Pharmacological properties of the drug Aminoplasmal 10% E
Aminoplasmal 10% E is a solution of amino acids (essential and essential) and electrolytes necessary for protein synthesis in the body and achieving a positive nitrogen balance during prolonged parenteral nutrition, as well as in the postoperative period. Eight of the basic set of 20 amino acids cannot be synthesized by the human body and come with food. These are essential amino acids - isoleucine, leucine, lysine, methionine, phenylalanine, threonine, valine. The introduction of non-essential amino acids improves the metabolic utilization of essential ones. This is especially important for bedridden patients, who may experience muscle breakdown of amino acids. Aminoplasmal 10% E contains an optimal set of electrolytes that provides the appropriate needs of the body when used parenterally. With total parenteral nutrition, Aminoplasmal 10% E should be used in combination with drugs that provide the body’s energy needs (fat emulsions and carbohydrate solutions). The components of Aminoplasmal 10% E are identical to substances that are present in the body during normal nutrition, therefore their metabolism occurs in accordance with normal physiological processes in the human body.
Aminoplasmal E15
For disorders of amino acid metabolism that are not congenital, the drug should be prescribed only in cases where the expected benefit of treatment outweighs the possible risk of complications.
Caution should be used when infusing large volumes of fluid into patients with heart failure.
Caution should be exercised in patients with increased plasma osmolarity. Before starting parenteral nutrition, water and electrolyte disturbances such as hypotonic dehydration, hyponatremia and hypokalemia should be corrected.
Water and electrolyte balance, blood glucose concentration, acid-base status and renal function should be constantly monitored.
Plasma protein concentrations and liver function tests should also be monitored.
In patients with renal failure, the dose of the drug should be carefully selected according to the individual needs of the patient, the severity of renal failure and the type of renal replacement therapy (hemodialysis, hemofiltration, etc.).
In patients with liver failure, the dose of the drug should be carefully selected according to the individual needs of the patient and the severity of liver failure.
Amino acid solutions are only one component of parenteral nutrition. Total parenteral nutrition, along with amino acids, requires the introduction of nutrients to meet the body's energy needs, essential fatty acids, electrolytes, vitamins, fluids and trace elements.
From the point of view of microbiological safety, after adding other drugs, Aminoplasmal E 15 should be used immediately. If the drug is not used immediately, it can be used no later than 24 hours after adding other drugs, and it can be stored during this period at a temperature of 2 to 8 ° C, only if aseptic conditions are observed when mixing.
Storage below 15°C may cause the formation of crystals, which will dissolve when the solution is heated to 25°C and gently shaken.
For single use only. The remaining unused volumes of the drug must be destroyed.
Do not reuse bottles with remaining contents.
Use the solution only if it is clear, colorless or pale yellow, and the bottle and stopper are intact.
For administration, a sterile infusion system must be used.
Use of the drug Aminoplasmal 10% E
Injected into the vena cava. Children aged 2–5 years : 15 ml/kg body weight per day, which corresponds to 1.5 g of amino acids per 1 kg of body weight. Children aged 6–14 years: 10 ml/kg body weight per day (1 g of amino acids per 1 kg of body weight). The maximum rate of administration is 1 ml/kg/h. Adults Up to 20 ml/kg body weight per day, depending on the patient’s individual need for amino acids. The rate of administration of the drug is up to 1.0 ml/kg/h, or up to 25 drops/min, which corresponds to approximately 70 ml/h. The recommended maximum dose is 20 ml/kg body weight and the rate of administration is 1 ml/kg/h and should not be exceeded!
Aminoplasmal-Hepa 10% 500 ml No. 10 bottle
Content
Special 10% solution of amino acids Advantages Key characteristics Pharmacodynamics Indications for use Contraindications With caution Method of administration and doses Recommended doses Side effects Overdose Special instructions Shelf life Storage conditions
Special 10% amino acid solution
Amino acid solution for parenteral nutrition of patients with liver diseases and for the treatment of hepatic encephalopathy
Advantages
- Has unsurpassed speed of action (about 8 hours from the start of therapy)
- Normalizes cirrhosis-induced amino acid imbalance
- Reduces blood ammonia levels
- Reduces cerebral manifestations of liver failure
- Reliable and safe to use - allows you to ensure adequate protein intake without the risk of developing hepatic encephalopathy
Key Features
- Aminoplasmal Hepa contains 20 amino acids. The composition of this solution is developed on the basis of pharmacokinetic data and is specially adapted to the protein needs of patients suffering from liver failure
- High content of branched amino acids
- Reduced content of aromatic amino acids and methionine
- Glass bottle 500 ml
Pharmacodynamics
Aminoplasmal Hepa contains 20 amino acids in the form of levorotatory isomers.
The composition of this solution is characterized by a relatively high content of branched amino acids relative to aromatic amino acids and is adapted to the metabolism of amino acids and proteins in patients with liver failure.
In acute and chronic liver failure, an imbalance of amino acids in the plasma is observed, characterized by a reduced level of branched amino acids - valine, leucine, isoleucine, and an increased level of aromatic amino acids - phenylalanine and tyrosine.
Decreased plasma levels of branched-chain amino acids are associated with increased catabolism of these amino acids in muscle.
An increase in the concentration of aromatic amino acids, the oxidative enzymes of which are localized only in the liver, is associated with reduced hepatic metabolism due to liver failure. In addition, in acute and chronic liver failure, protein breakdown in muscles is increased, which leads to additional release of aromatic amino acids into the plasma.
