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Lipid emulsion (plant oil-based): Pediatric drug information

Lipid emulsion (plant oil-based): Pediatric drug information
(For additional information see "Lipid emulsion (plant oil-based): Drug information" and see "Lipid emulsion (plant oil-based): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Deaths in preterm infants:

Deaths in preterm infants after infusion of IV lipid emulsions have been reported in the medical literature. Autopsy findings included intravascular fat accumulation in the lungs. Preterm infants and low birth weight infants have poor clearance of IV lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.

Brand Names: US
  • Clinolipid;
  • Intralipid;
  • Nutrilipid
Brand Names: Canada
  • Clinoleic;
  • Intralipid
Therapeutic Category
  • Caloric Agent;
  • Intravenous Nutritional Therapy
Dosing: Neonatal
Parenteral nutrition

Parenteral nutrition: Intralipid, Nutrilipid: Note: Lipid emulsion should not exceed 60% of the total daily calories. At the onset of therapy, the patient should be observed for any immediate allergic reactions such as dyspnea, cyanosis, and fever.

Premature neonates: IV: Initial dose: 0.5 to 1 g/kg/day; increase by 0.5 to 1 g/kg/day to a maximum of 3 g/kg/day depending upon the needs/nutritional goals (ASPEN [Corkins 2015]).

Term neonates: IV: Initial dose: 0.5 to 1 g/kg/day; increase by 0.5 to 1 g/kg/day to a maximum of 2.5 to 3 g/kg/day depending upon the needs/nutritional goals (ASPEN [Corkins 2015]).

Localized anesthetic toxicity

Localized anesthetic toxicity: Full-term neonate: Very limited data available: 20% lipid emulsion: IV: 1 mL/kg was reported in a single case report in a 2-day-old neonate undergoing caudal epidural block for a urologic procedure (Lin 2010).

Dosing: Pediatric
Parenteral nutrition

Parenteral nutrition: Intralipid, Nutrilipid: Note: Lipid emulsion should not exceed 60% of the total daily calories. At the onset of therapy, the patient should be observed for any immediate allergic reactions such as dyspnea, cyanosis, and fever.

Infants: IV: Initial dose: 0.5 to 1 g/kg/day; increase by 0.5 to 1 g/kg/day to a maximum of 2.5 to 3 g/kg/day depending upon the needs/nutritional goals (ASPEN [Corkins 2015]).

Children 1 to 10 years: IV: Initial dose: 1 to 2 g/kg/day; increase by 0.5 to 1 g/kg/day to a maximum of 2 to 2.5 g/kg/day depending upon the needs/nutritional goals (ASPEN [Corkins 2015]).

Children ≥11 years and Adolescents: IV: Initial dose: 1 g/kg/day, not to exceed 500 mL 20% lipid emulsion on the first day of therapy; increase by 1 g/kg/day to a maximum of 1 to 2 g/kg/day (ASPEN [Corkins 2015]).

Essential fatty acid deficiency, prevention

Essential fatty acid deficiency, prevention: Intralipid: Infants, Children, and Adolescents: IV: Administer 8% to 10% of total caloric intake as lipid emulsion; infuse 2 to 3 times weekly; may need to increase dose during stress.

Serious hemodynamic or other instability secondary to highly lipid soluble substances

Serious hemodynamic or other instability secondary to highly lipid soluble substances (including, but not limited to, local anesthetics, calcium channel blockers, tricyclic antidepressants, bupropion, lamotrigine, and quetiapine): Note: Use is reserved for patients not responsive to standard resuscitation measures.

Infants, Children, and Adolescents: Very limited data available, optimal dose not defined: 20% lipid emulsion: IV: 1.5 mL/kg bolus over 2 to 3 minutes followed immediately by a continuous IV infusion at 0.25 mL/kg/minute; assess response after 3 minutes of infusion. If the patient demonstrates a significant response, the infusion rate may be reduced to 0.025 mL/kg/minute (ie, one-tenth the initial rate). If instability re-emerges, the infusion rate may be increased to 0.25 mL/kg/minute or the 1.5 mL/kg bolus may be repeated (ACMT 2017). Suggested maximum dose: 10 to 12.5 mL/kg (ACMT 2017; Fettiplace 2015).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling; use with caution.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling; use with caution.

