Prosol (amino acids)

Prosol (amino acids) is indicated as a source of amino acids for patients requiring parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated. Prosol may be used to treat negative nitrogen balance in patients.

Side effects of Prosol include:

• pulmonary vascular emboli,
• hypersensitivity reactions,
• infection,
• refeeding syndrome,
• high blood sugar levels (hyperglycemia) and hyperosmolar hyperglycemic state,
• blood clots in veins (thrombosis),
• elevated liver function tests,
• hyperammonemia,
• electrolyte imbalances, and
• fluid overload (hypervolemia)

Important Preparation Information

Prosol is supplied as a pharmacy bulk package for admixing only and is not for direct intravenous infusion. Prior to administration, Prosol must be transferred to a separate PN container, diluted and used as an admixture with or without dextrose, electrolytes and/or lipid emulsion.

• The key factor in preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients.
• Do not remove container from overpouch until ready to use.
• Tear protective overpouch across top at slit and remove solution container. Small amounts of moisture may be found on the solution container from water permeating from inside the container.
  The amount of permeated water is insufficient to affect the solution significantly. If larger amounts of water are found, the container should be checked for tears or leaks.
• Inspect Prosol prior to use. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Amino acid crystals may be present. Crystals will redissolve upon dilution during admixture compounding.

Evaluate the following:

• If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired.
• Check to ensure the solution is clear, colorless or slightly yellow. Discard if the solution is bright yellow or yellowish brown.
• Check for minute leaks by squeezing inner container. If leaks are found, discard container.
• Prosol is intended for use in the preparation of sterile, intravenous admixtures. Because additives may be incompatible with Prosol, evaluate all additions for compatibility.

Recommended Dosage In Adults

The recommended adult daily dosage of Prosol and the nutritional requirements for protein (nitrogen) are shown in Table 1.

As a component of PN, Prosol provides 0.2 g protein/mL, which corresponds to 0.032 g nitrogen/mL.

As indicated on an individual basis, vitamins, electrolytes, trace elements and other components (including dextrose, electrolytes and lipid emulsion) can be added to the PN solution to meet nutrient needs and prevent deficiencies and complications from developing.

A maximum fluid supply of 40 mL/kg/day of PN solution, based on protein, should not be exceeded in adult patients; this volume does not take carbohydrates or electrolytes into consideration.

The flow rate of the PN solution must be adjusted taking into account the dose being administered, the daily volume intake, and the duration of the infusion. The flow rate should be increased gradually and governed, especially during the first few days of therapy, by the patient’s tolerance to dextrose. Daily intake of Prosol and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of blood glucose levels.

Table 1. Recommended Daily Dosage in Adults

Dosage Modifications In Patients With Renal Impairment

• Prior to administration, correct severe fluid or electrolyte imbalances. Closely monitor serum electrolyte levels and adjust the volume of parenteral nutrition administered as required.
• Patients with renal impairment not needing dialysis require 0.6 to 0.8 g of protein/kg/day.
• Serum electrolyte levels should be closely monitored.
• Patients on hemodialysis or continuous renal replacement therapy should receive 1.2 to 1.8 g of protein/kg/day up to a maximum of 2.5 g of protein/kg/day based on nutritional status and estimated protein losses.²

Recommended Dosage In Pediatric Patients

• The dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low weight infants, because of the increased risk of hyperglycemia/hypoglycemia.
• Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.
• The infusion rate and volume should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.
• In pediatric patients, Prosol is dosed on the basis of protein provided as amino acids. The recommended dosage, by age group is provided in Table 2.
• Infusion rates are based on protein and do not take carbohydrates, fluid or electrolytes into consideration.
• Prosol does not contain the amino acids cysteine and taurine, considered conditionally essential for neonates and infants.
• If possible, these amino acids should be added to the PN admixtures if used in this pediatric population.

Table 2. Recommended Daily Dosage in Pediatrics

Discontinuation Of Parenteral Nutrition

• To reduce the risk of hypoglycemia after discontinuation, a gradual decrease in flow rate in the last hour of infusion should be considered when administering PN solutions containing dextrose.

• It is also not known whether 20% Prosol sulfite-free (Amino Acid) Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
• 20% Prosol sulfite-free (Amino Acid) Injection should be given to a pregnant woman only if clearly needed.
• Caution should be exercised when 20% Prosol sulfite-free (Amino Acid) Injection is administered to a nursing woman.