Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3192
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NephrAmine (Injection)
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The objective of nutritional management of renal decompensation is the provision of sufficient amino acid and caloric support for protein synthesis without greatly exceeding the renal capacity to excrete metabolic wastes. Three grams of nitrogen per day provided as essential amino acids with adequate calories produce nitrogen equilibrium in many stable patients with chronic uremia. Although nitrogen requirements may be higher in stressed or acutely uremic patients, or those on dialysis,
provision of additional nitrogen may not be possible due to fluid intake limits or glucose intolerance. The usual methods of determining individual patient requirements for amino acids such as nitrogen balance or daily body weight are difficult to perform or interpret in the uremic patient. Therefore, dosage is guided by the patient's fluid intake limits and glucose and nitrogen tolerances, as well as metabolic and clinical response. Rate of rise of blood urea nitrogen generally diminishes with infusion of essential amino acids. However, excessive intake of dietary protein or increased protein catabolism may alter this response.<br/>Adult Use: Generally, 250 to 500 mL of 5.4% NephrAmine (Essential Amino Acid Injection), containing approximately 1.6 to 3.2 grams of nitrogen (in 13.4 to 26.8 grams of essential amino acids), are given daily. Adequate calories should be provided simultaneously. Each 250 mL of NephrAmine is typically mixed aseptically with 500 mL of 70% dextrose to yield a solution of 1.8% NephrAmine in 47% dextrose. This mixture provides a calorie-to-nitrogen ratio of 744:1. Solution administrated by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).<br/>Pediatric Use: Initial total daily dose should be low and increased slowly. As the dose is increased, frequent laboratory and clinical monitoring is strongly recommended, especially in very young patients, to avoid clinically significant elevations of serum ammonia and plasma amino acid levels. Dosage of NephrAmine above one gram of essential amino acids per kgof body weight per day is not recommended. In pediatric patients, the final solution should not exceed twice normal serum
osmolarity (718 mOsmol/L). Use of 5.4% NephrAmine 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. See INDICATIONS AND USAGE, WARNINGS, PRECAUTIONS, Pediatric Use, and Special Precautions in Pediatric Patients. Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (E.F.A.D.). Serum lipids should be monitored for evidence of E.F.A.D. in patients maintained on fat free TPN. Electrolyte supplementation may be required. Undiluted NephrAmine (Essential Amino Acid Injection) contains 5 mEq/liter of sodium. Elevated serum potassium, phosphorus, and magnesium levels generally decrease during treatment with NephrAmine. Although these effects are beneficial, especially in acute renal failure, in some instances the reduction may be so great that supplementation of these electrolytes is required, especially in the presence of cardiac arrhythmias or digitalis toxicity. During periods of anuria or oliguria, electrolyte supplementation should be done with caution, even if serum levels are in the low normal range. Compatibility of electrolyte additives to the 5.4% NephrAmine/hypertonic
dextrose mixture must be considered, and potentially incompatible ions such as calcium and phosphate may be added to alternate infusion bottles to avoid precipitation. In patients with hyperchloremic or other metabolic acidosis, sodium and potassium may be added as acetate or lactate salts to provide bicarbonate precursor. The electrolyte content of NephrAmine must be considered when
calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus, should be monitored frequently. If a patient's nutritional intake is primarily parenteral, vitamins,
especially the water soluble vitamins, should also be provided. Hypertonic mixtures of essential amino acids and dextrose may be
safely administered by continuous infusion through a central venous catheter with the tip located in the superior vena cava. Initial infusion rates should be slow, generally 20���30 mL/hour. Increases by increments of 10 mL/hour each 24 hours are recommended to a maximum of 60���100 mL/hour. If administration rate should fall behind schedule, no attempt to "catch up" to planned intake should be made. Administration rate is governed by the patient's nitrogen, fluid, and
glucose tolerance. Uremic patients are frequently glucose intolerant, especially in association with peritoneal dialysis, and may require the administration of exogenous insulin to prevent hyperglycemia. Blood glucose levels must be determined frequently. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose infusions are abruptly discontinued. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Care must be taken to avoid incompatible admixtures. Consult with
pharmacist.
