Trometamol Other names: Tris Tris(hydroxymethyl)aminomethane Tromethamine THAM

Animal reproduction studies have not been conducted with tromethamine. It is also not known whether tromethamine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tromethamine should be given to a pregnant woman only if clearly needed.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when trometamol solution is administered to a nursing mother.

Studies with trometamol solution have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Generally, side effects have been infrequent.

Respiratory: Although the incidence of ventilatory depression is low, it is important to keep in mind that such depression may occur. Respiratory depression may be more likely to occur in patients who have chronic hypoventilation or those who have been treated with drugs which depress respiration. In patients with associated respiratory acidosis, tromethamine should be administered with mechanical assistance to ventilation.

Vascular: Extreme care should be taken to avoid perivascular infiltration. Local tissue damage and subsequent sloughing may occur if extravasation occurs. Chemical phlebitis and venospasm also have been reported.

Hematologic: Transient depression of blood glucose may occur.

Hepatic: Infusion via low-lying umbilical venous catheters has been associated with hepatocellular necrosis.

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.