Dosing: Adult

(For additional information see "Lipid emulsion (plant oil-based): Drug information")

Note: At the onset of therapy, the patient should be observed for any immediate allergic reactions (eg, dyspnea, cyanosis, and fever).

Energy/Calories

Energy/Calories: Note: Lipid emulsion should not exceed 60% of the total daily calories. US guidelines recommend withholding soybean oil-based lipid emulsion for the first 7 to 10 days of peripheral nutrition therapy in the critically ill. If there is a concern for essential fatty acid deficiency, the weekly dose of soybean oil lipid emulsion should be limited to 100 g/week (Mirtallo 2020; Taylor 2016).

Stable: IV: Initial dose: 1 to 1.5 g/kg/day (not to exceed 500 mL Intralipid 10% or 20% or 330 mL Intralipid 30% [over 4 to 6 hours] on the first day of therapy); daily dose may be infused over 12 to 24 hours; maximum daily dose: 2.5 g/kg/day.

Critically ill:

Intralipid, Nutrilipid: IV: <1 g/kg/day (ASPEN 2019).

Clinolipid: IV: 1 to 1.5 g/kg/day (Mirtallo 2020).

Essential fatty acid deficiency, prevention

Essential fatty acid deficiency, prevention: IV: The minimum daily dose of essential fatty acid (EFA) as percent of total energy is at least 2% to 4% linoleic acid and 0.25% to 0.5% alpha-linolenic acid. There is a large difference in EFA content of lipid emulsion products. It is recommended that EFA dose be calculated for each product when lipid emulsion is used only as a source of EFA (Mirtallo 2020).

Essential fatty acid deficiency, treatment

Essential fatty acid deficiency, treatment: Intralipid: IV: Administer 8% to 10% of total caloric intake as lipid emulsion; may infuse up to once daily (Riella 1975). If EFA deficiency occurs with stress, the dosage needed to correct EFA deficiency may be increased.

Serious hemodynamic or other instability secondary to highly lipid soluble substances

Serious hemodynamic or other instability secondary to highly lipid soluble substances (off-label use): Note: May be considered when the patient does not respond to standard resuscitation measures (eg, fluids, vasopressors, inotropes) (ACMT 2017; AHA [Lavonas 2016]; ASRA [Neal 2018]). Continue chest compressions during administration if patient is in cardiac arrest to circulate the lipid emulsion. Consultation with a clinical toxicologist or poison control center is recommended.

Intralipid 20%: IV: 1.5 mL/kg (maximum: 100 mL; ASRA [Neal 2018]) administered over 1 to 3 minutes, followed immediately by an infusion of 0.25 mL/kg/minute (maximum: 200 to 250 mL; ASRA [Neal 2018]) (recommended infusion durations vary; see below); may repeat the bolus as necessary for persistent cardiovascular collapse or if instability re-emerges (ACMT 2017; AHA [Lavonas 2015]; ASRA [Neal 2018]). Some suggest dosing based on lean body weight (AHA [Lavonas 2015]; ASRA [Neal 2018]). Maximum suggested dose: 10 to 12 mL/kg over the first 30 to 60 minutes (AHA [Lavonas 2015]; ASRA [Neal 2018]).

After administration of the initial bolus and continuous infusion, recommendations regarding the continuous infusion vary significantly:

American College of Medical Toxicology: If after the bolus and continuing the infusion for 3 minutes the patient demonstrates a significant response, the infusion rate may be reduced to 0.025 mL/kg/minute (ie, one-tenth the initial rate). If instability re-emerges, the infusion rate may be increased back to 0.25 mL/kg/minute or the bolus may be repeated (ACMT 2017).

