amphotericin B 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antibiotics, polyene derivatives	197	1397-89-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: amphotericin B abelcet abelecet amphocin amphozone apothecon fungilin Amphotericin B liposome	Macrolide antifungal antibiotic produced by Streptomyces nodosus obtained from soil of the Orinoco river region of Venezuela. Molecular weight: 924.09 Formula: C47H73NO17 CLOGP: -3.65 LIPINSKI: 3 HAC: 18 HDO: 12 TPSA: 319.61 ALOGS: -4.05 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

amphotericin B
abelcet
abelecet
amphocin
amphozone
apothecon
fungilin
Amphotericin B liposome

Macrolide antifungal antibiotic produced by Streptomyces nodosus obtained from soil of the Orinoco river region of Venezuela.

Molecular weight: 924.09
Formula: C47H73NO17
CLOGP: -3.65
LIPINSKI: 3
HAC: 18
HDO: 12
TPSA: 319.61
ALOGS: -4.05
ROTB: 3

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
40	mg	O
0.40	g	O
0.20	g	V
35	mg	P

ADMET properties:

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Property	Value	Reference
t_half (Half-life)	40 hours	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	4.33 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
EoM (Fraction excreted unchanged in urine)	3.50 %	Benet LZ, Broccatelli F, Oprea TI
BA (Bioavailability)	3 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	0.62 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.17 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.03 %	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.00 mg/mL	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
Nov. 12, 1964	FDA	APOTHECON

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Multiple organ dysfunction syndrome	491.59	17.96	275	20082	56477	63412188
Drug ineffective	262.38	17.96	828	19529	1043937	62424728
Mucormycosis	256.08	17.96	75	20282	2796	63465869
Septic shock	234.21	17.96	184	20173	66445	63402220
Aspergillus infection	214.34	17.96	85	20272	8008	63460657
Bronchopulmonary aspergillosis	202.17	17.96	83	20274	8552	63460113
Febrile neutropenia	167.55	17.96	198	20159	118251	63350414
Hypokalaemia	152.58	17.96	177	20180	103627	63365038
Fatigue	147.39	17.96	51	20306	887977	62580688
Toxic epidermal necrolysis	144.47	17.96	94	20263	25240	63443425

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug ineffective	778.05	14.16	1433	30223	455318	34469957
Multiple organ dysfunction syndrome	313.64	14.16	366	31290	76200	34849075
Aspergillus infection	305.45	14.16	170	31486	12084	34913191
Immune reconstitution inflammatory syndrome	214.12	14.16	120	31536	8639	34916636
Mucormycosis	206.57	14.16	103	31553	5839	34919436
Choroiditis	169.16	14.16	57	31599	1158	34924117
Hypokalaemia	163.52	14.16	231	31425	57983	34867292
Drug resistance	155.64	14.16	152	31504	25775	34899500
Bronchopulmonary aspergillosis	153.26	14.16	118	31538	14541	34910734
Cerebral aspergillosis	144.99	14.16	53	31603	1379	34923896

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug ineffective	1166.93	14.13	2198	45414	1078715	78618061
Multiple organ dysfunction syndrome	735.84	14.13	594	47018	119652	79577124
Aspergillus infection	508.54	14.13	242	47370	18919	79677857
Mucormycosis	443.50	14.13	173	47439	8296	79688480
Immune reconstitution inflammatory syndrome	346.56	14.13	168	47444	13673	79683103
Septic shock	321.20	14.13	381	47231	122420	79574356
Bronchopulmonary aspergillosis	312.87	14.13	184	47428	22110	79674666
Fatigue	270.78	14.13	109	47503	929618	78767158
Hypokalaemia	261.15	14.13	373	47239	143667	79553109
Respiratory failure	228.66	14.13	397	47215	180514	79516262

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FDA Adverse Event Reporting System (Pediatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hepatotoxicity	66.54	52.08	19	154	98	89521
Drug ineffective	61.12	52.08	32	141	1020	88599

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Pharmacologic Action:

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Source	Code	Description
ATC	A01AB04	ALIMENTARY TRACT AND METABOLISM STOMATOLOGICAL PREPARATIONS STOMATOLOGICAL PREPARATIONS Antiinfectives and antiseptics for local oral treatment
ATC	A07AA07	ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS INTESTINAL ANTIINFECTIVES Antibiotics
ATC	G01AA03	GENITO URINARY SYSTEM AND SEX HORMONES GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS Antibiotics
ATC	J02AA01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOTICS FOR SYSTEMIC USE ANTIMYCOTICS FOR SYSTEMIC USE Antibiotics
CHEBI has role	CHEBI:35820	antiprotozoal drugs
CHEBI has role	CHEBI:171664	antiamoebic drugs
FDA CS	M0017172	Polyenes
FDA EPC	N0000175498	Polyene Antifungal
FDA EPC	N0000175510	Lipid-based Polyene Antifungal
MeSH PA	D000890	Anti-Infective Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Trachoma	indication	2576002	DOID:11265
Invasive pulmonary aspergillosis	indication	3214003
Actinomycotic infection	indication	11817007	DOID:8478
Histoplasmosis	indication	12962009	DOID:1731
Gonorrhea	indication	15628003	DOID:7551
Infection of skin AND/OR subcutaneous tissue	indication	19824006
Gingivostomatitis	indication	20607006
Candidiasis of the esophagus	indication	20639004	DOID:13146
Acute gonococcal cervicitis	indication	20943002	DOID:10615
Pulmonary cryptococcosis	indication	20953001

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.46	acidic
pKa2	10.11	acidic
pKa3	12.11	acidic
pKa4	12.74	acidic
pKa5	13.7	acidic
pKa6	8.62	Basic

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Orange Book patent data (new drug applications)

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Orange Book exclusivity data (new drug applications)

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Bioactivity Summary:

None

External reference:

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ID	Source
002887	NDDF
006390	NDDF
151803	RXNORM
2715	MMSL
358341	MMSL
3777	MMSL
4017616	VUID
4017616	VANDF
4021053	VANDF
412088006	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ABELCET	HUMAN PRESCRIPTION DRUG LABEL	3	57665-101	INJECTION	5 mg	INTRAVENOUS	NDA	20 sections
ABELCET	HUMAN PRESCRIPTION DRUG LABEL	3	57665-101	INJECTION	5 mg	INTRAVENOUS	NDA	20 sections
AmBisome	HUMAN PRESCRIPTION DRUG LABEL	1	0469-3051	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	NDA	20 sections
AmBisome	HUMAN PRESCRIPTION DRUG LABEL	1	0469-3051	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	NDA	20 sections
Amphotericin B	HUMAN PRESCRIPTION DRUG LABEL	1	39822-1055	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	ANDA	24 sections
Amphotericin B	Human Prescription Drug Label	1	55150-365	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	ANDA	20 sections
Amphotericin B	Human Prescription Drug Label	1	62756-233	INJECTABLE, LIPOSOMAL	50 mg	INTRAVENOUS	ANDA	22 sections

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