Aminosyn Sulfite Free
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Aminosyn Sulfite Free
Aminosyn®
Sulfite-Free
A CRYSTALLINE AMINO ACID SOLUTION
Flexible Plastic Container
DRUG 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 | 3.5% | 5% | 7% | 8.5% | 10% |
| Isoleucine | 252 | 360 | 510 | 620 | 720 |
| Leucine | 329 | 470 | 660 | 810 | 940 |
| Lysine (acetate)* | 252 | 360 | 510 | 624 | 720 |
| Methionine | 140 | 200 | 280 | 340 | 400 |
| Phenylalanine | 154 | 220 | 310 | 380 | 440 |
| Threonine | 182 | 260 | 370 | 460 | 520 |
| Tryptophan | 56 | 80 | 120 | 150 | 160 |
| Valine | 280 | 400 | 560 | 680 | 800 |
| *Amount cited is for Lysine alone and does not include the acetate salt. | |||||
Nonessential Amino Acids (mg/100 mL)
| Aminosyn | 3.5% | 5% | 7% | 8.5% | 10% |
| Alanine | 448 | 640 | 900 | 1100 | 1280 |
| Arginine | 343 | 490 | 690 | 850 | 980 |
| Histidine | 105 | 150 | 210 | 260 | 300 |
| Proline | 300 | 430 | 610 | 750 | 860 |
| Serine | 147 | 210 | 300 | 370 | 420 |
| Tyrosine | 31 | 44 | 44 | 44 | 44 |
| Glycine | 448 | 640 | 900 | 1100 | 1280 |
Electrolytes (mEq/Liter)
| Aminosyn | 3.5% | 5% | 7% | 8.5% | 10% |
| Sodium (Na+) | None | None | None | None | None |
| Potassium (K+) | None | None | None | None | None |
| Chloride (Cl–) | None | None | None | 35a | None |
| Acetate (C2H3O2–)b | 51 | 86 | 105 | 90 | 147 |
| a Includes chloride from HCl added for processing
and pH adjustment. b Includes acetate from acetic acid used in processing and from Lysine acetate. |
|||||
Product Characteristics
| Aminosyn | 3.5% | 5% | 7% | 8.5% | 10% |
| Protein Equivalent (approx. grams/liter) | 35 | 50 | 70 | 85 | 100 |
| Total Nitrogen (grams/liter) | 5.5 | 7.86 | 11.00 | 13.4 | 15.72 |
| Osmolarity (mOsmol/liter) | 322 | 462 | 655 | 802 | 932 |
| pH | 5.2 | 5.2 | 5.2 | 5.2 | 5.2 |
| Range | (4.5 –6.0c) | (4.5 – 6.0c) | (4.5 – 6.0c) | (4.5 – 6.0d) | (4.5 – 6.0c) |
| c Adjusted with acetic acid. d Adjusted with acetic acid and hydrochloric acid. |
|||||
The formulas for the individual amino acids present in Aminosyn are as follows:
Essential Amino Acids
| Isoleucine | (C6H13NO2) |
| Leucine | (C6H13NO2) |
| Lysine Acetate | (C6H14N2O2 • CH3COOH) |
| Methionine | (C5H11NO2S) |
| Phenylalanine | (C9H11NO2) |
| Threonine | (C4H9NO3) |
| Tryptophan | (C11H12N2O2) |
| Valine | (C5H11NO2) |
Nonessential Amino Acids
| Alanine | (C3H7NO2) |
| Arginine | (C6H14N4O2) |
| Histidine | (C6H9N3O2) |
| Proline | (C5H9NO2) |
| Serine | (C3H7NO3) |
| Tyrosine | (C9H11NO3) |
| Glycine | (C2H5NO2) |
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.
Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Aminosyn Sulfite Free Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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