American Heart Association recommendations: Continue infusion for 30 to 60 minutes (AHA [Lavonas 2015]).

American Society of Regional Anesthesia and Pain Medicine: Continue infusion for at least 10 minutes after hemodynamic stability has been restored. Consider rebolus or increase the infusion rate to 0.5 mL/kg/minute if hemodynamic instability persists or recurs. (ASRA [Neal 2018]).

Dosage adjustment for increased serum triglycerides: Stop infusion and monitor if triglycerides >400 mg/dL; restart at a lower dose/infusion rate and advance in smaller increments once triglycerides are <400 mg/dL. Use is contraindicated with triglycerides >1,000 mg/dL (Mirtallo 2020).

Dosage adjustment for concomitant therapy: For patients receiving other lipid emulsion-based medications (eg, propofol, clevidipine), reduce dosage to avoid fat overload syndrome (Mirtallo 2020). Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Emulsion, Intravenous:

Clinolipid: 20% (100 mL, 250 mL, 500 mL, 1000 mL)

Intralipid: 20% (100 mL, 250 mL, 500 mL, 1000 mL); 30% (500 mL) [contains egg yolk phospholipids, glycerin]

Nutrilipid: 20% (250 mL, 500 mL, 1000 mL) [contains egg yolk phospholipids, glycerin]

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Emulsion, Intravenous:

Clinoleic: 20% (100 mL, 250 mL, 350 mL, 500 mL, 1000 mL) [contains egg phosphatides]

Intralipid: 20% (100 mL, 250 mL, 500 mL, 1000 mL); 30% (250 mL, 333 mL, 500 mL)

Dosage Forms Considerations

Product oil source for Intralipid and Nutrilipid: soybean

Administration: Pediatric

IV: Administer by IV infusion only via peripheral line or by central venous infusion. All lipid emulsion infusions should be filtered whether part of an admixture or infused separately using a 1.2 micron in-line filter only (ASPEN [Worthington 2021]; ISMP 2016). Preparation and administration dependent upon use. Experts recommend parenteral nutrition admixtures and lipid emulsions for neonates and infants be protected from light as soon as possible after preparation and through infusion (ASPEN [Robinson 2021]).

Parenteral nutrition:

Intralipid: Prior to opening the overwrap, the integrity indicator should be inspected. If the indicator is black, the overwrap is damaged; do not use.

Nutrilipid: To avoid air embolism, use a nonvented infusion set or close the air vent on a vented set and use a dedicated line without any connections. Prior to opening the overwrap, the oxygen indicator should be inspected; if the indicator is pink or dark pink, do not use. May be infused concurrently into the same vein as carbohydrate-amino acid solutions by means of a Y-connector located near the infusion site; flow rates of each solution should be controlled separately by infusion pumps. Do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). See prescribing information for detailed administration information.

Administer via peripheral line or by central venous infusion. At the onset of therapy, the patient should be observed for any immediate allergic reactions such as dyspnea, cyanosis, and fever. Change tubing after each infusion. The 20% lipid emulsions may be simultaneously infused with amino acid and dextrose mixtures by means of Y-connector located near infusion site into either central or peripheral line or administered in total nutrient mixtures (3-in-1) with amino acids, dextrose, and other nutrients. Lipid emulsions of 30% should only be administered in total nutrient mixtures (3-in-1) with amino acids, dextrose, and other nutrients; not intended for direct infusion; must be further diluted to a final concentration not to exceed 20%. At the bedside, lipid emulsion solution should be elevated higher than other parenteral fluids to prevent it running up into other IV lines due to its low specific gravity.

