(tromethamine injection)
Blood pH, PCO2 bicarbonate, glucose and electrolyte determinations should be performed before, during and after administration of Tham Solution.
While it has not been shown that the drug increases coagulation time in humans, this possibility should be kept in mind since this has been noted experimentally in dogs.
Do not administer unless solution is clear and seal is intact. Discard unused portion.
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 THAM Solution is administered to a nursing mother.
Studies with THAM Solution have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
The safety and effectiveness of THAM Solution in pediatric patients is based on over 30 years’ clinical experience documented in the literature and on safety surveillance. THAM Solution has been used to treat severe cases of metabolic acidosis with concurrent respiratory acidosis because it does not raise PCO2 as bicarbonate does in neonates and infants with respiratory failure. It has also been used in neonates and infants with hypernatremia and metabolic acidosis to avoid the additional sodium given with the bicarbonate. However, because the osmotic effects of THAM Solution are greater and large continuous doses are required, bicarbonate is preferred to THAM Solution in the treatment of acidotic neonates and infants with RDS. Hypoglycemia may occur when this product is used in premature and even full-term neonates (see WARNINGS and ADVERSE REACTIONS).
Clinical studies of Tham solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
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