Intralipid® 20% should be administered as a part of Intravenous nutrition via peripheral vein or by central venous infusion.

Adult Patients

The initial rate of infusion in adults should be 0.5 mL/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 1 mL/minute. Not more than 500 mL of Intralipid® 20% should be infused into adults 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® 20% (A 20% I.V. Fat Emulsion) 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. 

Pediatric Patients

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 hours.3

The initial rate of infusion in older pediatric patients should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL of Intralipid® 20%/kg/hour. The daily dosage should not exceed 3 g of fat/kg of body weight.3 Intralipid® 20% 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® 20% is administered to correct essential fatty acid deficiency, eight to ten percent of the caloric input should be supplied by Intralipid® 20% in order to provide adequate amounts of linoleic and linolenic acids. When EFAD occurs together with stress, the amount of Intralipid® 20% needed to correct the deficiency may be increased.

Administration

See MIXING GUIDELINES AND LIMITATIONS section for information regarding mixing this fat emulsion with other parenteral fluids.

Intralipid® 20% can be infused into the same central or peripheral vein as carbohydrate/amino acids solutions by means of a Y-connector near the infusion site. This allows for mixing of the emulsion immediately before entering the vein or for alternation of each parenteral fluid. If infusion pumps are used, flow rates of each parenteral fluid should be controlled with a separate pump. Fat emulsion may also be infused through a separate peripheral site. Use a 1.2 micron filter with Intralipid® 20%. Filters of less than 1.2 micron pore size must not be used. Conventional administration sets and TPN pooling bags contain polyvinyl chloride (PVC) components that have DEHP (di(2-ethylhexyl) phthalate) as a plasticizer. Fat‑containing fluids such as Intralipid® 20% extract DEHP from these PVC components and it may be advisable to consider infusion of Intralipid® 20% through a non-DEHP administration set.

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

Intralipid® 20% (A 20% I.V. Fat Emulsion) may be mixed with Amino Acid and Dextrose Injections where compatibility have been demonstrated. Additives known to be incompatible should not be used. Please consult with pharmacist. 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).

When being mixed 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:

1\. Transfer Dextrose Injection to the TPN Admixture Container

2\. Transfer Amino Acid Injection

3\. Transfer Intralipid® 20% (A 20% Intravenous Fat Emulsion)

Note: Amino Acid Injection, Dextrose Injection and Intralipid® 20% may be simultaneously transferred to the admixture container. Admixing should be accompanied by gentle agitation to avoid localized concentration effects.

Additives must not be added directly to Intralipid® 20% 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.

If the admixture is not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and should normally not be longer than 24 hours at 2-8°C.

After removal from storage at 2-8°C, the admixture should be infused within 24 hours.

It is essential that the admixture be prepared using strict aseptic techniques as this nutrient mixture is a good growth medium for microorganisms.

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 additions 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.