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GLYCERIN, ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, GLYCINE, ARGININE, HISTIDINE, PROLINE, SERINE, CYSTEINE, SODIUM ACETATE, MAGNESIUM ACETATE, CALCIUM ACETATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, PHOSPHORIC ACID, and POTASSIUM METABISULFITE
Overview
What is ProcalAmine?
ProcalAmine® (3% Amino Acid and 3% Glycerin Injection with Electrolytes) is a sterile, nonpyrogenic, moderately hypertonic intravenous injection containing crystalline amino acids, a nonprotein energy substrate and maintenance electrolytes. A 1000 mL unit provides a total of 29 g of protein equivalent (4.6 g N) and 130 nonprotein calories.
All amino acids designated USP are the "L"-isomer with the exception of Glycine USP which does not have an isomer.
Each 100 mL contains:
Glycerin USP (glycerol) .............................................................................. 3.0 g
Essential amino acids
Nonessential amino acids
pH adjusted with Glacial Acetic Acid USPpH: 6.8 (6.5–7.0), Calculated Osmolarity: 735 mOsmol/literConcentration of Electrolytes (mEq/liter): Sodium 35; Potassium 24.5; Calcium 3Magnesium 5; Chloride 41; Phosphate (HPO ) 7; Acetate 47
What does ProcalAmine look like?
What are the available doses of ProcalAmine?
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What should I talk to my health care provider before I take ProcalAmine?
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How should I use ProcalAmine?
ProcalAmine® is indicated for peripheral administration in adults to preserve body protein and improve nitrogen balance in well-nourished, mildly catabolic patients who require short-term parenteral nutrition.
ProcalAmine® is a convenient source of nonprotein calories to preserve lean body mass, amino acids, maintenance electrolytes, and water for adult patients.
Determination of nitrogen balance and accurate daily body weights (corrected for fluid balance) are probably the best means of assessing individual protein requirements.
Approximately three liters per day of ProcalAmine® will provide a total of 90 grams of amino acids, 390 nonprotein calories and the recommended daily intake of principal intra- and extracellular electrolytes for the stable patient. Therapy can begin with three liters of ProcalAmine® on the first day with close monitoring of the patient.
As with all intravenous fluid therapy, the goal is to provide adequate water to compensate for insensible, urinary and other losses, and electrolytes for replacement and maintenance. These requirements should be determined frequently and appropriately administered.
Additional electrolytes should be administered evenly throughout the day, and irritating medications should be injected at an alternate infusion site.
What interacts with ProcalAmine?
Renal failure.
Severe liver disease and hepatic coma.
Metabolic disorders associated with impaired nitrogen utilization.
Hypersensitivity to one or more amino acids.
What are the warnings of ProcalAmine?
Applications to mucous membranes should be avoided due to the possibility of local inflammation and ulceration.
This product contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
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 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Peripheral intravenous infusion of amino acids may cause a normal, modest rise in blood urea nitrogen (BUN) as a result of increased protein intake. The BUN may become elevated in patients with impaired renal or hepatic function. If the BUN levels exceed post-prandial limits and continue to rise, further use of ProcalAmine® should be reevaluated.
Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma.
Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient's clinical status reevaluated.
Undesirable side effects of glycerol reported in the literature include hemolysis, hemoglobinuria and renal damage. None of these side effects was observed in clinical trials with ProcalAmine®. The manifestation of these side effects is highly dependent on dose and route of administration as well as on formulation. In general, high concentrations of glycerol (up to 40%) are not hemolytic, provided solution is prepared with isotonic saline. Subcutaneous injection of low doses of glycerol alone, , 3% without other solutes, can cause hemolysis. Much higher doses, up to 20 times that of subcutaneous injection are required to obtain similar effects intravenously. Subcutaneous injection of glycerol at low doses can produce hemoglobinuria. Therefore, there should be frequent monitoring to ensure early detection of infiltrations.
Administration of solutions containing electrolytes should be undertaken with extreme caution in the following circumstances:
Care should be taken to avoid circulatory overload, particularly in patients with cardiac insufficiency.
Blood sugar levels should be monitored frequently in diabetic patients.
- Solutions containing sodium ions should be used with care in patients with congestive heart failure, renal insufficiency and in clinical states in which there exists edema with sodium retention.