Neonates, Infants, Children, and Adolescents: Daily dose of lipid emulsion is typically infused over 24 hours; patients who have been on a stable TPN regimen for >2 weeks may have total infusion time incrementally decreased (ie, cycled) to 12 to 22 hours a day to decrease hepatic complications associated with TPN use and to ease daily activities (ASPEN [Corkins 2015]); do not exceed 1 g/kg in 4 hours (0.25 g/kg/hour); some experts have recommended lower rates of ≤0.15 g/kg/hour; the maximum adult rate is 0.125 g/kg/hour (ASPEN [Corkins 2015].

Product-specific infusion rates (volume):

Intralipid 20%: Initiate at ≤0.05 mL/minute for 10 to 15 minutes; if no untoward effects occur, the infusion rate may be increased to 0.5 mL/kg/hour.

Nutrilipid:

Neonates, Infants, Children, and Adolescents <17 years: Initiate at 0.05 mL/minute for 10 to 15 minutes; if no untoward effects the infusion may be gradually increased to required rate; maximum rate of infusion: Neonates, Infants, and Children ≤10 years: 0.75 mL/kg/hour; Children and Adolescents 11 to 16 years: 0.5 mL/kg/hour.

Adolescents ≥17 years: Initiate at 0.5 mL/minute for 15 to 30 minutes; if no untoward effects the infusion may be gradually increased; maximum rate of infusion: 0.5 mL/kg/hour.

Serious hemodynamic or other instability secondary to highly lipid soluble substances: 20% emulsion: Administer initial bolus undiluted over 2 to 3 minutes; bolus typically followed by a continuous infusion. Chest compressions should continue during administration if patient is in cardiac arrest. Some experts recommend a decreased infusion rate in patients who respond favorably to the initial bolus and infusion (ACMT 2017); repeat bolus or an increase in the infusion rate may be considered if instability persists or recurs (ACMT 2017; ASRA [Neal 2018]).

Administration: Adult

IV: Administer by IV infusion through a 1.2 micron in-line filter only via peripheral line or by central venous infusion. All lipid emulsion infusions should be filtered whether part of an admixture or infused separately using a 1.2-micron in-line filter only (ISMP 2016). At the onset of therapy, the patient should be observed for any immediate allergic reactions such as dyspnea, cyanosis, and fever. Change tubing after each infusion. May be simultaneously infused with amino acid and dextrose solutions by means of Y-connector located near infusion site or administered in total nutrient mixtures (3-in-1) with amino acids, dextrose, and other nutrients (ASPEN [Worthington 2021]). Lipid emulsions of 30% should only be administered in total nutrient mixtures (3-in-1) with amino acids, dextrose, and other nutrients. Hang lipid emulsion higher than other fluids (has low specific gravity and could run up into other lines).

Clinolipid: Prior to opening the overwrap of Clinolipid, check the color of the oxygen indicator and compare to the reference color next to the OK symbol. If the color of the oxygen absorber/indicator does not correspond to the reference color, do not use. After opening the bag, use the contents immediately and do not store for a subsequent infusion. Do not connect flexible bags in series to avoid air embolism due to possible residual gas contained in the primary bag. Do not use vented administration sets with vent in the open position to avoid air embolism. When preparing total parenteral nutrition admixture, do not use the EXACTAMIX Inlet H938173 with an EXACTAMIX compounder to transfer Clinolipid injection; EXACTAMIX Inlet H938174 is recommended.

Intralipid: Prior to opening the overwrap, the integrity indicator should be inspected. If the indicator is black, the overwrap is damaged; do not use. Do not exceed an infusion rate of 0.1 g/kg/hour.

Nutrilipid: To avoid air embolism, use a nonvented infusion set or close the air vent on a vented set and use a dedicated line without any connections. Prior to opening the overwrap, the oxygen indicator should be inspected; if the indicator is pink or dark pink, do not use. May be infused concurrently into the same vein as carbohydrate-amino acid solutions by means of a Y-connector located near the infusion site; flow rates of each solution should be controlled separately by infusion pumps. Do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). See prescribing information for detailed administration information.

