SMOFLIPID 20%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SMOFLIPID 20% (SMOFLIPID 20%).
SMOFlipid 20% is an intravenous lipid emulsion providing essential fatty acids (linoleic acid, alpha-linolenic acid) and energy as a component of parenteral nutrition. The soybean oil, medium-chain triglycerides, olive oil, and fish oil mixture supplies omega-6 and omega-3 fatty acids to prevent essential fatty acid deficiency and support cellular membrane function and metabolic processes.
| Metabolism | Metabolized by lipoprotein lipase in the peripheral tissues (adipose, muscle) and liver; clearance via reticuloendothelial system. The medium-chain triglycerides are rapidly oxidized, while long-chain triglycerides undergo slower metabolism requiring carnitine-dependent transport. |
| Excretion | Renal: negligible; biliary/fecal: >90% as triglycerides and free fatty acids (metabolized); <5% unchanged in urine |
| Half-life | Triglyceride half-life: 0.5-1 hour (rapid clearance by lipoprotein lipase); free fatty acids: 1-2 minutes (tissue uptake). Clinical context: rapid clearance prevents accumulation. |
| Protein binding | Triglycerides: bound to lipoproteins (chylomicrons, VLDL) – no specific binding protein; free fatty acids: >99% bound to albumin |
| Volume of Distribution | Triglycerides: ~0.05 L/kg (confined to plasma); free fatty acids: ~0.1 L/kg (extracellular space). Clinical meaning: low Vd indicates minimal tissue distribution, primarily intravascular. |
| Bioavailability | Intravenous: 100% (bioavailability not applicable for infusion; administered directly into bloodstream) |
| Onset of Action | Intravenous: immediate (within minutes) for fatty acid and caloric supply due to direct intravascular administration |
| Duration of Action | Caloric effect: 1-2 hours post-infusion; fatty acids cleared from circulation within hours. Continuous infusion required for sustained effect. |
Intravenous infusion: 15-20 mL/kg/day (equivalent to 3-4 g fat/kg/day) administered over 12-24 hours; typical adult dose 250-500 mL/day.
| Dosage form | EMULSION |
| Renal impairment | No specific dose adjustment for renal impairment; use with caution in severe renal failure due to risk of fluid overload and electrolyte disturbances. |
| Liver impairment | Contraindicated in severe hepatic impairment (Child-Pugh C); in mild to moderate impairment (Child-Pugh A or B) reduce dose by 50% and monitor triglycerides and liver function. |
| Pediatric use | Neonates and infants: 0.5-1 g fat/kg/day initially, titrate up to 3-4 g fat/kg/day; administer as continuous infusion over 24 hours. |
| Geriatric use | Use standard adult dose but monitor for fluid overload and hypertriglyceridemia; consider lower initial doses due to decreased metabolic clearance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SMOFLIPID 20% (SMOFLIPID 20%).
| Breastfeeding | Excretion in human milk unknown; caution advised. M/P ratio not established. |
| Teratogenic Risk | No adequate human data; animal studies not suggestive of teratogenicity. Use only if clearly needed. |
| Fetal Monitoring | Monitor serum triglycerides, hepatic function, coagulation parameters, and signs of fat overload syndrome. |
■ FDA Black Box Warning
Death in preterm infants: Use of intravenous lipid emulsions (including SMOFlipid 20%) in preterm infants has been associated with increased risk of death, particularly in very low birth weight infants. Do not use in preterm infants unless clearly necessary and only when alternative sources are not available.
| Serious Effects |
["Absolute: Known hypersensitivity to egg, soybean, or peanut proteins; severe hyperlipidemia; coagulation disorders with increased bleeding risk; acute pancreatitis with hypertriglyceridemia.","Relative: Renal failure, hepatic failure, severe metabolic acidosis, or conditions with altered lipid metabolism (e.g., uncontrolled diabetes, sepsis)."]
| Precautions | ["Risk of fat overload syndrome (hypertriglyceridemia, hepatomegaly, splenomegaly, anemia, coagulopathy).","Avoid in patients with severe hyperlipidemia or pancreatitis associated with hypertriglyceridemia.","Monitor serum triglycerides frequently, especially in neonates and patients with impaired lipid metabolism.","May cause allergic reactions (hypersensitivity to egg, soybean, peanut proteins).","Use caution in patients with hepatic impairment, coagulopathies, or pulmonary disease."] |
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| Fertility Effects | No known adverse effects on fertility. |