Tromethamine

Overview

An organic amine proton acceptor. It is used in the synthesis of surface-active agents and pharmaceuticals; as an emulsifying agent for cosmetic creams and lotions, mineral oil and paraffin wax emulsions, as a biological buffer, and used as an alkalizer. (From Merck, 11th ed; Martindale, The Extra Pharmacopoeia, 30th ed, p1424)

Indication

For the prevention and correction of metabolic acidosis.

Associated Conditions

Metabolic Acidosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Single Ascending Dose Safety and Tolerability of NTS-104 Healthy Adults	2022/09/21	NCT05547438	Phase 1	Recruiting	NeuroTrauma Sciences, LLC
MVA-BN-RSV Vaccine Trial	2022/02/14	NCT05238025	Phase 3	Terminated	Bavarian Nordic
Atomized Intranasal Vs Intravenous Ketorolac in Acute Renal Colic Pain Management.	2020/06/22	NCT04441762	Phase 2	Completed	Oman Medical Speciality Board
Intravenous Metoclopramide Versus Dexketoprofen Trometamol Versus Metoclopramide+ Dexketoprofen Trometamol in Migraine	2020/02/05	NCT04252521	Not Applicable	Completed	Adiyaman University Research Hospital
Comparison of Drugs on Headache Treatment After ECT Treatment	2019/02/05	NCT03830398	Phase 4	UNKNOWN	Mustafa Kemal University
Airway Alkalinization and Nasal Colonization	2017/03/13	NCT03078088	Phase 1	Completed	Lakshmi Durairaj
Study of Metatinib Tromethamine Tablet	2016/01/08	NCT02650375	Phase 1	UNKNOWN	Jiangsu Simcere Pharmaceutical Co., Ltd.
Effect of Morphine, Tramadol, and Ketorolac on Postoperative Stress and Immune Responses	2015/05/21	NCT02449954	Phase 2	UNKNOWN	Assiut University
Phase I Clinical Study of Metatinib Tromethamine Tablet	2013/12/09	NCT02004548	Phase 1	Completed	Jiangsu Simcere Pharmaceutical Co., Ltd.
Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery	2005/12/19	NCT00266786	Phase 3	Completed	Egalet Ltd

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
THAM	Hospira, Inc.	0409-1593	INTRAVENOUS	3.6 g in 100 mL	12/18/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
THAM SOLUTION 36MG/ML	hospira healthcare ulc	00244287	Solution - Intravenous	36 MG / ML	12/31/1972

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
CARDI-BRAUN REPERFUSION SOLUCION PARA PERFUSION	B Braun Medical S.A.	69785	SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
CARDI-BRAUN MANTENIMIENTO SOLUCION PARA PERFUSION	B Braun Medical S.A.	69784	SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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