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Drug ReportsFosfomycin tromethamine
Fosfomycin tromethamine
Fosfomycin Tromethamine (fosfomycin tromethamine) is a small molecule pharmaceutical. Fosfomycin tromethamine was first approved as Monurol on 1996-12-19. It is used to treat escherichia coli infections, gram-positive bacterial infections, klebsiella infections, proteus infections, and serratia infections amongst others in the USA.
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Financial
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Events Timeline
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
Trade Name
FDA
EMA
Fosfomycin tromethamine (discontinued: Monurol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fosfomycin tromethamine
Tradename
Company
Number
Date
Products
MONUROLZambonN-050717 DISCN1996-12-19
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
fosfomycin tromethamineANDA2024-10-22
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
J01: Antibacterials for systemic use
J01X: Other antibacterials in atc
J01XX: Other antibacterials in atc
J01XX01: Fosfomycin
HCPCS
No data
Clinical
Clinical Trials
77 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544146181138
Urinary tract infectionsD014552EFO_0003103N39.016616734
Communicable diseasesD0031412512826
CystitisD003556EFO_1000025N302248
PneumoniaD011014EFO_0003106J1812137
Bacterial infectionsD001424A491157
BacteremiaD016470EFO_0003033R78.811236
SepsisD018805EFO_0001420A41.91236
Intraabdominal infectionsD059413123
EndocarditisD004696EFO_0000465I33123
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients213
NeutropeniaD009503D70112
GonorrheaD006069DOID_7551A5411
Escherichia coli infectionsD004927EFO_1001318B96.2011
NeoplasmsD009369C80111
FeverD005334R50.911
Febrile neutropeniaD06414711
HyperthermiaD00008446211
ProstatitisD011472EFO_0003830N4111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bacterial pneumoniaD018410EFO_1001272J15.9213
AppendicitisD001064EFO_0007149K3722
ToxemiaD014115112
Urinary bladder neoplasmsD001749C6711
Urologic surgical proceduresD01352011
Colonic neoplasmsD003110C1811
AdenomaD00023611
Neonatal sepsisD00007107411
Ulcerative colitisD003093EFO_0000729K51111
ColitisD003092EFO_0003872K52.9111
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OsteomyelitisD010019EFO_0003102M86112
Multiple drug resistanceD018432112
Pseudomonas infectionsD011552EFO_0001076A41.5211
Disease resistanceD06046711
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gram-negative bacterial infectionsD01690533
HemorrhageD006470MP_0001914R5822
Heart failureD006333EFO_0003144I5022
HypertensionD006973EFO_0000537I1022
MenorrhagiaD008595EFO_0003945N92.022
Hemophilia aD006467EFO_0007267D6622
PainD010146EFO_0003843R5222
HyperaldosteronismD006929E2622
Pulmonary arterial hypertensionD00008102922
HypokalemiaD007008E87.622
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFosfomycin tromethamine
INN
Description
Fosfomycin is a phosphonic acid having an (R,S)-1,2-epoxypropyl group attached to phosphorus. It has a role as an antimicrobial agent and an EC 2.5.1.7 (UDP-N-acetylglucosamine 1-carboxyvinyltransferase) inhibitor. It is an epoxide and a member of phosphonic acids. It is functionally related to a phosphonic acid. It is a conjugate acid of a (1R,2S)-epoxypropylphosphonate(1-).
Classification
Small molecule
Drug classphosphoro-derivatives; antibiotics (Streptomyces strain)
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Structure (InChI/SMILES or Protein Sequence)
C[C@@H]1O[C@@H]1P(=O)(O)O.NC(CO)(CO)CO
Identifiers
PDB
CAS-ID23155-02-4
RxCUI4550
ChEMBL IDCHEMBL1200331
ChEBI ID
PubChem CID446987
DrugBankDB00828
UNII ID
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,866 adverse events reported
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