Aminosyn Sulfite Free (Crystalline Amino Acid Solution): Uses, Dosage, Side Effects, Interact… Page 1 of 15
`
`AMINOSYN SULFITE
`FREE
`
`Generic Name: crystalline amino acid solution
`
`Brand Name: Aminosyn Sulfite Free
`
`Last reviewed on RxList: 10/15/2019
`
`Drug Description
`
`Aminosyn®
`Sulfite-Free
`
`A CRYSTALLINE AMINO ACID SOLUTION
`Flexible Plastic Container
`
`DESCRIPTION
`
`Aminosyn®, Sulfite-Free, (a crystalline amino acid solution) is a sterile, nonpyrogenic solution for
`intravenous infusion. Aminosyn is oxygen sensitive. Five different formulations are available:
`
`Aminosyn Formulations Essential Amino Acids (mg/100 mL)
`
`Aminosyn
`
`Isoleucine
`
`Leucine
`
`Lysine (acetate)*
`
`Methionine
`
`Phenylalanine
`
`Threonine
`
`Tryptophan
`
`Valine
`
`3.5%
`
`252
`
`329
`
`252
`
`140
`
`154
`
`182
`
`56
`
`280
`
`5%
`
`360
`
`470
`
`360
`
`200
`
`220
`
`260
`
`80
`
`400
`
`7%
`
`510
`
`660
`
`510
`
`280
`
`310
`
`370
`
`120
`
`560
`
`8.5%
`
`620
`
`810
`
`624
`
`340
`
`380
`
`460
`
`150
`
`680
`
`10%
`
`720
`
`940
`
`720
`
`400
`
`440
`
`520
`
`160
`
`800
`
`*Amount cited is for Lysine alone and does not include the acetate salt.
`
`https://www.rxlist.com/aminosyn-sulfite-free-drug.htm
`
`5/6/2020
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`Eton Ex. 1052
`1 of 15
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`

`

`Aminosyn Sulfite Free (Crystalline Amino Acid Solution): Uses, Dosage, Side Effects, Interact… Page 2 of 15
`
`Nonessential Amino Acids (mg/100 mL)
`
`3.5%
`
`448
`
`343
`
`105
`
`300
`
`147
`
`31
`
`448
`
`5%
`
`640
`
`490
`
`150
`
`430
`
`210
`
`44
`
`640
`
`7%
`
`900
`
`690
`
`210
`
`610
`
`300
`
`44
`
`900
`
`Aminosyn
`
`Alanine
`
`Arginine
`
`Histidine
`
`Proline
`
`Serine
`
`Tyrosine
`
`Glycine
`
`Electrolytes (mEq/Liter)
`
`Aminosyn
`
`Sodium (Na )
`+
`
`3.5%
`
`None
`
`5%
`
`None
`
`7%
`
`None
`
`8.5%
`
`1100
`
`850
`
`260
`
`750
`
`370
`
`44
`
`1100
`
`8.5%
`
`None
`
`10%
`
`1280
`
`980
`
`300
`
`860
`
`420
`
`44
`
`1280
`
`10%
`
`None
`
`None
`
`Potassium (K )
`+
`
`Chloride (Cl )
`–
`
`Acetate (C H O –)
`b
`2 3 2
`
`None
`
`None
`
`51
`
`None
`
`None
`
`86
`
`None
`
`None
`
`105
`
`None
`
`35
`a
`
`90
`
`None
`
`147
`
`a
`
`Includes chloride from HCl added for processing and pH adjustment.
`Includes acetate from acetic acid used in processing and from Lysine acetate.
`
`b
`
`Aminosyn
`
`3.5%
`
`Protein Equivalent
`(approx. grams/liter)
`
`Total Nitrogen
`(grams/liter)
`
`Osmolarity
`(mOsmol/liter)
`
`pH
`
`Range
`
`35
`
`5.5
`
`322
`
`5.2
`
`Product Characteristics
`
`5%
`
`50
`
`7.86
`
`462
`
`5.2
`
`7%
`
`70
`
`11.00
`
`655
`
`5.2
`
`8.5%
`
`85
`
`13.4
`
`802
`
`5.2
`
`10%
`
`100
`
`15.72
`
`932
`
`5.2
`
`(4.5 –6.0 )
`c
`
`(4.5 – 6.0 )
`c
`
`(4.5 – 6.0 )
`c
`
`(4.5 – 6.0 )
`d
`
`(4.5 – 6.0 )
`c
`
`c
`
`Adjusted with acetic acid.