The purpose of the drug Aminoplasmal Hepa is aimed at reducing the catabolic utilization of amino acids and maintaining amino acid homeostasis in the plasma.
The introduction of all amino acids necessary for protein synthesis (including conditionally essential and non-essential amino acids) included in the drug Aminoplasmal Hepa ensures high nutritional efficiency and reduces the burden on the body during protein synthesis.
Thus, the main therapeutic effect of the drug Aminoplasmal Hepa is to supply the body with a substrate for protein synthesis during parenteral nutrition of patients with liver failure. At the same time, cerebral manifestations of the disease, i.e. hepatic encephalopathy, hepatic precoma or coma, are weakened, and protein tolerance and biosynthesis are significantly improved.
With the infusion of the drug Aminoplasmal Hepa, the following results are achieved: the level of branched chain amino acids is normalized; the level of aromatic amino acids is normalized; Fisher coefficient is normalized; the severity of symptoms of hepatic encephalopathy decreases; the concentration of ammonia in the blood decreases.
Indications for use
For parenteral nutrition in cases of amino acid imbalance occurring in acute and chronic liver diseases, as well as for the prevention and treatment of hepatic encephalopathy.
Contraindications
- Disorders of amino acid metabolism of extrahepatic etiology;
- Severe circulatory disorders (shock);
- Pulmonary edema;
- Severe acidosis;
- Overhydration;
- Severe hypokalemia;
- Severe hyponatremia;
- Hypersensitivity to the components of the drug;
- Children under 2 years of age;
- Pregnancy;
- Lactation period.
Due to the peculiarity of the amino acid composition, Aminoplasmal Hepa should be used only in accordance with the above indications. When using the drug Aminoplasmal Hepa in other cases, disturbances in amino acid metabolism may occur.
Carefully
Should be used with caution in patients with increased plasma osmolarity.
Directions for use and doses
Aminoplasmal Hepa is administered intravenously through a central venous catheter.
Method of using the drug:
The drug is supplied in bottles designed for single use. Any unused volumes of the drug cannot be stored and must be thrown away. Do not use the drug if the solution is not transparent, the bottle has obvious signs of damage or the seal is broken.
Recommended doses
Unless otherwise prescribed by a physician, the following doses are recommended, taking into account the individual needs of the patient:
For adults
:
Standard dose:
7-10 ml/kg body weight/day, which corresponds to 0.7 – 1 g amino acids/kg body weight/day.
Maximum dose:
15 ml/kg body weight/day, which corresponds to 1.5 g amino acids/kg body weight/day.
Children from 2 years old:
Standard dose:
7-10 ml/kg body weight/day, which corresponds to 0.7 – 1 g amino acids/kg body weight/day.
When using the drug Aminoplasmal Hepa in children, it is necessary to especially carefully consider the age, nutritional status and underlying disease of the patient.
In the case of total parenteral nutrition, it is also necessary to administer carbohydrates, essential fatty acids, vitamins and microelements.
Infusion rate:
Treatment of hepatic coma
For patients with hepatic encephalopathy, it is recommended to administer Aminoplasmal Hepa at a high rate at the beginning of treatment until the effect occurs. For example, for a patient weighing 70 kg:
During the first two hours of infusion:
50 drops/min, which approximately corresponds to 150 ml/hour (2 ml/kg body weight/hour)
from the 3rd to the 4th hour of infusion:
25 drops/min, which approximately corresponds to 75 ml/hour (1 ml/kg body weight/hour)
starting from the 5th hour of infusion:
15 drops/min, which corresponds to approximately 45 ml/hour (0.6 ml/kg body weight/hour).
Maintenance therapy/parenteral nutrition:
15-25 drops/min, which approximately corresponds to 45-75 ml/hour (0.6 - 1.0 ml/kg body weight/hour).
Duration of use:
Aminoplasmal Hepa should be used until the threat of developing hepatic encephalopathy disappears.
Side effects
If the recommendations regarding the specified precautions, speed of administration and dosage are followed, no side effects are observed, but allergic reactions may develop.
Overdose
An overdose or exceeding the recommended rate of infusion of the drug may lead to symptoms such as chills, nausea, vomiting and increased excretion of amino acids by the kidneys. In such cases, the drug should be stopped and resumed later at a lower infusion rate.
Interactions with other drugs and other types of interactions
There are no known drug interactions with other drugs.
Due to the danger of bacterial contamination and physicochemical incompatibility, it is not recommended to introduce any other drugs into Aminoplasmal Hepa; it is preferable to include them in standard solutions of carbohydrates or electrolytes. However, it is possible to mix Aminoplasmal Hepa with other solutions for parenteral nutrition after checking their compatibility.
special instructions
Do not inject into peripheral veins.
If the patient simultaneously has renal failure, the dose of amino acids should be adjusted depending on the level of urea and creatinine in the serum.
Therapy with amino acid solutions does not replace other therapeutic measures established for the treatment of hepatic encephalopathy.
Simultaneously with the introduction of the amino acid composition, the use of other nutrients is indicated. The administration of the drug Aminoplasmal Hepa should be accompanied by the introduction of an adequate amount of carbohydrates.
Electrolytes should be used as needed.
During the treatment period, it is necessary to monitor water and electrolyte balance, plasma osmolarity, acid-base balance, blood glucose concentration and liver function. The frequency and method of monitoring depend on the severity of the disease and the severity of the patient’s condition.
The duration of administration from one bottle should not exceed 24 hours.
Best before date
3 years.
Do not use after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 25 ° C in a place protected from light. Do not freeze! Keep out of the reach of children.
