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Intralipid
Overview
What is Intralipid?
Intralipid 10% (A 10% Intravenous Fat Emulsion) is a sterile, non-pyrogenic fat emulsion prepared for intravenous administration as a source of calories and essential fatty acids. It is made up of 10% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and Water for Injection. In addition, sodium hydroxide has been added to adjust the pH so that the final product pH is 8. pH range is 6 to 8.9.
The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:
where , and are saturated and unsaturated fatty acid residues.
The major component fatty acids are linoleic acid (44-62%), oleic acid (19-30%), palmitic acid (7-14%), α-linolenic acid (4-11%) and stearic acid (1.4-5.5%). These fatty acids have the following chemical and structural formulas:
Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:
3
Glycerin is chemically designated CHO and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:
Intralipid 10% (A 10% Intravenous Fat Emulsion) has an osmolality of approximately 300 mOsmol/kg water (which represents 260 mOsmol/L of emulsion) and contains emulsified fat particles of approximately 0.5 micron size.
The total caloric value, including fat, phospholipid and glycerin, is 1.1 kcal per mL of Intralipid 10%. The phospholipids present contribute 47 milligrams or approximately 1.5 mmol of phosphorus per 100 mL of the emulsion.
The primary plastic container (Biofine™) is made from multilayered film specifically designed for parenteral nutrition drug products. The film is polypropylene based comprising three co-extruded layers. It contains no plasticizers and exhibits virtually no leachables. The container does not contain DEHP (di(2-ethylhexyl) phthalate) or PVC. The container is nontoxic and biologically inert. This product is not made with natural rubber latex.
The container-emulsion unit is a closed system and is not dependent upon entry of external air during administration.
The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.
What does Intralipid look like?
What are the available doses of Intralipid?
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What should I talk to my health care provider before I take Intralipid?
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How should I use Intralipid?
Intralipid 10% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and as a source of essential fatty acids for prevention of EFAD.
Intralipid 10% should be administered as a part of intravenous nutrition via peripheral vein or by central venous infusion.
What interacts with Intralipid?
The administration of Intralipid 10% is contraindicated in patients with disturbances of normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipidemia.
What are the warnings of Intralipid?
Deaths in preterm infants after infusion of intravenous fat emulsion have been reported in the medical literature.
Autopsy findings included intravascular fat accumulation in the lungs. Treatment of premature and low birth weight infants with intravenous fat emulsion must be based upon careful benefit-risk assessment. Strict adherence to the recommended total daily dose is mandatory; hourly infusion rate should be as slow as possible in each case and fat should not in any case exceed 1 g fat/kg in four hours. Premature and small for gestational age infants have poor clearance of intravenous fat emulsion and increased free fatty acid plasma levels following fat emulsion infusion; therefore, serious consideration must be given to administration of less than the maximum recommended doses in these patients in order to decrease the likelihood of intravenous fat overload. The infant’s ability to eliminate the infused fat from the circulation must be carefully monitored (such as serum triglycerides and/or plasma free fatty acid levels).
The lipemia must clear between daily infusions.
Caution should be exercised in administering Intralipid 10% (A 10% Intravenous Fat Emulsion) to patients with severe liver damage, pulmonary disease, anemia or blood coagulation disorders, or when there is danger of fat embolism.
WARNING:
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
What are the precautions of Intralipid?
When Intralipid 10% is administered, the patients capacity to eliminate the infused fat from the circulation must be monitored by use of an appropriate laboratory determination of serum triglycerides. Overdosage must be avoided.
During long term intravenous nutrition with Intralipid 10%, liver function tests should be performed. If these tests indicate that liver function is impaired, the therapy should be withdrawn.
Frequent (some advise daily) platelet counts should be done in neonatal patients receiving parenteral nutrition with Intralipid 10%.
Drug product contains no more than 25 mcg/L of aluminum.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Studies with Intralipid have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
Pregnancy Category C:
Nursing Mothers:
Pediatric Use:
AVOID OVERDOSAGE ABSOLUTELY.