`Adjusted with acetic acid and hydrochloric acid.
`
`d
`
`The formulas for the individual amino acids present in Aminosyn are as follows:
`
`https://www.rxlist.com/aminosyn-sulfite-free-drug.htm
`
`5/6/2020
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`Eton Ex. 1052
`2 of 15
`
`

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`Aminosyn Sulfite Free (Crystalline Amino Acid Solution): Uses, Dosage, Side Effects, Interact… Page 3 of 15
`
`Essential Amino Acids
`
`(C H NO )
`6 13
`2
`
`(C H NO )
`6 13
`2
`
`(C H N O • CH COOH)
`6 14 2 2
`3
`
`Nonessential Amino Acids
`
`(C H NO S)
`5 11
`2
`
`(C H NO )
`9 11
`2
`
`(C H NO )
`4 9
`3
`
`(C H N2O )
`11
`12
`2
`
`(C H NO )
`5 11
`2
`
`(C H NO )
`3 7
`2
`
`(C H N O )
`6 14 4 2
`
`(C H N O )
`6 9 3 2
`
`(C H NO )
`5 9
`2
`
`(C H NO )
`3 7
`3
`
`(C H NO )
`9 11
`3
`
`(C H NO )
`2 5
`2
`
`Isoleucine
`
`Leucine
`
`Lysine Acetate
`
`Methionine
`
`Phenylalanine
`
`Threonine
`
`Tryptophan
`
`Valine
`
`Alanine
`
`Arginine
`
`Histidine
`
`Proline
`
`Serine
`
`Tyrosine
`
`Glycine
`
`The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can
`permeate from inside the container into the overwrap but not in amounts sufficient to affect the
`solution significantly.
`
`Solutions in contact with the plastic container may leach out certain chemical components from the
`plastic in very small amounts; however, biological testing was supportive of the safety of the plastic
`container materials.
`
`Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in
`moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses
`will lead to clinically significant changes within the expiration period.
`
`Indications
`
`https://www.rxlist.com/aminosyn-sulfite-free-drug.htm
`
`5/6/2020
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`Eton Ex. 1052
`3 of 15
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`Aminosyn Sulfite Free (Crystalline Amino Acid Solution): Uses, Dosage, Side Effects, Interact… Page 4 of 15
`
`INDICATIONS
`
`Aminosyn, Sulfite-Free, (a crystalline amino acid solution) infused with dextrose by peripheral vein
`infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate
`stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is
`undesirable, or inadequate.
`
`SUPPLEMENTAL ELECTROLYTES, IN ACCORDANCE WITH THE PRESCRIPTION OF THE ATTENDING
`PHYSICIAN, MUST BE ADDED TO AMINOSYN SOLUTIONS WITHOUT ELECTROLYTES.
`
`Aminosyn can be administered peripherally with dilute (5 to 10%) dextrose solution and I.V. fat
`emulsion as a source of nutritional support. This form of nutritional support can help to preserve
`protein and reduce catabolism in stress conditions where oral intake is inadequate.
`
`When administered with concentrated dextrose solutions with or without fat emulsions, Aminosyn is
`also indicated for central vein infusion to prevent or reverse negative nitrogen balance in patients
`where: (a)  the alimentary tract, by the oral, gastrostomy or jejunostomy route cannot or should not
`be used; (b)  gastrointestinal absorption of protein is impaired; (c) metabolic requirements for protein
`are substantially increased as with extensive burns and (d) morbidity and mortality may be reduced
`by replacing amino acids lost from tissue breakdown, thereby preserving tissue reserves, as in acute
`renal failure.
