Intralipid

DOSAGE AND ADMINISTRATION

Intralipid 10% 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 1 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 2 mL/minute. V. Fat Emulsion) 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.

5 g of fat/kg of body weight (25 mL of Intralipid 10% per kg). Intralipid 10% should make up no more than 60% of the total caloric input to the patient. 1 g/kg/hr. Carbohydrate and a source of amino acids should comprise the remaining caloric input.

5 g fat/kg body weight/24 hours (5 mL Intralipid 10%) 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 10%, perform liver tests to monitor for PNALD. 1 mL/minute for the first 10 to 15 minutes. 1 g/kg/hour). The daily dosage should not exceed 3 g of fat/kg of body weight 3 . 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. V. Fat Emulsion) is administered to correct essential fatty acid deficiency, eight to ten percent of the caloric input should be supplied by Intralipid 10% in order to provide adequate amounts of linoleic and linolenic acids.

When EFAD occurs together with stress, the amount of Intralipid 10% 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 10% 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.

ADVERSE REACTIONS

The adverse reactions observed can be separated into two classes:

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. V. Fat Emulsion).

Less frequent reactions more directly related to Intralipid 10% 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 tests, and overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly, splenomegaly and shock).

The deposition of a brown pigmentation in the reticuloendothelial system, the so-called “intravenous fat pigment,” has been reported in patients infused with Intralipid 10%. The causes and significance of this phenomenon are unknown.

CONTRAINDICATIONS

Intralipid 10% is contraindicated in patients with:

Disturbances of normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipidemia. Known hypersensitivity to egg, soybean, peanut protein, or to any of the active ingredients or excipients of Intralipid 10%.