2010/09/20

Aminosol-Neo

Composition, structure and packing 

Solution for infusion 10% transparent, ranging from colorless to slightly yellow l -1, 10% p-ra 1 l 15% p-ra.
L-isoleucine 5 g / 5.2 g;
L-leucine 7.4 g/8.9 g;
L-valine 6.2 g/5.5 g;
L-lysine monoatsetat 9.31 g / 15.66 g which corresponds to the content of L-lysine 6.6 g / 11.1 g;
L-methionine 4.3 g / 3.8 g;
L-threonine 4.4 g/8.6 g;
L-phenylalanine 5.1 g/5.5 g;
L-alanine 14 g/25 g;
L-arginine 12 g/20 g;
glycine g/18.5 11 g;
L-histidine 3 g/7.3 g;
L-proline 11.2 g/17 g;
L-serine 6.5 g/9.6 g;
L-tyrosine 0.4 g/0.4 g;
Taurine 1 g / 2 g;
L-tryptophan 2 g / .6 g;
Energy value 400 kcal / l (1680 kJ / l) / 600 kcal / l (2520 kJ / l);
osmolarity of 990 mOsm / l / 1505 mOsm / l pH 5.5-6.5 5.5-6.5;
L-malic acid - qs

Excipients: glacial acetic acid, water d / and.

Clinico-pharmacological group: The preparation for parenteral nutrition - a solution of amino acids.

Pharmacological action

Combined preparation for parenteral nutrition, which contains essential and nonessential amino acid in the optimum ratio. All amino acids are L-form that allows their direct involvement in the biosynthesis of proteins.

The product contains 8 essential amino acids (not synthesized in the human body): L-isoleucine, L-Leucine, L-lysine, L-methionine, L-phenylalanine, L-threonine, L-tryptophan and L-valine, as well as conventionally interchangeable L -arginine and L-histidine. They are synthesized by the body, but under certain pathophysiological states (eg, renal and hepatic failure) and in young children their concentration does not reach the required level. L-arginine contributes to optimal transformation of ammonia into urea, binding toxic ammonium ions, which are formed during the catabolism of proteins in the liver. L-isoleucine, L-leucine and L-valine - amino acids with branched side chains satisfy the energy needs of the organism, which is especially important immediately in the postoperative period. Amino acids containing aromatic rings represented L-phenylalanine and L-tyrosine in a small and safe amount that is due to the potential for tserebrotoksicheskogo action at high concentrations.

Mainly, minimizing the concentration applies to L-tyrosine, one of the derivatives of which is octopamine - a false neurotransmitter, toxic effect on the CNS. The nitrogen content of 10% solution of -16.2 g / l in 15% solution - 25.7 g / liter. The content of amino acids in 10% solution - 100 g / 1 liter, 15% solution - 150 g / 1 liter. Pharmacokinetics Input parenteral amino acids used in the body in the synthesis of protein. Unused in this process, amino acids deaminated with the formation of urea, which is then excreted in the urine. T1 / 2 amino acids in healthy individuals is 5-15 min. Some amino acids can not undergo biotransformation and is excreted in unchanged form, the desired effect of these compounds in such a case is lost. This pharmacokinetic feature can be eliminated by introducing the drug slowly enough that the concentration of amino acids in the blood is not sharply increased. This method avoids the introduction of amino acid excretion by the kidneys unchanged.

Statement

Parenteral nutrition partial or complete (with the addition of fat emulsion, electrolytes and carbohydrates), as well as prevention and treatment of loss of protein and fluid when it is impossible to use enteral nutrition:
severe cases of gastrointestinal disease (obstruction, malabsorption, inflammatory bowel disease, pancreatitis, intestinal fistulas);
hypermetabolic states (trauma, burns, sepsis);
Other cases requiring parenteral nutrition (malignancies, in preparation for surgery and after surgery).

