Aminosyn II: Package Insert and Label Information

AMINOSYN II- isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, acetyl l-tyrosine and glycine injection, solution
ICU Medical Inc.

AN AMINO ACID INJECTION, Sulfite-Free

Pharmacy Bulk Package – Not For Direct Infusion.

Flexible Plastic Container

Rx only

DESCRIPTION

Aminosyn 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)100150

Total Nitrogen

(grams/liter)15.323.0

Osmolarity

(mOsmol/liter, actual)8401270

pHa

5.8 (5.0 – 6.5)5.8 (5.0 – 6.5)

Specific Gravity

1.031.05

Electrolytes

(mEq/L)

Sodium

(Na+)b 3850

Acetate

(C2 H3 O2 )c 71.8107.6

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:

structural formula amino acids
(click image for full-size original)

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.

CLINICAL PHARMACOLOGY

Aminosyn II, Sulfite-Free, (an amino acid injection) provides crystalline amino acids to promote protein synthesis and wound healing, and to reduce the rate of endogenous protein catabolism. Aminosyn II, given by central venous infusion in combination with concentrated dextrose, electrolytes, vitamins, trace metals, and ancillary fat supplements, constitutes total parenteral nutrition (TPN). Aminosyn II 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 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.

CONTRAINDICATIONS

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

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.

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 even at lower rates of administration.

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.

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