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Drug ReportsAmiodarone
Amiodarone
Amiodarone, Nexterone, Pacerone (amiodarone) is a small molecule pharmaceutical. Amiodarone was first approved as Cordarone on 1985-12-24. It is used to treat cardiac arrhythmias, supraventricular tachycardia, and ventricular fibrillation in the USA. It is known to target muscarinic acetylcholine receptor M5, potassium voltage-gated channel subfamily A member 7, and sodium channel protein type 5 subunit alpha.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Nexterone (generic drugs available since 1998-04-30, discontinued: Cordarone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amiodarone hydrochloride
Tradename
Company
Number
Date
Products
NEXTERONEBaxterN-022325 RX2010-11-16
2 products, RLD, RS
Show 4 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
amiodarone hciANDA2022-12-10
amiodarone hclANDA2023-03-02
amiodarone hydrochlorideANDA2024-01-28
nexteroneNew Drug Application2021-09-07
nexterone (amiodarone hci)New Drug Application2020-02-23
paceroneANDA2024-02-02
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Amiodarone Hydrochloride, Nexterone, Baxter Hlthcare
76357732029-03-13DP
ATC Codes
C: Cardiovascular system drugs
— C01: Cardiac therapy drugs
— C01B: Antiarrhythmics, class i and iii
— C01BD: Antiarrhythmics, class iii
— C01BD01: Amiodarone
HCPCS
Code
Description
J0282
Injection, amiodarone hydrochloride, 30 mg
Clinical
Clinical Trials
174 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atrial fibrillationD001281EFO_0000275I48.017263634102
Ventricular tachycardiaD017180—I47.2—149721
Cardiac arrhythmiasD001145EFO_0004269I49.9—143715
Heart failureD006333HP_0001635I50——2338
Atrial flutterD001282EFO_0003911——22317
Ventricular fibrillationD014693HP_0001663I49.01——3115
CardiomyopathiesD009202EFO_0000318I42——1214
Septic shockD012772—A48.3——1214
Coronary artery diseaseD003324—I25.11—21—4
SepsisD018805HP_0100806A41.9——12—3
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart diseasesD006331EFO_0003777I51.9——5—27
Cardiovascular diseasesD002318HP_0001626———4—26
Heart arrestD006323EFO_0009492I46—13—15
Chagas cardiomyopathyD002598EFO_0005529———1—23
Sudden death cardiacD016757EFO_0004278———2—13
Covid-19D000086382—U07.1—11—12
Ebola hemorrhagic feverD019142EFO_0007243A98.4—11——1
Catheter ablationD017115————1——1
Implantable defibrillatorsD017147EFO_0010674———1——1
Hypertrophic cardiomyopathyD002312EFO_0000538I42.1——1——1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Out-of-hospital cardiac arrestD058687———1——23
Supraventricular tachycardiaD013617HP_0004755I47.1—1——23
Immunoglobulin light-chain amyloidosisD000075363———1———1
Blood pressureD001794EFO_0004325——1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10————22
Chronic renal insufficiencyD051436—N18————22
HyperuricemiaD033461HP_0002149—————22
PhlebitisD010689EFO_1001395I80————22
HemorrhageD006470MP_0001914R58————11
MenorrhagiaD008595EFO_0003945N92.0————11
Hemophilia aD006467EFO_0007267D66————11
PainD010146EFO_0003843R52————11
Down syndromeD004314EFO_0001064Q90————11
PneumoniaD011014EFO_0003106—————11
Show 20 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAmiodarone
INNamiodarone
Description
Amiodarone is a member of the class of 1-benzofurans that is 1-benzofuran substituted by a butyl group at position 2 and a 4-[2-(diethylamino)ethoxy]-3,5-diiodobenzoyl group at position 3. It is a cardiovascular drug used for the treatment of cardiac dysrhythmias. It has a role as a cardiovascular drug. It is a member of 1-benzofurans, an organoiodine compound, an aromatic ketone and a tertiary amino compound.
Classification
Small molecule
Drug classantiarrhythmics: indicates high iodine content
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1
Identifiers
PDB—
CAS-ID1951-25-3
RxCUI—
ChEMBL IDCHEMBL633
ChEBI ID2663
PubChem CID2157
DrugBankDB01118
UNII IDN3RQ532IUT (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
SCN5A
SCN5A
SIRT3
SIRT3
Organism
Homo sapiens
Gene name
SCN5A
Gene synonyms
NCBI Gene ID
Protein name
sodium channel protein type 5 subunit alpha
Protein synonyms
cardiac tetrodotoxin-insensitive voltage-dependent sodium channel alpha subunit, hH1, Sodium channel protein cardiac muscle subunit alpha, Sodium channel protein type V subunit alpha, sodium channel, voltage-gated, type V, alpha subunit, Voltage-gated sodium channel subunit alpha Nav1.5
Uniprot ID
Mouse ortholog
Scn5a (20271)
sodium channel protein type 5 subunit alpha (Q9JJV9)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Amiodarone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 27,738 documents
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Safety
Black-box Warning
Black-box warning for: Amiodarone hcl, Pacerone
Adverse Events
Top Adverse Reactions
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29,262 adverse events reported
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