Trometamol of N

General characteristics. Structure:

Active ingredients: трометамол 36,30 g; potassium chloride of 0,37 g; sodium chloride of 1,75 g;
Excipients: acetic acid of 99%, water for injections. To + - 5 mm/l, Na + - 30 mm/l, Sl-35 mm/l. Theoretical osmolarity: 470 ¼Äß¼«½ý/l.

Pharmacological properties:

Pharmacodynamics. The therapy purpose Trometamoly N consists in decrease in concentration of ions of hydrogen by introduction of the connections operating as H+ acceptors.

Trometamol who is Trometamol's part of N is an acceptor of protons: трометамол + H2CO3 <=> trometamol-N + + NSO3-

Use of the principle of therapeutic action of a trometamol is shown, first of all, when the introduction of ions of Na+ connected with return of a hydrocarbonate for electrolytic balance is undesirable, and also at a respiratory acidosis at which introduction of a hydrocarbonate increases the partial pressure of carbon of dioxide even more.

1 The m of a trometamol neutralizes 1 M of H2CO3 and provides to an organism 1 M of a hydrocarbonate. Thanks to it the partial pressure of carbon of dioxide and concentration of ions of hydrogen decrease without attraction of function of lungs. Thus, трометамол it is possible to apply at respiratory and metabolic acidosises.

Pharmacokinetics. Trometamol and trometamol-N + are removed by kidneys in not changed look; in 8 h 75% are brought out of an organism. Trometamol is exposed to glomerular filtering and is not exposed to a canalicular resorption in this connection he, as well as osmotic diuretics, increases a diuresis and at the kept glomerular filtering is brought from an organism respectively quickly. This action on function of kidneys as additional effect of a trometamol can be desirable at a metabolic acidosis and an oliguria.

Indications to use:

Severe forms of metabolic and respiratory acidosises:
• puerperal acidosises;
• transfusion acidosis as a result of a long hemotransfusion;
• cellular acidosis at a hyper glycemic coma;
• heavy burns;
• shock;
• use of extracorporal blood circulation in cordial surgery;
• brain hypostasis;
• severe forms of a toxic fluid lungs;
• functional postoperative renal failure;
• poisoning with barbiturates, salicylates and methyl alcohol.

Route of administration and doses:

Drug is intended only for intravenous administration by long drop infusion within not less than one hour.

In need of introduction the second and next days the dose should be reduced.

The dose is established depending on severity of the available acidosis. Method of the choice is purposeful buffer therapy under control of an acid-base condition of blood. Respectively, Trometamol's number of N, necessary for injection, is proportional to the calculated negative size of surplus of the basis (BE) and body weight and if it is not offered differently, makes: 1 ml of Trometamol of N = BE (mm/l) x kg of body weight x 2 (the coefficient 2 is received as a result of reduction of buffer capacity after addition of 100 mm of acetate/l).

Blind buffering

If specifications for definition of indicators of an acid-base condition of blood are absent, then in the presence of clinical indications it is possible to carry out blind buffering by Trometamol N.

If it is not offered differently, the average dose for adults makes 5-10 ml of Trometamol Nkg of mass of body/h that corresponds to 500 ml/h. Daily dose of-1000 (-2000) ml.

The daily dose for children of 1 year makes 10-20 ml of Trometamol Nkg of body weight.

The maximum dose - 1,5 g/kg/days.

When using high doses it is recommended (in order to avoid reduction of concentration of electrolytes in blood) to add NaCl at the rate of 1,75 g and KSL at the rate of 0,372 g on 1 l of 3,66% of solution.

If there is a danger of development of a hypoglycemia, it is recommended to enter at the same time 5-10% dextrose solution with insulin (at the rate of 1 PIECE of insulin on 4 g of a dry dextrose).

Features of use:

Hit of drug in paravenous space can lead to development of a local necrosis of fabrics.

There is a danger of development of a tendency to respiratory depression (see. Side effect).

In the course of use of drug control of content of glucose in blood (danger of a hypoglycemia), ionogramma of serum, concentration of bicarbonate, partial pressure of carbon of dioxide and acid-base equilibrium is necessary; carrying out an artificial diuresis.

Use of drug for newborns is possible only if the estimated advantage exceeds possible risk.

In order to avoid development of by-effects трометамол it is not necessary to enter with high speed. Bystry introduction (to 60 ml/min.) is allowed in exceptional cases (for example, for elimination of acidosis at a cardiac standstill).

Side effects:

Usually Trometamol of N is had well.

At too high speed of infusion can be observed: the irritation of walls of veins and hemolysis, is possible a lowering of arterial pressure, a hypopotassemia, веноспазм. Owing to irritation of fabrics in the place of an injection thrombophlebitis can develop.

Rapid reduction of partial pressure of carbon of dioxide and increase in value рН can lead to respiratory depression. In this regard at a respiratory acidosis Trometamol's injection the N is recommended only under a condition if there is a possibility of carrying out artificial ventilation of the lungs.

Owing to the strengthened release of insulin and the accelerated utilization of glucose on the periphery the hypoglycemia can develop.

Increases in a diuresis can be caused: hyponatremia and hypochloraemia. Because of the hyperpotassemia at first developing in connection with replacement of cellular potassium (in particular, at a renal failure), and because of secondary losses of potassium if necessary monitoring procedure of level of potassium in blood serum is required (see. Special instructions).

Interaction with other medicines:

At simultaneous use of Trometamol of N and antidiabetic drugs mutual strengthening of hypoglycemic action (danger of development of a hypoglycemia) in this connection it is necessary to avoid simultaneous use or to reduce a dose of the corresponding antidiabetic drug can take place.

When mixing in one container with other medicines it is necessary to consider that рН Trometamol's solution of N makes value 8,1-8,7 that can lead to formation of a deposit in mix.

If when mixing Trometamol's the N in one container with other solutions for parenteral administration is observed opacification or opalescence, then such combined solution cannot be used.

The effect of narcotic analgetics, aminoglycosides, macroleads (erythromycin, Oleandomycinum), chloramphenicol, tricyclic antidepressants amplifies.

The effect of indirect anticoagulants (coumarin derivatives), barbiturates, salicylates is weakened at simultaneous use with Trometamol N.

Contraindications:

• hypersensitivity to drug components;
• alkalosis;
• heavy renal failure;
• the chronic compensated respiratory insufficiency (emphysema of lungs);
• shock in an end-stage;
• overhydratation;
• hypopotassemia;
• hyponatremia;
• children till 1 year.

With care: moderate renal and/or liver failure.

Use at pregnancy and a lactation

Use of drug during pregnancy and in the period of a lactation perhaps only if the estimated advantage for mother exceeds possible risk for a fruit or the child.

Overdose:

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

Treatment: there is no specific antidote. Performing symptomatic therapy, in case of need, - artificial ventilation of the lungs.

Storage conditions:

In the place protected from light at a temperature not above 25 °C. To store medicine in the place, unavailable to children! Period of validity 2 years. Not to apply after the expiry date specified on packaging.

To use only transparent solutions in the unimpaired bottles!

Issue conditions:

According to the recipe

Packaging:

Solution for infusions.

On 500 ml in bottles from transparent glass like I (Evr. T.), closed a brombutilovy rubber stopper like I (Evr. T) for piercing and a plastic cover under an aluminum running in with the plastic holder strengthened on a bottle.

On 10 bottles in a cardboard box with the application instruction (for hospitals).