Trometamol

(BAN, rINN)
Trometamol Chemical formula
Synonyms: NSC-6365; THAM; Trihydroxymethylaminomethane; TRIS; Tris(hydroksymetylo)aminometan; Tris(hydroxymethyl)aminomethane; Trométamol; Trometamoli; Trometamolis; Trometamolum; Tromethamine pane-1,3-diol.
Cyrillic synonym: Трометамол.

💊 Chemical information

Chemical formula: C4H11NO3 = 121.1.
CAS — 77-86-1.
ATC — B05BB03; B05XX02.
ATC Vet — QB05BB03; QB05XX02.

Pharmacopoeias.

In Eur. and US.

Ph. Eur. 6.2

(Trometamol). A white or almost white, crystalline powder or colourless crystals. Freely soluble in water; sparingly soluble in alcohol; very slightly soluble in ethyl acetate. A 5% solution in water has a pH of 10.0 to 11.5.

USP 31

(Tromethamine). A white, crystalline powder having a slight characteristic odour. Soluble 1 in 1.8 of water and 1 in 45.5 of alcohol; freely soluble in low-molecular-weight aliphatic alcohols; practically insoluble in carbon tetrachloride, in chloroform, and in benzene. pH of a 5% solution in water is between 10.0 and 11.5. Store in airtight containers.

Incompatibilities.

There is evidence to suggest that fluorouracil degrades to cardiotoxic compounds in formulations buffered with trometamol. 1 1. Lukaschek J, et al. Cardiotoxicity and neurotoxicity of high-dose continuous fluorouracil as a result of degradation compounds in the drug vials. J Clin Oncol 2004; 22: 5022–5.

💊 Adverse Effects and Precautions

Great care must be taken to avoid extravasation at the injection site as solutions may cause tissue damage. Local irritation, venospasm and phlebitis have occurred. Respiratory depression can occur and mechanical ventilation may be required. Hypoglycaemia may also occur. Trometamol is contra-indicated in anuria and uraemia, and should be used cautiously in patients with renal impairment as hyperkalaemia has been reported in such patients. Trometamol is not recommended for use in patients with respiratory acidosis alone. If it is used in patients with respiratory acidosis accompanying metabolic acidosis, ventilation should be maintained mechanically. Trometamol is contra-indicated in chronic respiratory acidosis. Blood concentrations of bicarbonate, glucose, and electrolytes, partial pressure of carbon dioxide, and blood pH should be monitored during infusion of trometamol.

💊 Uses and Administration

Trometamol is an organic amine proton acceptor used as an alkalinising agent in the treatment of metabolic acidosis. It also acts as a weak osmotic diuretic. Trometamol is mainly used during cardiac bypass surgery and during cardiac arrest. It may also be used to reduce the acidity of citrated blood for use in bypass surgery. The dose used should be the minimum required to increase the pH of the blood to within normal limits and is based on the bodyweight and the base deficit. Trometamol is given by slow intravenous infusion as a 0.3M solution; it should not be given for longer than a day except in life-threatening emergencies. Trometamol citrate is given by mouth for the management of urinary calculi and acidosis. Trometamol acefyllinate has also been used for acidosis.
1. Nahas GG, et al. Guidelines for the treatment of acidaemia with THAM. Drugs 1998; 55: 191–224.

💊 Preparations

USP 31: Tromethamine for Injection.

Proprietary Preparations

Austral.: Tham; Austria: Tris; Ger.: Tham; Tris; Ital.: Thamesol; Swed.: Addex-THAM. Multi-ingredient: Arg.: Solocalm Plus; Austral.: Blink-N-Clean; Fr.: Alcaphor; Norw.: Tribonat; Swed.: Theranyl†; Tribonat; Switz.: Saltrates†.
Published May 08, 2019.