Intralipid 20%

INTRALIPID® 20% (20% i.v. fat emulsion) (A 20% 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 20% 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:

- ARE SATURATED AND UNSATURATED FATTY ACID RESIDUES.

The major component fatty acids are linoleic (44-62%), oleic (19-30%), palmitic (7-14%), linolenic (4-11%) and stearic (1.4-5.5%)1. 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:

R1C- AND R2C- CONTAIN SATURATED AND UNSATURATED FATTY ACIDS THAT ABOUND IN NEUTRAL FATS. R3 IS PRIMARILY EITHER THE CHOLINE OR ETHANOLAMINE ESTER OF PHOSPHORIC ACID.

GLYCERIN IS CHEMICALLY DESIGNATED C3H8O3 AND IS A CLEAR COLORLESS, HYGROSCOPIC SYRUPY LIQUID. IT HAS THE FOLLOWING STRUCTURAL FORMULA:

INTRALIPID® 20% (20% i.v. fat emulsion) (A 20% INTRAVENOUSA FAT EMULSION) HAS AN OSMOLALITY OF APPROXIMATELY 350 MOSMOL/KG WATER (WHICH REPRESENTS 260 MOSMOL/LITER OF EMULSION) AND CONTAINS EMULSIFIED FAT PARTICLES OF APPROXIMATELY 0.5 MICRON SIZE.

THE TOTAL CALORIC VALUE, INCLUDING FAT, PHOSPHOLIPID AND GLYCERIN, IS 2.0 KCAL PER ML OF INTRALIPID® 20% (20% i.v. fat emulsion) . THE PHOSPHOLIPIDS PRESENT CONTRIBUTE 47 MILLIGRAMS OR APPROXIMATELY 1.5 MMOL OF PHOSPHORUS PER 100 ML OF THE EMULSION.

THE PRIMARY CONTAINER IS MANUFACTURED FROM EXCEL® FILM, A POLYPROPYLENE BASED MATERIAL COMPRISED OF THREE CO-EXTRUDED LAYERS.

THE PLASTIC CONTAINER IS MADE FROM MULTILAYERED FILM SPECIFICALLY DESIGNED FOR PARENTERAL DRUGS. IT CONTAINS NO PLASTICIZERS AND EXHIBITS VIRTUALLY NO LEACHABLES. THE SOLUTION CONTACT LAYER IS A RUBBERIZED COPOLYMER OF ETHYLENE AND PROPYLENE. THE CONTAINER IS NONTOXIC AND BIOLOGICALLY INERT. THE CONTAINER-SOLUTION 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.

1. PADLEY FB: "MAJOR VEGETABLE FATS," THE LIPID HANDBOOK (GUNSTONE FD, HARWOOD JL, PADLEY FB, EDS.), CHAPMAN AND HALL LTD., CAMBRIDGE, UK (1986), PP. 88-9.

IN THE EVENT OF FAT OVERLOAD DURING THERAPY, STOP THE INFUSION OF INTRALIPID® 20% 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 WARNINGS AND PRECAUTIONS.

INTRALIPID®20% 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® 20% (20% i.v. fat emulsion) WILL PREVENT THE BIOCHEMICAL LESIONS OF ESSENTIAL FATTY ACID DEFICIENCY (EFAD), AND CORRECT THE CLINICAL MANI-FESTATIONS OF THE EFAD SYNDROME.

THE ADVERSE REACTIONS OBSERVED CAN BE SEPARATED INTO TWO CLASSES:

1. 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 HYPERALIMENTATION PROCEDURE WITH OR WITHOUT INTRALIPID® 20% (A 20% I.V. FAT EMULSION).
2. LESS FREQUENT REACTIONS MORE DIRECTLY RELATED TO INTRALIPID® 20% (20% i.v. fat emulsion) 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).

THE DEPOSITION OF A BROWN PIGMENTATION IN THE RETICULOEN-DOTHELIAL SYSTEM, THE SO CALLED "INTRAVENOUS FAT PIGMENT," HAS BEEN REPORTED IN PATIENTS INFUSED WITH INTRALIPID® 20% (20% i.v. fat emulsion) . THE CAUSES AND SIGNIFICANCE OF THIS PHENOMENON ARE UNKNOWN.

Read the entire FDA prescribing information for Intralipid 20 (20% I.V. Fat Emulsion)