slow rate of elimination, antiarrhythmic effects persist for weeks or months after amiodarone hydrochloride is discontinued, but the time of recurrence is variable and unpredictable.
In general, when the drug is resumed after recurrence of the arrhythmia, control is established relatively rapidly compared to the initial response, presumably because tissue stores were not wholly depleted.
12.3Pharmacokinetics Absorption Following oral administration in humans, amiodarone hydrochloride is slowly and variably absorbed. The bioavailability of amiodarone hydrochloride is approximately 50%. Maximum plasma concentrations are attained 3 to 7 hours after a single dose. Plasma concentrations with chronic dosing at…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Amiodarone is considered a class III antiarrhythmic drug, but it possesses electrophysiologic characteristics of all four Vaughan Williams classes. Like class I drugs, amiodarone blocks sodium channels at rapid pacing frequencies, and like class II drugs, amiodarone exerts a noncompetitive antisympathetic action. One of its main effects, with prolonged administration, is to lengthen the cardiac action potential, a class III effect.
The negative chronotropic effect of amiodarone in nodal tissues is similar to the effect of class IV drugs. In addition to blocking sodium channels, amiodarone blocks myocardial potassium channels, which contributes to slowing of conduction and prolongation of refractoriness. The antisympathetic action and the block of calcium and potassium channels are responsible for the negative dromotropic effects on the sinus node and for the slowing of conduction and prolongation of refractoriness in the atrioventricular (AV) node.
Its vasodilatory action can decrease cardiac workload and consequently myocardial oxygen consumption. Pacerone prolongs the duration of the action potential of all cardiac fibers while causing minimal reduction of dV/dt (maximal upstroke velocity of the action potential). The refractory period is prolonged in all cardiac tissues.
Amiodarone hydrochloride increases the cardiac refractory period without influencing resting membrane potential, except in automatic cells where the slope of the prepotential is reduced, generally reducing automaticity. These electrophysiologic effects are reflected in a decreased sinus rate of 15% to 20%, increased PR and QT intervals of about 10%, the development of U-waves, and changes in T-wave contour. These changes should not require discontinuation of Pacerone as they are evidence of its pharmacological action, although Pacerone can cause marked sinus bradycardia or sinus arrest and heart block [see Warnings and Precautions (5.4) ] .
Hemodynamics In animal studies and after intravenous administration in man, amiodarone hydrochloride relaxes vascular smooth muscle, reduces peripheral vascular resistance (afterload), and slightly increases cardiac index. After oral dosing, however, amiodarone hydrochloride produces no significant change in left ventricular ejection fraction (LVEF), even in patients with depressed LVEF. After acute intravenous dosing in man, amiodarone hydrochloride may have a mild negative inotropic effect.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Pacerone ® (amiodarone hydrochloride tablets, USP) 100 mg are peach, round, flat-faced, uncoated tablets, debossed with "P" on one side, and "U-S" above "144" on the other side. They are supplied as follows: Bottles of 30 with child-resistant closure, NDC 0245-0144-30 Bottles of 100 with child-resistant closure, NDC 0245-0144-11 Unit-dose cartons of 100 tablets, NDC 0245-0144-01 Pacerone ® (amiodarone hydrochloride tablets, USP) 200 mg, are pink, round, flat-faced, scored, uncoated tablets, debossed with "P 200 " on the unscored side, and "U-S" above and "0147" below the score on the reverse side.
They are supplied as follows: Bottles of 60 with child-resistant closure, NDC 0245-0147-60 Bottles of 90 with child-resistant closure, NDC 0245-0147-90 Bottles of 500 tablets, NDC 0245-0147-15 Unit-dose cartons of 100 tablets, NDC 0245-0147-01 Pacerone ® (amiodarone hydrochloride tablets, USP) 400 mg, are white to off-white, round, uncoated, scored tablets, debossed with "U-S" above and "1645" below the score on one side and "P 400 " on the unscored side. They are supplied as follows: Bottles of 30 with child-resistant closure, NDC 0245-1645-30 Unit-dose cartons of 100 tablets, NDC 0245-1645-01 Keep tightly closed.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container with a child-resistant closure.
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container with a child-resistant closure.
📋 Description ▾
11 DESCRIPTION Pacerone (amiodarone hydrochloride tablets, USP) are an antiarrhythmic drug, available for oral administration as 100 mg; peach tablets, 200 mg; pink tablets and 400 mg; white tablets containing amiodarone hydrochloride, USP. All three strengths of Pacerone tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, povidone, pregelatinized corn starch, sodium starch glycolate and stearic acid. The 200 mg tablets also contain FD&C Red No.