- Solutions containing potassium ions should be used with care in patients with hyperkalemia, renal insufficiency and in conditions in which potassium retention is present.
- Solutions containing acetate ions from inorganic salts should be used with care in patients with metabolic or respiratory alkalosis.
- Solutions containing calcium ions should not be administered through the same administration set as blood because of the likelihood of coagulation.
What are the precautions of ProcalAmine?
General
Safe, effective use of parenteral nutrition requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of complications which can occur. Frequent evaluation and laboratory determinations are necessary for proper monitoring of parenteral nutrition. Peripheral infusion therapy is intended to provide nutritional support for a limited period of time. If a patient requires an extended period of nutritional support, enteral or parenteral regimens should include nonprotein calories adequate for weight maintenance.
The electrolyte pattern of ProcalAmine® is designed for maintenance only during peripheral infusion therapy in adults. Abnormal losses should be monitored and replaced as required.
During peripheral vein infusion of ProcalAmine®, care should be taken to assure proper placement of the needle or catheter.
The utilization of hypertonic solutions has been associated with an increased incidence of phlebitis. The incidence of phlebitis with ProcalAmine® was marginally higher than that observed with a less hypertonic solution. Phlebitis can be minimized by using an in-line filter and/or by changing the site of infusion.
To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.
Use only if solution is clear and vacuum is present.
Drug product contains no more than 25 g/L of aluminum.
Laboratory Tests
Drug Interactions
Administration of barbiturates, narcotics, hypnotics or systemic anesthetics should be adjusted with caution in patients also receiving magnesium-containing solutions because of an additive central depressive effect.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No or carcinogenesis, mutagenesis, or fertility studies have been conducted with ProcalAmine® (3% Amino Acid and 3% Glycerin Injection with Electrolytes).
Pregnancy
Labor and Delivery
Information is unknown.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised with ProcalAmine® if administered to a nursing woman.
Pediatric Use
Safety and effectiveness of amino acid injections in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acid injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is well established in the medical literature. See and .
Geriatric Use
Clinical studies of ProcalAmine® did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from 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 other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
See .
What are the side effects of ProcalAmine?
Local reactions of the infusion site consisting of a warm sensation, erythema, phlebitis and thrombosis have been reported in the literature with peripheral amino acid infusions. Generalized flushing, fever and nausea have been reported in the literature during the peripheral administration of amino acids.
What should I look out for while using ProcalAmine?
Renal failure.
Severe liver disease and hepatic coma.
Metabolic disorders associated with impaired nitrogen utilization.
Hypersensitivity to one or more amino acids.
This product contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
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 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Peripheral intravenous infusion of amino acids may cause a normal, modest rise in blood urea nitrogen (BUN) as a result of increased protein intake. The BUN may become elevated in patients with impaired renal or hepatic function. If the BUN levels exceed post-prandial limits and continue to rise, further use of ProcalAmine® should be reevaluated.
Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma.
Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient's clinical status reevaluated.
Undesirable side effects of glycerol reported in the literature include hemolysis, hemoglobinuria and renal damage. None of these side effects was observed in clinical trials with ProcalAmine®. The manifestation of these side effects is highly dependent on dose and route of administration as well as on formulation. In general, high concentrations of glycerol (up to 40%) are not hemolytic, provided solution is prepared with isotonic saline. Subcutaneous injection of low doses of glycerol alone, , 3% without other solutes, can cause hemolysis. Much higher doses, up to 20 times that of subcutaneous injection are required to obtain similar effects intravenously. Subcutaneous injection of glycerol at low doses can produce hemoglobinuria. Therefore, there should be frequent monitoring to ensure early detection of infiltrations.
Administration of solutions containing electrolytes should be undertaken with extreme caution in the following circumstances:
Care should be taken to avoid circulatory overload, particularly in patients with cardiac insufficiency.
Blood sugar levels should be monitored frequently in diabetic patients.
What might happen if I take too much ProcalAmine?
In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition and institute appropriate corrective treatment.
How should I store and handle ProcalAmine?
