Intralipid Dosage

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. Maximum infusion rate should not exceed 0.1 g/kg/hr.

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 recommended dosage is 3 g fat/kg/24 hours.

Pediatric patients may be at risk for parenteral nutrition-associated liver disease (PNALD), also known as intestinal failure-associated liver disease (see WARNINGS section) when receiving Intralipid for durations exceeding two weeks. During intravenous administration of Intralipid 20%, perform liver tests to monitor for PNALD.

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 (equivalent to 0.1 g/kg/hour). The daily dosage should not exceed 3 g of fat/kg of body weight3. Intralipid 20% (equivalent to 0.125 g/kg/hour) 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.