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| dailymed-instance:descripti... |
5.4% NephrAmine (Essential Amino Acid Injection) is a sterile, nonpyrogenic solution containing crystalline essential amino acids plus histidine. Each 250 mL unit provides Rose's recommended daily intake of essential amino acidsplus 625 mg of histidine, considered essential for uremics. The total nitrogen content of a 250 mL unit is approximately 1.6 grams (10 g of protein equivalent) in 14 grams of amino acids. All amino acids designated USP are the "L" isomer. Each 100 mL contains: Histidine USP..............................................0.25 g Isoleucine USP..............................................0.56 g Leucine USP.................................................0.88 g Lysine...........................................................0.64 g (added as Lysine Acetate USP....................0.90 g) Methionine USP............................................0.88 g Phenylalanine USP.........................................0.88 g Threonine USP..............................................0.40 g Tryptophan USP...........................................0.20 g Valine USP....................................................0.64 g Cysteine....................................................<0.014 g (as Cysteine HCl���HO USP....................<0.020 g) Sodium Bisulfite (as an antioxidant)..............<0.05 g Water for Injection USP......................................qs pH adjusted with Sodium Hydroxide NF as required. pH: 6.5 (6.0���7.0); Calculated Osmolarity: 435 mOsmol/liter Total Nitrogen: Approx. 0.65 g/100 mL Concentration of Electrolytes (mEq/liter): Sodium 5 Chloride<3; Acetate Approx. 44
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NephrAmine provides an intravenously compatible mixture of essential amino acids which, when infused with hypertonic dextrose as a source of calories, plus electrolytes, minerals, and vitamins, provides in a small
volume of fluid all ingredients (with the exception of essential fatty acids) needed for total parenteral nutrition in patients with renal disease. Infusion of NephrAmine and hypertonic dextrose provides essential
amino acids and calories for protein synthesis to promote improved cellular metabolic balance. Infusion of these components can decrease the rate of rise of blood urea nitrogen and minimize deterioration of serum potassium, magnesium, and phosphorus balance in patients with impaired renal function. The extent to which essential amino
acids and calories promote incorporation of waste urea nitrogen into newly synthesized amino acids in man, as it does in experimental animals, is, so far, not established. The accelerated decrease in serum creatinine levels seen in patients with limited extra-renal complications suggests that treatment with NephrAmine and hypertonic dextrose leads to earlier return of renal function in patients with potentially reversible acute renal failure. By providing nutritional support and promoting biochemical improvement as well as earlier return of renal function, NephrAmine and hypertonic dextrose decrease morbidity associated with acute renal failure. It is thought that acetate from Iysine acetate, under the condition of parenteral nutrition, does not impact net acid-base balance when renal and respiratory functions are normal. Clinical evidence seems to support this thinking; however, confirmatory experimental evidence is not available. The amounts of sodium and chloride present are not of clinical
significance.
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NephrAmine is contraindicated in patients with severe, uncorrected electrolyte and acid-base imbalance, hyperammonemia, decreased
(subcritical) circulating blood volume, inborn errors of amino acid metabolism, or hypersensitivity to one or more amino acids present in the solution.
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5.4% NephrAmine (Essential Amino Acid Injection) is supplied sterile
and nonpyrogenic in glass containers with solid stoppers packaged 12 per case. NDC Cat. No. Size5.4% NephrAmine(Essential Amino Acid Injection)(Canada DIN 02029464)0264-1909-55 S9092-SS 250 mL 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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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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Histidine, isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, and cysteine hydrochloride
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NephrAmine (Injection)
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| dailymed-instance:adverseRe... |
See WARNINGS and Special Precautions for Central Venous Nutrition. Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis, and hypervolemia. Symptoms may result from an excess or deficit of one or more of the ions present in the solution infused, therefore, frequent monitoring of
electrolyte levels is essential. Infrequent instances of hyperammonemia have been reported following
administration of essential amino acid solutions to patients with massive gastrointestinal hemorrhage, nonuremic infants and pediatric patients or following administration of higher than recommended doses to adult or pediatric patients. Elevated plasma amino acid levels (hypermethionemia) have also been reported in infants especially in higher dosage ranges. Elevated serum ammonia levels, plasma amino acid levels, and clinicalsymptoms may subside when the infusions are discontinued. Phosphorus deficiency may lead to impaired tissue oxygenation and
acute hemolytic anemia. Relative to calcium, excessive phosphorus intake can precipitate hypocalcemia with cramps, tetany, and muscular hyperexcitability. If an adverse reaction does occur, discontinue the infusion, evaluate
the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
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| dailymed-instance:indicatio... |
5.4% NephrAmine (Essential Amino Acid Injection) is indicated for adult and pediatric use, in conjunction with other measures, to provide
nutritional support for uremic patients, particularly when oral nutrition is infeasible or impractical. See WARNINGS, PRECAUTIONS, Pediatric Use, Special Precautions in Pediatric Patients, and DOSAGE AND ADMINISTRATION.
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NephrAmine
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