Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 25 January 2017
PRECAUTIONS 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
Do not administer unless
Pregnancy Category C: Animal reproduction studies have not been conducted with tromethamine.
It is also not known whether tromethamine can cause fetal
Tromethamine should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk,
Studies with THAM
Solution have not been performed to evaluate carcinogenic
Pediatric Use: The
THAM Solution has been used to treat
It has also been used in neonates and infants with hypernatremia and metabolic acidosis to
See WARNINGS and
Geriatric Use: Clinical studies of Tham solution did not include
Other reported clinical experience has not identified differences in response between the elderly and younger patients.
Because elderly patients are more likely to have
Respiratory: Although the incidence of ventilatory
In patients with associated respiratory acidosis, tromethamine should be administered with mechanical
Chemical phlebitis and venospasm also have been reported.
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,
DOSAGE AND ADMINISTRATION Tham Solution (tromethamine injection) is administered by
For infusion by peripheral vein, a
Pretreatment and subsequent determinations of
The total quantity to be administered during the period of
The possibility of some retention of tromethamine, especially in
The intravenous dosage of Tham Solution (tromethamine injection) may be estimated from the buffer base
The following formula is intended as a general guide: Tham Solution (mL of 0.3_M)
* Factor of 1.1 accounts for an approximate reduction of 10 % in buffering capacity due to the presence of
Correction of Metabolic Acidosis Associated with Cardiac Bypass Surgery: An
This is equivalent to a total dose of 630 mL (189 mEq) for 70 kg patient.
A total single dose of 500 mL (150 mEq) is considered
Thus, for a 70 kg (154 pound) patient
Repeated determinations of pH and other clinical observations should be used as a guide to the
Correction of Acidity of ACD Blood in Cardiac Bypass Surgery: The pH of stored
The amount of Tham Solution used to correct this acidity ranges from 0.5 to 2.5 g (15 to 77 mL of a 0.3_M solution) added to each 500 mL of ACD
Clinical experience indicates that 2 g (62 mL of a 0.3_M solution) added to 500 mL of
Correction of Metabolic Acidosis Associated with Cardiac
If the chest is open, Tham Solution is injected directly into the ventricular cavity.
From 2 to 6 g (62 to 185 mL of a 0.3_M solution) should be injected immediately.
Do not inject into the cardiac muscle.
If the chest is not open, from 3.6 to 10.8 g (111 to 333 mL of a 0.3_M solution) should be injected immediately into a
Correction of Metabolic Acidosis Associated with RDS in Neonates and Infants: The initial dose of Tham Solution should be based on initial pH and birthweight amounting to approximately 1 mL per kg for each pH unit below 7.4.
Further doses have been given according to changes in PaO2, pH and PCO2.
Parenteral drug products should be inspected visually for particulate matter and
|Date Last Revised||26-01-2010|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Hospira, Inc.|