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Liposyn II

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Liposyn® II
(Intravenous Fat Emulsion)

DRUG 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 (intravenous fat emulsion) 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 (intravenous fat emulsion) 10% has an osmolarity of 276 mOsmol/liter (actual). The total caloric value of Liposyn II (intravenous fat emulsion) 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 (intravenous fat emulsion) 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 (intravenous fat emulsion) 20% has an osmolarity of 258 mOsmol/liter (actual). The total caloric value of Liposyn II (intravenous fat emulsion) 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 (intravenous fat emulsion) 10% and Liposyn II (intravenous fat emulsion) 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:

Safflower oil Structural Formula Illustration

Soybean Oil Structural Formula Illustration

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:

Major component fatty acids Structural Formula Illustration

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:

Egg phosphatides - Structural Formula Illustration

Egg phosphatides - Structural Formula Illustration

are the same saturated and unsaturated fatty acid residues that abound in neutral fats. R3 is primarily either the choline [HOCH2CH2N(CH3)3OH] ester or ethanolamine (HOCH2CH2NH2) ester of phosphoric acid (H3PO4).

Glycerin, USP is chemically designated C3H803 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:

Glycerin Structural Formula Illustration

Last reviewed on RxList: 1/30/2009
This monograph has been modified to include the generic and brand name in many instances.

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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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