40 and FD&C Yellow No. 6. The 100 mg tablets also contain FD&C Yellow No.
6. Amiodarone hydrochloride, USP is a benzofuran derivative: 2-butyl-3-benzofuranyl 4-[2-(diethylamino)-ethoxy]-3,5-diiodophenyl ketone hydrochloride. The structural formula is as follows: C 25 H 29 I 2 NO 3 ∙ HCl Molecular Weight: 681.8 C 25 H 29 I 2 NO 3 ∙ HCl Molecular Weight: 681.8 Amiodarone hydrochloride, USP is a white to cream-colored crystalline powder.
It is slightly soluble in water, soluble in alcohol, and freely soluble in chloroform. It contains 37.3% iodine by weight. Meets USP Dissolution Test 4.
Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1) ] .
Advise women that breastfeeding is not recommended during treatment with Pacerone [see Use in Specific Populations (8.2) ] . Advise patients to avoid grapefruit juice and St. John's Wort.
Advise patients to seek medical attention if they experience the signs and symptoms of pulmonary toxicity, worsening arrhythmia, bradycardia, visual impairment, or hypo- and hyperthyroidism. This product's label may have been updated. For full prescribing information, please visit www.upsher-smith.com.
💬 Medication Guide ▾
MEDICATION GUIDE Pacerone ® (PĀS-ər-ōn) Tablets (Amiodarone Hydrochloride) What is the most important information I should know about Pacerone tablets? Pacerone tablets can cause serious side effects that can lead to death, including: lung problems liver problems worsening of heartbeat problems Call your healthcare provider or get medical help right away if you have any of the following symptoms during treatment with Pacerone tablets: trouble breathing, wheezing, shortness of breath, coughing chest pain, spitting up of blood, or fever nausea or vomiting, brown or dark-colored urine, feel more tired than usual, yellowing of your skin or the whites of your eyes (jaundice), or right upper stomach-area pain heart pounding, skipping a beat, beating fast or slowly, feel light-headed, or if you faint vision problems, including blurred vision, see halos, or your eyes become sensitive to light.
You should have regular eye exams before and during treatment with Pacerone tablets. Pacerone tablets should be started in a hospital so that your medical condition can be carefully monitored. Pacerone tablets should only be used to treat people who have been diagnosed with life-threatening heartbeat problems called ventricular arrhythmias, when other treatments did not work or you cannot tolerate them.
Pacerone tablets can cause other serious side effects. See " What are the possible side effects of Pacerone tablets? " If you get serious side effects during treatment you may need to stop Pacerone tablets, have your dose changed, or get medical treatment. Talk with your healthcare provider before you stop taking Pacerone tablets.
You may still have side effects after stopping Pacerone tablets because the medicine stays in your body for months after treatment is stopped. You should have regular check-ups, blood tests, chest x-rays before and during treatment with Pacerone tablets to check for serious side effects. You should also have lung function tests before starting treatment with Pacerone tablets.
What are Pacerone tablets? Pacerone tablets are a prescription medicine used to treat people who have been diagnosed with life-threatening heartbeat problems called ventricular arrhythmias, when other treatments did not work or you cannot tolerate them. It is not known if Pacerone tablets are safe and effective in children.
Who should not take Pacerone tablets? Do not take Pacerone tablets if you: have a serious heart problem called cardiogenic shock have certain types of the heart condition called heart block, with or without a slow heart rate have a slow heart rate with dizziness or lightheadedness, and you do not have an implanted pacemaker are allergic to amiodarone, iodine, or any of the other ingredients in Pacerone tablets. See the end of this Medication Guide for a complete list of ingredients in Pacerone tablets.
Before taking Pacerone tablets, tell your healthcare provider about all of your medical conditions, including if you: have lung or breathing problems have liver problems have or had thyroid problems have a slow heart rate or blood pressure problems have diarrhea or have had diarrhea for a long period of time have been told that you have low levels of potassium, magnesium, or calcium in your blood have an implanted pacemaker or defibrillator if you plan to have surgery with general anesthesia are pregnant or plan to become pregnant.
Pacerone tablets may harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with Pacerone tablets. Pacerone can stay in your body for months after treatment is stopped. are breastfeeding or plan to breastfeed.
Pacerone can pass into your breast milk and may harm your baby. You should not breast feed while taking Pacerone tablets. Pacerone can stay in your body for months after treatment is stopped.
Talk to your healthcare provider about the best way to feed your baby during this time. Tell your healthcare provider about all the medicines you take includin…