Dosage regimen

Aminosol-Neo is used as in / infusion through a central vein. Dose was set individually according to severity of metabolic disturbances and body's need for amino acids. With the introduction of 10% solution of the average dose for adults is 10-20 ml / kg / day, respectively - 1.2 g amino acids / kg / day. Maximum speed of introduction - 1 ml / kg / h, the recommended infusion rate - 20-35 drops / min, the maximum daily dose is 20 ml / kg.

With the introduction of 10% solution of the average dose for adults is 6.7-13.3 ml / kg / day, respectively - 2.1 g amino acids / kg / day. Maximum speed of introduction - 0.67 ml / kg / h, the maximum daily dose is 13.3 ml / kg. For patients weighing 70 kg daily dose is 470-930 mL, the recommended rate of introduction - 16 drops / min.

Patients with renal failure (without dialysis) recommend the introduction of proteins in a dose of 0.6-1 g / kg / day, patients with renal failure on dialysis - 1.2-2.7 g / kg / day. When liver failure protein requirements of 0.8-1.1 g / kg / day.

Side effect

In applying the drug is possible folate deficiency in the body, resulting in the therapy with this drug requires a daily intake of folic acid.

Contraindications
metabolic acidosis;
severe renal insufficiency;
severe hepatic impairment;
shock;
hypoxia;
heart failure in the stage of decompensation;
Pregnancy
Lactation (breastfeeding);
childhood and adolescence to 18 years (the effectiveness and safety have not been established).

Precautions should be prescribed the drug in sepsis, essential hypertension, liver disease, diabetes mellitus.

Pregnancy and lactation

Efficacy and safety of the drug during pregnancy and lactation (breastfeeding) is not installed.

Application for violations of liver function

In hepatic failure patients' needs in proteins sostavlet 0.8-1.1 g / kg / day.

Application for violations of renal function

Patients with renal insufficiency who are not on dialysis, recommended the introduction of proteins in a dose of 0.6-1 g / kg / day, patients with renal failure on dialysis, - 1.2-2.7 g / kg / day.

Cautions

Arginine, which is part of the drug may lead to a decrease in phosphorus concentration and increased concentration of potassium in the plasma. These changes were particularly pronounced in patients with diabetes mellitus. Insulin prevents the development of hyperkalemia caused by arginine, so patients in stressful conditions, as well as patients with diabetes (both type 1 and type 2), insulin must be entered if they get Aminosol-Neo. As a result of damage to the central vein with hemorrhage during catheterization possible bacterial or fungal thrombophlebitis.

Avoid uncontrolled addition of other drugs to the solution Aminosol-Neo. It should be used only clear solution of the intact bottle.

Overdose

Symptoms: nausea, vomiting, increased sweating, fever, tachycardia. At high speeds the introduction of possible violation of hypervolemia and electrolyte composition of plasmas.

Treatment: Symptoms of overdose are reversible. Need to reduce speed or stop the introduction of the drug and to appoint symptomatically.

Drug Interactions

Simultaneous injection of arginine with thiazide diuretics and aminophylline increases levels of insulin in the blood. Estrogens and oral contraceptives may cause an increased concentration of growth hormone induced by arginine, and lower glyukagonovy and insulin response to arginine.

With simultaneous application of arginine with spironolactone may develop severe hyperkalemia.

Pharmaceutical interactions

With the introduction of the drug should be aware that arginine is incompatible with sodium thiopental. The product is compatible with antibiotics (amikacin, ampicillin, cefotaxime, ceftriaxone, doxycycline, erythromycin, gentamicin, chloramphenicol, clindamycin, netilmitsin, penicillin, piperacillin, tetracycline, and vancomycin tobramitsin), as well as with other drugs (aminophylline, cyclophosphamide, cimetidine, cytarabine, digoxin, dopamine, famotidine, fitomenadion, fluorouracil, folic acid, furosemide, heparin, chlorpromazine, insulin, calcium gluconate, lidocaine, methyldopa, methylprednisolone, metoclopramide, methotrexate, morphine, nizatidin, norepinephrine, propranolol, ranitidine, and riboflavin).

Terms and Conditions of storage

The drug should be kept in the dark, away from children at a temperature of 15 ° to 25 ° C.

Shelf life - 2 years.