What are the side effects of Intralipid?
The adverse reactions observed can be separated into two classes:
The deposition of a brown pigmentation in the reticuloendothelial system, the so-called “intravenous fat pigment,” has been reported in patients infused with Intralipid 10%. The causes and significance of this phenomenon are unknown.
- Those more frequently encountered are due: either to contamination of the intravenous catheter and result in sepsis, or to vein irritation by concurrently infused hypertonic solutions and may result in thrombophlebitis. These adverse reactions are inseparable from the hyper-alimentation procedure with or without Intralipid 10% (A 10% I.V. Fat Emulsion).
- Less frequent reactions more directly related to Intralipid 10% are: a) immediate or early adverse reactions, each of which has been reported to occur in clinical trials, in an incidence of less than 1%; dyspnea, cyanosis, allergic reactions, hyperlipemia, hypercoagulability, nausea, vomiting, headache, flushing, increase in temperature, sweating, sleepiness, pain in the chest and back, slight pressure over the eyes, dizziness, and irritation at the site of infusion, and, rarely, thrombocytopenia in neonates; b) delayed adverse reactions such as hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leukopenia, transient increases in liver function tests, and overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly, splenomegaly and shock).
What should I look out for while using Intralipid?
The administration of Intralipid 10% is contraindicated in patients with disturbances of normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipidemia.
What might happen if I take too much Intralipid?
In the event of fat overload during therapy, stop the infusion of Intralipid 10% until visual inspection of the plasma, determination of triglyceride concentrations, or measurement of plasma light-scattering activity by nephelometry indicates the lipid has cleared. Re-evaluate the patient and institute appropriate corrective measures. See and .
How should I store and handle Intralipid?
Store at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Intralipid 10% is supplied as a sterile emulsion in the following fill sizes: 100 mL, 250 mL, and 500 mL.100 mL: 0338-0518-58250 mL: 0338-0518-12500 mL: 0338-0518-13Intralipid 10% is supplied as a sterile emulsion in the following fill sizes: 100 mL, 250 mL, and 500 mL.100 mL: 0338-0518-58250 mL: 0338-0518-12500 mL: 0338-0518-13
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Intralipid 10% is metabolized and utilized as a source of energy causing an increase in heat production, decrease in respiratory quotient and increase in oxygen consumption. The infused fat particles are cleared from the blood stream in a manner thought to be comparable to the clearing of chylomicrons.
Intralipid 10% will prevent the biochemical lesions of essential fatty acid deficiency (EFAD), and correct the clinical manifestations of the EFAD syndrome.
Non-Clinical Toxicology
The administration of Intralipid 10% is contraindicated in patients with disturbances of normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipidemia.Increases in prothrombin time have been noted in patients receiving long-term warfarin therapy after flutamide was initiated. Therefore close monitoring of prothrombin time is recommended and adjustment of the anticoagulant dose may be necessary when flutamide capsules are administered concomitantly with warfarin.
When Intralipid 10% is administered, the patients capacity to eliminate the infused fat from the circulation must be monitored by use of an appropriate laboratory determination of serum triglycerides. Overdosage must be avoided.
During long term intravenous nutrition with Intralipid 10%, liver function tests should be performed. If these tests indicate that liver function is impaired, the therapy should be withdrawn.
Frequent (some advise daily) platelet counts should be done in neonatal patients receiving parenteral nutrition with Intralipid 10%.
Drug product contains no more than 25 mcg/L of aluminum.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Studies with Intralipid have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
Pregnancy Category C:
Nursing Mothers:
Pediatric Use:
AVOID OVERDOSAGE ABSOLUTELY.
The adverse reactions observed can be separated into two classes:
The deposition of a brown pigmentation in the reticuloendothelial system, the so-called “intravenous fat pigment,” has been reported in patients infused with Intralipid 10%. The causes and significance of this phenomenon are unknown.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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