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Overview
What is ProSol?
20% PROSOL - sulfite-free (Amino Acid) Injection is a sterile, nonpyrogenic, hypertonic solution of essential and nonessential amino acids provided in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.
The VIAFLEX Plastic Container is fabricated from a specially formulated polyvinyl chloride ( Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
Each 100 mL of 20% PROSOL - sulfite-free (Amino Acid) Injection contains:
(pH adjusted with glacial acetic acid.)
What does ProSol look like?
What are the available doses of ProSol?
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What should I talk to my health care provider before I take ProSol?
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How should I use ProSol?
20% PROSOL - sulfite-free (Amino Acid) Injection is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns. 20% PROSOL - sulfite-free (Amino Acid) Injection can be used to reduce fluid intake in patients who require both fluid restriction and total parenteral nutrition (TPN). 20% PROSOL - sulfite-free (Amino Acid) Injection is intended to be dosed on the basis of grams of amino acids/kg body weight/day. Therefore, this more concentrated amino acid solution provides the same nutritional value (grams of total amino acids) as in a more dilute form, but with the opportunity to limit fluid intake.
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.
What interacts with ProSol?
Hypersensitivity to one or more amino acids
Severe liver disease or hepatic coma
Anuria
What are the warnings of ProSol?
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
This injection is for compounding only, not for direct infusion.
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
Because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture.
Caution should be exercised when admixing 20% PROSOL - sulfite-free (Amino Acid) Injection. This solution should be used promptly after admixing. Any storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours. Reference should be made to I.V. Fat Emulsion package insert and high concentration dextrose injection from Baxter Healthcare Corporation package insert for detailed information on each component.
Proper administration of this injection requires a knowledge of fluid and electrolyte balance and nutrition as well as clinical expertise in recognition and treatment of the complications which may occur.
Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, stupor and coma.
Hyperammonemia is of This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants.
Conservative doses of this injection should be given to patients with known or suspected hepatic dysfunction. Should symptoms of hyperammonemia develop, administration should be discontinued and the patient's clinical status reevaluated.
Administration of amino acid solutions in the presence of impaired renal function presents special issues associated with retention of electrolytes.
This injection should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 μg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Administration by central venous catheter should be used only by those familiar with this technique and its complications.
What are the precautions of ProSol?
20% PROSOL - sulfite-free (Amino Acid) Injection is a highly concentrated amino acid solution used for the preparation of sterile total parenteral nutrition admixtures (see ). Some of the amino acids in 20% PROSOL - sulfite-free (Amino Acid) Injection are close to their limit of solubility, and, as such, a small number of amino acid crystals may form upon storage. If amino acid crystals are present, they will re-dissolve upon dilution during admixture compounding. Do not use unless admixture is free of visible particulate. Use of a final filter is recommended during administration of all parenteral solutions where possible.
It is essential to provide adequate calories concurrently if parenterally administered amino acids are to be retained by the body and utilized for protein synthesis. Concentrated dextrose solutions are an effective source of such calories.
With the administration of 20% PROSOL - sulfite-free (Amino Acid) Injection in combination with highly concentrated dextrose solutions, hyperglycemia, glycosuria and hyperosmolar syndrome may result. Blood and urine glucose should be monitored on a routine basis in patients receiving this therapy.
Sudden cessation in administration of a concentrated dextrose solution may result in insulin reaction due to high levels of endogenous insulin. Parenteral nutrition mixtures should be withdrawn slowly.
The metabolizable acetate anion and amino acid profile in this injection were designed to minimize or prevent occurrences of hyperchloremic metabolic acidosis and hyperammonemia. However, the physician should be aware of appropriate countermeasures if they become necessary.
Strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava.
Because of its antianabolic activity, concurrent administration of tetracycline may reduce the protein-sparing effect of infused amino acids.
Care should be taken to avoid excess fluid accumulation, particularly in patients with renal disease, pulmonary insufficiency and heart disease.
During protein-sparing therapy in the absence of supporting carbohydrate metabolism, an accumulation of ketone bodies in the blood often occurs. Correction of ketonemia usually can be accomplished by administering some carbohydrates.
Protein-sparing therapy is useful for periods up to 10 to 12 days. Patients requiring nutritional support thereafter should be placed on oral or parenteral regimens that employ adequate nonprotein calorie components.
