• Parenteral nutrition

Smoflipid Generic Name & Formulations

General Description

Lipid content 0.2g/mL (mixture of soybean oil, medium-chain triglycerides, olive- and fish-oil); emulsion for IV infusion; contains aluminum.

Pharmacological Class

Fatty acids.

How Supplied

Emulsion (100mL)—10, 20; (250mL)—10; (500mL)—12


Generic Availability


Smoflipid Indications


To provide a source of calories and essential fatty acids in adults and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Smoflipid Dosage and Administration


Individualize. Dose based on patient’s energy requirements, age, clinical status, body wt, tolerance, ability to eliminate and metabolize lipids, and additional energy given orally/enterally. Administer by IV infusion via a peripheral or central vein. Usual dose: 1–2g/kg/day; max 2.5g/kg/day. Initiate rate at 0.1g/min for the first 15–30mins; increase gradually to required rate after 30mins; max 0.1g/kg/hr. Max daily dose: 60% of total energy requirements. Usual infusion duration: 12–24 hours based on patient’s clinical status. If serum triglycerides (>400mg/dL): initiate at a lower dose and increase in smaller increments; check levels before each adjustment.


Individualize. Dose based on patient’s clinical status. Administer by IV infusion via a peripheral or central vein. Max infusion rate at 0.15g/kg/hr. Birth–2yrs (including preterm and term neonates): initially 0.5–1g/kg/day, may increase by 0.5–1g/kg/day (max 3g/kg/day); 2–<2yrs: initially 1–2g/kg/day, may increase by 0.5–1g/kg/day (max 3g/kg/day); 12–17yrs: initially 1–2g/kg/day (max 2.5g/kg/day). Usual infusion duration: 20–24 hours for preterm and term neonates; 12–24 hours for ≥1 month of age.

Smoflipid Contraindications


Fish, egg, soybean, or peanut allergy. Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride >1000mg/dL).

Smoflipid Boxed Warnings

Not Applicable

Smoflipid Warnings/Precautions


Risk of parenteral nutrition-associated liver disease (PNALD)(eg, cholestasis or hepatic steatosis), other hepatobiliary disorders (eg, cholecystitis and cholelithiasis). Risk of deaths in preterm and small-for-gestational-age neonates; monitor for signs/symptoms of pleural or pericardial effusion. Correct severe fluid and electrolyte disorders prior to initiation. Increased risk of hypertriglyceridemia esp. in those with inherited lipid disorders, obesity, diabetes mellitus, or metabolic syndromes. Measure serum triglycerides at baseline and during therapy; if serum triglyceride >400mg/dL, discontinue and monitor levels. Assess high-risk patients for overall energy intake to minimize risk of new or worsening of hypertriglyceridemia. Discontinue if signs/symptoms of fat overload syndrome or hypersensitivity reactions occur; treat appropriately. Monitor for signs/symptoms of infection, essential fatty acid deficiency (EFAD). Severely undernourished: avoid overfeeding. Monitor fluids, electrolytes, blood glucose, liver (consider discontinuation or dose reduction if abnormal LFTs occur) and kidney function, CBCs, platelets, coagulation parameters throughout treatment. Hepatic impairment. Pregnancy. Nursing mothers.

Smoflipid Pharmacokinetics

See Literature

Smoflipid Interactions


Vitamin K content may antagonize anticoagulants (eg, coumarin, warfarin); monitor. High lipid levels in plasma may interfere with blood tests (eg, hemoglobin, triglycerides, bilirubin, LDH, oxygen saturation).

Smoflipid Adverse Reactions

Adverse Reactions

Nausea, vomiting, hyperglycemia, flatulence, pyrexia, abdominal pain, hypertriglyceridemia, hypertension, sepsis, dyspepsia, UTI, anemia, device-related infections; refeeding syndrome, PNALD, aluminum toxicity (esp. preterm infants, renal impairment).

Smoflipid Clinical Trials

See Literature

Smoflipid Note

Not Applicable

Smoflipid Patient Counseling

See Literature