Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1148
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THAM Solution (Injection, Solution)
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Tham Solution (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, PO,
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 Tham Solution (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. The following formula is intended
as a general guide: Tham Solution (mL of 0.3 M) Required
= Body Weight (kg) X Base Deficit
(mEq/liter) 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.
The need for administration of additional Tham Solution is determined by serial
determinations of the existing base deficit. * 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. Correction
of Metabolic Acidosis Associated with Cardiac Bypass Surgery: 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. Correction of Acidity of ACD Blood in Cardiac Bypass Surgery: The pH of stored blood ranges from 6.80 to 6.22 depending upon
the duration of storage. 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 blood used for priming the pump-oxygenator. Clinical experience
indicates that 2 g (62 mL of a 0.3 Msolution) added to 500 mL of ACD blood
is usually adequate. Correction
of Metabolic Acidosis Associated with Cardiac Arrest: In the treatment
of cardiac arrest, Tham Solution should be given at the same time that other
standard resuscitative measures, including manual systole, are being applied.
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 larger peripheral vein. Additional amounts may be required to control
acidosis persisting after cardiac arrest is reversed. 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 PO,
pH and PCO. Parenteral drug products should
be inspected visually for particulate matter and discoloration prior to administration,
whenever solution and container permit. See CONTRAINDICATIONS.
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| dailymed-instance:descripti... |
Tham Solution (tromethamine injection) is a sterile, non-pyrogenic
0.3 M solution of tromethamine, adjusted to a pH of approximately 8.6 with
glacial acetic acid. It is administered by intravenous injection, by addition
to ACD blood for priming cardiac bypass equipment and by injection into the
ventricular cavity during cardiac arrest. Each 100 mL
contains tromethamine 3.6 g (30 mEq) in water for injection. The solution
is hypertonic 389 mOsmol/L (calc.). pH 8.6 (8.4-8.7). The
solution contains no bacteriostat, antimicrobial agent or added buffer (except
acetic acid for pH adjustment) and is intended only for use as a single-dose
injection. When smaller doses are required the unused portion should be discarded. Tham
solution is a parenteral systemic alkalizer and fluid replenisher. Tromethamine,
USP (sometimes called���tris���or���tris buffer���)
is chemically designated 2-amino-2-(hydroxymethyl)-1, 3-propanediol, a solid
readily soluble in water, also classified as an organic amine buffer. It has
the following structural formula: Water
for Injection, USP is chemically designated H0.
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When administered intravenously as a 0.3 M solution, tromethamine
act as a proton acceptor and prevents or corrects acidosis by actively binding
hydrogen ions (H). It binds not only cations of fixed or metabolic
acids, but also hydrogen ions of carbonic acid, thus increasing bicarbonate
anion (HCO���). Tromethamine also acts as an osmotic diuretic,
increasing urine flow, urinary pH, and excretion of fixed acids, carbon dioxide
and electrolytes. A significant fraction of tromethamine (30% at pH 7.40)
is not ionized and therefore is capable of reaching equilibrium in total body
water. This portion may penetrate cells and may neutralize acidic ions of
the intracellular fluid. The drug is rapidly eliminatedby the kidney; 75% or more appears in the urine after eight hours. Urinary
excretion continues over a period of three days. Water
is an essential constituent of all body tissues and accounts for approximately
70% of total body weight. Average normal adult daily requirement ranges from
two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration
and urine production). Water balance is maintained by
various regulatory mechanisms. Water distribution depends primarily on the
concentration of electrolytes in the body compartments and sodium (Na)
plays a major role in maintaining physiologic equilibrium.
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Tham Solution (tromethamine injection) is contraindicated
in uremia and anuria. In neonates it is also contraindicated in chronic respiratory
acidosis and salicylate intoxication.
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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. HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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Do not administer unless solution is clear and seal is intact.
Discard unused portion.<br/>Pregnancy Category C:: 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.<br/>Nursing Mothers:: 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.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:: Studies with THAM Solution have not been performed to evaluate
carcinogenic potential, mutagenic potential or effects on fertility.<br/>Pediatric Use:: 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 PCOas 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.<br/>Geriatric Use:: 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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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
LDvalues for the acute intravenous toxicity of THAM are influenced
by the rate of infusion of the dose administered. Intravenous LDMice
= 3500 mg/kg Intravenous LDRats = 2300 mg/kg
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Tromethamine Injection
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THAM Solution (Injection, Solution)
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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.
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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. Additives
may be incompatible. Consult with pharmacist, if available. When introducing
additives, use aseptic technique, mix thoroughly and do not store.
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Tham Solution (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:
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THAM Solution
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