Hospira Inc.
Product Description:Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.
Status:Ongoing
City:Lake Forest
State:IL
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Press Release
Distribution Pattern:Nationwide
Classification:Class I
Product Quantity:17,256 containers
Reason For Recall:Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
Recall Initiation Date:20130830
Report Date:20140122

Aminosyn Ii

Aminosyn Ii

Aminosyn Ii Recall

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Questions & Answers

Side Effects & Adverse Reactions

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 at even lower rates of administration.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

When administered with concentrated dextrose solution with or without fat emulsions, Aminosyn II 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.

History

There is currently no drug history available for this drug.

Other Information

Aminosyn® II, Sulfite-Free, (an amino acid injection) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn II is oxygen sensitive. The following formulations are available:

Aminosyn II Formulations
Essential Amino Acids (mg/100 mL)
Aminosyn II
7%
8.5%
10%

Isoleucine

462

561

660

Leucine

700

850

1000

Lysine (acetate)*

735

893

1050

Methionine

120

146

 172

Phenylalanine

209

253

 298

Threonine

280

340

 400

Tryptophan

140

170

 200

Valine

350

425

 500

*Amount cited is for lysine alone and does not include the acetate.


Nonessential Amino Acids (mg/100 mL)
Aminosyn II
7%
8.5%
10%

Alanine

695

844

  993

Arginine

713

865

1018

L-Aspartic Acid

490

595

  700

L-Glutamic Acid

517

627

  738

Histidine

210

255

  300

Proline

505

614

  722

Serine

371

450

  530

N-AcetyI-L-Tyrosine

189

230

  270

Glycine

350

425

  500

Product Characteristics
Aminosyn II
7%
8.5%
10%

Protein Equivalent

(approx. grams/liter)

70

85

100

Total Nitrogen

(grams/liter)

10.7

13.0

15.3

Osmolarity

(mOsmol/liter)

589

706

1040

pHa

(range)

5.8

5.0—6.5

5.8

5.0—6.5

5.8

5.0—6.5

a Contains sodium hydroxide for pH adjustment.

Electrolytes (mEq/Liter)
Aminosyn II
7%
8.5%
10%

Sodium (Na+)b

25

32

38

Acetate(C2H3O2)c

50

61

72

b Na+ from pH adjustor.

c Includes acetate from lysine acetate.

The formulas for the individual amino acids present in Aminosyn® II, are as follows:

Essential Amino Acids

Isoleucine, USP

C6H13NO2

Leucine, USP

C6H13NO2

Lysine Acetate, USP

C6H14N2O2 • CH3COOH

Methionine, USP

C5H11NO2S

Phenylalanine, USP

C9H11NO2

Threonine, USP

C4H9NO3

Tryptophan, USP

C11H12N2O2

Valine, USP

C5H11NO2

Nonessential Amino Acids

Alanine, USP

C3H7NO2

Arginine, USP

C6H14N4O2

L-Aspartic Acid

C4H7NO4

HO2CCH2CH(NH2)CO2H

L-Glutamic Acid

C5H9NO4

HO2CCH2CH2CH(NH2)CO2H

Glycine, USP

C2H5NO2

Histidine, USP

C6H9N3O2

Proline, USP

C5H9NO2

Serine, USP

C3H7NO3

N-Acetyl-L-Tyrosine

C11H13NO4

structural formula N-Acetyl-L-Tyrosine

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.

Aminosyn Ii Manufacturers


  • Hospira, Inc.
    Aminosyn Ii (Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine) Injection, Solution [Hospira, Inc.]
  • Hospira, Inc.
    Aminosyn Ii (Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyltyrosine, And Glycine) Injection, Solution [Hospira, Inc.]
  • Hospira, Inc.
    Aminosyn Ii (Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyltyrosine, And Glycine) Injection, Solution [Hospira, Inc.]

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