Caloric source/EFAD: Initiate infusions of 10% emulsions at 1 mL/minute for 15 to 30 minutes; if no untoward effects occur, the infusion rate may be increased to 2 mL/minute. Initiate infusions of 20% emulsions at 0.5 mL/minute for 15 to 30 minutes; if no untoward effects occur, the infusion rate may be increased to 1 mL/minute.

Serious hemodynamic or other instability secondary to highly lipid soluble substances (off-label use): Administer initial bolus over 1 to 3 minutes followed by a continuous infusion. Chest compressions should continue during administration if patient is in cardiac arrest. Some experts recommend a decreased infusion rate in patients who respond favorably to the initial bolus and infusion (ACMT 2017); repeat bolus or an increase in the infusion rate may be considered if instability persists or recurs. (ACMT 2017; AHA [Lavonas 2015]; ASRA [Neal 2018]).

Storage/Stability

Do not freeze. If accidentally frozen, discard. Do not store partly used containers; lipid emulsion can support the growth of various organisms. Do not use if the emulsion appears to be oiling out. Once the closure is penetrated, the contents should be used as soon as possible; the transfer of contents to suitable TPN admixture containers must be completed within 4 hours of closure penetration. Admixtures prepared using lipid emulsion should be used promptly or stored under refrigeration at 2°C to 8°C (36°F to 46°F) for 24 hours or less and used completely within 24 hours after removal from refrigeration.

Intralipid, Nutrilipid: Store below 25°C (77°F).

Clinolipid: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Avoid excessive heat. Store in overpouch until ready to use.

Pharmacy supply of emergency antidotes: Guidelines suggest that at least 1,250 mL of 20% lipid emulsion be stocked. Suggested amount is stated to be a sufficient quantity to treat 1 patient weighing 100 kg for an initial 8- to 24-hour period (Dart 2018); actual amount to be stocked should take into account site-specific and population-specific needs.

Use

Intralipid: Source of calories and essential fatty acids for patients requiring parenteral nutrition of extended duration (FDA approved in all ages); prevention and treatment of essential fatty acid deficiency (FDA approved in all ages).

Nutrilipid: Source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time or when oral or enteral nutrition is not possible, insufficient, or contraindicated (FDA approved in all ages).

Clinolipid: Source of calories and essential fatty acids for patients requiring parenteral nutrition of extended duration (FDA approved in adults).

Fat emulsion (plant based) has also been used for treatment of serious hemodynamic or other instability secondary to local anesthetics (and other highly lipid soluble substances) that is unresponsive to conventional resuscitation.

Medication Safety Issues
Sound-alike/look-alike issues:

Intralipid may be confused with ViperSlide (lubricant used during atherectomy procedures)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Endocrine and metabolic: Hyperlipidemia (≤10%), hyperglycemia (2% to 10%)

Gastrointestinal: Nausea (≤10%), vomiting (≤10%)

Hematologic & oncologic: Hypoproteinemia (2% to 10%)

Hepatic: Abnormal hepatic function tests (2% to 10%)

Frequency not defined:

Cardiovascular: Thrombophlebitis

Gastrointestinal: Cholestasis (central lobular), melanosis (brown fat pigmentation in the reticuloendothelial system)

Genitourinary: Urinary tract infection

Hematologic & oncologic: Leukopenia, splenomegaly, thrombocytopenia

Hepatic: Fat overload syndrome, hepatomegaly, increased liver enzymes

Infection: Septicemia

Miscellaneous: Fever

<1%, postmarketing, and/or case reports: Back pain, chest pain, cyanosis, decreased INR, diaphoresis, diarrhea, dizziness, drowsiness, dyspnea, flushing, headache, hypercoagulability state, hypersensitivity reaction, increased body temperature, infusion site irritation, pruritus, pulmonary embolism (fat), sensation of eye pressure

Contraindications

Intralipid 10%, 20%, 30%: Hypersensitivity to egg, soybean, peanut protein, or any component of the formulation; disturbances in normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if accompanied by hyperlipidemia; pharmacy bulk package is not intended for direct IV administration (20%, 30%).

