Tromethamine
Dibasic, Monobasic, Monohydrate, Phosphate (tromethamine) is a small molecule pharmaceutical. Tromethamine was first approved as Sodium phosphates in plastic container on 1983-05-10. It is used to treat acidosis in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Tham, Tromethamine (discontinued: Tham)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tromethamine
Tradename
Company
Number
Date
Products
THAMHospiraN-013025 RX1982-01-01
1 products, RLD, RS
Potassium chloride
+
Sodium chloride
+
Tromethamine
Tradename
Company
Number
Date
Products
THAM-EHospiraN-013025 DISCN1982-01-01
1 products
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Brand Name
Status
Last Update
acdANDA2025-01-22
acularNew Drug Application2024-09-25
acular lsNew Drug Application2024-06-21
acunistat-30ANDA2022-02-22
acunistat-60ANDA2022-02-22
acunivive 15ANDA2022-02-24
acunivive 30ANDA2022-02-25
acunivive 60ANDA2022-02-25
acunivive 90ANDA2022-02-25
acuvailNew Drug Application2024-05-31
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
acidosisEFO_1000014D000138E87.2
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Sodium Phosphate, Dibasic, Anhydrous / Sodium Phosphate, Monobasic, Monohydrate, Osmoprep, Salix Pharms
76870752028-06-22DS, DP
ATC Codes
B: Blood and blood forming organ drugs
B05: Blood substitutes and perfusion solutions
B05B: Iv solutions used in parenteral administration of fluids, electrolytes and nutrients
B05BB: Solutions affecting the electrolyte balance
B05BB03: Trometamol
B05X: I.v. solution additives
B05XX: Other i.v. solution additives in atc
B05XX02: Trometamol
HCPCS
Code
Description
J1885
Injection, ketorolac tromethamine, per 15 mg
Clinical
Clinical Trials
398 clinical trials
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Indications Phases 2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeiomyomaD007889D25134
PneumoniaD011014EFO_0003106J1833
Pneumococcal pneumoniaD011018EFO_1001474J1333
Pneumococcal infectionsD011008EFO_0000772J1333
MyofibromaD047708123
GliomaD005910EFO_000052011
EpendymomaD00480611
Myeloid sarcomaD023981C92.311
Choroid plexus neoplasmsD016545EFO_000720611
OsteosarcomaD01251611
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Common coldD003139EFO_0007214J0033
AgnosiaD000377EFO_0007136F8822
Postoperative nausea and vomitingD020250EFO_000488822
VomitingD014839R11.122
KeratoconusD007640EFO_0004223H18.622
BunionD000071378M21.6111
Hammer toe syndromeD037801EFO_1001336M21.5311
Tailor's bunionD050489M21.6211
NauseaD009325R11.011
ContraceptionD00326711
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTromethamine
INNtrometamol
Description
Tris, or tris(hydroxymethyl)aminomethane, or known during medical use as tromethamine or THAM, is an organic compound with the formula (HOCH2)3CNH2. It is extensively used in biochemistry and molecular biology as a component of buffer solutions such as in TAE and TBE buffers, especially for solutions of nucleic acids. It contains a primary amine and thus undergoes the reactions associated with typical amines, e.g. condensations with aldehydes. Tris also complexes with metal ions in solution. In medicine, tromethamine is occasionally used as a drug, given in intensive care for its properties as a buffer for the treatment of severe metabolic acidosis in specific circumstances. Some medications are formulated as the "tromethamine salt" including hemabate (carboprost as trometamol salt), and "ketorolac trometamol".
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Classification
Small molecule
Drug class
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
NC(CO)(CO)CO
Identifiers
PDB
CAS-ID77-86-1
RxCUI
ChEMBL IDCHEMBL1200391
ChEBI ID9754
PubChem CID6503
DrugBankDB03754
UNII ID023C2WHX2V (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Acunistat-30, Acunistat-60, Acunivive 15, Acunivive 30, Acunivive 60, Acunivive 90, Ketorlac tromethamine, Ketorocaine l kit, Ketorocaine lm kit, Ketorolac, Ketorolac trometham, Ketorolac tromethamine, Ketorolac tromethamine ketorolac tromethamine, Ketotolac tromethamine, Pentetate calcium trisodium, Pentetate zinc trisodium, Sprix, Toronova ii suik, Toronova suik, Trisenox, Tristart dha, Vasovist
Adverse Events
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46,125 adverse events reported
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