SOYACAL 20%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SOYACAL 20% (SOYACAL 20%).
Soybean oil emulsion provides essential fatty acids (linoleic and linolenic acid) as a caloric source and substrate for lipid synthesis and membrane integrity.
| Metabolism | Soybean oil is hydrolyzed by lipoprotein lipase to free fatty acids and glycerol; metabolized via beta-oxidation in tissues. |
| Excretion | Soybean oil in SOYACAL 20% is metabolized and eliminated primarily through oxidation and incorporation into body tissues. Less than 5% is excreted unchanged in urine. Biliary/fecal excretion of metabolites is minimal. |
| Half-life | The terminal elimination half-life of the triglyceride component is approximately 1 to 2 hours under steady-state conditions. Clinical context: In critically ill patients, clearance may be reduced, prolonging half-life. |
| Protein binding | Soybean oil triglycerides are not significantly protein-bound; they are transported in chylomicron-like particles. Free fatty acids released after hydrolysis are >99% bound to albumin. |
| Volume of Distribution | Apparent volume of distribution is approximately 0.1 L/kg, reflecting confinement to the plasma compartment and rapid tissue uptake. Clinical meaning: Limited extravascular distribution; large Vd would suggest impaired clearance. |
| Bioavailability | Intravenous administration yields 100% bioavailability. No other relevant routes of administration exist for this formulation. |
| Onset of Action | Intravenous administration: Caloric effect begins immediately as the lipid emulsion is metabolized, with measurable increases in plasma triglycerides within 15–30 minutes. |
| Duration of Action | The caloric effect persists for 4–6 hours following infusion, corresponding to the time required for clearance of infused triglycerides. Continuous infusion is often used to maintain sustained energy supply. |
Intravenous infusion: 20% lipid emulsion, initial dose 1 g/kg/day (5 mL/kg/day) infused over 12-24 hours; maximum 2.5 g/kg/day (12.5 mL/kg/day).
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment required; monitor serum triglycerides and electrolytes in severe renal impairment. |
| Liver impairment | Child-Pugh B or C: Reduce dose by 50% and monitor triglycerides; contraindicated in severe cholestasis or acute liver failure. |
| Pediatric use | Neonates and infants: 0.5-1 g/kg/day (2.5-5 mL/kg/day) initially, increase to 1-2 g/kg/day (5-10 mL/kg/day) as tolerated; maximum 3 g/kg/day (15 mL/kg/day) under monitoring. |
| Geriatric use | Dose reduction may be needed due to decreased clearance; start at 1 g/kg/day and monitor triglycerides and lipemia; adjust based on tolerance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SOYACAL 20% (SOYACAL 20%).
| Breastfeeding | Excretion into human milk is minimal. M/P ratio unknown. It is generally considered safe during breastfeeding when clinically indicated, as lipids are normal constituents of breast milk. Caution is advised in preterm infants due to immature lipid metabolism; avoid use in mothers nursing preterm infants unless necessary. |
| Teratogenic Risk | Soyacal 20% (intravenous soybean oil emulsion) is not directly teratogenic; however, it is used as a source of calories and essential fatty acids. There are no adequate studies in pregnant women. In animal reproduction studies, high doses of lipid emulsions have not shown fetal harm. First trimester: no known teratogenic risk. Second and third trimesters: use only if clearly needed; no specific malformations reported. Risk cannot be excluded but likely low for standard therapeutic doses. |
■ FDA Black Box Warning
Intravenous fat emulsions are contraindicated in patients with severe hyperlipidemia, lipoid nephrosis, acute pancreatitis with hyperlipidemia, or severe hepatic insufficiency.
| Serious Effects |
Severe hyperlipidemia, lipoid nephrosis, acute pancreatitis with hyperlipidemia, severe hepatic insufficiency, known allergy to soybean oil or egg yolk phospholipids.
| Precautions | Risk of fat overload syndrome (hepatomegaly, jaundice, coagulopathy, hyperlipidemia, fever); monitor triglycerides; use with caution in renal impairment, hepatic disease, or coagulation disorders. |
Loading safety data…
| Fetal Monitoring | Monitor maternal serum triglycerides, liver function tests, complete blood count, and coagulation parameters. During infusion, watch for signs of fat overload syndrome (fever, hepatomegaly, jaundice, coagulopathy). Monitoring of fetal well-being is not specifically required for this drug. |
| Fertility Effects | No adverse effects on fertility have been reported. Soybean oil emulsions do not affect reproductive organs or hormonal balance. Use during pregnancy does not impair future fertility. |