20% PROSOL - sulfite-free (Amino Acid) Injection is not intended for direct infusion, and, as such, should never be administered undiluted.
Drug product contains no more than 25 μg/L of aluminum.
Laboratory Tests
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Studies with 20% PROSOL - sulfite-free (Amino Acid) Injection have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
Pregnancy:
Nursing Mothers:
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for adverse reactions, e.g., hyperammonemia in nursing infants, caution should be exercised when 20% PROSOL - sulfite-free (Amino Acid) Injection is administered to a nursing mother.
Pediatric Use:
Safety and effectiveness of 20% PROSOL - sulfite-free (Amino Acid) Injection have not been established by adequate and well-controlled studies in pediatric patients.
Geriatric Use:
Clinical studies of 20% PROSOL - sulfite-free (Amino Acid) Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from other younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.
What are the side effects of ProSol?
See , and
Infusion of any hypertonic solution can result in local inflammatory reactions. Policies and procedures should be established for the recognition and management of such reactions.
What should I look out for while using ProSol?
Hypersensitivity to one or more amino acids
Severe liver disease or hepatic coma
Anuria
This injection is for compounding only, not for direct infusion.
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
Because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture.
Caution should be exercised when admixing 20% PROSOL - sulfite-free (Amino Acid) Injection. This solution should be used promptly after admixing. Any storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours. Reference should be made to I.V. Fat Emulsion package insert and high concentration dextrose injection from Baxter Healthcare Corporation package insert for detailed information on each component.
Proper administration of this injection requires a knowledge of fluid and electrolyte balance and nutrition as well as clinical expertise in recognition and treatment of the complications which may occur.
Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, stupor and coma.
Hyperammonemia is of This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants.
Conservative doses of this injection should be given to patients with known or suspected hepatic dysfunction. Should symptoms of hyperammonemia develop, administration should be discontinued and the patient's clinical status reevaluated.
Administration of amino acid solutions in the presence of impaired renal function presents special issues associated with retention of electrolytes.
This injection should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 μg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Administration by central venous catheter should be used only by those familiar with this technique and its complications.
What might happen if I take too much ProSol?
In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See and .
How should I store and handle ProSol?
Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Manufactured and Distributed by:Carlsbad Technology, Inc.Carlsbad, CA 92008 USA Marketed/ Packaged by:GSMS, Inc.Camarillo, CA 93012 USARevised: February 2010CTI-11 Rev. CPrinted in USAStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Manufactured and Distributed by:Carlsbad Technology, Inc.Carlsbad, CA 92008 USA Marketed/ Packaged by:GSMS, Inc.Camarillo, CA 93012 USARevised: February 2010CTI-11 Rev. CPrinted in USAStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Manufactured and Distributed by:Carlsbad Technology, Inc.Carlsbad, CA 92008 USA Marketed/ Packaged by:GSMS, Inc.Camarillo, CA 93012 USARevised: February 2010CTI-11 Rev. CPrinted in USAStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Manufactured and Distributed by:Carlsbad Technology, Inc.Carlsbad, CA 92008 USA Marketed/ Packaged by:GSMS, Inc.Camarillo, CA 93012 USARevised: February 2010CTI-11 Rev. CPrinted in USAStore at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Manufactured and Distributed by:Carlsbad Technology, Inc.Carlsbad, CA 92008 USA Marketed/ Packaged by:GSMS, Inc.Camarillo, CA 93012 USARevised: February 2010CTI-11 Rev. CPrinted in USA20% PROSOL - sulfite-free (Amino Acid) Injection is supplied in VIAFLEX plastic Pharmacy Bulk Package containers in the following sizes:Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25ºC/77ºF): brief exposure up to 40ºC/104ºF does not adversely affect the product.Do not remove container from overpouch until ready to use.Do not use if overpouch has been previously opened or damaged.20% PROSOL - sulfite-free (Amino Acid) Injection is supplied in VIAFLEX plastic Pharmacy Bulk Package containers in the following sizes:Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25ºC/77ºF): brief exposure up to 40ºC/104ºF does not adversely affect the product.Do not remove container from overpouch until ready to use.Do not use if overpouch has been previously opened or damaged.20% PROSOL - sulfite-free (Amino Acid) Injection is supplied in VIAFLEX plastic Pharmacy Bulk Package containers in the following sizes:Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25ºC/77ºF): brief exposure up to 40ºC/104ºF does not adversely affect the product.Do not remove container from overpouch until ready to use.Do not use if overpouch has been previously opened or damaged.20% PROSOL - sulfite-free (Amino Acid) Injection is supplied in VIAFLEX plastic Pharmacy Bulk Package containers in the following sizes:Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25ºC/77ºF): brief exposure up to 40ºC/104ºF does not adversely affect the product.Do not remove container from overpouch until ready to use.Do not use if overpouch has been previously opened or damaged.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
20% PROSOL - sulfite-free (Amino Acid) Injection administered via central vein, after appropriate dilution, will provide biologically utilizable source material for protein synthesis when used with concentrated calorie sources (such as hypertonic dextrose and/or fat emulsion), electrolytes, vitamins and minerals. Administered peripherally after appropriate dilution or with minimal calorie supplementation (such as 5% dextrose), it enhances the conservation of body protein.
Non-Clinical Toxicology
Hypersensitivity to one or more amino acidsSevere liver disease or hepatic coma
Anuria
This injection is for compounding only, not for direct infusion.
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
Because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture.
Caution should be exercised when admixing 20% PROSOL - sulfite-free (Amino Acid) Injection. This solution should be used promptly after admixing. Any storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours. Reference should be made to I.V. Fat Emulsion package insert and high concentration dextrose injection from Baxter Healthcare Corporation package insert for detailed information on each component.
Proper administration of this injection requires a knowledge of fluid and electrolyte balance and nutrition as well as clinical expertise in recognition and treatment of the complications which may occur.
Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, stupor and coma.
Hyperammonemia is of This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants.
Conservative doses of this injection should be given to patients with known or suspected hepatic dysfunction. Should symptoms of hyperammonemia develop, administration should be discontinued and the patient's clinical status reevaluated.
Administration of amino acid solutions in the presence of impaired renal function presents special issues associated with retention of electrolytes.
This injection should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 μg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Administration by central venous catheter should be used only by those familiar with this technique and its complications.
20% PROSOL - sulfite-free (Amino Acid) Injection is a highly concentrated amino acid solution used for the preparation of sterile total parenteral nutrition admixtures (see ). Some of the amino acids in 20% PROSOL - sulfite-free (Amino Acid) Injection are close to their limit of solubility, and, as such, a small number of amino acid crystals may form upon storage. If amino acid crystals are present, they will re-dissolve upon dilution during admixture compounding. Do not use unless admixture is free of visible particulate. Use of a final filter is recommended during administration of all parenteral solutions where possible.
It is essential to provide adequate calories concurrently if parenterally administered amino acids are to be retained by the body and utilized for protein synthesis. Concentrated dextrose solutions are an effective source of such calories.
With the administration of 20% PROSOL - sulfite-free (Amino Acid) Injection in combination with highly concentrated dextrose solutions, hyperglycemia, glycosuria and hyperosmolar syndrome may result. Blood and urine glucose should be monitored on a routine basis in patients receiving this therapy.
Sudden cessation in administration of a concentrated dextrose solution may result in insulin reaction due to high levels of endogenous insulin. Parenteral nutrition mixtures should be withdrawn slowly.
The metabolizable acetate anion and amino acid profile in this injection were designed to minimize or prevent occurrences of hyperchloremic metabolic acidosis and hyperammonemia. However, the physician should be aware of appropriate countermeasures if they become necessary.
Strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava.
Because of its antianabolic activity, concurrent administration of tetracycline may reduce the protein-sparing effect of infused amino acids.
Care should be taken to avoid excess fluid accumulation, particularly in patients with renal disease, pulmonary insufficiency and heart disease.
During protein-sparing therapy in the absence of supporting carbohydrate metabolism, an accumulation of ketone bodies in the blood often occurs. Correction of ketonemia usually can be accomplished by administering some carbohydrates.
Protein-sparing therapy is useful for periods up to 10 to 12 days. Patients requiring nutritional support thereafter should be placed on oral or parenteral regimens that employ adequate nonprotein calorie components.
20% PROSOL - sulfite-free (Amino Acid) Injection is not intended for direct infusion, and, as such, should never be administered undiluted.
Drug product contains no more than 25 μg/L of aluminum.
See , and
Infusion of any hypertonic solution can result in local inflammatory reactions. Policies and procedures should be established for the recognition and management of such reactions.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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