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Tham Dosage and Administration (ADULT Calculation)
- Tham Solution (mL of 0.3 M) Required =
Kg x Base deficit x 1.1*
Thus, a 70 kg patient with a buffer base deficit (“negative base excess”) of 5 mEq/liter would require 70 x 5 x 1.1 = 385 mL of Tham Solution containing 13.9 g (115 mEq) of tromeThamine.
* Factor of 1.1 accounts for an approximate reduction of 10% in buffering capacity due to the presence of sufficient acetic acid to lower pH of the 0.3 M solution to approximately 8.6.
- An adverse dose of approximately 9.0 mL/kg (324 mg/kg) has been used in clinical studies with Tham Solution (tromeThamine injection). 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 adequate for most adults. Larger single doses (up to 1000 mL) may be required in unusually severe cases.
- It is recommended that individual doses should not exceed 500 mg/kg (227 mg/lb) over a period of not less than one hour.
- Thus, for a 70 kg (154 pound) patient the dose should not exceed a maximum of 35 g per hour (1078 mL of a 0.3 M solution). Repeated determinations of pH and other clinical observations should be used as a guide to the need for repeat doses.
Half Life & Excretion (Kidney)
- Although 25% of THAM can be recovered from the urine within an hour after infusion (32),
- it may take between 24 to 72 h to achieve 80% excretion (9, 11).
- Brasch and colleagues (11) reported that the half-life of THAM was between 16 and 45 h in surgical patients with metabolic acidosis.
How is Tham Supplied
Tham Solution (tromeThamine injection) is supplied in a single-dose 500 mL large volume glass container (List No. 1593).
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
- Protect from freezing.
- Large doses of Tham Solution may depress ventilation, as a result of increased blood pH and reduced CO2 concentration. Thus, dosage should be adjusted so that blood pH is not allowed to increase above normal. In situations in which respiratory acidosis may be present concomitantly with metabolic acidosis, the drug may be used with mechanical assistance to ventilation.
- Care must be exercised to prevent perivascular infiltration since this can cause inflammation, necrosis and sloughing of tissue. Venospasm and intravenous thrombosis, which may occur during infusion, can be minimized by insuring that the injection needle is well within the largest available vein and that solutions are slowly infused. Intravenous catheters are recommended. If perivascular infiltration occurs, institute appropriate countermeasures. See ADVERSE REACTIONS.
- Tham Solution (tromeThamine injection) should be administered slowly and in amounts sufficient only to correct the existing acidosis, and to avoid overdosage and alkalosis. Overdosage in terms of total drug and/or too rapid administration, may cause hypoglycemia of a prolonged duration (several hours). Therefore, frequent blood glucose determinations should be made during and after therapy.
- Extreme care should be exercised in patients with renal disease or reduced urinary output because of potential hyperkalemia and the possibility of a decreased excretion of tromeThamine. In such patients, the drug should be used cautiously with electrocardiographic monitoring and frequent serum potassium determinations.
- Because clinical experience has been limited generally to short-term use, the drug should not be administered for more than a period of one day except in a life-threatening situation.
- The intravenous administration of Tham Solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.