Trometamol H (Trometamol N)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspsolution for infusions
Composition:In one liter of solution contains:
Active substances:
trometamol 36.30 g, potassium chloride 0.37 g, sodium chloride - 1.75 g.
Excipients:
acid acetic 99% - 6.01 g, water for injections - 968.2 g.
TO+ - 5 Mm / l, Na+ - 30 mM / l, Cl- - 35 mM / l.
Theoretical osmolarity: 470 mOsmol / l.
Description:transparent colorless or almost colorless liquid, free of particles, odorless
Pharmacotherapeutic group:antacidemic agent
Pharmacodynamics:

The aim of therapy with Trometamol H is to reduce the concentration of hydrogen ions by administering compounds acting as acceptors of H+.

Trometamol, which is part of Trometamol H, is a proton acceptor: trometamol + H2C03 <=> trometamol-H+ + HC03-

The use of the principle of therapeutic effect of trometamol is shown, first of all, in cases when the introduction of ions Na+, associated with the return of hydrocarbonate, is undesirable for electrolyte balance, as well as for respiratory acidosis, in which the introduction of bicarbonate further increases the partial pressure of carbon dioxide.

1 M trometamol neutralizes 1 M H2C03 and provides the body with 1 M bicarbonate. Due to this, the partial pressure of carbon dioxide and the concentration of hydrogen ions decrease without the involvement of lung function. In this way, trometamol can be used for respiratory and metabolic acidosis.

Pharmacokinetics:

Trometamol and trometamol-H+ are excreted by the kidneys unchanged; in 8 hours from the body is deduced 75%. Trometamol undergoes glomerular filtration and does not undergo tubular resorption, and therefore, like osmotic diuretics, it increases diuresis and, with preserved glomerular filtration, is eliminated from the body accordingly quickly. This effect on kidney function as an additional effect of trometamol may be desirable in metabolic acidosis and oliguria.

Indications:

Heavy forms of metabolic and respiratory acidosis:

- postpartum acidosis;

- transfusion acidosis as a result of prolonged blood transfusion;

- cellular acidosis in hyperglycemic coma;

- severe burns;

- shock;

- use of extracorporeal circulation in cardiac surgery;

- cerebral edema;

- severe forms of toxic pulmonary edema;

- functional postoperative renal failure;

- poisoning with barbiturates, salicylates and methyl alcohol.

Contraindications:

- Hypersensitivity to the components of the drug;

- alkalosis;

- severe renal insufficiency;

- chronic compensated respiratory failure (emphysema);

- shock in the terminal stage;

- hyperhydration;

- hypokalemia;

- hyponatremia;

- children under 1 year.

Carefully:With caution: moderate renal, and / or hepatic insufficiency.
Pregnancy and lactation:

The use of the drug during pregnancy and lactation is possible only if the intended benefit to the mother exceeds the possible risk to the fetus or child.

Dosing and Administration:

The drug is intended only for intravenous administration by prolonged dropping infusion for at least one hour.

If necessary, the dose should be reduced on the second and subsequent days.

The dose is set depending on the severity of the existing acidosis. The method of choice is targeted buffer therapy under the control of the acid-alkaline state of the blood. Accordingly, the amount of Trometamol H needed for the infusion is proportional to the calculated negative excess of the base (BE) and the mass of the body and, unless prescribed otherwise, is:

1 ml of Trometamol H = BE (mM / l) x kg body weight x 2

(coefficient 2 was obtained as a result of a decrease in the buffer capacity after addition of 100 mM acetate / l).

Blind Buffering

If the technical conditions for determining the parameters of the acid-base state of the blood are absent, then in the presence of clinical indications, one can perform blind buffering with Trometamol N.

Unless otherwise prescribed, the average adult dose is 5-10 ml of Trometamol N / kg body weight / h, corresponding to 500 ml / h. The daily dose is 1000 (-2000) ml.

The daily dose for children from 1 year is 10-20 ml of Trometamol N / kg of body weight.

The maximum dose is 1.5 g / kg / day.