`
`SLIDESHOW
`
`Heart Healthy Diet: 25 Foods You
`Should Eat
`
`See Slideshow
`
`Dosage
`
`https://www.rxlist.com/aminosyn-sulfite-free-drug.htm
`
`5/6/2020
`
`Eton Ex. 1052
`4 of 15
`
`

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`Aminosyn Sulfite Free (Crystalline Amino Acid Solution): Uses, Dosage, Side Effects, Interact… Page 5 of 15
`
`DOSAGE AND ADMINISTRATION
`
`The total daily dose of the solution depends on the daily protein requirements and on the patient's
`metabolic and clinical response. 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 infusions are abruptly discontinued.
`
`Parenteral drug products should be inspected visually for particulate matter and discoloration prior to
`administration, whenever solution and container permit.
`
`1. Peripheral Vein Nutritional Maintenance
`
`Aminosyn® 3.5%, Sulfite-Free, (a crystalline amino acid solution) together with dextrose in
`concentrations of 5% to 10% is suitable for administration by peripheral vein. This solution is not
`intended for central vein infusion since it does not contain adequate amounts of amino acids or
`electrolytes for administration with high concentrations of dextrose. Aminosyn 7%, 8.5% or 10% may
`be diluted with sterile water for injection or 5 to 10% Dextrose Injection to achieve a final amino acid
`concentration of 3.5, 4.25 or 5% for peripheral administration.
`
`For peripheral intravenous infusion, 1.0 to 1.5 g/kg/day of total amino acids will reduce protein
`catabolism. Infusion or ingestion of carbohydrate or lipid will not reduce the nitrogen sparing effect
`of intravenous amino acid infusions at this dose.
`
`As with all intravenous fluid therapy, the primary aim is to provide sufficient water to compensate for
`insensible, urinary and other (nasogastric suction, fistula drainage, diarrhea) fluid losses. Total fluid
`requirements, as well as electrolyte and acid-base needs, should be estimated and appropriately
`administered.
`
`For an amino acid solution of specified total concentration, the volume required to meet amino acid
`requirements per 24 hours can be calculated. After making an estimate of the total daily fluid (water)
`requirement, the balance of fluid needed beyond the volume of amino acid solution required can be
`provided either as a noncarbohydrate or a carbohydrate-containing electrolyte solution. I.V. lipid
`emulsion may be substituted for part of the carbohydrate containing solution. Vitamins and
`additional electrolytes as needed for maintenance or to correct imbalances may be added to the
`amino acid solution.
`
`If desired, only one-half of an estimated daily amino acid requirement of 1.5 g/kg can be given on the
`first day. Amino acids together with dextrose in concentrations of 5% to 10% infused into a peripheral
`vein can be continued while oral nutrition is impaired. However, if a patient is unable to take oral
`nourishment for a prolonged period of time, institution of total parenteral nutrition with exogenous
`calories should be considered.
`
`https://www.rxlist.com/aminosyn-sulfite-free-drug.htm
`
`5/6/2020
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`Eton Ex. 1052
`5 of 15
`
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`Aminosyn Sulfite Free (Crystalline Amino Acid Solution): Uses, Dosage, Side Effects, Interact… Page 6 of 15
`
`2. Central Vein Total Parenteral Nutrition
`
`For central vein infusion with concentrated dextrose solution, alone or with I.V. lipid, the total daily
`dose of the amino acid solution depends upon daily protein requirements and the patient's metabolic
`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 protein requirements.
`
`Adults
`
`Solutions containing 3.5 to 5% amino acids with 5 to 10% glucose may be coinfused with a fat
`emulsion by peripheral vein to provide approximately 1400 to 2000 kcal/day. Fat emulsion
`coadministration should be considered when prolonged parenteral nutrition is required in order to
`prevent essential fatty acid deficiency (E.F.A.D.). Serum lipids should be monitored for evidence of
`EFAD in patients maintained on fat-free total parenteral nutrition.