Clinolipid, Nutrilipid: Known hypersensitivity to egg or soybean proteins or to any component of the formulation; severe hyperlipidemia (serum triglyceride concentrations above 1,000 mg/dL) or severe disorders of lipid metabolism characterized by hypertriglyceridemia.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to egg, soya, or peanut protein or to any component of the formulation; acute shock; severe hyperlipidemia; conditions characterized by severely disordered fat metabolism (eg, severe hepatic impairment, acute MI, hemophagocytotic syndrome, shock).

Note: In a life-threatening toxicity situation in which all other interventions have failed, experts recommend that clinicians weigh the risk:benefit ratio of lipid emulsion therapy in patients with contraindications to administration.

Warnings/Precautions

Concerns related to adverse effects

• Fat overload syndrome: Although rare, a reduced or limited ability to metabolize lipids accompanied by prolonged plasma clearance resulting in a sudden deterioration in the patient's condition accompanied by fever, anemia, leukopenia, thrombocytopenia, coagulation disorders, hyperlipidemia, liver fatty infiltration (hepatomegaly), deteriorating liver function, and CNS (eg, coma) can occur; usually reversible upon discontinuation.

• Hepatic effects: Parenteral nutrition: Although the exact etiology is unknown and likely multifactorial, parenteral nutrition associated liver disease (PNALD) has been reported in patients receiving parenteral nutrition for extended periods of time, especially preterm infants, and can present as cholestasis or steatohepatitis, fibrosis and cirrhosis, possibly leading to hepatic failure; cholecystitis and cholelithiasis have also been observed. Consider discontinuation or dose reduction in patients who develop abnormal LFTs.

• Hypersensitivity: Allergic reactions (eg, tachypnea, dyspnea, hypoxia, bronchospasm, tachycardia, vomiting, headache, sweating) to lipid emulsion may occur; discontinue infusion immediately if signs or symptoms of hypersensitivity or allergic reactions occur.

• Refeeding syndrome: Parenteral nutrition: Refeeding severely undernourished patients with parenteral nutrition may result in the refeeding syndrome (eg, intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic); thiamine deficiency and fluid retention may also develop. Carefully monitor severely undernourished patients and slowly increase their nutrient intakes, while avoiding overfeeding.

• Serum lipemia: Use may result in serum lipemia, especially with high doses or rates of administration (eg, when used for toxic exposure). Serum lipemia has been reported to cause failure of CRRT filters (Smolinske 2019); may also delay and prevent the analysis of serum electrolytes, hematocrit, LFTs, and coagulation function for up to 39 hours after administration (Cao 2014; Grunbaum 2016; Smolinske 2019).

Disease-related concerns:

• Anemia: The use of lipid emulsion has been associated with anemia likely due to hemodilution (Zellner 1967). Use with caution in patients with anemia.

• Bleeding disorders: Use with caution in patients with bleeding disorders.

• Fat embolism: Use with caution in patients who may be at danger for fat embolism.

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Pancreatitis: Use with caution in patients with pancreatitis without hyperlipidemia; ensure triglyceride levels remain <400 mg/dL.

• Respiratory disease: Use with caution in patients with respiratory disease.

• Renal impairment: Use with caution; some formulations may contain aluminum, which may accumulate following prolonged administration in renally impaired patients.

• Toxicity secondary to highly lipid soluble substances: Hemodynamic and other instability: Successful resuscitation following the administration of lipid emulsion has been reported in animal studies and several human case reports in which cardiovascular toxicity was unresponsive to conventional resuscitation and antidotal measures. Successful resuscitation following the administration of lipid emulsion has been reported in pediatric patients (Fuzaylov 2010; Ludot 2008; Shah 2009; Wong 2010). Consider use when toxicity secondary to a highly lipid soluble substance is likely and conventional methods are unsuccessful. Continue CPR throughout treatment with lipid emulsion. Consultation with a medical toxicologist or poison control center is highly recommended.