ProcalAmine® (3% Amino Acid and 3% Glycerin Injection with Electrolytes) is supplied sterile and nonpyrogenic in 1000 mL intravenous infusion bottles, packaged six per case.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
ProcalAmine® provides a physiological ratio of biologically utilizable essential and nonessential amino acids, a nonprotein energy source, and a balanced pattern of maintenance electrolytes.
The amino acids provide substrates for protein synthesis as well as sparing body protein and muscle mass. Glycerin USP (glycerol), a utilizable energy substrate, is also provided which serves to preserve body protein. Glycerol participates as an active energy substrate through its phosphorylation to α-glycerophosphate and subsequent conversion to dihydroxyacetone phosphate, one of the two key trioses in the metabolism of glucose for energy generation.
The metabolism of glycerol has been investigated in both animals and humans. The liver is chiefly responsible for the high potential of glycerol utilization for gluconeogenesis, accounting for at least three-fourths of the total capacity of the body to utilize glycerol. Further, the kidney accounts for up to one-fifth of this total capacity. Among other kinds of cells and tissues shown to utilize glycerol at various rates are the brain, intestine, muscle, leukocytes, lungs and spermatozoa.
In a multicenter clinical study, mildly catabolic post-surgical patients receiving ProcalAmine® (3% Amino Acid and 3% Glycerin Injection with Electrolytes) showed a significant improvement in nitrogen balance when compared with patients receiving isonitrogenous amino acids.
Non-Clinical Toxicology
Renal failure.Severe liver disease and hepatic coma.
Metabolic disorders associated with impaired nitrogen utilization.
Hypersensitivity to one or more amino acids.
This product contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
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 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Peripheral intravenous infusion of amino acids may cause a normal, modest rise in blood urea nitrogen (BUN) as a result of increased protein intake. The BUN may become elevated in patients with impaired renal or hepatic function. If the BUN levels exceed post-prandial limits and continue to rise, further use of ProcalAmine® should be reevaluated.
Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma.
Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient's clinical status reevaluated.
Undesirable side effects of glycerol reported in the literature include hemolysis, hemoglobinuria and renal damage. None of these side effects was observed in clinical trials with ProcalAmine®. The manifestation of these side effects is highly dependent on dose and route of administration as well as on formulation. In general, high concentrations of glycerol (up to 40%) are not hemolytic, provided solution is prepared with isotonic saline. Subcutaneous injection of low doses of glycerol alone, , 3% without other solutes, can cause hemolysis. Much higher doses, up to 20 times that of subcutaneous injection are required to obtain similar effects intravenously. Subcutaneous injection of glycerol at low doses can produce hemoglobinuria. Therefore, there should be frequent monitoring to ensure early detection of infiltrations.
Administration of solutions containing electrolytes should be undertaken with extreme caution in the following circumstances:
Care should be taken to avoid circulatory overload, particularly in patients with cardiac insufficiency.
Blood sugar levels should be monitored frequently in diabetic patients.
Administration of barbiturates, narcotics, hypnotics or systemic anesthetics should be adjusted with caution in patients also receiving magnesium-containing solutions because of an additive central depressive effect.
Safe, effective use of parenteral nutrition requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of complications which can occur. Frequent evaluation and laboratory determinations are necessary for proper monitoring of parenteral nutrition. Peripheral infusion therapy is intended to provide nutritional support for a limited period of time. If a patient requires an extended period of nutritional support, enteral or parenteral regimens should include nonprotein calories adequate for weight maintenance.
The electrolyte pattern of ProcalAmine® is designed for maintenance only during peripheral infusion therapy in adults. Abnormal losses should be monitored and replaced as required.
During peripheral vein infusion of ProcalAmine®, care should be taken to assure proper placement of the needle or catheter.
The utilization of hypertonic solutions has been associated with an increased incidence of phlebitis. The incidence of phlebitis with ProcalAmine® was marginally higher than that observed with a less hypertonic solution. Phlebitis can be minimized by using an in-line filter and/or by changing the site of infusion.
To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.
Use only if solution is clear and vacuum is present.
Drug product contains no more than 25 g/L of aluminum.
Local reactions of the infusion site consisting of a warm sensation, erythema, phlebitis and thrombosis have been reported in the literature with peripheral amino acid infusions. Generalized flushing, fever and nausea have been reported in the literature during the peripheral administration of amino acids.
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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