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
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Tham (discontinued: Tham)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acular | New Drug Application | 2024-09-25 |
| acular ls | New Drug Application | 2024-06-21 |
| acunistat-30 | ANDA | 2022-02-22 |
| acunistat-60 | ANDA | 2022-02-22 |
| acunivive 15 | ANDA | 2022-02-24 |
| acunivive 30 | ANDA | 2022-02-25 |
| acunivive 60 | ANDA | 2022-02-25 |
| acunivive 90 | ANDA | 2022-02-25 |
| acuvail | New Drug Application | 2024-05-31 |
| alomide | New Drug Application | 2024-06-04 |
Show 28 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| acidosis | EFO_1000014 | D000138 | E87.2 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Sodium Phosphate, Dibasic, Anhydrous / Sodium Phosphate, Monobasic, Monohydrate, Osmoprep, Salix Pharms | |||
| 7687075 | 2028-06-22 | DS, 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
4946 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 178 | 297 | 57 | 5 | 27 | 485 |
| Lymphoma | D008223 | — | C85.9 | 123 | 228 | 36 | 5 | 29 | 360 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 47 | 38 | 129 | 88 | 56 | 353 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 23 | 41 | 127 | 76 | 34 | 292 |
| Syndrome | D013577 | — | — | 63 | 130 | 33 | 24 | 42 | 263 |
| Myelodysplastic syndromes | D009190 | — | D46 | 76 | 144 | 18 | 1 | 16 | 224 |
| Myeloid leukemia | D007951 | — | C92 | 82 | 119 | 19 | 1 | 8 | 197 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 84 | 112 | 22 | 1 | 8 | 195 |
| Lymphoid leukemia | D007945 | — | C91 | 62 | 115 | 33 | 3 | 8 | 190 |
| Preleukemia | D011289 | — | — | 61 | 120 | 14 | 1 | 14 | 185 |
Show 627 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Plasma cell neoplasms | D054219 | — | — | 36 | 61 | 2 | — | 13 | 101 |
| Hodgkin disease | D006689 | — | C81 | 24 | 63 | 11 | — | 7 | 90 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 19 | 64 | 4 | — | 4 | 82 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 15 | 42 | 5 | — | 7 | 63 |
| Follicular lymphoma | D008224 | — | C82 | 24 | 40 | 4 | — | 7 | 62 |
| Mantle-cell lymphoma | D020522 | — | — | 27 | 38 | 4 | — | 6 | 62 |
| Graft vs host disease | D006086 | — | D89.81 | 11 | 40 | 9 | — | 3 | 56 |
| Small cell lung carcinoma | D055752 | — | — | 15 | 28 | 15 | — | 1 | 54 |
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | 19 | 33 | 2 | — | 4 | 49 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 19 | 32 | 3 | — | 4 | 49 |
Show 341 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Plasmacytoma | D010954 | — | C90.3 | 16 | 32 | — | — | 9 | 53 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 13 | 25 | — | — | 7 | 39 |
| T-cell lymphoma cutaneous | D016410 | — | — | 8 | 16 | — | — | 7 | 28 |
| Mycosis fungoides | D009182 | — | C84.0 | 9 | 16 | — | — | 6 | 27 |
| Lymphomatoid granulomatosis | D008230 | — | C83.8 | 8 | 17 | — | — | 6 | 27 |
| T-cell leukemia | D015458 | — | — | 7 | 17 | — | — | 5 | 26 |
| Myeloid leukemia accelerated phase | D015465 | — | — | 5 | 20 | — | — | 3 | 26 |
| Sezary syndrome | D012751 | — | C84.1 | 7 | 15 | — | — | 6 | 25 |
| Adult t-cell leukemia-lymphoma | D015459 | — | C91.5 | 5 | 14 | — | — | 5 | 22 |
| Blast crisis | D001752 | — | — | 5 | 15 | — | — | 1 | 19 |
Show 309 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dengue | D003715 | — | A90 | 6 | — | — | — | — | 6 |
| Pruritus | D011537 | HP_0000989 | L29 | 2 | — | — | — | 3 | 5 |
| Drug interactions | D004347 | — | — | 2 | — | — | — | 1 | 3 |
| Blood pressure | D001794 | EFO_0004325 | — | 1 | — | — | — | 2 | 3 |
| Papillomavirus infections | D030361 | — | — | 1 | — | — | — | 1 | 2 |
| Papilledema | D010211 | EFO_1001074 | H35.81 | 1 | — | — | — | 1 | 2 |
| Urologic neoplasms | D014571 | — | C64-C68 | 2 | — | — | — | — | 2 |
| Carcinosarcoma | D002296 | — | — | 2 | — | — | — | — | 2 |
| Uveal neoplasms | D014604 | EFO_1001230 | — | 2 | — | — | — | — | 2 |
| Gram-positive bacterial infections | D016908 | — | — | 2 | — | — | — | — | 2 |
Show 90 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Critical illness | D016638 | — | — | — | — | — | — | 5 | 5 |
| Peri-implantitis | D057873 | EFO_1001390 | — | — | — | — | — | 5 | 5 |
| Sinus floor augmentation | D059546 | — | — | — | — | — | — | 5 | 5 |
| Graves disease | D006111 | EFO_0004237 | E05.0 | — | — | — | — | 3 | 3 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | — | 3 | 3 |
| Injection site reaction | D000075662 | — | — | — | — | — | — | 3 | 3 |
| Acid-base imbalance | D000137 | — | — | — | — | — | — | 3 | 3 |
| Common cold | D003139 | EFO_0007214 | J00 | — | — | — | — | 3 | 3 |
| Flatfoot | D005413 | EFO_0003874 | — | — | — | — | — | 3 | 3 |
| Mycoplasma pneumonia | D011019 | EFO_0007387 | J15.7 | — | — | — | — | 2 | 2 |
Show 224 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tromethamine |
| INN | trometamol |
| 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".
|
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NC(CO)(CO)CO |
Identifiers
| PDB | — |
| CAS-ID | 77-86-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200391 |
| ChEBI ID | 9754 |
| PubChem CID | 6503 |
| DrugBank | DB03754 |
| UNII ID | 023C2WHX2V (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
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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, Osmoprep, Readysharp anesthetics plus ketorolac, Readysharp ketorolac, Sprix, Toradol, Toronova ii suik, Toronova suik
Adverse Events
Top Adverse Reactions
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29,623 adverse events reported
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