Special populations:

• Pediatric: [US Boxed Warning]: Deaths in preterm infants after infusion of IV lipid emulsions have been reported in the medical literature. Autopsy findings included intravascular fat accumulation in the lungs. Preterm infants and low birth weight infants have poor clearance of IV lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion. To avoid hyperlipidemia and/or fat deposition, do not exceed recommended daily doses and consider administering less than the maximum recommended doses in preterm and small for gestational age infants. Clinolipid is not indicated for use in pediatric patients. Pediatric clinical studies did not establish that Clinolipid provides sufficient amounts of essential fatty acids (EFA) in pediatric patients, which may predispose them to neurologic complications due to EFA insufficiency. Because free fatty acids displace bilirubin from albumin binding sites, the use of lipid infusions in jaundiced or premature infants should be done with caution.

Dosage form specific issues:

• Aluminum: The parenteral product may contain aluminum; toxic aluminum concentrations may be seen with high doses, prolonged use, or renal dysfunction. Premature neonates are at higher risk due to immature renal function and aluminum intake from other parenteral sources. Parenteral aluminum exposure of >4 to 5 mcg/kg/day is associated with CNS and bone toxicity; tissue loading may occur at lower doses (Federal Register 2002). See manufacturer's labeling.

Other warnings/precautions:

• Administration: The too-rapid administration of lipid emulsion can cause fluid and/or lipid overloading, resulting in dilution of serum electrolyte concentrations, overhydration, congested states, pulmonary edema, impaired pulmonary diffusion capacity, serum lipemia (Cao 2014; Grunbaum 2016; Smolinske 2019), or metabolic acidosis; hourly infusion rate should be as low as possible.

• Three-in-one mixtures: Lipid emulsion in a three-in-one mixture may obscure the presence of a precipitate; follow compounding guidelines, especially for calcium and phosphate additions.

Warnings: Additional Pediatric Considerations

Lipid emulsion (plant based) administration has resulted in successful resuscitation following cardiovascular toxicity secondary to highly lipid soluble substances (including, but not limited to, local anesthetics, calcium channel blockers, tricyclic antidepressants, bupropion, lamotrigine, and quetiapine) which was unresponsive to conventional resuscitation measures (Fuzaylov 2010; Hendron 2011; Levine 2012; Ludot 2008; Montiel 2011; Sirianni 2008; Shah 2009; Wong 2010); current expert opinion is to initiate using guideline recommendations with careful clinical monitoring for any adjustments necessary (see Dosing: Pediatric). Following administration reports of lipemia, interference with laboratory analysis, elevated triglycerides, pancreatitis, and pulmonary changes similar to acute respiratory distress syndrome have been documented (AHA [Lavonas 2015]; Bucklin 2013; Weinberg 2012). Pediatric case reports have used variable regimens: 0.8 to 3 mL/kg bolus (ages: 1 month to 18 years).

Dietary Considerations

Phosphorus: ~1.5 mMol /100 mL of emulsion.

Caloric content: 10% lipid emulsion = 1.1 kcal/mL; 20% lipid emulsion = 2 kcal/mL; 30% lipid emulsion = 3 kcal/mL.

Lipid emulsion should not exceed 60% of the total daily calories.

Pregnancy Considerations

Indications for lipid emulsion therapy in pregnant women are the same as in nonpregnant women. The ASPEN guidelines for parenteral and enteral nutrition state that IV lipid emulsion may be used safely in pregnant women to provide calories and prevent essential fatty acid deficiency (ASPEN Guidelines 2002). Medications used for the treatment of cardiac arrest in pregnancy are the same as in the nonpregnant woman. Doses and indications should follow current Advanced Cardiovascular Life Support guidelines. Appropriate medications should not be withheld due to concerns of fetal teratogenicity (AHA [Jeejeebhoy 2015]). Lipid emulsion therapy has been used successfully in the resuscitation of a pregnant female with suspected bupivacaine toxicity (Dun-Chi Lin 2017; Spence 2007).

