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Amiodarone Hydrochloride 200 mg Tablet, 100-count — NDC 0904-6993-61 (Billing 00904-6993-61)

by Major Pharmaceuticals · 100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK

This is a package of 100 tablets of Amiodarone Hydrochloride 200 mg Tablet from Major Pharmaceuticals, marketed since Mar 2001 and currently FDA-listed, this package's marketing is listed to end Jan 2027; retail pharmacies pay about $0.1218 per tablet (NADAC). It is this product's only package size.

NDC 00904-6993-61
🏷️ FDA NDC (as labeled) 0904-6993-61 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0904-6993-61 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0904 labeler · 6993 product · 61 package
Package marketed since
Apr 20, 2020
Package marketing ended
Jan 31, 2027
Sample package
No — commercial package
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 0904699361 2
Medicaid fills, this package
43 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Amiodarone Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0814-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0904-6993-61
Product NDC 0904-6993
11-digit billing NDC 00904699361
NCPDP billing unit EA — each (per item)
RxCUI 833528
UNII 976728SY6Z
Application # ANDA075424
SPL Set ID 352ed423-fc16-47bb-8e25-98e1c20f9991
Established class (EPC) Antiarrhythmic
Mechanism of action Cytochrome P450 1A2 Inhibitors; Cytochrome P450 2C9 Inhibitors; Cytochrome P450 2D6 Inhibitors; Cytochrome P450 3A Inhibitors; P-Glycoprotein Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2001-03-30
Marketing end 2027-01-31
Route ORAL
Dosage form TABLET
Substance AMIODARONE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 35400005000305
GPI class Amiodarone HCl
GCN Seq No 000266
GCN 10920
HICL code 000083
Ingredient (HICL) Amiodarone Hcl
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A2
Therapeutic class — intermediate (HIC2) Cardiac Depressants
HIC3 code A2A
Therapeutic class — specific (HIC3) Antiarrhythmics
AHFS code 24:04.04.20
AHFS class Class Iii Antiarrhythmics
FDB label name AMIODARONE HCL 200 MG TABLET
FDB brand name Amiodarone Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 000266
  • GCN: 10920
  • GPI-14 (Medi-Span): 35400005000305
  • HICL (First Databank): 000083
  • AHFS class code: 24:04.04.20
  • RxCUI (RxNorm): 833528
Why two NDCs? The FDA registers this code as 0904-6993-61 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00904-6993-61. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Antiarrhythmic class.

Pharmacologic class Antiarrhythmic
Drug family (ATC) Antiarrhythmics, class III
How it works Cytochrome P450 2D6 Inhibitors, Cytochrome P450 1A2 Inhibitors, P-Glycoprotein Inhibitors, Cytochrome P450 2C9 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name AMIODARONE HCL 200 MG TABLET Ingredient Amiodarone Hcl
📗 Our plain-language guide HelloPharmacist
  • It treats life-threatening ventricular rhythm problems, specifically ventricular fibrillation and unstable ventricular tachycardia. It is usually used when other heart rhythm medic...
  • Take them the same way with respect to meals each day. Your prescriber may start you on a higher loading amount and then lower it. If the daily total is high or your stomach is ups...
  • Call right away for a new cough, shortness of breath, fever, yellow skin or eyes, dark urine, fainting, a very slow or irregular heartbeat, or vision changes. These can signal lung...
  • No, avoid it. Grapefruit juice raises amiodarone levels in your body. Also check with me before starting any new medicine, since amiodarone interacts with many, including warfarin,...
📖 Read our full Amiodarone guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.122 $12.18 / 100 tablet
Medicaid paysCMS SDUD · 12 mo $1.76 $176.23 / 100 tablet
Medicare drug plans payPart D · Q2 2026 $0.2277 $22.77 / 100 tablet
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.135 $0.107
▼ Down 7% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00904-6993-61 You're viewing this Main listing 100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK 2020-04-20 Jan 31, 2027 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Amiodarone Hydrochloride 200 mgthis 00904-6993-61 Major 100 tablets $0.122 AB Availability likely —
Amiodarone Hydrochloride 200 mg 00904-7576-61 Major 100 tablets $0.122 AB Availability likely —
Amiodarone Hydrochloride 200 mg 29300-0359-05 Unichem 500 tablets $0.122 AB Availability likely —
Amiodarone Hydrochloride 200 mg 60687-0437-01 American 100 tablets $0.122 AB Availability likely —
Amiodarone Hydrochloride 200 mg 62135-0577-60 Chartwell 60 tablets $0.122 AB Availability likely —
amiodarone hydrochloride 200 mg 68382-0227-05 Zydus 500 tablets $0.122 AB Availability likely —
Amiodarone Hydrochloride 200 mg 72888-0039-05 Advagen 500 tablets $0.122 AB Availability likely —
Amiodarone Hydrochloride 200 mg 75907-0006-60 Dr. 60 tablets $0.122 AB Availability likely —
Pacerone 200 mg 00245-0147-01 Upsher-Smith 100 tablets $0.125 AB Availability likely +3%
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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2001
On the market since
Mar 2001
📍
2026
Currently FDA-listed
25 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

🧪 Avoiding an ingredient? See Amiodarone inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMajor Pharmaceuticals
Application holderTARO PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA075424 (ANDA)
Labeler code00904
First marketedMar 2001
Product typeHuman Prescription Drug
Portfolio630 products on file

More NDCs from Major Pharmaceuticals labeler code 00904

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: PULMONARY, HEPATIC and CARDIAC TOXICITY Amiodarone hydrochloride is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity [see Indications and Usage (1) ] . Amiodarone hydrochloride 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 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 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 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'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 68 words ▾

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

( 1 )

⏱️ Dosage and Administration 198 words ▾

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 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 ) 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.

