Generic name: soybean oil
Dosage form: intravenous emulsion
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Intralipid® 20% (A 20% I.V. Fat Emulsion) Pharmacy Bulk Package should be administered only as a part of a three-in-one or total nutrient admixture via peripheral vein or by central venous infusion.
Directions For Proper Use of Pharmacy Bulk Package.
INTRALIPID® 20% PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INFUSION. The container closure may be penetrated only once using a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Once the closure is penetrated, the contents should be dispensed as soon as possible; the transfer of contents to suitable TPN admixture containers must be completed within 4 hours of closure penetration. The bag should be stored below 25°C (77°F) after the closure has been entered. Date and time of container entry should be noted in the area designated on the container label.
Admixtures made using Intralipid® 20% should be used promptly. See MIXING GUIDELINES AND LIMITATIONS section for admixture storage recommendations.
The initial infusion rate of the nutrient admixture in adults should be 0.1 g fat/minute for the first 15 to 30 minutes of infusion. If no untoward reactions occur (see ADVERSE. REACTIONS section), the infusion rate can be increased to 0.2 g fat/minute. For adults, the admixture should not contain more than 500 mL of Intralipid® 20% on the first day of therapy. If the patient has no untoward reactions, the dose can be increased on the following day. The daily dosage should not exceed 2.5 g of fat/kg of body weight (12.5 mL of Intralipid® 20% per kg). Intralipid® should make up no more than 60% of the total caloric input to the patient. Carbohydrate and a source of amino acids should comprise the remaining caloric input.
The dosage for premature infants starts at 0.5 g fat/kg body weight/24 hours (2.5 mL Intralipid® 20%) and may be increased in relation to the infant’s ability to eliminate fat. The maximum dosage recommended by the American Academy of Pediatrics is 3 g fat/kg/24 hours3
The initial rate of infusion in older pediatric patients should be no more than 0.01 g fat/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.1 g of fat/kg/hour. The daily dosage should not exceed 3 g of fat/kg of body weight3 Intralipid® should make up no more than 60% of the total caloric input to the patient. Carbohydrate and a source of amino acids should comprise the remaining caloric input.
Essential Fatty Acid Deficiency
When Intralipid® is administered to correct essential fatty acid deficiency, eight to ten percent of the caloric input should be supplied by Intralipid® in order to provide adequate amounts of linoleic and linolenic acids. When EFAD occurs together with stress, the amount of Intralipid® needed to correct the deficiency may be increased.
See MIXING GUIDELINES AND LIMITATIONS section for information regarding mixing this fat emulsion with other parenteral fluids.
INTRALIPID® 20% (A 20% I.V. FAT EMULSION) PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INFUSION. It must be infused as part of an admixture into a central or peripheral vein.
The flow rate of the admixture should be controlled with an infusion pump. Filters of less than 1.2 micron pore size must not be used with admixtures containing Intralipid® 20%. Conventional administration sets and TPN pooling bags contain polyvinyl chloride (PVC) components that have DEHP (diethyl hexyl phthalate) as a plasticizer. Fat-containing fluids such as Intralipid® extract DEHP from these PVC components. Therefore it may be advisable to use a non-DEHP administration set for infusing admixtures which contain Intralipid®.
Do not use any bag in which there appears to be an oiling out on the surface of the emulsion.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. whenever solution and container permit.
MIXING GUIDELINES AND LIMITATIONS
Investigations have been conducted which demonstrate the compatibility of Intralipid® 20% when properly mixed with either Novamine® (8.5%, 11.4% or 15%) or 8.5% Travasol® or 10% Travasol® Amino Acid Injections without Electrolytes for use in TPN therapy. Because of the potential for life threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrition mixture.
Perform all manipulations in a suitable work area, such as a laminar flow hood.
Failure to follow the Mixing Guidelines and Limitations below, including recommended storage temperature, storage time. order of mixing, etc., may result in an unstable admixture.
The following proper mixing sequence must be followed to minimize pH related problems by ensuring that typically acidic Dextrose Injections are not mixed with lipid emulsions alone:
- Transfer Dextrose Injection to the TPN (Total Parenteral Nutrition) Admixture Container
- Transfer Amino Acid Injection
- Transfer Intralipid® 20%
Note: Amino Acid Injection, (Novamine® 8.5, 11.4 or 15% or 8.5 Travasol® 8.5 or 15% without electrolytes), Dextrose Injection and Intralipid® 20% may be simultaneously transferred to the admixture container using an automatic mixer. Admixing should be accompanied by gentle agitation to avoid localized concentration effects.
These admixtures should be used promptly with storage under refrigeration (2-8°C) not to exceed 24 hours and must be completely used within 24 hours after removal from refrigeration.
It is essential that the admixture be prepared using strict aseptic techniques as this nutrient mixture is a good growth medium for microorganisms.
Additives other than those named above may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives (e.g., vitamins and minerals). Additives must not be added directly to Intralipid® 20% (A 20% I.V. Fat Emulsion) Pharmacy Bulk Package and in no case should Intralipid® 20% be added to the TPN container first. Bags should be shaken gently after each addition to minimize localized concentration.
Supplemental electrolytes, trace metals or multivitamins may be required in accordance with the prescription of the attending physician.
The prime destabilizers of emulsions are excessive acidity (low pH) and inappropriate electrolyte content. Careful consideration should be given to addition of divalent cations (Ca++ and Mg++) which have been shown to cause emulsion instability. Amino acid solutions exert a buffering effect protecting the emulsion.
The admixture should be inspected carefully for “breaking or oiling out” of the emulsion. “Breaking or oiling out” is described as the separation of the emulsion and can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the admixed emulsion. The admixture should also be examined for particulates. The admixture must be discarded if any of the above is observed.