Amiodarone Hydrochloride 400 mg Tablet, 30-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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🧪 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.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 68401960MK
Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
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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 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 ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
5 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 | $0.394 | $11.81 / 30 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.8042 | $24.13 / 30 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.8784 | $26.35 / 30 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Amiodarone Hydrochloride 400 mg 62135-0578-30 | Chartwell | 30 tablets | $0.394 | AB | Availability likely | — |
| amiodarone hydrochloride 400 mg 68382-0298-06 | Zydus | 30 tablets | $0.394 | AB | Availability likely | — |
| Amiodarone Hydrochloride 400 mgthis 72888-0061-30 | Advagen | 30 tablets | $0.394 | AB | Availability likely | — |
| Pacerone 400 mg 00245-1645-01 | Upsher-Smith | 100 tablets | $0.719 | AB | Availability likely | +83% |
| Amiodarone Hydrochloride 400 mg 51672-4057-00 | Sun | 100 tablets | — | — | FDA listed | — |
| Amiodarone hydrochloride 400 mg 65841-0841-06 | Zydus | 30 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72888-0061-30 You're viewing this | 30 TABLET in 1 BOTTLE (72888-061-30) | 2020-08-21 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: PULMONARY, HEPATIC and CARDIAC TOXICITY Amiodarone Hydrochloride Tablets 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 Tablets 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 Tablets therapy is initiated. Repeat history, physical exam, and chest X-ray every 3 to 6 months [see Warnings and Precautions 5.2) ]. Amiodarone Hydrochloride Tablets 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 Tablets if the patient experiences signs or symptoms of clinical liver injury [see Warnings and Precautions (5.3) ]. Amiodarone Hydrochloride Tablets can exacerbate arrhythmias.
Initiate Amiodarone Hydrochloride Tablets 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 Tablets 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 ) Amiodarone Hydrochloride Tablet’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 Amiodarone Hydrochloride Tablets 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. Amiodarone Hydrochloride Tablets 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 Recommended Dosage: Initiate treatment with a loading doses 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 Amiodarone Hydrochloride Tablets dose to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day. Administration: Administer Amiodarone Hydrochloride Tablets consistently with regard to meals [see Clinical Pharmacology (12.3) ] .
Administration of Amiodarone Hydrochloride Tablets in divided doses with meals is suggested for total daily doses of 1000 mg or higher, or when gastrointestinal intolerance occurs. Initiate treatment with a loading doses 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 Amiodarone Hydrochloride Tablets dose to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day.
( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 100 mg tablets: Mottled pink, round, flat-faced, bevelled-edge tablets, engraved “^ 53” on one side and plain on other side. 200 mg tablets: Mottled pink, round, flat-faced, bevelled-edge tablets, engraved ‘^’ over score and ‘54’ below score on one side and plain on other side 400 mg tablets: Mottled pink, round, flat-faced bevelled-edge tablets, engraved “^” over score and “055” below score on one side and plain on the other side. Tablets, 100 mg, 200 mg, 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.
Amiodarone Hydrochloride Tablets 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 Amiodarone Hydrochloride Tablets 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 Tablets 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 Amiodarone Hydrochloride Tablets 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 Tablets 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 Amiodarone Hydrochloride Tablets 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 Amiodarone Hydrochloride Tablets, obtain follow-up tests and treat appropriately.
5.4Worsened Arrhythmia Amiodarone Hydrochloride Tablets 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 Tablets, 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 Amiodarone Hydrochloride Tablets and promptly refer for ophthalmic examination. Regular ophthalmic examination, including funduscopy and slit-lamp examination, is recommended during administration of Amiodarone Hydrochloride Tablets [see Adverse Re…
🤒 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 Hydrochloride Tablets include pulmonary toxicity, paroxysmal ventricular tachycardia, congestive heart failure, and elevation of liver enzymes.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd. at 866-488-0312 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 Tablets 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 Tablets, the adverse reactions most frequently requiring discontinuation of Amiodarone Hydrochloride Tablets 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.
