pharmacopeia
GET
/api/v1/drug/tromethamine

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Alkalinizing Activity.

Indications

Sourced from openFDA
  • Tromethamine Injection is indicated for the prevention and correction of metabolic acidosis. In the following conditions it may help to sustain vital functions and thus provide time for treatment of the primary disease: Metabolic Acidosis Associated with Cardiac Bypass Surgery.

Contraindications

Sourced from openFDA
  • Tromethamine Injection is contraindicated in uremia and anuria. In neonates it is also contraindicated in chronic respiratory acidosis and salicylate intoxication.contraindicated

Dosage & administration

Sourced from openFDA

Tromethamine Injection is administered by slow intravenous infusion, by addition to pump-oxygenator ACD blood or other priming fluid or by injection into the ventricular cavity during cardiac arrest. For infusion by peripheral vein, a large needle should be used in the largest antecubital vein or an indwelling catheter placed in a large vein of an elevated limb to minimize chemical irritation of the alkaline solution during infusion. Catheters are recommended. Dosage and rate of administration should be carefully supervised to avoid overtreatment (alkalosis). Pretreatment and subsequent determinations of blood values (e.g. pH, PCO 2 , PO 2 , glucose and electrolytes) and urinary output should be made as necessary to monitor dosage and progress of treatment. In general, dosage should be limited to an amount sufficient to increase blood pH to normal limits (7.35 to 7.45) and to correct acid-base derangements. The total quantity to be administered during the period of illness will depend upon the severity and progression of the acidosis. The possibility of some retention of tromethamine, especially in patients with impaired renal function, should be kept in mind. The intravenous dosage of Tromethamine Injection may be estimated from the buffer base deficit of the extracellular fluid in mEq/liter determined by means of the Siggaard-Andersen nomogram.

Warnings & precautions

Sourced from openFDA

Large doses of Tromethamine Injection may depress ventilation, as a result of increased blood pH and reduced CO 2 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 ). 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.

Adverse reactions

Sourced from openFDA

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.

Overdosage

Sourced from openFDA

Too rapid administration and/or excessive amounts of tromethamine may cause alkalosis, hypoglycemia, overhydration or solute overload. In the event of overdosage, discontinue the infusion, evaluate the patient and institute appropriate countermeasures. (See WARNINGS , PRECAUTIONS and ADVERSE REACTIONS ). The LD 50 values for the acute intravenous toxicity of Tromethamine Injection are influenced by the rate of infusion of the dose administered. Intravenous LD 50 Mice = 3,500 mg/kg Intravenous LD 50 Rats = 2,300 mg/kg

Approval history

Sourced from openFDA
  • Dec 16, 1965NDANDA013025Hospira
  • Jan 9, 1979NDANDA017989Pfizer
  • Nov 9, 1992NDANDA019700Abbvie
  • May 16, 1997ANDAANDA074754Teva
  • May 30, 2003NDANDA021528Abbvie
  • Jul 22, 2009NDANDA022427Abbvie
  • May 14, 2010NDANDA022382Zyla
  • Jul 2, 2020NDANDA212950Viiv Hlthcare

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
7,151 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective6388.9%
  2. 2Nausea5687.9%
  3. 3Off Label Use4726.6%
  4. 4Vomiting4416.2%
  5. 5Diarrhoea3695.2%
  6. 6Dyspnoea3665.1%
  7. 7Headache3605.0%
  8. 8Drug Hypersensitivity3524.9%
  9. 9Pain3224.5%
  10. 10Fatigue3124.4%
  11. 11Dizziness2563.6%
  12. 12Treatment Failure2183.0%
  13. 13Abdominal Pain Upper2163.0%
  14. 14Eye Pain2062.9%
  15. 15Abdominal Pain2002.8%

Literature

View JSON

Recent PubMed references pinned to Tromethamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 397 ClinicalTrials.gov registrations naming Tromethamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Tromethamine work?
Mechanism-of-action class: Alkalinizing Activity.
What is Tromethamine used for?
According to FDA labeling, Tromethamine carries indications including: Tromethamine Injection is indicated for the prevention and correction of metabolic acidosis. In the following conditions it may help to sustain vital functions and thus provide time for treatment of the primary disease: Metabolic Acidosis Associated with Cardiac Bypass Surgery.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Tromethamine?
Tromethamine is classified as Other i.v. solution additives, Solutions affecting the electrolyte balance, Alkalinizing Activity, Increased Renal HCO3- Excretion.
What are the contraindications for Tromethamine?
Tromethamine labeling lists contraindications including: Tromethamine Injection is contraindicated in uremia and anuria. In neonates it is also contraindicated in chronic respiratory acidosis and salicylate intoxication.. Always consult the full prescribing information and a clinician.
Note. Data for tromethamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients