Aminosyn Electrolytes

Name: Aminosyn Electrolytes

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
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 COOH
Serine HOCH2CH(NH2)COOH
Tyrosine CH2CH(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.

Side effects

Peripheral Infusions

Aminosyn 3.5% M* Sulfite-Free, (a crystalline amino acid solution* with maintenance electrolytes) is hypertonic. Local reactions consisting of a warm sensation, erythema, phlebitis and thrombosis at the infusion site have occurred with peripheral intravenous infusion of amino acids particularly if other substances, such as antibiotics, are also administered through the same site. In such cases the infusion site should be changed promptly to another vein. Use of large peripheral veins, inline filters, and slowing the rate of infusion may reduce the incidence of local venous irritation. Irritating additive medications may need to be injected at another venous site.

Generalized flushing, fever and nausea also have been reported during peripheral infusions of amino acid solutions.

Overdose

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

Clinical pharmacology

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

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