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of Amiodarone Hydrochloride Tablets. 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, b…
🔄 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 postmarketing 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%-4% and 15%-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 Amiodarone Hydrochloride Tablets 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 HCl in doses of 25 mg/kg/day (approximately 0.4 and 0.9 times, respectively, the maximum recommended human maintenance dose*) 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…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from postmarketing 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%-4% and 15%-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 Amiodarone Hydrochloride Tablets 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 HCl in doses of 25 mg/kg/day (approximately 0.4 and 0.9 times, respectively, the maximum recommended human maintenance dose*) 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 at a dose of 5 mg/kg/day (approximately 0.04 times the maximum rec…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of Amiodarone Hydrochloride Tablets 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 Tablets 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 Amiodarone Hydrochloride Tablets 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. Amiodarone Hydrochloride Tablets 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 Tablets 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 Amiodarone Hydrochloride Tablets as they are evidence of its pharmacological action, although Amiodarone Hydrochloride Tablets 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 Tablets relaxes vascular smooth muscle, reduces peripheral vascular resistance (afterload), and slightly increases cardiac index. After oral dosing, however, Amiodarone Hydrochloride Tablets produces no significant change in left ventricular ejection fraction (LVEF), even in patients with depressed LVEF. After acute intravenous dosing in man, Amiodarone Hydrochloride Tablets 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 Tablets 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 Tablets is slowly and variably absorbed. The bioavailability of Amiodarone Hydrochloride Tablets is approximately…
🧬 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. Amiodarone Hydrochloride Tablets 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 Tablets 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 Amiodarone Hydrochloride Tablets as they are evidence of its pharmacological action, although Amiodarone Hydrochloride Tablets 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 Tablets relaxes vascular smooth muscle, reduces peripheral vascular resistance (afterload), and slightly increases cardiac index. After oral dosing, however, Amiodarone Hydrochloride Tablets produces no significant change in left ventricular ejection fraction (LVEF), even in patients with depressed LVEF. After acute intravenous dosing in man, Amiodarone Hydrochloride Tablets may have a mild negative inotropic effect.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Amiodarone Hydrochloride Tablets are available in three strengths as follows: 100 mg, Mottled pink, round, flat-faced, bevelled-edge tablets, engraved “^ 53” on one side and plain on other side. Bottles of 30 (NDC 72888-060-30) 200 mg, Mottled pink, round, flat-faced, bevelled-edge tablets, engraved ‘^’ over score and ‘54’ below score on one side and plain on other side Bottles of 60 (NDC 72888-039-60) Bottles of 500 (NDC 72888-039-05) Carton of 100 (10 x 10) Unit dose blisters (NDC 72888-039-09) 400 mg, Mottled pink, round, flat-faced bevelled-edge tablets, engraved “^” over score and “055” below score on one side and plain on the other side.
Bottles of 30 (NDC 72888-061-30) Store at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container [See USP].
📋 Description ▾
11 DESCRIPTION Amiodarone Hydrochloride Tablets (amiodarone HCl) is an antiarrhythmic drug, available for oral administration as mottled pink, round, flat faced bevelled edge tablets containing 100 mg, 200 mg and 400 mg of amiodarone hydrochloride. The inactive ingredients present are colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C Red #40 Al Lake and magnesium stearate. Amiodarone Hydrochloride Tablets 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 Amiodarone HCl 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.
The Product meets USP Dissolution Test 2. 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 Amiodarone Hydrochloride Tablets [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. Manufactured by Manufactured for Rubicon Research Limited Advagen Pharma Ltd Thane 421506, India East Windsor, NJ 08520, USA
💬 Medication Guide ▾
MEDICATION GUIDE Amiodarone Hydrochloride Tablets (A-mee-OH-da-rone) What is the most important information I should know about Amiodarone Hydrochloride Tablets? Amiodarone Hydrochloride 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 Amiodarone Hydrochloride 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 Amiodarone Hydrochloride Tablets. Amiodarone Hydrochloride Tablets should be started in a hospital so that your medical condition can be carefully monitored. Amiodarone Hydrochloride 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.
Amiodarone Hydrochloride Tablets can cause other serious side effects. See “What are the possible side effects of Amiodarone Hydrochloride Tablets?” If you get serious side effects during treatment you may need to stop Amiodarone Hydrochloride Tablets, have your dose changed, or get medical treatment. Talk with your healthcare provider before you stop taking Amiodarone Hydrochloride Tablets.
You may still have side effects after stopping Amiodarone Hydrochloride 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 Amiodarone Hydrochloride Tablets to check for serious side effects. You should also have lung function tests before starting treatment with Amiodarone Hydrochloride Tablets.
What is Amiodarone Hydrochloride Tablets? Amiodarone Hydrochloride Tablets is 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 Amiodarone Hydrochloride Tablets is safe and effective in children.
Who should not take Amiodarone Hydrochloride Tablets? Do not take Amiodarone Hydrochloride 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 Amiodarone Hydrochloride Tablets. See the end of this Medication Guide for a complete list of ingredients in Amiodarone Hydrochloride Tablets.
Before taking Amiodarone Hydrochloride 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 defribrillator if you plan to have surgery with general anesthesia are pregnant or plan to become pregnant.
Amiodarone Hydrochloride Tablets may harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with Amiodarone Hydrochloride Tablets. Amiodarone Hydrochloride Tablets can stay in your body for months after treatment is stopped. are breast…