LIPOSYN II 20%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for LIPOSYN II 20% (LIPOSYN II 20%).
Lipid emulsion providing essential fatty acids (linoleic and linolenic acids) and calories for parenteral nutrition. The triglycerides are hydrolyzed by lipoprotein lipase to free fatty acids and glycerol, which are then utilized for energy or stored.
| Metabolism | Triglycerides are hydrolyzed by lipoprotein lipase in the vascular endothelium; free fatty acids are metabolized via beta-oxidation in the liver and other tissues; glycerol is phosphorylated and enters glycolysis or gluconeogenesis. |
| Excretion | Intravenous lipid emulsions are metabolized by lipoprotein lipase and eliminated as free fatty acids; less than 1% excreted unchanged in urine, negligible biliary/fecal excretion. |
| Half-life | Terminal elimination half-life of triglycerides is approximately 30 minutes for the fast phase and 12-24 hours for the slow phase, reflecting clearance from plasma and tissue distribution. |
| Protein binding | Not applicable; lipid particles do not bind to plasma proteins; free fatty acids bind extensively to albumin. |
| Volume of Distribution | Vd of triglycerides is 0.1-0.2 L/kg, reflecting confinement to plasma compartment initially; free fatty acids have larger Vd (0.5-1 L/kg) due to tissue uptake. |
| Bioavailability | Intravenous: 100%. |
| Onset of Action | Intravenous: immediate caloric and essential fatty acid provision upon infusion start. |
| Duration of Action | Duration of caloric effect depends on infusion rate and metabolic clearance; continuous infusion provides sustained energy source. |
Intravenous fat emulsion; 20% formulation: Initial rate 1 mL/min for 15-30 minutes, then increase to 2 mL/min if tolerated. Max infusion rate: 100 mL/hour. Total daily dose: 1-2 g/kg (5-10 mL/kg) to provide up to 60% of nonprotein calories.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment required for renal impairment; monitor serum triglycerides and electrolytes closely in patients with renal failure due to potential accumulation of soybean oil and egg phospholipids. |
| Liver impairment | Use caution in hepatic impairment. Reduce dose or discontinue if signs of hepatic dysfunction develop. No specific Child-Pugh based guidelines; monitor hepatic function and triglycerides. |
| Pediatric use | Intravenous fat emulsion 20%: Initial infusion rate 0.1-0.2 mL/min; maximum rate 1 mL/min. Daily dose: 0.5-1 g/kg (2.5-5 mL/kg) for premature infants; 1-2 g/kg (5-10 mL/kg) for term infants and children. Not to exceed 60% of total calories from fat. |
| Geriatric use | Start at lower end of dosing range (e.g., 1 g/kg/day) due to reduced clearance. Infuse at slower rates (e.g., 0.5-1 mL/min) and monitor triglycerides, hepatic function, and fluid status closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for LIPOSYN II 20% (LIPOSYN II 20%).
| Breastfeeding | Excretion in human milk unknown. Caution advised. M/P ratio: not available. Consider benefits of breastfeeding vs risks to infant. |
| Teratogenic Risk | Liposyn II 20% is a fat emulsion used for parenteral nutrition. No adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. Use only if clearly needed. No specific teratogenic effects identified, but high free fatty acids from lipid emulsions may theoretically affect fetal development. Fetal risks by trimester: First trimester: unknown risk; avoid unless essential. Second and third trimesters: use if maternal benefit outweighs potential fetal risk. |
■ FDA Black Box Warning
Death in preterm infants: Use in preterm infants has been associated with increased risk of death due to pulmonary lipid accumulation, particularly in those with pulmonary disease. Contraindicated in premature infants with hyperbilirubinemia or suspected pulmonary disease.
| Serious Effects |
["Severe hyperlipidemia or disorders of lipid metabolism (e.g., familial hypercholesterolemia)","Egg, soybean, or peanut allergy","Preterm infants with hyperbilirubinemia or suspected pulmonary disease"]
| Precautions | ["Monitor serum triglycerides regularly; discontinue if hypertriglyceridemia develops","Risk of fat overload syndrome (hepatomegaly, coagulopathy, thrombocytopenia)","Use with caution in patients with impaired lipid metabolism (e.g., renal failure, pancreatitis, hypothyroidism)","May cause pulmonary lipid accumulation in preterm infants","Risk of infection from catheter-related sepsis"] |
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| Fetal Monitoring | Monitor maternal serum triglycerides, liver function tests, and coagulation parameters during prolonged use. Monitor for signs of fat overload syndrome (hepatomegaly, splenomegaly, thrombocytopenia, coagulopathy). Fetal monitoring: standard obstetric care. |
| Fertility Effects | No animal or human data on fertility effects. No known impairment of fertility. |