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Amphotericin b
Abelcet, Ambisome (amphotericin b) is a small molecule pharmaceutical. Amphotericin b was first approved as Fungizone on 1982-01-01. It is used to treat aids-related opportunistic infections, aspergillosis, blastomycosis, chronic mucocutaneous candidiasis, and coccidioidomycosis amongst others in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
respiratory tract diseasesD012140
nervous system diseasesD009422
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Abelcet, Ambisome (generic drugs available since 1992-04-29, discontinued: Amphotec, Fungizone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amphotericin b
Tradename
Company
Number
Date
Products
AMBISOMEAstellas PharmaN-050740 RX1997-08-11
1 products, RLD, RS
ABELCETLeadiant BiosciencesN-050724 RX1995-11-20
1 products, RLD, RS
Show 4 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
abelcetNew Drug Application2020-11-19
ambisomeNew Drug Application2020-08-14
amphotec2006-02-27
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
aids-related opportunistic infections—D017088—
aspergillosisEFO_0007157D001228B44
blastomycosisEFO_0007174D001759B40
chronic mucocutaneous candidiasisOrphanet_1334D002178B37.2
coccidioidomycosisEFO_0007211D003047B38
cryptococcal meningitisEFO_0007228D016919B45.1
cutaneous candidiasis—D002179—
cystitisEFO_1000025D003556N30
fungemia—D016469B49
histoplasmosisEFO_0007310D006660B39
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Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AB: Antiinfectives and antiseptics for local oral treatment
— A01AB04: Amphotericin b
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07A: Intestinal antiinfectives
— A07AA: Antibiotics, intestinal
— A07AA07: Amphotericin b
G: Genito urinary system and sex hormones
— G01: Gynecological antiinfectives and antiseptics
— G01A: Antiinfectives and antiseptics, excl. combinations with corticosteroids
— G01AA: Antibiotics, gynecological
— G01AA03: Amphotericin b
J: Antiinfectives for systemic use
— J02: Antimycotics for systemic use
— J02A: Antimycotics for systemic use
— J02AA: Antibiotics for systemic use
— J02AA01: Amphotericin b
HCPCS
Code
Description
J0285
Injection, amphotericin b, 50 mg
J0287
Injection, amphotericin b lipid complex, 10 mg
J0288
Injection, amphotericin b cholesteryl sulfate complex, 10 mg
J0289
Injection, amphotericin b liposome, 10 mg
Clinical
Clinical Trials
130 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cryptococcal meningitisD016919EFO_0007228B45.147411023
Visceral leishmaniasisD007898B55.01473116
MycosesD009181B35-B49—253111
Invasive pulmonary aspergillosisD055744B44.01332—9
CandidiasisD002177B37——4116
Invasive candidiasisD058365EFO_1001283B37—211—4
NeutropeniaD009503D70—121—4
Liver transplantationD016031EFO_0010682——11—2
BlastomycosisD001759EFO_0007174B40——11—2
SepsisD018805A41.9———112
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B20245—818
AspergillosisD001228EFO_0007157B44—33——5
InfectionsD007239EFO_0000544——3—14
Vulvovaginal candidiasisD002181EFO_0007543B37.3—21——3
Lung transplantationD016040——3——3
Allergic bronchopulmonary aspergillosisD001229EFO_0007140B44.81—21——2
NeoplasmsD009369C80——2——2
Bacterial vaginosisD016585EFO_0003932——2——2
Myelodysplastic syndromesD009190D46—11——2
Acquired immunodeficiency syndromeD000163EFO_0000765B20—11——2
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470C92.0—4———4
MucormycosisD009091EFO_0007380B46.5—2———2
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0—2———2
VulvovaginitisD014848EFO_1001240N76.0—2———2
LeishmaniasisD007896EFO_0005044B5512———2
Hematopoietic stem cell transplantationD018380—1———1
FeverD005334HP_0001945R50.9—1———1
CryptococcosisD003453EFO_0007229B4511———1
HivD006678O98.7—1———1
MeningitisD008581EFO_0000584G03—1———1
Show 5 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1————1
Therapeutic equivalencyD0138101————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiratory distress syndromeD012128EFO_1000637J80————11
Critical illnessD016638————11
Ventilator-associated pneumoniaD053717EFO_1001865J95.851————11
Respiratory tract infectionsD012141J06.9————11
PneumoniaD011014EFO_0003106J18————11
Healthy dietD000072001————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAMPHOTERICIN B
INNamphotericin b
Description
Amphotericin B is a macrolide antibiotic used to treat potentially life-threatening fungal infections. It has a role as an antiprotozoal drug, a bacterial metabolite and an antiamoebic agent. It is a macrolide antibiotic, a polyene antibiotic and an antibiotic antifungal drug.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C[C@@H]1OC(=O)C[C@H](O)C[C@H](O)CC[C@@H](O)[C@H](O)C[C@H](O)C[C@]2(O)C[C@H](O)[C@@H](C(=O)O)[C@H](C[C@@H](O[C@@H]3O[C@H](C)[C@@H](O)[C@H](N)[C@@H]3O)/C=C/C=C/C=C/C=C/C=C/C=C/C=C/[C@H](C)[C@@H](O)[C@H]1C)O2
Identifiers
PDB—
CAS-ID1397-89-3
RxCUI732
ChEMBL IDCHEMBL267345
ChEBI ID2682
PubChem CID5280965
DrugBankDB00681
UNII ID7XU7A7DROE (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Ambisome - Gilead Sciences
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 71,688 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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20,292 adverse events reported
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