Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3897
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ProcalAmine (Injection)
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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.<br/>Pediatric Use: ProcalAmine is intended for use in adults. Use of ProcalAmine in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to three g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solutions administered by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L). Venous irritation at an infusion site can be minimized by the selection of a large peripheral vein as well as by slowing the rate of infusion. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L). Parenteral drug products should be inspected visually for particulate matter and discoloration, prior to administration, whenever solution and container permit.
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| dailymed-instance:descripti... |
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:Nonprotein energy source:Glycerin USP (glycerol) .............................................................................. 3.0 g Essential amino acidsIsoleucine USP .......................................................................................... 0.21 gLeucine USP ............................................................................................. 0.27 gLysine ....................................................................................................... 0.22 g(added as Lysine Acetate USP ................................................................ 0.31 g)Methionine USP ........................................................................................ 0.16 gPhenylalanine USP .................................................................................... 0.17 gThreonine USP .......................................................................................... 0.12 gTryptophan USP ...................................................................................... 0.046 gValine USP ................................................................................................ 0.20 g Nonessential amino acidsAlanine USP .............................................................................................. 0.21 gGlycine USP .............................................................................................. 0.42 gArginine USP ............................................................................................. 0.29 gHistidine USP............................................................................................ 0.085 gProline USP ............................................................................................... 0.34 gSerine USP ................................................................................................ 0.18 gCysteine ...................................................................................................<0.014 g(as Cysteine HCl���HO USP ...................................................................<0.020 g)Sodium Acetate���3HO USP........................................................................ 0.20 gMagnesium Acetate���4HO......................................................................... 0.054 gCalcium Acetate���HO ............................................................................... 0.026 gSodium Chloride USP ................................................................................. 0.12 gPotassium Chloride USP.............................................................................. 0.15 gPhosphoric Acid NF ................................................................................. 0.041 gPotassium Metabisulfite NF (as an antioxidant) ............................................<0.05 gWater for Injection USP .................................................................................... qs 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
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| dailymed-instance:clinicalP... |
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��-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.
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Renal failure. Severe liver disease and hepatic coma. Metabolic disorders associated with impaired nitrogen utilization. Hypersensitivity to one or more amino acids.
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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. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25��C); however, brief exposure up to 40��C does not adversely affect the product. Protect from light until use.
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| dailymed-instance:precautio... |
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.<br/>Laboratory Tests: Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration. Laboratory tests should include measurement of blood sugar, electrolyte, and serum protein concentrations; kidney and liver function tests; and evaluation of acid-base balance and fluid balance. Other laboratory tests may be suggested by the patient's condition.<br/>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.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: No in vitro or in vivo carcinogenesis, mutagenesis, or fertility studies have been conducted with ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes).<br/>Pregnancy:<br/>Teratogenic Effects:<br/>Labor and Delivery: Information is unknown.<br/>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.<br/>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 WARNINGS and DOSAGE AND ADMINISTRATION.<br/>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 WARNINGS.
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| dailymed-instance:overdosag... |
In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition and institute appropriate corrective treatment.
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| dailymed-instance:genericMe... |
Glycerin, Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Glycine, Histidine, Proline, Serine, Cysteine Hydrochloride, Sodium Acetate, Magnesium Acetate, Calcium Acetate, Sodium Chloride, Potassium Chloride, and Phosphoric Acid
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ProcalAmine (Injection)
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| dailymed-instance:adverseRe... |
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.
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| dailymed-instance:indicatio... |
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.
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ProcalAmine
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