LIPOSYN II- safflower oil, soybean oil and egg phospholipids injection, emulsion
Hospira, Inc.
INTRAVENOUS FAT EMULSION
Rx only
DESCRIPTION
Liposyn II (Intravenous Fat Emulsion) is a sterile, nonpyrogenic fat emulsion for intravenous administration. It is supplied in both a 10% and 20% concentration.
Liposyn II 10% contains 5% safflower oil, 5% soybean oil, up to 1.2% egg phosphatides added as an emulsifier and 2.5% glycerin in water for injection. May contain sodium hydroxide for pH adjustment. pH 8.0 (6.0 ? 9.0). Liposyn II 10% has an osmolarity of 276 mOsmol/liter (actual). The total caloric value of Liposyn II 10% including fat, phospholipid and glycerol is 1.1 kcal/mL. Of this total, approximately 0.6 kcal/mL is supplied by linoleic acid.
Liposyn II 20% contains 10% safflower oil, 10% soybean oil, 1.2% egg phosphatides and 2.5% glycerin in water for injection. May contain sodium hydroxide for pH adjustment. pH 8.3 (6.0 ? 9.0). Liposyn II 20% has an osmolarity of 258 mOsmol/liter (actual). The total caloric value of Liposyn II 20% including fat, phospholipid and glycerol is 2 kcal/mL. Of this total, approximately 1.2 kcal/mL are supplied by linoleic acid.
Both Liposyn II 10% and Liposyn II 20% contain emulsified fat particles of approximately 0.4 micron in diameter, similar to naturally occurring chylomicrons.
Safflower oil and Soybean Oil, USP are mixtures of neutral triglycerides with the following structure:
structural formula safflower oil and soybean oil
structural formula, structural formula and structural formula are saturated and unsaturated fatty acid residues. The major component fatty acids of the 50/50 safflower/soybean oil mixture are approximately 65.8% linoleic, 17.7% oleic, 8.8% palmitic, 3.4% stearic, and 4.2% linolenic acid. These fatty acids have the following chemical and structural formulas:
structural formula linoleic acid
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structural formula oleic acid
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structural formula palmitic acid
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structural formula stearic acid
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structural formula linolenic acid
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Egg phosphatides, purified, are primarily a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:
phospholipids general structure
structural formula and structural formula are the same saturated and unsaturated fatty acid residues that abound in neutral fats. R3 is primarily either the choline [HOCH2 CH2 N(CH3 )3 OH] ester or ethanolamine (HOCH2 CH2 NH2 ) ester of phosphoric acid (H3 PO4 ).
Glycerin, USP is chemically designated C3 H8 03 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:
structural formula glycerinstructural formula safflower oil and soybean oilstructural formulastructural formulastructural formulastructural formula linoleic acidstructural formula oleic acidstructural formula palmitic acidstructural formula stearic acidstructural formula linolenic acidphospholipids general structurestructural formula glycerin
CLINICAL PHARMACOLOGY
Liposyn II (Intravenous Fat Emulsion) provides the patient requiring parenteral nutrition with a source of calories and the essential fatty acids normally obtained from a nutritionally complete oral diet. The supplemental polyunsaturated fat prevents biochemical changes of essential fatty acid deficiency (EFAD) and prevents and reverses EFAD clinical manifestations (e.g., scaliness of skin, growth retardation, poor wound healing and sparse hair growth).
The infused fat particles are cleared from the bloodstream in a manner thought to be similar to the clearing of chylomicrons. Following infusion, there is a transient increase in plasma triglycerides. The triglycerides are hydrolyzed to free fatty acids and glycerol by the enzyme, lipoprotein lipase. The free fatty acids either enter the tissues (where they may be oxidized or resynthesized into triglycerides and stored) or circulate in the plasma, bound to albumin. In the liver, circulating free fatty acids are oxidized or converted to very low density lipoproteins that re-enter the bloodstream.
Phosphatides are the hydrophobic components of membranes and provide electrically insulated layers. They are involved in the formation of membrane structures. Choline prevents the deposition of fat in the liver.
Glycerol is metabolized to carbon dioxide and glycogen or is used in the synthesis of body fats.
INDICATIONS AND USAGE
Liposyn II is indicated as a source of calories for patients requiring parenteral nutrition. Where such nutrition is required for extended periods of time (more than 5 days), Liposyn II is also indicated as a source of essential fatty acids to prevent or reverse biochemical changes in fatty acid composition of plasma lipids (elevated triene/tetraene ratio) and the clinical manifestations of EFAD.
CONTRAINDICATIONS