`
`Aminosyn 5%, 7%, 8.5% and 10% solutions should only be infused via a central vein when admixed
`with sufficient dextrose to provide full caloric requirements in patients who require prolonged total
`parenteral nutrition. I.V. lipid may be administered separately to provide part of the calories, if
`desired.
`
`Total parenteral nutrition (TPN) may be started with 10% dextrose added to the calculated daily
`requirement of amino acids (1.5 g/kg for a metabolically stable patient). Dextrose content is gradually
`increased over the next few days to the estimated daily caloric need as the patient adapts to the
`increasing amounts of dextrose. Each gram of dextrose provides approximately 3.4 kcal. Each gram
`of fat provides 9 kcal.
`
`The average depleted major surgical patient with complications requires between 2500 and 4000
`kcal and between 12 and 24 grams of nitrogen per day. An adult patient in an acceptable weight
`range with restricted activity who is not hypermetabolic, requires about 30 kcal/kg of body
`weight/day. Average daily adult fluid requirements are between 2500 and 3000 mL and may be
`much higher with losses from fistula drainage or severe burns. Typically, a hospitalized patient may
`lose 12 to 18 grams of nitrogen a day, and in severe trauma the daily loss may be 20 to 25 grams or
`more.
`
`Aminosyn solutions without electrolytes are intended for patients requiring individualized electrolyte
`therapy. Sodium, chloride, potassium, phosphate, calcium and magnesium are major electrolytes
`which should be added to Aminosyn as required.
`
`SERUM ELECTROLYTES SHOULD BE MONITORED AS INDICATED. 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. Vitamins, including folic acid and vitamin K are required additives. The trace element
`supplements should be given when long-term parenteral nutrition is undertaken.
`
`https://www.rxlist.com/aminosyn-sulfite-free-drug.htm
`
`5/6/2020
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`Eton Ex. 1052
`6 of 15
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`Aminosyn Sulfite Free (Crystalline Amino Acid Solution): Uses, Dosage, Side Effects, Interact… Page 7 of 15
`
`Calcium and phosphorus are added to the solution as indicated. The usual dose of phosphate added
`to a liter of TPN solution (containing 25% dextrose) is 12 mM. This requirement is related to the
`carbohydrate calories delivered. Iron is added to the solution or given intramuscularly in depot form
`as indicated. Vitamin B , vitamin K and folic acid are given intramuscularly or added to the solution as
`12
`desired.
`
`Calcium and phosphate additives are potentially incompatible when added to the TPN admixture.
`However, if one additive is added to the amino acid bottle, and the other to the bottle of concentrated
`dextrose, and if the contents of both bottles are swirled before they are combined, then the likelihood
`of physical incompatibility is reduced.
`
`In patients with hyperchloremic or other metabolic acidosis, sodium and potassium may be added as
`the acetate or lactate salts to provide bicarbonate alternates.
`
`In adults, 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 vena cava. Typically, the 7%,
`8.5% or 10% solution is used in equal volume with 50% dextrose to provide an admixture containing
`3.5%, 4.25% or 5% amino acids and 25% dextrose.
`
`The rate of intravenous infusion initially should be 2 mL/min and may be increased gradually. If
`administration 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 is governed by the patient's
`glucose tolerance estimated by glucose levels in blood and urine.
`
`Aminosyn 10% solution, when mixed with an appropriate volume of concentrated dextrose, offers a
`higher concentration of calories and nitrogen per unit volume. This solution is indicated for patients
`requiring larger amounts of nitrogen than could otherwise be provided or where total fluid load must
`be kept to a minimum, for example, patients with renal failure.
`
`Provision of adequate calories in the form of hypertonic dextrose may require exogenous insulin to
`prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, do not abruptly
`discontinue administration of nutritional solutions.
