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Intralipid 10

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Intralipid 10%

Intralipid® 10%
(10% I.V. Fat Emulsion)
In Excel® Container

Intralipid 10%

DRUG DESCRIPTION

INTRALIPID® 10% (10% i.v fat emulsion) (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:

Soybean oil structural formula illustration

- 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:

Fatty acids structural formula illustration

PURIFIED EGG PHOSPHATIDES ARE A MIXTURE OF NATURALLY OCCURRING PHOSPHOLIPIDS WHICH ARE ISOLATED FROM THE EGG YOLK. THESE PHOSPHOLIPIDS HAVE THE FOLLOWING GENERAL STRUCTURE:

Purified egg phosphatides structural formula illustration

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

Choline and ethanolamine structural formula illustration

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

Glycerin structural formula illustration

INTRALIPID® 10% (10% i.v fat emulsion) (A 10% INTRAVENOUS FAT EMULSION) HAS AN OSMOLALITY OF APPROXIMATELY 300 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 1.1 KCAL PER ML OF INTRALIPID 10% (10% 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.

What are the precautions when taking 10% i.v fat emulsion (Intralipid 10%)?

See also Warning section.

Before receiving the fat emulsion, tell your doctor or pharmacist if you are allergic to it; or to eggs, soybean oil, or safflower oil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This product should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: high fat (lipid) levels in the blood.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder.

Kidney function declines as you grow older. This medication...

Read All Potential Precautions of Intralipid 10% »

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.

What are the precautions when taking 10% i.v fat emulsion (Intralipid 10%)?

See also Warning section.

Before receiving the fat emulsion, tell your doctor or pharmacist if you are allergic to it; or to eggs, soybean oil, or safflower oil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This product should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: high fat (lipid) levels in the blood.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder.

Kidney function declines as you grow older. This medication...

Read All Potential Precautions of Intralipid 10% »

Last reviewed on RxList: 7/30/2007
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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