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Side Effects & Adverse Reactions
Deaths in preterm infants after infusion of intravenous fat emulsions have been reported in the medical literature.1,2 Autopsy findings included intravascular fat accumulation in the lungs. Treatment of premature and low birth weight infants with intravenous fat emulsion must be based upon careful benefit-risk assessment. Strict adherence to the recommended total daily dose is mandatory; hourly infusion rate should be as slow as possible in each case and should not in any case exceed 1 g/kg in four hours. Premature and small for gestational age infants have poor clearance of intravenous fat emulsion and increased free fatty acid plasma levels following fat emulsion infusion; therefore, serious consideration must be given to administration of less than the maximum recommended doses in these patients in order to decrease the likelihood of intravenous fat overload. The infant’s ability to eliminate infused fat from the circulation must be carefully monitored (such as triglyceride and/or plasma free fatty acid levels). The lipemia must clear between daily infusions.
Caution should be exercised in administering Liposyn III (intravenous fat emulsion) to patients with severe liver damage, pulmonary disease, anemia or blood coagulation disorders or when there is danger of fat embolism. The too rapid administration of Liposyn III can cause fluid and/or fat overloading resulting in dilution of serum electrolyte concentrations, over-hydration, congested states, pulmonary edema, impaired pulmonary diffusion capacity or metabolic acidosis.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
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Liposyn III (intravenous fat emulsion) 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 III 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.
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Liposyn III (Intravenous Fat Emulsion) is a sterile, nonpyrogenic fat emulsion for intravenous administration. It is supplied in both a 10% and 20% concentration.
Liposyn III 10% contains 10% soybean oil, up to 1.2% egg phosphatides added as an emulsifier and 2.5% glycerin in water for injection. Sodium hydroxide has been added for pH adjustment. pH 8.3 (6.0 to 9.0). Liposyn III 10% has an osmolarity of 284 mOsmol/L (approx.) and a specific gravity of 0.995. The total caloric value of Liposyn III 10% including fat, phospholipid and glycerol is 1.1 kcal/mL. Of this total, approximately 0.5 kcal/mL is supplied by linoleic acid.
Liposyn III 20% contains 20% soybean oil, 1.2% egg phosphatides and 2.5% glycerin in water for injection. Sodium hydroxide has been added for pH adjustment. pH 8.3 (6.0 to 9.0). Liposyn III 20% has an osmolarity of 292 mOsmol/L (approx.) and a specific gravity of 0.988. The total caloric value of Liposyn III 20% including fat, phospholipid and glycerol is 2.0 kcal/mL. Of this total, approximately 1.0 kcal/mL is supplied by linoleic acid.
Both Liposyn III 10% and Liposyn III 20% contain emulsified fat particles of approximately 0.4 micron in diameter, similar to naturally occurring chylomicrons.
Soybean Oil, USP is a mixture of neutral triglycerides with the following structure:
|are saturated and unsaturated fatty acid residues. The major component fatty acids are approximately 54.5% linoleic, 22.4% oleic, 10.5% palmitic, 4.2% stearic, and 8.3% linolenic acid. These fatty acids have the following chemical and structural formulas:|
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:
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: