Vamin (Amino Acids)

VAMIN® 18 ELECTROLYTE-FREE

Pharmacia & Upjohn

Amino Acids

Nutritive and Electrolyte Supplements for I.V. Infusion

Action And Clinical Pharmacology: Vamin 18 Electrolyte-Free acts as a source for protein synthesis in patients with insufficient enteral supply of precursors for protein synthesis. The solution contains all 18 essential and nonessential amino acids. The balance between the amino acids is such that positive nitrogen balance can be achieved in the postoperative period. When the current needs of energy, electrolytes, trace elements and vitamins are covered, the infused amino acids will be utilized maximally for protein synthesis.

The metabolism of the Vamin preparations is the same as for amino acids and electrolytes obtained in food. The Vamin preparations are used in the body to maintain or restore body cell mass and electrolyte content and for the supply of energy.

They have no pharmacodynamic effects when administered at recommended rates. No effects were observed on blood pressure, heart rate and respiratory frequency in patients and healthy subjects when Vamin 18 Electrolyte-Free alone and with additional electrolytes were administered at and above the recommended dosage rates. Only negligible amounts of the infused amino acids were excreted in urine.

Plasma amino acid concentrations have been measured in patients receiving infusions of Vamin 18. The plasma concentration of valine, leucine, phenylalanine, lysine, glycine, alanine, histidine and arginine increased during a study period of 7 days. However, these increases are not considered to be clinically significant. Evaluation of amino acid concentration in patients is complicated by the derangement of the plasma aminogram which varies with the clinical situation.

Efficacy has been determined by nitrogen balance studies which indicate that the amino acid content of Vamin 18 Electrolyte-Free is used in minimizing losses of, maintaining or increasing the amount of body proteins.

The infusion of 18 g of nitrogen daily as Vamin 18 in patients with severe burns, an example of patients with a greatly increased protein requirement, led to significantly improved nitrogen balance when compared to similar patients receiving the same amount of energy but no amino acids. The nitrogen balance did not improve further when 24 g of nitrogen were administered.

Positive nitrogen balance was achieved in most surgical patients, an example of patients with a moderately increased protein requirement, by infusion of 18 g of nitrogen as Vamin 18. However, severely ill patients with highly increased excretion of nitrogen were not brought into positive nitrogen balance on all days.

To obtain a positive effect on protein metabolism there is an additional requirement. Amino acids should be infused as part of a complete nutritional regimen supplying sufficient amounts of energy and essential nutrients, e.g., essential fatty acids, electrolytes, trace elements and vitamins.

Indications And Clinical Uses: As a source of amino acids for protein synthesis in patients requiring i.v. nutrition. Vamin 18 Electrolyte-Free is suitable for patients with varying degrees of metabolic stress, from unstressed malnourished patients in an anabolic state to severely catabolic patients such as those who have experienced major surgery, severe trauma or burns.

Contra-Indications: Irreversible liver damage. Severe uremia when dialysis facilities are not available. Hypersensitivity to one or more amino acids. tag_WarningWarnings

Manufacturers’ Warnings In Clinical States: At the recommended rate of infusion single cases of nausea may occur. Vomiting, flushing and sweating may occur when the infusion rate is high.

Appropriate laboratory tests, especially those for monitoring of liver functions and renal functions, should be performed periodically during the course of use of the product.

The solutions are hypertonic and thrombophlebitis may occur when a hypertonic solution is infused into peripheral veins. Consequently, when it is infused peripherally care should be taken to select a vein so that blood flow is not reduced by the pressure of the needle or catheter. Furthermore, the risk of thrombophlebitis can be reduced if the solution is infused simultaneously with the almost isotonic fat emulsion Intralipid. A Y-connector should be employed to provide a dilution effect when using the peripheral technique.

Administration of Vamin 18 Electrolyte-Free simultaneously with blood through the same infusion apparatus can provoke pseudo-agglutination.

