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Tromethamine (THAM): Drug information

Tromethamine (THAM): Drug information
(For additional information see "Tromethamine (THAM): Patient drug information" and see "Tromethamine (THAM): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Tham
Pharmacologic Category
  • Alkalinizing Agent, Parenteral
Dosing: Adult

Note: Limit dose to amount sufficient to increase blood pH to near normal limits (~7.35) and to correct metabolic acidosis. Retention of tromethamine in patients with impaired kidney function may occur and may lead to metabolic alkalosis. Evaluate blood pH and clinical status during therapy.

Correction of acidity of acid citrate dextrose blood used in cardiac bypass surgery

Correction of acidity of acid citrate dextrose blood used in cardiac bypass surgery: 15 to 77 mL of 0.3 M solution (500 mg to 2.5 g) added to each 500 mL of acid citrate dextrose (ACD) blood; 62 mL (2g) added to 500 mL of ACD blood is adequate for most adults.

Estimated dose when buffer base deficit is known

Estimated dose when buffer base deficit is known: IV: tromethamine dose (mL of 0.3 M solution) = body weight (kg) x base deficit (mEq/L) x 1.1.

Metabolic acidosis associated with cardiac arrest

Metabolic acidosis associated with cardiac arrest:

IV: Initial: 111 to 333 mL of 0.3 M solution (3.6 to 10.8 g); additional amounts may be required to control acidosis after arrest reversed.

Open chest: Intraventricular cavity: 62 to 185 mL of 0.3 M solution (2 to 6 g). Note: Do not inject into cardiac muscle.

Metabolic acidosis associated with cardiac bypass surgery

Metabolic acidosis associated with cardiac bypass surgery: IV: 500 mL of 0.3 M solution (150 mEq) is adequate for most adults; in severe cases up to 1,000 mL may be needed; average dose: 9 mL/kg (324 mg/kg) of 0.3 M solution; maximum single dose: 500 mg/kg over at least 1 hour; reevaluate blood pH and clinical status to guide repeat dosing.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. Tromethamine is substantially excreted by the kidneys; use with caution; monitor ECG and potassium levels.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Tromethamine (THAM): Pediatric drug information")

Note: Dose dependent upon severity and progression of acidosis; doses should be administered slowly to prevent overtreatment. Tromethamine is available as a 0.3 M solution (THAM). Each mL of THAM = 0.3 mmol = 36 mg = 0.3 mEq

Metabolic acidosis

Metabolic acidosis: Infants, Children, and Adolescents: IV: Empiric dosage calculation equation based upon base deficit:

Dose (mL) of THAM = body weight (kg) x base deficit (mEq/L) x 1.1*

*Factor of 1.1 accounts for an approximate reduction of 10% in buffering capacity due to the presence of sufficient acetic acid to lower the pH of the 0.3 M solution to approximately 8.6.

Metabolic acidosis with respiratory distress

Metabolic acidosis with respiratory distress: Infants: IV: Initial: 1 mL/kg for each pH unit below 7.4; additional doses to be determined by changes in PaO2, pH, and pCO2.

Metabolic acidosis with cardiac arrest

Metabolic acidosis with cardiac arrest: Limited data available: Note: Routine use of buffering agents during cardiac arrest not recommended (AHA [Kleinman 2010]):

Infants, Children, and Adolescents: THAM: IV: 1 mL/kg should raise bicarbonate concentration by 1 mEq/L (Fuhrman 2016).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling. Tromethamine is substantially excreted by the kidneys; use with caution; monitor ECG and potassium serum levels.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified.

Frequency not defined:

Cardiovascular: Localized phlebitis, venospasm, venous thrombosis

Endocrine & metabolic: Hyperkalemia, hypervolemia, hypoglycemia

Hepatic: Hepatic necrosis (resulted during delivery via umbilical venous catheter)

Local: Injection site infection, local irritation

Respiratory: Pulmonary edema, respiratory depression

Miscellaneous: Fever

Contraindications

Uremia or anuria; chronic respiratory acidosis (neonates); salicylate intoxication (neonates).

Warnings/Precautions

Concerns related to adverse effects:

• Extravasation: Vesicant; ensure proper needle or catheter placement prior to and during administration; avoid extravasation. May cause tissue inflammation, sloughing, and necrosis.

• Hypoglycemia: May cause hypoglycemia with rapid administration or extremely large doses; monitor serum blood glucose during and after therapy.

• Respiratory depression: Large doses may decrease respiratory ventilation due to increased blood pH and reduced CO2; adjust dose so that blood pH is not increased above normal. Monitor closely especially if patient not intubated. In patients with concomitant respiratory acidosis, use only with mechanical ventilation.

Disease-related concerns:

• Renal impairment: Use with caution in patients with renal impairment; possibly decrease excretion of tromethamine; use ECG monitoring and monitor serum potassium.

Other warnings/precautions:

• Duration of therapy: Drug should not be given for a period of >24 hours, unless for a life-threatening situation.

Warnings: Additional Pediatric Considerations

Avoid infusion via low-lying umbilical venous catheters (particularly with concentrations ≥1.2 M) due to associated risk of hepatocellular necrosis; severe local tissue necrosis and sloughing may occur if solution extravasates; administer via central line or large peripheral vein slowly. Due to the greater osmotic effects of tromethamine, use of sodium bicarbonate for the treatment of acidotic neonates and infants with respiratory distress syndrome may be preferred; may cause prolonged hypoglycemia in premature and full-term neonates or with rapid IV infusion and overdosage. Monitor pH carefully as large doses may increase blood pH greater than normal which may result in depressed respiration.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Tham: 30 mEq/100 mL (500 mL) [latex free]

Generic Equivalent Available: US

No

Pricing: US

Solution (Tham Intravenous)

30 mEq/100 mL (per mL): $0.86

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

IV: Correction of metabolic acidosis in cardiac bypass surgery: Administer by slow IV infusion over at least 1 hour (maximum rate: 500 mg/kg over at least 1 hour); rapid administration may result in prolonged hypoglycemia.