💊 Dosage Forms and Strengths 131 words ▾

3 DOSAGE FORMS AND STRENGTHS 100 mg tablets: round, flat, beveled edge, white tablets; one side plain, the second side engraved with "TARO" at the top and "55" below. 200 mg tablets: round, flat, beveled edge, light orange tablets; one side plain, the second side scored and engraved with "TARO" above the score and "56" below the score line. 300 mg tablets: round, flat, beveled edge, peach tablets; one side plain, the second side scored and engraved with "TARO" above the score and "58" below the score line.

400 mg tablets: round, flat, beveled edge, light yellow tablets; one side plain, the second side scored and engraved with "TARO" above the score and "59" below the score line. Tablets, 100 mg, 200 mg, 300 mg and 400 mg. ( 3 )

⛔ Contraindications 78 words ▾

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 are 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 ~2 min read ▾

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 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 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 amiodarone hydrochloride 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 Reactions (6.1) ] .

Corneal… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

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 Taro Pharmaceuticals U.S.A., Inc. at 1-866-923-4914 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 tablets, 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.

6.2Postmarketing 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… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

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 ~3 min read ▾

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% 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 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 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.… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

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% 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 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 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… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 18 words ▾

8.4Pediatric Use The safety and effectiveness of amiodarone hydrochloride tablets in pediatric patients have not been established.

🧓 Geriatric Use 66 words ▾

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 53 words ▾

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 amiodarone hydrochloride nor its metabolite is dialyzable.

🧬 Clinical Pharmacology ~3 min read ▾

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 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 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 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 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 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… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action ~2 min read ▾

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 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 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 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 tablets may have a mild negative inotropic effect.

📦 How Supplied / Storage and Handling 109 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Amiodarone Hydrochloride Tablets USP, 200 mg are round, flat, beveled edge, light orange tablets; one side plain, the second side scored and engraved with "TARO" above the score and "56" below the score line and are available as follows: Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6993-61 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Keep tightly closed.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a light-resistant, tight container.

📦 Storage and Handling 25 words ▾

Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a light-resistant, tight container.

📋 Description 163 words ▾

11 DESCRIPTION Amiodarone Hydrochloride Tablets, USP is an antiarrhythmic drug, available for oral administration as white tablets containing 100 mg of amiodarone hydrochloride, light orange, scored tablets containing 200 mg of amiodarone hydrochloride, peach, scored tablets containing 300 mg of amiodarone hydrochloride, and light yellow, scored tablets containing 400 mg of amiodarone hydrochloride. The inactive ingredients present are colloidal silicon dioxide, corn starch, D&C yellow No. 10 lake (200 and 400 mg only), FD&C yellow No.

6 lake (200 and 300 mg only), lactose anhydrous, magnesium stearate and povidone. Amiodarone is a benzofuran derivative: 2-butyl-3-benzofuranyl 4-[2-(diethylamino)-ethoxy]-3,5-diiodophenyl ketone hydrochloride. The structural formula is as follows: Amiodarone hydrochloride 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. Amiodarone Hydrochloride Tablets USP, 100 mg and 200 mg meet USP Dissolution Test 3.

Amiodarone Hydrochloride Tablets USP, 300 mg and 400 mg meet USP Dissolution Test 4. Chemical Structure

💬 Information for Patients 102 words ▾

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.

💬 Medication Guide ~3 min read ▾

Dispense with Medication Guide available at: https://www.taro.com/usa-medication-guides MEDICATION GUIDE Amiodarone Hydrochloride (A-mee-OH-da-rone HYE-droe-KLOR-ide) Tablets, USP 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 are amiodarone hydrochloride tablets? Amiodarone hydrochloride 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 amiodarone hydrochloride tablets are 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 defibrillator • if you plan to have surgery with general anesthesia • are pregnant or plan to become pregnant.

Amiodarone hydrochloride may harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatm… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

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 100 to 600 mg/day are approximately dose proportional, with a mean 0.5 mg/L increase for each 100 mg/day. These means, however, include considerable individual variability. Food increases the rate and extent of absorption of amiodarone hydrochloride.

The effects of food upon the bioavailability of amiodarone hydrochloride have been studied in 30 healthy subjects who received a single 600-mg dose immediately after consuming a high-fat meal and following an overnight fast. The area under the plasma concentration-time curve (AUC) and the peak plasma concentration (C max ) of amiodarone hydrochloride increased by 2.3 (range 1.7 to 3.6) and 3.8 (range 2.7 to 4.4) times, respectively, in the presence of food. Food also increased the rate of absorption of amiodarone hydrochloride, decreasing the time to peak plasma concentration (T max ) by 37%.

The mean AUC and mean C max of the major metabolite of amiodarone, DEA increased by 55% (range 58 to 101%) and 32% (range 4 to 84%), respectively, but there was no change in the T max in the presence of food. Distribution Amiodarone hydrochloride is highly protein-bound (approximately 96%). Amiodarone hydrochloride has a very large but variable volume of distribution, averaging about 60 L/kg, because of extensive accumulation in various sites, especially adipose tissue and highly perfused organs, such as the liver, lung, and spleen.

One major metabolite of amiodarone hydrochloride, DEA, has been identified in man; it accumulates to an even greater extent in almost all tissues. No data are available on the activity of DEA in humans, but in animals, it has significant electrophysiologic and antiarrhythmic effects generally similar to amiodarone itself. DEA's precise role and contribution to the antiarrhythmic activity of oral amiodarone are not certain.

The development of maximal ventricular class III effects after oral amiodarone hydrochloride administration in humans correlates more closely with DEA accumulation over time than with amiodarone accumulation. Elimination Following single dose administration in 12 healthy subjects, amiodarone hydrochloride exhibited multi-compartmental pharmacokinetics with a mean apparent plasma terminal elimination half-life of 58 days (range 15 to 142 days) for amiodarone and 36 days (range 14 to 75 days) for the active metabolite (DEA).

In patients, following discontinuation of chronic oral therapy, amiodarone hydrochloride has been shown to have a biphasic elimination with an initial 50% reduction of plasma levels after 2.5 to 10 days. A much slower terminal plasma-elimination phase shows a half-life of the parent compound ranging from 26 to 107 days, with a mean of approximately 53 days and most patients in the 40- to 55-day range. In the absence of a loading-dose period, steady-state plasma concentrations, at constant oral dosing, would therefore be reached between 130 and 535 days, with an average of 265 days.

For the metabolite, the mean plasma-elimination half-life was approximately 61 days. These data probably reflect an initial elimination of drug from well-perfused tissue (the 2.5- to 10-day half-life phase), followed by a terminal phase representing extremely slow elimination from poorly perfused tissue compartments such as fat. The considerable inter-subject variation in both phases of elimination, as well as uncertainty as to what compartment is critical to drug effect, requires attention to individual responses once arrhythmia control is achieved with loading doses because the correct maintenance dose is determined, in part, by the elimination rates.

Individualize maintenance doses of amiodarone hydrochloride [see Dosage and Adm… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 184 words ▾

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.

🧪 Nonclinical Toxicology 128 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Amiodarone hydrochloride was associated with a statistically significant, dose-related increase in the incidence of thyroid tumors (follicular adenoma and/or carcinoma) in rats. The incidence of thyroid tumors was greater than control at the lowest dose level tested, i.e., 5 mg/kg/day (approximately 0.08 times the maximum recommended human maintenance dose 600 mg in a 60 kg patient (dose compared on a body surface area basis) ). Mutagenicity studies (Ames, micronucleus, and lysogenic tests) with amiodarone hydrochloride tablets were negative.

In a study in which amiodarone hydrochloride was administered to male and female rats, beginning 9 weeks prior to mating, reduced fertility was observed at a dose level of 90 mg/kg/day (approximately 1.4 times the maximum recommended human maintenance dose ).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 125 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Amiodarone hydrochloride was associated with a statistically significant, dose-related increase in the incidence of thyroid tumors (follicular adenoma and/or carcinoma) in rats. The incidence of thyroid tumors was greater than control at the lowest dose level tested, i.e., 5 mg/kg/day (approximately 0.08 times the maximum recommended human maintenance dose 600 mg in a 60 kg patient (dose compared on a body surface area basis) ). Mutagenicity studies (Ames, micronucleus, and lysogenic tests) with amiodarone hydrochloride tablets were negative.

In a study in which amiodarone hydrochloride was administered to male and female rats, beginning 9 weeks prior to mating, reduced fertility was observed at a dose level of 90 mg/kg/day (approximately 1.4 times the maximum recommended human maintenance dose ).

📄 Package Label / Principal Display Panel 29 words ▾

Package/Label Display Panel MAJOR® NDC 0904-6993-61 Unit Dose Amiodarone HCl Tablets USP 200 mg Pharmacist: Dispense with Medication Guide 100 TABLETS (10 x 10) Rx only 200mg carton label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
43
Units reimbursed last 4 qtrs
47
Gross reimbursed last 4 qtrs
$82.83
Avg / prescription
$1.93
Avg / unit
$1.7623
Latest quarter Q1 2026
0Rx
Medicaid pays / ea
$1.7623
gross reimbursed
vs
NADAC / ea
$0.1218
acquisition cost
=
Spread
+$1.6405
+1347% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 43 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 47 units · 1.0 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.01.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 1.0 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
← 00904-6992-61 · Major 00904-6994-46 · Major →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.