Smoflipid Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Smoflipid Indications
Indications
Smoflipid Dosage and Administration
Adult
Children
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
Contraindications
Smoflipid Boxed Warnings
Not Applicable
Smoflipid Warnings/Precautions
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
Interactions
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