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, 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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acd | ANDA | 2025-01-22 |
| acular | New Drug Application | 2025-03-14 |
| 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 |
Show 79 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
483 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | 6 | 13 | 10 | 30 | 12 | 68 |
| Pain | D010146 | EFO_0003843 | R52 | 3 | 7 | 8 | 14 | 10 | 41 |
| Acute pain | D059787 | — | R52 | 4 | 4 | 5 | 4 | 2 | 18 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | 1 | 2 | 3 | 6 | 4 | 15 |
| Infections | D007239 | EFO_0000544 | — | 4 | 4 | 3 | 4 | 1 | 15 |
| Neoplasms | D009369 | — | C80 | 7 | 6 | 2 | 1 | 1 | 14 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | 3 | 5 | 6 | — | 14 |
| Cataract | D002386 | EFO_0001059 | H26.9 | 2 | 1 | 3 | 6 | 2 | 13 |
| Agnosia | D000377 | EFO_0007136 | F88 | 1 | — | 1 | 4 | 6 | 12 |
| Renal colic | D056844 | EFO_1001412 | N23 | — | 1 | 2 | 4 | 4 | 10 |
Show 131 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 5 | 2 | — | — | 7 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | 5 | 2 | — | — | 7 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 2 | 5 | 1 | — | — | 7 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 3 | 3 | 1 | — | 1 | 6 |
| Neuroblastoma | D009447 | EFO_0000621 | — | — | 2 | 3 | — | — | 5 |
| Appendicitis | D001064 | EFO_0007149 | K37 | — | 1 | 3 | — | 1 | 5 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 2 | 2 | — | — | 5 |
| Respiratory syncytial virus infections | D018357 | EFO_1001413 | — | 2 | 2 | 1 | — | — | 5 |
| Lymphoma | D008223 | — | C85.9 | 1 | 2 | 2 | — | — | 4 |
| Syndrome | D013577 | — | — | — | 3 | 1 | — | — | 4 |
Show 55 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 17 | 2 | — | — | 1 | 20 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 9 | 2 | — | — | — | 10 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 9 | 3 | — | — | — | 10 |
| Recurrence | D012008 | — | — | 1 | 4 | — | — | — | 5 |
| Leukemia | D007938 | — | C95 | — | 4 | — | — | — | 4 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | — | 4 | — | — | — | 4 |
| Myeloid leukemia | D007951 | — | C92 | — | 4 | — | — | — | 4 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | 1 | — | — | 1 | 3 |
| Germ cell and embryonal neoplasms | D009373 | — | — | 2 | 1 | — | — | — | 3 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | 3 | — | — | — | 3 |
Show 70 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leiomyoma | D007889 | — | D25 | 1 | — | — | — | 3 | 4 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 3 | — | — | — | — | 3 |
| Pneumococcal pneumonia | D011018 | EFO_1001474 | J13 | 3 | — | — | — | — | 3 |
| Pneumococcal infections | D011008 | EFO_0000772 | J13 | 3 | — | — | — | — | 3 |
| Myofibroma | D047708 | — | — | 1 | — | — | — | 2 | 3 |
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | — | 1 |
| Ependymoma | D004806 | — | — | 1 | — | — | — | — | 1 |
| Myeloid sarcoma | D023981 | — | C92.3 | 1 | — | — | — | — | 1 |
| Choroid plexus neoplasms | D016545 | EFO_0007206 | — | 1 | — | — | — | — | 1 |
| Osteosarcoma | D012516 | — | — | 1 | — | — | — | — | 1 |
Show 34 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Keratoconus | D007640 | EFO_0004223 | H18.6 | — | — | — | — | 4 | 4 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | — | — | — | 3 | 3 |
| Common cold | D003139 | EFO_0007214 | J00 | — | — | — | — | 3 | 3 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | — | — | — | — | 3 | 3 |
| Dry eye syndromes | D015352 | — | H04.12 | — | — | — | — | 3 | 3 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | — | — | — | 2 | 2 |
| Vomiting | D014839 | — | R11.1 | — | — | — | — | 2 | 2 |
| Pathologic dilatation | D004108 | — | — | — | — | — | — | 2 | 2 |
| Regeneration | D012038 | — | — | — | — | — | — | 2 | 2 |
| Parenting | D016487 | — | — | — | — | — | — | 2 | 2 |
Show 63 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
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Variants
No data
Financial
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Sprix – Assertio Therapeutics
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Sprix – Zyla Life Sciences
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 882,580 documents
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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
Top Adverse Reactions
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49,364 adverse events reported
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