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    • Aminosyn Electrolytes

    DRUG DESCRIPTION

    Aminosyn® WITH ELECTROLYTES, Sulfite-Free, (a crystalline amino acid solution with electrolytes) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn WITH ELECTROLYTES is oxygen sensitive. Three different formulations are available.

    Aminosyn Formulations Essential Amino Acids (mg/100 mL)

    Aminosyn 3.5% M* 7% WITH ELECTROLYTES 8.5% WITH ELECTROLYTES
    Isoleucine 252 510 620
    Leucine 329 660 810
    Lysine (acetate)** 252 510 624
    Methionine 140 280 340
    Phenylalanine 154 310 380
    Threonine 182 370 460
    Tryptophan 56 120 150
    Valine 280 560 680
    *Contains maintenance electrolytes.
    **Amount cited is for lysine alone and does not include the acetate salt.

    Nonessential Amino Acids (mg/100 mL)

    Aminosyn 3.5% M* 7% WITH ELECTROLYTES 8.5% WITH ELECTROLYTES
    Alanine 448 900 1100
    Arginine 343 690 850
    Histidine 105 210 260
    Proline 300 610 750
    Serine 147 300 370
    Tyrosine 31 44 44
    Glycine 448 900 1100
    *Contains maintenance electrolytes.

    Essential Amino Acids

    Isoleucine CH3CH2CH(CH3)CH(NH2)COOH
    Leucine (CH3)2CHCH2CH(NH2)COOH
    Lysine Acetate H2N(CH2)4CH(NH2)COOH • CH3COOH
    Methionine CH3S(CH2)2CH(NH2)COOH
    Phenylalanine
    Aminosyn® WITH ELECTROLYTES (crystalline amino acid solution with electrolytes) Sulfite-Free Structural Formula Illustration
    CH2CH(NH2)COOH
    Threonine CH3CH(OH)CH(NH2)COOH
    Tryptophan

    CH2CH(NH2)COOH
    Valine (CH3)2CHCH(NH2)COOH

    Nonessential Amino Acids

    Alanine CH3CH(NH2)COOH
    Arginine H2NC(NH)NH(CH2)3CH(NH2)COOH
    Glycine H2NCH2COOH
    Histidine

    CH2CH(NH2)COOH
    Proline
    Serine HOCH2CH(NH2)COOH
    Tyrosine
    2CH(NH2)COOH

    Electrolytes (mEq/Liter)

    Aminosyn 3.5% M* 7% WITH ELECTROLYTES 8.5% WITH ELECTROLYTES
    Sodium (Na+) 40 65 65
    Potassium (K+) 13 65 65
    Magnesium (Mg++) 3 10 10
    Phosphorus (P) 3.5 (mM)a 30 (mM)a 30 (mM)a
    Chloride (Cl–) 40 96b 98b
    Acetate (C2H3O2–) 65c 124d 142d
    a mM = millimoles; one mM of phosphorus = 31 mg.
    b Includes chloride from HCl added for processing and pH adjustment.
    c Includes acetate from acetic acid used in processing and the acetate salts of potassium, magnesium and lysine.
    d Includes acetate from acetic acid used in processing and from lysine acetate.

    Product Characteristics

    Aminosyn 3.5% M* 7% WITH ELECTROLYTES 8.5% WITH ELECTROLYTES
    Protein Equivalent (approx. grams/liter) 35 70 85
    Total Nitrogen (grams/liter) 5.5 11.00 13.4
    Specific Gravity 1.01 1.03 1.03
    Osmolarity (mOsmol/liter) 421 883 1040
    pH 5.2 (4.5—6.0)e 5.2 (4.5 — 6.0)f 5.2 (4.5 — 6.0)f
    e Contains acetic acid for pH adjustment.
    f Contains hydrochloric acid and acetic acid for pH adjustment.

    Electrolytes (mg/100 mL)

    Aminosyn 3.5% M*
    Sodium Chlorideg 234
    Potassium Acetateh 128
    86.5% Phosphoric Acidi 40
    Magnesium Acetate, anhydrousj 21
    *Contains Maintenance Electrolytes

    Aminosyn 7% WITH ELECTROLYTES 8.5% WITH ELECTROLYTES
    Sodium Chlorideg 28 28
    Magnesium Chloride, hexahydratek 102 102
    Sodium Phosphate, dibasicl 425 425
    Potassium Chloridem 487 487
    g Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.
    h Potassium Acetate, USP is chemically designated CH3COOK, colorless crystals or white crystalline powder very soluble in water.
    i Phosphoric Acid 86.5%, NF is chemically designated H3PO4, a colorless, syrupy liquid miscible with water.
    j Magnesium Acetate is chemically designated magnesium acetate, tetrahydrate, Mg(CH3COO)2 • 4H2O, colorless or white crystals very soluble in water.
    k Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate, MgCl2 • 6H2O, deliquescent crystals very soluble in water.
    l Sodium Phosphate, dibasic, USP is chemically designated Na2HPO4, white granules very soluble in water.
    m Potassium Chloride, USP is chemically designated KCI, a white granular powder freely soluble in water.

    The formulas for the individual amino acids present in Aminosyn 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)
      Histidine, USP (C6H9N3O2)
      Proline, USP (C5H9NO2)
      Serine, USP (C3H7NO3)
      Tyrosine, USP (C9H11NO3)
      Glycine, USP (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.



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