Correction of acid citrate dextrose (ACD) blood acidity in cardiac bypass surgery: Add to each 500 mL of ACD blood used to prime the pump-oxygenator.

Correction of metabolic acidosis in cardiac arrest: If chest is open, instill directly into ventricular cavity; do NOT inject into cardiac muscle. If chest is not open, inject into a large peripheral vein. Administer at same time as other standard resuscitative measures.

Vesicant (with IV administration); ensure proper needle or catheter placement prior to and during administration; avoid extravasation.

Extravasation management: If extravasation occurs, stop IV administration immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity.

Administration: Pediatric

Parenteral: IV infusion: Infuse undiluted solution (0.3 M) slowly; may administer via central line (preferred) or large peripheral vein using a large needle.

Metabolic acidosis: Administer over at least 1 hour.

Vesicant (with IV administration); ensure proper needle or catheter placement prior to and during administration; avoid extravasation. If extravasation occurs, stop IV administration immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity.

Use: Labeled Indications

Metabolic acidosis: Correction of metabolic acidosis associated with cardiac bypass surgery or cardiac arrest; to correct acidity of stored blood that is preserved with acid citrate dextrose; metabolic acidosis associated with respiratory distress syndrome in neonates and infants.

Medication Safety Issues
Sound-alike/look-alike issues:

Tromethamine may be confused with TrophAmine

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Alpha-/Beta-Agonists (Indirect-Acting): Alkalinizing Agents may increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapy

Amantadine: Alkalinizing Agents may increase the serum concentration of Amantadine. Risk C: Monitor therapy

Amphetamines: Alkalinizing Agents may decrease the excretion of Amphetamines. Management: Consider alternatives to using amphetamines and alkalinizing agents in combination. If these agents must be used together, patients should be monitored closely for excessive amphetamine effects. Risk D: Consider therapy modification

Flecainide: Alkalinizing Agents may decrease the excretion of Flecainide. Risk C: Monitor therapy

Mecamylamine: Alkalinizing Agents may increase the serum concentration of Mecamylamine. Risk C: Monitor therapy

Memantine: Alkalinizing Agents may increase the serum concentration of Memantine. Risk C: Monitor therapy

QuiNIDine: Alkalinizing Agents may increase the serum concentration of QuiNIDine. Risk C: Monitor therapy

QuiNINE: Alkalinizing Agents may increase the serum concentration of QuiNINE. Risk C: Monitor therapy

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Breastfeeding Considerations

It is not known if tromethamine is present in breast milk.

The manufacturer recommends that caution be exercised when administering tromethamine to breastfeeding women.

Monitoring Parameters

Serum electrolytes (especially potassium, blood glucose); renal function, urinary output, arterial blood gases, ECG monitoring, fluid status, ventilation rate.

Check infusion site frequently during administration.

Reference Range

Blood pH (physiologic): 7.38-7.42

Mechanism of Action

Acts as a proton acceptor, which combines with hydrogen ions, liberating bicarbonate buffer, to correct acidosis. It buffers both metabolic and respiratory acids, limiting carbon dioxide generation. Also an osmotic diuretic.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: 30% of dose is not ionized.

Excretion: Urine (>75%) within 8 hours.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Tris fresenius kabi;
  • (DE) Germany: 3 M Trometamol | Tham Koehler;
  • (FI) Finland: Aci-tham;
  • (LT) Lithuania: Tham Koehler;
  • (SE) Sweden: Addex-tham;
  • (UY) Uruguay: Trometamina
  1. Adrogue HJ and Madias NE, “Management of Life-Threatening Acid-Base Disorders: First of Two Parts,” N Engl J Med, 1998, 338(1):26-34. [PubMed 9414329]
  2. Brierley J, Carcillo JA, Choong K, et al, “Clinical Practice Parameters for Hemodynamic Support of Pediatric and Neonatal Septic Shock: 2007 Update from the American College of Critical Care Medicine,” Crit Care Med, 2009, 37(2):666-88. [PubMed 19325359]
  3. Fuhrman B, Zimmerman J, eds. Pediatric Critical Care. 5th ed. Elsevier Health; 2016.
  4. Gupta JM, Dahlenburg GW, Davis JA. Changes in blood gas tensions following administration of amine buffer THAM to infants with respiratory distress syndrome. Arch Dis Child. 1967;42(224):416-427. [PubMed 4951641]
  5. Kleinman ME, Chameides L, Schexnayder SM, et al. Part 14: pediatric advanced life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010;122(18 Suppl 3):S876-908. [PubMed 20956230]
  6. Kliegman RM, Behrman RE, Jenson HB, et al, eds. Nelson Textbook of Pediatrics. 18th ed. Philadelphia, PA: Saunders Elsevier; 2007.
  7. Nahas GG, Sutin KM, Fermon C, et al, “Guidelines for the Treatment of Acidaemia With THAM,” Drugs, 1998, 55(2): 191-224.
  8. Strauss J. Tris (hydroxymethyl) amino-methane (Tham): a pediatric evaluation. Pediatrics. 1968;41(3):667-689. [PubMed 4868611]
  9. Tham (tromethamine) [prescribing information]. Lake Forest, IL: Hospira Inc; February 2020.
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