Generic name: VALINE 1.44g in 100mL, LYSINE ACETATE 1.35g in 100mL, HISTIDINE 1.18g in 100mL, ISOLEUCINE 1.08g in 100mL, LEUCINE 1.08g in 100mL, PHENYLALANINE 1g in 100mL, THREONINE 980mg in 100mL, METHIONINE 760mg in 100mL, TRYPTOPHAN 320mg in 100mL, ALANINE 2.76g in 100mL, GLYCINE 2.06g in 100mL, ARGININE 1.96g in 100mL, PROLINE 1.34g in 100mL, GLUTAMIC ACID 1.02g in 100mL, SERINE 1.02g in 100mL, ASPARTIC ACID 600mg in 100mL, TYROSINE 50mg in 100mL
Dosage form: injection
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If a patient is unable to take enteral nourishment for a prolonged period of time, institution of total parenteral nutrition (TPN) with exogenous calories should be considered.
The total daily dose of 20% PROSOL – sulfite-free (Amino Acid) Injection depends on the patient’s metabolic requirement and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual nitrogen requirements.
Recommended Dietary Allowances* of protein range from approximately 0.75 g/kg of body weight for adults to 1.68 g/kg for infants. It must be recognized, however, that protein as well as caloric requirements in traumatized or malnourished patients may be increased substantially. Daily amino acid doses of approximately 1.0 to 1.5 g/kg of body weight for adults with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance.
For the initial treatment of trauma or protein calorie malnutrition, higher doses of protein with corresponding quantities of carbohydrate may be necessary to promote adequate patient response to therapy. The severity of the illness being treated is the primary consideration in determining proper dose level. Such higher doses, especially in infants, must be accompanied by more frequent laboratory evaluation.
For protein-sparing in well nourished patients not receiving significant additional calories, amino acid dosages of 1.0 to 1.7 g/kg/day reduce nitrogen losses and spare body protein. If daily increases in BUN in the range of 10 to 15 mg% for more than three days should occur, then protein-sparing therapy should be discontinued and a regimen with full nonprotein calorie substrates should be adopted.
*Food and Nutrition Board National Academy of Sciences - National Research Council (Revised 1989)
Care should be exercised to insure the maintenance of proper levels of serum potassium. Quantities of 60 to 180 mEq of potassium per day have been used with adequate clinical effect. It may be necessary to add quantities of this electrolyte to this injection, depending primarily on the amount of carbohydrate administered to and metabolized by the patient.
Total daily fluid requirements can be met beyond the volume of amino acid solutions by supplementing with noncarbohydrate or carbohydrate-containing electrolyte solutions.
Maintenance vitamins, additional electrolytes and trace elements should be administered as required.
Fat emulsion coadministration should be considered when prolonged parenteral nutrition (more than 5 days) is required in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat free total parenteral nutrition. Caution should be exercised in administering fat emulsions to patients with severe liver damage, pulmonary disease, anemia or blood coagulation disorders, or when there is danger of fat embolism.
Fat emulsion admixed into total parenteral formula may obscure the presence of precipitate formation.
Central Vein Administration:
Hypertonic mixtures of amino acids and dextrose may be administered safely by continuous infusion through a central venous catheter with the tip located in the vena cava. In addition to meeting nitrogen needs, the administration rate is governed, especially during the first few days of therapy, by the patient's tolerance to dextrose. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of urine and blood sugar levels.
In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria.
Parenteral nutrition may be started with infusates containing lower concentrations of dextrose; dextrose content may be gradually increased to estimated caloric needs as the patient's glucose tolerance increases. Sudden cessation in administration of a concentrated dextrose solution may result in insulin reaction due to high levels of endogenous insulin. Such solutions should be withdrawn slowly.
Peripheral Vein Administration:
In patients requiring parenteral nutrition for whom the central vein route is not indicated, this injection can be mixed with low concentration dextrose solutions and administered by peripheral vein with or without fat emulsion.
Intravenous fat emulsion provides approximately 1.1 kcal/mL (10%) or 2.0 kcal/mL (20%) and may be administered along with amino acid-dextrose solutions by means of a short Y-connector near the infusion site to supplement caloric intake. Fat, however, should not be the sole caloric intake since studies have indicated that glucose is more nitrogen sparing in the stressed patient.
For well nourished patients who require short-term parenteral support, this injection can be administered peripherally with or without carbohydrate calories. Such infusates can be prepared by dilution of this injection with 5% Dextrose Injection and/or Sterile Water for Injection to prepare solutions which may be administered by peripheral vein, not to exceed twice normal serum osmolarity.
Depending upon the clinical condition of the patient, approximately 3 liters of solution may be administered per 24 hour period. When used postoperatively, the therapy should begin with 1000 mL the first postoperative day. Thereafter, the dose may be increased to 3000 mL per day.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions where possible. Filters of less than 1.2 microns pore size must not be used with admixtures containing fat emulsions.
A slight yellow color does not alter the quality and efficacy of the product.
Do not use unless solution is clear and seal is intact.
20% PROSOL - sulfite-free (Amino Acid) Injection in the Pharmacy Bulk Package is intended for use in the preparation of sterile, intravenous admixtures. Additives may be incompatible with the fluid withdrawn from this container. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store any unused portion of 20% PROSOL - sulfite-free (Amino Acid) Injection.
Any storage of admixtures should be under refrigeration and limited to a brief period of time, preferably less than 24 hours.