Vamin, like any other arginine containing amino acid solution, is an insulin secretagogue, and should be infused concomitantly with a glucose solution in order to avoid hypoglycemia.

Pregnancy and Lactation: Animal reproduction studies have not been carried out with Vamin 18 Electrolyte-Free. There are published reports on the successful and safe infusion of amino acid solutions during pregnancy. However, Vamin 18 Electrolyte-Free should be administered with caution to pregnant and lactating women and only when this is deemed essential to the patient’s welfare, as judged by the physician.

Children: No controlled studies have been conducted to establish the mode of use of Vamin 18 Electrolyte-Free in children.

Precautions: Infusion by central venous catheter should be used only by those familiar with this technique and its complications.

In patients with risk of electrolyte retention, e.g., impaired renal function, Vamin 18 Electrolyte-Free is recommended.

Adverse Reactions: Single cases of nausea may occur at the recommended rate of infusion. Vomiting, flushing, sweating may occur when the infusion rate is high. If these symptoms appear or are severe, reduce or discontinue the infusion.

Hypersensitivity. Rarely, patients may exhibit hypersensitivity to one or more amino acids.

Symptoms of thrombophlebitis can appear at the site of a peripheral vein infusion. In such instances, the infusion site should be changed to another vein. Use of a larger peripheral vein and reducing the rate of infusion might be helpful. Alternatively, infusion by central venous catheter can be used (see Precautions).

Symptoms And Treatment Of Overdose: Symptoms and Treatment: If the solution is administered at a rate exceeding that recommended, there is an increased risk of nausea and vomiting as well as thrombophlebitis.

Dosage And Administration: Adults: Up to 1 L i.v./day depending upon the patient’s requirement. The infusion time of 1 L Vamin 18 Electrolyte-Free should be 8 hours or longer.

Energy requirements should be met by infusing additional carbohydrate solution and lipid emulsion according to the individual energy requirements calculated for each patient (see Warnings). When Vamin 18 Electrolyte-Free is infused simultaneously with 500 mL of the fat emulsion Intralipid 20% over 8 hours, the drip rate should be adjusted to about 40 drops/minute of the amino acid solution and to about 20 drops/minute of the fat emulsion. This will reduce the risk for thrombophlebitis when infused into peripheral veins.

The nitrogen requirement for maintenance of body protein mass depends on the patient’s condition, i.e., nutritional state and degree of metabolic stress. The requirements are: 0.10 to 0.15 g nitrogen/kg/day: no or minor metabolic stress and normal nutritional state; 0.15 to 0.20 g nitrogen/kg/day: moderate metabolic stress with or without malnutrition; 0.20 to 0.25 g nitrogen/kg/day: severe catabolism as in burns, sepsis and trauma; 0.40 g nitrogen/kg/day: pure malnutrition without metabolic stress (patient must be adequately monitored.

The dosage range of 0.10 to 0.25 g nitrogen/kg/day, corresponds to 6 to 14 mL Vamin 18 Electrolyte-Free/kg/day.

In obese patients, the dose should be based on the estimated ideal weight.

Vamin 18 Electrolyte-Free is particularly suitable for the most catabolic patients who require the highest doses and also for fluid restricted patients because it is the most concentrated solution.

Vamin 18 Electrolyte-Free allows individualized dosing of electrolytes.

Electrolytes can be added to the amino acid solution in amounts depending on the particular requirement of the patient.

1 000 mL of Vamin 18 Electrolyte-Free can be added without risk for precipitation together or separately 480 mmol Naand 480 mmol Kas chlorides, 24 mmol Ca+as glubionate and 48 mmol Mg+as sulfate.

Additions should be performed aseptically immediately before the start of the infusion. Discard unused contents.

Availability And Storage: Each 100 mL of sterile solution contains: Sulfite-free. Bottles of 500 and 1 000 mL. Store at 15 to 25°C. Do not freeze.

VAMIN® 18 ELECTROLYTE-FREE Pharmacia & Upjohn Amino Acids Nutritive and Electrolyte Supplements for I.V. Infusion

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