`
`Pediatric
`
`Pediatric requirements for parenteral nutrition are constrained by the greater relative fluid
`requirements of the infant and greater caloric requirements per kilogram. Amino acids are probably
`best administered in a 2.5% concentration. For most pediatric patients on intravenous nutrition, 2.5
`grams amino acids/kg/day with dextrose alone or with I.V. lipid calories of 100 to 130 kcal/kg/day is
`recommended. In cases of malnutrition or stress, these requirements may be increased. It is
`acceptable in pediatrics to start with a nutritional solution of half strength at a rate of about 60 to 70
`mL/kg/day. Within 24 to 48 hours the volume and concentration of the solution can be increased
`until the full strength pediatric solution (amino acids and dextrose) is given at a rate of 125 to 150
`mL/kg/day.
`
`https://www.rxlist.com/aminosyn-sulfite-free-drug.htm
`
`5/6/2020
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`Eton Ex. 1052
`7 of 15
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`Aminosyn Sulfite Free (Crystalline Amino Acid Solution): Uses, Dosage, Side Effects, Interact… Page 8 of 15
`
`Supplemental electrolytes and vitamin additives should be administered as deemed necessary by
`careful monitoring of blood chemistries and nutritional status. Addition of iron is more critical in the
`infant than the adult because of the increasing red cell mass required for the growing infant. Serum
`lipids should be monitored for evidence of essential fatty acid deficiency in patients maintained on
`fat-free TPN. Bicarbonate should not be administered during infusion of the nutritional solution
`unless deemed absolutely necessary.
`
`To insure 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.
`
`A basic solution for pediatric use should contain 25 grams of amino acids and 200 to 250 grams of
`glucose per 1000 mL, administered from bottles containing 250 or 500 mL. Such a solution given at
`the rate of 145 mL/kg/day provides 130 kcal/kg/day.
`
`WARNING: Do not use flexible container in series connections.
`
`HOW SUPPLIED
`
`List No.
`
`Concentration
`
`Container (mL)
`
`4159
`
`4181
`
`4184
`
`4187
`
`4191
`
`Aminosyn 3.5%, Sulfite-Free, (an amino acid solution)
`
`Aminosyn 5%, Sulfite-Free, (an amino acid solution)
`
`Aminosyn 7%, Sulfite-Free, (an amino acid solution)
`
`Aminosyn 8.5%, Sulfite-Free, (an amino acid solution)
`
`Aminosyn 10%, Sulfite-Free, (an amino acid solution)
`
`*Provides sufficient volume to withdraw 1050 mL.
`
`1000
`
`1000
`500
`
`500
`
`1000
`500
`
`1000*
`500
`
`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). Avoid
`exposure to light.
`
`Revised: June, 2004. Hospira, Inc., Lake Forest, IL 60045 USA. FDA Rev date: 3/9/2004
`
`Side Effects & Drug Interactions
`
`https://www.rxlist.com/aminosyn-sulfite-free-drug.htm
`
`5/6/2020
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`Eton Ex. 1052
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`Aminosyn Sulfite Free (Crystalline Amino Acid Solution): Uses, Dosage, Side Effects, Interact… Page 9 of 15
`
`SIDE EFFECTS
`
`Peripheral Infusions
`
`A 4.25 or 5% solution of amino acids (without additives) is slightly hypertonic. A 3.5% concentration
`of amino acids (without additives) is slightly hypertonic. Local reactions consisting of a warm
`sensation, erythema, phlebitis and thrombosis at the infusion site have occurred with peripheral
`intravenous infusion of amino acids particularly if other substances, such as antibiotics, are also
`administered through the same site. In such cases the infusion site should be changed promptly to
`another vein. Use of large peripheral veins, inline filters, and slowing the rate of infusion may reduce
`the incidence of local venous irritation. Electrolyte additives should be spread throughout the day.
`Irritating additive medications may need to be injected at another venous site.
`
`Generalized flushing, fever and nausea also have been reported during peripheral infusions of amino
`acid solutions.
`
`DRUG INTERACTIONS
`
`Because of its antianabolic activity, concurrent administration of tetracycline may reduce the
`potential anabolic effects of amino acids infused with dextrose as part of a parenteral feeding
`regimen.
`
`Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use
`aseptic technique, mix thoroughly and do not store.
`
`QUESTION
`
`According to the USDA, there is no
`difference between a “portion” and
`a “serving.”
