Amino acids for parenteral nutrition + Other preparations [Fat emulsions for parenteral nutrition + Dextrose + Minerals] - instructions for use, doses, side effects, contraindications

Clinical and pharmacological group: & nbsp

Means for enteral and parenteral nutrition

Included in the formulation

АТХ:

B.05.B.A.10 Combined preparations for parenteral nutrition

Pharmacodynamics:The three-component mixture is designed to maintain protein and energy metabolism. The source of organic nitrogen is L-amino acids, the energy source is the dextrose and fatty acids. In addition, the mixture contains electrolytes. It replenishes the deficiency of essential fatty acids in the body. Olive oil contains a significant amount of alpha-tocopherol, which in combination with a small amount of polyunsaturated fatty acids increases the amount of vitamin E in the body and reduces lipid peroxidation. Source of amino acids, dextrose and fat emulsions. Dextrose - participation in the metabolism in the form of glucose-6-phosphate. Normalization of electrolyte balance - ions of sodium, chlorine, acetate-ion.

Pharmacokinetics:

Ingredients of the emulsion for infusions (amino acids, electrolytes, dextrose, lipids) are metabolized and removed from the body in the same way as when they are assigned separately. The pharmacokinetic properties of amino acids injected intravenously coincide with the properties of amino acids supplied by natural (enteral) nutrition (however, in this case the amino acids derived from food proteins pass through the liver before entering the systemic bloodstream). The rate of elimination of lipid emulsion particles depends on their size. Small lipid particles are released more slowly, while they are more quickly cleaved by the action of lipoprotein lipase. The particle size of lipid emulsion in the preparation approaches the size of chylomicrons, so they have a similar elimination rate.

With intravenous administration, absolute bioavailability is 100%. Amino acids are included in the pool of free amino acids of the body, distributed in the interstitial fluid and the intercellular space. Assimilation of essential amino acids - 99%, replaceable - 97%. The total and renal clearance of essential amino acids is 0.5 l / min and 1.5 ml / min, for most interchangeable amino acids - 0.6 l / min and 3 ml / min. The elimination half-life depends on the age.Biotransformation in the liver is carried out by deamination of the α-amino group to urea. Arginine almost completely reabsorbed in the renal tubules. Urea is excreted by the kidneys (5% of amino acids - in unchanged form).

Dextrose is metabolized completely, not eliminated (detection in the urine indicates a pathology).

Biotransformation in the liver occurs through the formation of pyruvate or lactic acid to water and carbon dioxide with the release of energy. Calcium and magnesium ions penetrate the placental barrier and into breast milk. Elimination by the kidneys (potassium ions - in the distal tubules in exchange for sodium or hydrogen ions), a small amount is excreted with sweat. 25-30% of magnesium binds to plasma proteins.

The rate of elimination of lipid emulsion particles depends on their size. Small lipid particles are released more slowly, while they are more quickly cleaved by the action of lipoprotein lipase.

Indications:Parenteral nutrition.

ICD-10

IV.E40-E46.E44 Protein-energy insufficiency of moderate and weak degree

IV.E50-E64.E61.7 Insufficiency of many cells

Contraindications:Hypersensitivity, severe renal failure in the absence of the possibility of hemofiltration or dialysis, severe hepatic insufficiency, congenital disorders of amino acid metabolism, severe blood clotting disorders, severe hyperlipidemia, hyperglycemia, electrolyte metabolism disorders, increased plasma concentration of one of the electrolytes included in the mixture, lactic acidosis, pulmonary edema, hyperhydration, decompensated heart failure, hypotonic dehydration, unstable states (in tons including severe posttraumatic conditions, decompensated diabetes mellitus, acute phase of hypovolemic shock, acute phase of myocardial infarction, severe metabolic acidosis, severe sepsis, hyperosmolar coma), children's age (up to 2 years).

Carefully:

Hyperosmolarity of plasma, adrenal insufficiency, heart failure, lung diseases, pregnancy, lactation.

Pregnancy and lactation:

The category of FDA recommendations is not defined. Adequate and well-controlled studies on humans and animals have not been conducted.

There is no information on the penetration into breast milk.

Dosing and Administration:

Intravenous (through the central vein).

The dose and duration of the appointment depends on the patient's condition and the needs of the body. The average requirement for organic nitrogen is 0.16-0.35 g / kg per day (1-2 g of amino acids per 1 kg of weight per day); the energy requirement varies depending on the patient's condition and intensity of catabolic processes, on average 25-40 kcal / kg per day.

The maximum daily dose: 36 ml / kg of body weight (equivalent to 1.44 g of amino acids, 5.76 g of dextrose and 1.44 g of lipids per 1 kg of body weight), that is, 2520 ml of emulsion to a patient weighing 70 kg.

The infusion rate is no more than 1.5 ml / kg / h, that is, not more than 0.06 g of amino acids, 0.24 g of dextrose and 0.06 g of lipids per kg / h.

Use in children

2-18 years: average requirement for organic nitrogen is 0.35-0.45 g / kg per day (approximately 2-3 g of amino acids per 1 kg of weight per day); the energy requirement is 60-110 kcal / kg per day. The dose depends on the amount of fluid that has entered the body, from the daily requirement for protein and the state of water metabolism. The maximum daily dose is 75 ml / kg (equivalent to 3 g of amino acids, 12 g of dextrose and 3 g of lipids per 1 kg of body weight).