Monitoring Parameters

Monitor for signs and symptoms of infection (including vascular access device complications); fluid and electrolyte status; serum osmolarity; blood glucose; blood counts (including platelets and coagulation parameters); signs and symptoms of essential fatty acid deficiency, fat overload syndrome, refeeding syndrome, and/or hypersensitivity reactions.

Monitor liver and renal function tests periodically. Monitor triglycerides before initiation of therapy, at least weekly during hospitalization, and after changes are made in the amount of lipid emulsion administered; once stable, monitoring frequency may range from weekly to monthly depending on patient clinical status and history; monitor more frequently in patients at risk for hypertriglyceridemia, such as premature infants (especially those that are extremely low birthweight); patients receiving high lipid or glucose doses; critically ill patients; patients with sepsis, severe thrombocytopenia, or coagulopathy; patients with pancreatitis or liver disease; or in patients receiving other lipid emulsion-based medications (eg, propofol) (ASPEN [Mirtallo 2020]; ESPGHAN [Lapillonne 2018]).

Monitor hepatic function (direct bilirubin, ALT/AST, alkaline phosphatase, and gamma-glutamyl transferase) at least weekly during hospitalization and at least every 3 months for patients receiving home parenteral nutrition (Deshpande 2020; ESPGHAN [Lapillonne 2018]).

Mechanism of Action

Lipid emulsion is metabolized and utilized as an energy source; provides the essential fatty acids, linoleic acid, and alpha linolenic acid necessary for normal structure and function of cell membranes; in local anesthetic toxicity, lipid emulsion probably extracts lipophilic local anesthesia from cardiac muscle.

In toxicity secondary to highly lipid soluble substances, exogenous lipids provide an alternative source of binding (Rowlingson 2008), commonly known as the "lipid sink" effect. High lipid partition constant and large volumes of distribution are good predictors of success when using lipid therapy (French 2011). Lipid administration may also affect the heart in a metabolically advantageous way by improving fatty acid transport (Weinberg 2006).

Pharmacokinetics (Adult data unless noted)

Metabolism: Fatty acids, phospholipids, and glycerol are metabolized by cells to adenosine triphosphate (ATP), carbon dioxide, and water

Half-life elimination: 0.5 to 1 hour

Excretion: Biliary (phospholipids)

Pricing: US

Emulsion (Clinolipid Intravenous)

20% (per mL): $0.23

Emulsion (Intralipid Intravenous)

20% (per mL): $0.23

30% (per mL): $0.15

Emulsion (Nutrilipid Intravenous)

20% (per mL): $0.06

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Intrafat (TW);
  • Intralipid (AE, AU, BE, BG, BH, CH, CN, CY, CZ, DK, EE, EG, ES, FI, HK, HU, ID, IL, IN, IQ, IR, IS, JO, KR, KW, LK, LT, LU, LY, MT, MY, NL, NO, NZ, OM, PH, PL, PT, PY, QA, RO, RU, SA, SE, SG, SI, SK, SY, TH, TR, UA, YE);
  • Intralipide (FR);
  • Intralipos (KR, MY, TH, TW);
  • Lipofundin-S (MY, TW);
  • Liposyn II (MX, PE);
  • Lipovenos (CL, PH)


For country code abbreviations (show table)
  1. Aluminum in large and small volume parenterals used in total parenteral nutrition. Fed Regist. 2002;67(244):77792-77793. To be codified at 21 CFR §201.323.
  2. American College of Medical Toxicology (ACMT). ACMT position statement: guidance for the use of intravenous lipid emulsion. J Med Toxicol. 2017;13(1):124-125. doi:10.1007/s13181-016-0550-z [PubMed 27121236]
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