`
`See Answer
`
`Warnings
`
`https://www.rxlist.com/aminosyn-sulfite-free-drug.htm
`
`5/6/2020
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`Eton Ex. 1052
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`Aminosyn Sulfite Free (Crystalline Amino Acid Solution): Uses, Dosage, Side Effects, Intera… Page 10 of 15
`
`WARNINGS
`
`Intravenous infusion of amino acids may induce a rise in blood urea nitrogen (BUN), especially in
`patients with impaired hepatic or renal function. Appropriate laboratory tests should be performed
`periodically and infusion discontinued if BUN levels exceed normal postprandial limits and continue to
`rise. It should be noted that a modest rise in BUN normally occurs as a result of increased protein
`intake.
`
`Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum
`amino acid imbalances, metabolic alkalosis, prerenal azotemia, hyperammonemia, stupor and coma.
`
`Administration of amino acid solutions in the presence of impaired renal function may augment an
`increasing BUN, as does any protein dietary component.
`
`Solutions containing sodium ion should be used with great care, if at all, in patients with congestive
`heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium
`retention.
`
`Solutions which contain potassium ion should be used with great care, if at all, in patients with
`hyperkalemia, severe renal failure and in conditions in which potassium retention is present.
`
`Solutions containing acetate ion should be used with great care in patients with metabolic or
`respiratory alkalosis. Acetate should be administered with great care in those conditions in which
`there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency.
`
`Hyperammonemia is of special significance in infants, as it can result in mental retardation.
`Therefore, it is essential that blood ammonia levels be measured frequently in infants.
`
`Instances of asymptomatic hyperammonemia have been reported in patients without overt liver
`dysfunction. The mechanisms of this reaction are not clearly defined, but may involve genetic
`defects and immature or subclinically impaired liver function.
`
`Aminosyn, Sulfite-Free, (a crystalline amino acid solution) can be infused simultaneously with fat
`emulsion by means of a Y-connector located near the infusion site using separate flow rate controls
`for each solution.
`
`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.
`
`https://www.rxlist.com/aminosyn-sulfite-free-drug.htm
`
`5/6/2020
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`Eton Ex. 1052
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`Aminosyn Sulfite Free (Crystalline Amino Acid Solution): Uses, Dosage, Side Effects, Intera… Page 11 of 15
`
`Precautions
`
`PRECAUTIONS
`
`Special care must be taken when administering glucose to provide calories in diabetic or prediabetic
`patients.
`
`Feeding regimens which include amino acids should be used with caution in patients with history of
`renal disease, pulmonary disease, or with cardiac insufficiency so as to avoid excessive fluid
`accumulation.
`
`The effect of infusion of amino acids, without dextrose, upon carbohydrate metabolism of children is
`not known at this time.
`
`Nitrogen intake should be carefully monitored in patients with impaired renal function.
`
`For long-term total nutrition, or if a patient has inadequate fat stores, it is essential to provide
`adequate exogenous calories concurrently with the amino acids. Concentrated dextrose solutions are
`an effective source of such calories. Such strongly hypertonic nutrient solutions should be
`administered through an indwelling intravenous catheter with the tip located in the superior vena
`cava.
`
`SPECIAL PRECAUTIONS FOR CENTRAL INFUSIONS
`
`ADMINISTRATION BY CENTRAL VENOUS CATHETER SHOULD BE USED ONLY BY THOSE FAMILIAR
`WITH THIS TECHNIQUE AND ITS COMPLICATIONS.
`
`Central vein infusion (with added concentrated carbohydrate solutions) of amino acid solutions
`requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of
`complications. Attention must be given to solution preparation, administration and patient
`monitoring. IT IS ESSENTIAL THAT A CAREFULLY PREPARED PROTOCOL BASED ON CURRENT
`MEDICAL PRACTICES BE FOLLOWED, PREFERABLY BY AN EXPERIENCED TEAM.
`
`Summary Highlights Of Complications
`
`(consult current medical literature).