Side effects:Hyperthermia, sweating, tremor, nausea, headache, respiratory failure; sometimes (especially during prolonged use - for several weeks), - a temporary increase in the concentration of biochemical markers of liver function (including alkaline phosphatase, transaminases, bilirubin); in rare cases - hepatomegaly, jaundice, anemia in children with severe allergic reaction (contains soybean oil), with reduced ability to eliminate from the blood lipids or introduction rate exceeding the recommended (at the beginning of the infusion) - a syndrome "fat overload" (hyperlipidemia, fever, fatty liver, hepatomegaly, anemia, leukopenia, thrombocytopenia, impaired coagulation, coma).

Overdose:

Symptoms: hypervolemia, acidosis, nausea, vomiting, tremor, electrolyte imbalance syndrome "fat overload", hyperglycemia, glucosuria and a hyperosmolar syndrome.

Treatment: the administration is immediately stopped, in severe cases, hemodialysis, haemofiltration or hemodiafiltration may be required.

Interaction:

Blood products - pharmaceutical incompatibility.

Compatible with solutions of vitamins, microelements, organic phosphates, electrolytes.

Special instructions:

Before the start of the infusion, correction of the water and electrolyte balance and metabolic disturbances should be carried out.

Does not contain vitamins and trace elements; when they are added before the start of infusion, it is necessary to determine the doses of these substances (depending on the need) and calculate the osmolality of the resulting solution.

Simultaneous introduction of other nutrients: additional nutrients (including vitamins) can be added to the prepared mixture or into the section with a solution of dextrose before stirring the contents of the sections. It is possible to add electrolytes (emulsion stability retained if added to 150 mM sodium, 150 mM potassium, 5.6 mM magnesium, calcium 5 mmol per 1 liter of final mixture), organic phosphates (emulsion stability is preserved by the addition of 15 mmol per package) , microelements and vitamins (the stability of the emulsion is preserved by adding doses not exceeding daily allowances).

Do not administer into the peripheral vein.

During the course of treatment, it is necessary to control the water-electrolyte balance, plasma osmolality, acid-base state,blood glucose concentrations and functional hepatic tests, triglyceride levels and the ability to remove lipids from the bloodstream, blood counts and coagulograms.

The concentration of serum triglycerides during infusion should not exceed 3 mmol / l. It should be measured no earlier than 3 hours after the start of the infusion. If the lipid metabolism is suspected, the same tests are repeated 5 to 6 hours after the administration of the emulsion is stopped. In adults, elimination of lipids should occur less than 6 hours after stopping the infusion of the lipid emulsion. The next infusion is carried out only after the concentration of triglycerides is normalized.

A regular clinical examination should be performed in case of hepatic insufficiency (risk of occurrence or strengthening of neurological disorders associated with hyperammonemia), renal insufficiency, hyperkalemia (risk of development or enhancement of metabolic acidosis, hyperaemia, hemophilia or dialysis), diabetes mellitus (glucose control, glucosuria , ketonuria and correction of insulin dose), clotting disorders, anemia, hyperlipidemia.

When choosing a dose, take into account the child's age, protein and energy requirements, as well as the nature of the disease. If necessary, proteins and / or energy components (carbohydrates, lipids) are added enterally.

For children over the age of 2 years, it is advisable to choose the volume of the container in accordance with the daily dose. Vitamins and trace elements are added according to the age requirement.

If symptoms of an allergic reaction (fever, chills, skin rash, breathing disorder) or "fat overload" syndrome occur, the infusion should be stopped.

When carrying out the treatment, it is necessary to take into account the state of the veins and periodically change the place of administration of the solution.

Intravenous introduction of amino acid solutions is accompanied by increased release of trace elements (especially Cu2 + and Zn2 +) in the urine. It is necessary to adjust the content of microelements (especially with long-term treatment).

Patients in need of prolonged parenteral nutrition may require additional micronutrients. In severely depleted patients at the beginning of treatment, there may be a disturbance of the water balance with the development of pulmonary edema and congestive heart failure.In addition, within 24-48 hours in blood plasma can be observed a decrease in the concentrations of potassium, phosphorus, magnesium and water-soluble vitamins. It is recommended to begin parenteral nutrition slowly, with careful monitoring and appropriate correction of the amount of fluid, electrolytes, vitamins and trace elements.

In connection with the risk of pseudoagglutination, it is not recommended to use the same infusion systems for the administration of blood products and multicomponent amino acid solutions. If blood sampling is performed before the lipids are eliminated from the plasma (usually 5-6 hours after the injection of emulsion ceased), the lipids contained in it can influence the results of some laboratory tests (including the determination of bilirubin concentration, lactate dehydrogenase activity, saturation hemoglobin with oxygen).

Plastic containers are designed for single use. The drug can not be used for damage to the container, a violation of transparency or tightness.

Instructions

Amino acids for parenteral nutrition + Other drugs [Fat emulsions for parenteral nutrition + Dextrose + Minerals] (Aminoacids for parenteral nutrition + Other medicines [Fat emulsions + Dextrose + Multimineral])