When using high doses, it is recommended (to avoid a decrease in the concentration of electrolytes in the blood) to add NaCl at the rate of 1.75 g and KC1 at a rate of 0.372 g per liter of 3.66% solution.

If there is a danger of developing hypoglycemia, it is recommended to simultaneously inject 5-10% dextrose solution with insulin (at the rate of 1 unit of insulin per 4 g of dry dextrose).

Side effects:

Normally, Trometamol H is well tolerated.

If the rate of infusion is too high, there may be: irritation of the veins and hemolysis, possibly lowering blood pressure, hypokalemia, and venous spasm.Due to tissue irritation, thrombophlebitis may develop at the injection site.

The rapid decrease in the partial pressure of carbon dioxide and the increase in pH can lead to respiratory depression. In this connection, in the case of respiratory acidosis, the infusion of Trometamol H is recommended only if it is possible to carry out artificial ventilation. Due to the increased release of insulin and the accelerated utilization of glucose on the periphery, hypoglycemia may develop.

As a result of increased diuresis may occur: hyponatremia and hypochloremia. Because of hyperkalemia, which first develops due to the displacement of cellular potassium (in particular, with renal insufficiency), and because of secondary losses of potassium, if necessary, it is required to control the potassium level in the serum (see. Special instructions).

Overdose:

Symptoms: general weakness, arterial hypotension, respiratory depression, hypoglycemia, disturbance of water-electrolyte balance and acid-base balance.

Treatment: there is no specific antidote. Conduction of symptomatic therapy, if necessary - artificial ventilation.

Interaction:

With the simultaneous use of Trometamol H and anti-diabetic drugs, there may be a mutual increase in hypoglycemic action (a risk of hypoglycemia), and therefore simultaneous use or reduction of the dose of the corresponding antidiabetic drug should be avoided.

When mixed in the same container with other medicinal products, it should be taken into account that the pH value of the solution of Trometamol H is 8.1-8.7, which can lead to the formation of a sediment B in the mixture.

If Trometamol H is mixed in one container with other solutions for parenteral administration, cloudiness or opalescence is observed, then such a combined solution can not be used.

The effect of narcotic analgesics, aminoglycosides, macrolides (erythromycin, oleandomycin), chloramphenicol, and tricyclic antidepressants is increasing.

Weaken the effect of indirect anticoagulants (coumarin derivatives), barbiturates, salicylates with simultaneous use with Trometamol N.

Special instructions:

The ingestion of the drug into the paravenous space can lead to the development of local tissue necrosis.

There is a danger of developing a tendency towards respiratory depression (see Fig. Side effect).

In the process of using the drug, it is necessary to monitor the glucose content in the blood (the risk of hypoglycemia), ionograms of serum, bicarbonate concentration, carbon dioxide partial pressure and acid-base balance; conducting forced diuresis.

The use of the drug in newborns is possible only if the intended benefit exceeds the possible risk.

To avoid the development of side effects trometamol do not enter at high speed. Rapid administration (up to 60 ml / min) is allowed in exceptional cases (for example, to eliminate acidosis during cardiac arrest).

Form release / dosage:Solution for infusion.
Packaging:

500 ml in bottles of transparent glass type I (Hebrew F.), closed with a bromobutyl rubber stopper type I (Eur.F) for piercing and a plastic lid under aluminum with a plastic holder fixed to the bottle.

10 bottles in a cardboard box with instructions for use (for hospitals).

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep the medicine out of the reach of children!

Shelf life:

2 years.

Do not use after the expiration date stated on the package.

Use only clear solutions in intact vials!

Terms of leave from pharmacies:On prescription
Registration number:LSR-001567/08
Date of registration:14.03.2008
The owner of the registration certificate:Berlin-Chemie / Menarini Pharma, GmbH Berlin-Chemie / Menarini Pharma, GmbH Germany
Manufacturer: & nbsp
Representation: & nbspBERLIN-CHEMI / MENARINI PHARMA GmbH BERLIN-CHEMI / MENARINI PHARMA GmbH Germany
Information update date: & nbsp18.10.2015
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