`
`1. Technical
`
`The placement of a central venous catheter should be regarded as a surgical procedure. One should
`be fully acquainted with various techniques of catheter insertion. For details of technique and
`placement sites, consult the medical literature. X-ray is the best means of verifying catheter
`placement. Complications known to occur from the placement of central venous catheters are
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`pneumothorax, hemothorax, hydrothorax, artery puncture and transection, injury to the brachial
`plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis, thrombosis and air
`and catheter emboli.
`
`2. Septic
`
`The constant risk of sepsis is present during administration of total parenteral nutrition. It is
`imperative that the preparation of the solution and the placement and care of catheters be
`accomplished under strict aseptic conditions.
`
`Solutions should ideally be prepared in the hospital pharmacy in a laminar flow hood using careful
`aseptic technique to avoid inadvertent touch contamination. Solutions should be used promptly after
`mixing. Storage should be under refrigeration and limited to a brief period of time, preferably less
`than 24 hours.
`
`Administration time for a single bottle and set should never exceed 24 hours.
`
`3. Metabolic
`
`The following metabolic complications have been reported with TPN administration: Metabolic
`acidosis and alkalosis, hypophosphatemia, hypocalcemia, osteoporosis, glycosuria, hyperglycemia,
`hyperosmolar nonketotic states and dehydration, rebound hypoglycemia, osmotic diuresis and
`dehydration, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances and
`hyperammonemia in children. Frequent evaluations are necessary especially during the first few days
`of therapy to prevent or minimize these complications.
`
`Administration of glucose at a rate exceeding the patient's utilization rate may lead to hyperglycemia,
`coma and death.
`
`Pregnancy Category C
`
`Animal reproduction studies have not been conducted with Aminosyn. It is not known whether
`Aminosyn, Sulfite-Free, (a crystalline amino acid solution) can cause fetal harm when administered to
`a pregnant woman or can affect reproduction capacity. Aminosyn should be given to a pregnant
`woman only if clearly needed.
`
`Geriatric Use
`
`Clinical studies of Aminosyn 3.5% have not been performed to determine whether patients over 65
`years respond differently from younger subjects. Other reported clinical experience has not identified
`differences in responses between elderly and younger patients. In general, dose selection for elderly
`patients should be cautious, 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
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`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 functions.
`
`CLINICAL EVALUATION AND LABORATORY DETERMINATIONS, AT THE DISCRETION OF THE
`ATTENDING PHYSICIAN, ARE NECESSARY FOR PROPER MONITORING DURING ADMINISTRATION.
`Do not withdraw venous blood for blood chemistries through the peripheral infusion site, as
`interference with estimations of nitrogen containing substances may occur. Blood studies should
`include glucose, urea nitrogen, serum electrolytes, ammonia, cholesterol, acid-base balance, serum
`proteins, kidney and liver function tests, osmolarity and hemogram. White blood count and blood
`cultures are to be determined if indicated. Urinary osmolality and glucose should be determined as
`necessary.
`
`Aminosyn contains no more than 25 mcg/L of aluminum.
`
`Overdosage & Contraindications
`
`OVERDOSE
`
`In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate
`corrective measures. See WARNINGS and PRECAUTIONS.
`
`CONTRAINDICATIONS
`
`This preparation should not be used in patients with hepatic coma or metabolic disorders involving
`impaired nitrogen utilization.
`
`Clinical Pharmacology
`
`CLINICAL PHARMACOLOGY
`
`Aminosyn, Sulfite-Free, (a crystalline amino acid solution) provides crystalline amino acids to
`promote protein synthesis and wound healing, and to reduce the rate of endogenous protein
`catabolism. Aminosyn, given by central venous infusion in combination with concentrated dextrose,
`electrolytes, vitamins, trace metals, and ancillary fat supplements, constitutes total parenteral
`nutrition (TPN). Aminosyn can also be administered by peripheral vein with dextrose and
`maintenance electrolytes. Intravenous fat emulsion may be substituted for part of the carbohydrate
`calories during either TPN or peripheral vein administration of Aminosyn.
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`Medication Guide
`
`PATIENT INFORMATION
`
`No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.
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