Intralipid

Intralipid

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Questions & Answers

Side Effects & Adverse Reactions

Deaths in preterm infants after infusion of intravenous fat emulsion have been reported in the medical literature.2 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 the total 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 of Intralipid® 30% to patients with severe liver damage, pulmonary disease, anemia or blood coagulation disorders, or when there is danger of fat embolism.

WARNING:  This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Intralipid® 30% Pharmacy Bulk Package is indicated for use in a pharmacy admixture program for the preparation of three-in-one or total nutrient admixtures (TNAs) to provide 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.

History

There is currently no drug history available for this drug.

Other Information

Intralipid® 30% (A 30% I.V. Fat Emulsion) Pharmacy Bulk Package is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids for use in a pharmacy admixture program. It is made up of 30% Soybean Oil, 1.2% Egg Yolk Phospholipids, 1.7% 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.

Intralipid® 30% Pharmacy Bulk Package is not intended for direct infusion. It is a sterile dosage form which contains several single doses for use in the preparation of three-in-one or total nutrient admixtures (TNAs) in a pharmacy admixture program.

The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:


fatacid


where r1c, r2c and r3c 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%).1 These fatty acids have the following chemical and structural formulas:


Linoleic acid
C18H32O2
linacd
Oleic acid
C18H34O2
olacd
Palmitic acid
C16H32O2
palacd
α-Linolenic acid
C18H30O2
lncacid
Stearic acid
C18H36O2
stracd

Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:

phsph


r1 and r2 contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or the ethanolamine ester of phosphoric acid.



phoscl
      
phosam
Phosphatidylcholine Phosphatidylethanolamine

Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:


hysyp

Intralipid® 30% (A 30% I.V. Fat Emulsion) has an osmolality of approximately 310 mOsmoL/kg water (which represents 200 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 3.0 kcal per mL of Intralipid® 30%. 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. This product is not made with natural rubber latex. The container is nontoxic and biologically inert.

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.

Intralipid Manufacturers


  • Baxter Healthcare Corp
    Intralipid (Soybean Oil) Emulsion [Baxter Healthcare Corp]
  • Baxter Healthcare Corp
    Intralipid (Soybean Oil) Emulsion [Baxter Healthcare Corp]
  • Baxter Healthcare Corp
    Intralipid (Soybean Oil) Emulsion [Baxter Healthcare Corp]
  • Baxter Healthcare Corp
    Intralipid (Soybean Oil) Emulsion [Baxter Healthcare Corp]
  • Fresenius Kabi Ab
    Intralipid (Soybean Oil, Egg Yolk Phospholipids And Glycerin) Emulsion [Fresenius Kabi Ab]
  • Baxter Healthcare Corporation
    Intralipid (Soybean Oil) Emulsion [Baxter Healthcare Corporation]
  • Baxter Healthcare Corporation
    Intralipid (Soybean Oil) Emulsion [Baxter Healthcare Corporation]
  • Baxter Healthcare Corporation
    Intralipid (Soybean Oil) Emulsion [Baxter Healthcare Corporation]
  • Baxter Healthcare Corporation
    Intralipid (Soybean Oil) Emulsion [Baxter Healthcare Corporation]

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