dministration for additional information. central venous infusion central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted infants or those requiring long-term parenteral nutrition. peripheral parenteral nutrition for moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions mixed with 5 to 10% dextrose solutions may be infused by peripheral vein, supplemented, if desired, with fat emulsion.

portional to the electrolyte concentrations of the solutions. administration of amino acid solutions to a patient with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. hyperammonemia is of special significance in infants , as its occurrence in the syndrome caused by genetic metabolic defects is sometimes associated, although not necessarily in a causal relationship, with mental retardation. this reaction appears to be dose-related and is more likely to develop during prolonged therapy. it is essential that blood ammonia levels be measured frequently in infants. conservative doses of amino acids should be given, dictated by the nutritional status of the patient. should symptoms of hyperammonemia develop, amino acid dosage levels should be reduced and titrated against serum ammonia levels. 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.

initial amino acid dosage levels of 1.0 g/kg/day may be increased gradually in increments of 0.5 g/kg/day to approximate desired intake levels. aminosyn-pf 10% should be diluted with dextrose prior to use. nonprotein calories should constitute approximately 100 to 130 kcal/kg/day. part of the nonprotein caloric requirement may be provided as lipid emulsion administered concurrently to provide up to 60% of daily calories at a dose not to exceed 4 g fat/kg/day. fluid intake for the infant receiving central venous tpn should be approximately 125 ml/kg/day (range: 100 to 175 ml/kg/day), depending on the clinical condition of the patient. fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition 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 tpn. premature infants with respiratory distress syndrome suspected of having a patent ductus arteriosus should be given fluids more cautiously. cysteine is considered to be an essential amino acid for infants, especially preterm infants with potentially immature enzyme pathways. therefore, addition of a cysteine supplement to the tpn admixture is recommended. the intake of cysteine by the preterm infant ingesting maternal milk is approximately 78 mg/kg/day. the suggested intravenous dosage level for cysteine hydrochloride injection, usp is 500 mg (10 ml) for every 12.5 g (125 ml) of aminosyn-pf 10% administered (see package insert for cysteine hydrochloride injection, usp). in order to avoid potential insolubility of cysteine hydrochloride in admixtures, the foregoing concentration should not be exceeded. 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. to prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose solutions are abruptly discontinued. serum electrolytes should be monitored frequently. electrolytes may be added to the nutrient solution as indicated by the patient’s clinical condition and laboratory determinations of plasma values. major electrolytes are sodium, chloride, potassium, phosphate, magnesium and calcium. daily administration of intravenous vitamin supplements including a complete complement of fat and water-soluble vitamins is required. trace metal additives including zinc, copper, manganese, and chromium should also be provided, especially when long-term parenteral therapy is anticipated. calcium and phosphorus are added to the solution as indicated. potentially incompatible ions such as calcium and phosphate may be added to alternate infusate bottles to avoid precipitation. in patients with hyperchloremic or other metabolic acidosis, sodium and potassium may be added as the acetate or lactate salts to provide bicarbonate alternates. bicarbonate should not be administered during infusion of the nutritional solution unless deemed absolutely necessary. additives may be incompatible. consult with pharmacist, if available. when introducing additives, use aseptic technique, mix thoroughly and do not store. to ensure the precise delivery of the small volumes of fluid necessary for total parenteral nutrition in infants, accurately calibrated and reliable infusion systems should be used. central venous nutrition hypertonic mixtures of 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, and gradually increased to the recommended 60-125 ml per kilogram body weight per day. if administration rate should fall behind schedule, no attempt to “catch up” to planned intake should be made. in addition to meeting protein needs, the rate of administration, particularly during the first few days of therapy, is governed by the patient’s glucose tolerance. daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of glucose levels in blood and urine. peripheral parenteral nutrition for patients in whom the central venous route is not indicated and who can consume adequate calories enterally, aminosyn-pf 10% may be administered by peripheral vein with parenteral nonprotein calories. the concentration of dextrose in the final admixture is 5 to 10%, and simultaneous administration of lipid emulsion is recommended both as a calorie source and to attenuate the potentially irritating effects of the hypertonic nutritional admixture. fat emulsion may comprise up to 60% of the daily caloric intake at a dosage level not to exceed 4 g fat/kg/day. it is essential that peripheral infusion be accompanied by adequate caloric intake. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. color variation from pale yellow to yellow is normal and does not alter efficacy. recommended directions for use of the pharmacy bulk package use aseptic technique during use, container must be stored, and all manipulations performed, in an appropriate laminar flow hood. remove cover from outlet port at bottom of container. insert piercing pin of sterile transfer set and suspend unit in a laminar flow hood. insertion of a piercing pin into the outlet port should be performed only once in a pharmacy bulk package solution. once the outlet site has been entered, the withdrawal of container contents should be completed promptly in one continuous operation. should this not be possible, a maximum time of 4 hours from transfer set pin or implement insertion is permitted to complete fluid transfer operations; i.e., discard container no later than 4 hours after initial closure puncture. sequentially dispense aliquots of aminosyn-pf 10% into i.v. containers using appropriate transfer set. during fluid transfer operations, the pharmacy bulk package should be maintained under the storage conditions recommended in the labeling. additives may be incompatible with fluid withdrawn from this container. consult with pharmacist, if available. when compounding admixtures, use aseptic technique. mix thoroughly. do not store solutions containing additives. because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient mixture. warning: do not use flexible container in series connections.

, nitrogen balance, and serum protein concentrations were consistent with an improving nutritional status. when infused with hypertonic dextrose as a calorie source, supplemented with cysteine hydrochloride, electrolytes, vitamins, and minerals, aminosyn-pf 10% provides tpn for infants and young children, with the exception of essential fatty acids. it is thought that the acetate from lysine acetate under the conditions 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 acetate in aminosyn-pf 10% are not of clinical significance. the addition of a cysteine hydrochloride additive will contribute to the chloride load. the electrolyte content of any additives that are introduced should be carefully considered and included in input computations. the human newborn conjugates bile with taurine which becomes the primary method of biliary excretion. taurine deficiency because of its effect on bile salt conjugation and, therefore, on bile salt flow may be of major importance in the genesis of cholestasis. taurine has also been shown to play a role in central nervous system development.