Aminosyn II

INDICATIONS AND USAGE Aminosyn II, Sulfite-Free, (an amino acid injection) 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 II SOLUTIONS WITHOUT ELECTROLYTES. Aminosyn II 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. Aminosyn II is also indicated for central vein infusion to prevent or reverse negative nitrogen balance in patients where the alimentary tract, by the oral, gastrostomy or jejunostomy route cannot or should not be used and gastrointestinal absorption of protein is impaired.

DOSAGE AND ADMINISTRATION Each 100 mL of Aminosyn II contains: Amino Acids Nitrogen Aminosyn II 10% 10 g 1.53 g Aminosyn II 15% 15 g 2.30 g 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. COLOR VARIATION FROM PALE YELLOW TO YELLOW IS NORMAL AND DOES NOT ALTER EFFICACY. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Aminosyn II in the 2000 mL flexible Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated gravimetric compounding devices for preparing intravenous nutritional admixtures. Admixtures must be stored under refrigeration and used within 24 hours of admixing. Peripheral Vein Nutritional Maintenance A mixture of Aminosyn II and dextrose diluted to a final concentration of 5% to 10% amino acids and 5% to 10% dextrose is suitable for administration by peripheral vein. This solution is not intended for central vein administration because it does not contain adequate amounts of amino acids or electrolytes. For peripheral intravenous infusion, 1 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. 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 infused with a fat emulsion by peripheral vein to provide approximately 1400 to 2000 kcal/day. Fat emulsion administration should be considered when prolonged parenter …

CONTRAINDICATIONS This preparation should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization.

ADVERSE REACTIONS Peripheral Infusions A 3.5% to 5% solution of amino acids (without additives) is slightly hypertonic. 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 infused 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 effects of amino acids infused with dextrose as part of a parenteral feeding regimen.

DESCRIPTION Aminosyn TM II, Sulfite-Free, (an amino acid injection) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn II is oxygen sensitive. The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program. The formulations are described below: Essential Amino Acids (mg/100 mL) Aminosyn II 10% 15% Isoleucine 660 990 Leucine 1000 1500 Lysine (acetate)* 1050 1575 Methionine 172 258 Phenylalanine 298 447 Threonine 400 600 Tryptophan 200 300 Valine 500 750 *Amount cited is for lysine alone and does not include the acetate. Nonessential Amino Acids (mg/100 mL) Alanine 993 1490 Arginine 1018 1527 L-Aspartic Acid 700 1050 L-Glutamic Acid 738 1107 Histidine 300 450 Proline 722 1083 Serine 530 795 N-Acetyl-L-Tyrosine 270 405 Glycine 500 750 Other Characteristics Protein Equivalent (approx. grams/liter) 100 150 Total Nitrogen (grams/liter) 15.3 23.0 Osmolarity (mOsmol/liter, actual) 840 1270 pH a 5.8 (5.0 – 6.5) 5.8 (5.0 – 6.5) Specific Gravity 1.03 1.05 Electrolytes (mEq/L) Sodium (Na + ) b 38 50 Acetate (C 2 H 3 O 2 - ) c 71.8 107.6 a Solution contains sodium hydroxide for pH adjustment. b Figure includes Na + from the pH adjustor. c Includes acetate from lysine acetate. 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 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. The formulas for the individual amino acids are as follows: The Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile parenteral nutrient admixtures; it contains no bacteriostat. Multiple single doses may be dispensed during continual aliquoting operations. Withdrawal of container contents should be promptly completed within 4 hours after initial closure puncture. structural formula amino acids

OVERDOSAGE In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS and PRECAUTIONS .)

HOW SUPPLIED Aminosyn II is supplied as a Pharmacy Bulk Package in a 2000 mL flexible container for continuous admixture compounding procedures. Two concentrations are available: Aminosyn II 10%, Sulfite-Free NDC 0409-7172-17 Aminosyn II 10%, Sulfite-Free NDC 0990-7172-17 Aminosyn II 15%, Sulfite-Free NDC 0409-7171-17 Aminosyn II 15%, Sulfite-Free NDC 0990-7171-17 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Avoid exposure to light. Revised: June, 2018 EN-4657 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA