Intralipid (Fat Emulsions)

INTRALIPID® 10% INTRALIPID® 20% INTRALIPID® 30%

Pharmacia & Upjohn

Fat Emulsions

I.V. Nutrition

Action And Clinical Pharmacology: Intralipid acts as an energy source in patients for whom the usual i.v. therapy would not be adequate and as a source of essential fatty acids to prevent essential fatty acid deficiency.

Providing sufficient amounts of calories to satisfy basal metabolic requirements plus the additional needs imposed by disease and/or surgical stress can be difficult and sometimes even impossible. If the i.v. route has to be used and only carbohydrates are given as an energy source large amounts of fluid or very hypertonic solutions must be employed. Fat has an energy value a little more than twice that of carbohydrates, and is therefore an excellent source of energy for use in parenteral nutrition. By including fat emulsion in the nutritional program a balanced i.v. nutrition can be achieved.

Moreover, Intralipid is practically isotonic with blood which makes it possible to infuse large amounts of energy providing substrate in a small volume of fluid via peripheral veins. This property makes possible peripheral vein infusion of solutions that otherwise have to be administered by central veins, (see Dosage, Administration).

Fat emulsions may be used to supply up to 40% of the nonprotein energy requirements of the patient. Each mL of Intralipid 10% contains 4.6 kJ (1.1 kcal), each mL of Intralipid 20% contains 8.4 kJ (2.0 kcal) and each mL of Intralipid 30% contains 12.6 kJ (3.0 kcal). Half a litre (1 bottle) of Intralipid 10%, Intralipid 20% and Intralipid 30% thus contains 2.3 MJ (550 kcal), 4.2 MJ (1 000 kcal) and 6.3 MJ (1 500 kcal), respectively. Particle size and biological properties are similar to those of natural chylomicrons.

The i.v. administered fat is utilized as an energy source by the organism in the same manner as orally ingested fat, as demonstrated in a number of investigations and by different methods e.g., growth experiments. Parenterally administered fat is utilized rapidly by the body for energy purposes.

The elimination of fat from the blood stream after i.v. administration has been studied in the dog, rabbit and in man by determination of the plasma triglyceride content.

Studies in the dog and man have demonstrated that after infusion of Intralipid, fat particles are cleared from the blood stream in a manner similar to that of chylomicrons. The rate of elimination of fat emulsion is dependent both on the capacity of the chylomicron receptor sites in the capillary walls of different organs and the rate of blood flow in these vessels.

Significant amounts of Intralipid are removed by skeletal muscle (47%), splanchnic viscera (25%), myocardium (14%) and s.c. tissue (13%), with no removal observed in the liver.

Even after the i.v. administration of large doses of fat no losses occur via the urine or feces.

Indications And Clinical Uses: Should be used as an energy source in patients for whom the usual i.v. fluid therapy would not be adequate and as a source of essential fatty acids to prevent essential fatty acid deficiency.

Pre- and postoperative nutritional disorders, in which an increased administration of energy is necessary.

Nutritive disorders resulting from decreased or inhibited intestinal absorption. Such disorders may be due to tumors of the digestive tract, or to acute or chronic intestinal diseases, such as ulcerative colitis or terminal ileitis.

In burn cases where the energy requirements can be excessive. In these cases every energy supplement is of the utmost importance. Even if the patients are able to take nourishment by mouth, difficulties are often encountered in supplying sufficient amounts of energy in the diet. The administration of i.v. fat is, therefore, indicated in such cases.

Prolonged states of unconsciousness e.g., following trauma, or intoxication, if tube feeding is inadvisable or impossible.

Cachexia due to serious diseases in organs other than the alimentary tract, e.g., metastasized tumors, systemic diseases.

Impaired renal function in which adequate energy supply is essential to reduce protein breakdown.

Essential fatty acid deficiency. To prevent clinical manifestations during parenteral nutrition.

Contra-Indications: Only in conditions characterized by severely disordered fat metabolism such as in severe liver damage, acute myocardial infarction and shock, is Intralipid contraindicated. tag_WarningWarnings

Manufacturers’ Warnings In Clinical States: Fat metabolism may be disturbed in patients with special diseases and conditions. In these cases, fat elimination must be checked daily. For instructions see Precautions.

Pregnancy: The safety of Intralipid for use in pregnancy has not yet been established; therefore, it should not be used in pregnant women, unless, in the judgment of the physician, its use is deemed absolutely necessary to the welfare of the patient.

Rare cases of hypersensitivity have been observed in patients allergic to soybean protein, egg yolk and egg whites.

Precautions: Patients with Special Diseases and Conditions: Fat metabolism may be disturbed in conditions such as renal insufficiency, uncompensated diabetes, certain forms of liver insufficiency, metabolic disorders and sepsis. When i.v. fat is considered to be indicated in patients with the above mentioned disorders, fat elimination should be checked daily (see Fat Elimination Test) and the dosage adjusted to the patient’s capacity for fat elimination. In cases of verified or suspected liver insufficiency, liver function must be closely followed.

If increased levels of transaminases, alkaline phosphatases or bilirubin appear, further infusion of Intralipid should be postponed, or the dosage decreased, until normalization is achieved.

Children: Very low birth weight preterm infants and small for gestational age infants clear i.v. fat emulsion more slowly than term infants and are at a greater risk of developing hyperlipidemia. This has the potential risk for lowering oxygen tension. The rate of infusion of Intralipid should be as slow as possible, the daily dose preferably administered continuously over 24 hours by infusion pump. The infant’s ability to eliminate infused fat from the circulation must be carefully monitored. The lipemia must clear prior to proceeding to the next daily infusion.

Due to the lack of experience, Intralipid 30% is not recommended for use in infants and children.

Fat Elimination Test: Before the beginning of infusion in the morning a citrated blood sample is drawn, preferably when the patient is still in a fasting state. The blood sample is centrifuged at 20 to 25 Hz (or 1 200 to 1 500 rpm). If the plasma is then strongly opalescent or milky, the planned infusion is postponed. In the great majority of cases, plasma is completely clear 12 hours after the infusion of the daily dose. In patients with no suspected metabolic disturbances this test should be carried out once a week.

Laboratory Tests: Interference: Lipemic serum interferes with colorimetric laboratory analyses. To avoid this, blood samples should be drawn in the morning prior to infusion of Intralipid.

Adverse Reactions: Adverse reactions reported to occur during and/or following infusion of Intralipid include: fever, chills, nausea, vomiting, headache, back or chest pain with dyspnea and cyanosis.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: When fat emulsion is given in amounts exceeding the capacity of fat elimination the following symptoms may occur: hyperlipemia, hepatosplenomegaly, jaundice, hemolytic anemia, prolonged clotting time and thrombocytopenia. All symptoms clear in days to weeks after cessation of fat infusion. tag_DosageDosage

Dosage And Administration: Adults: Dosage should normally not exceed 2 g of fat/kg body weight/day (20 mL, 10 mL and 6.7 mL/kg of Intralipid 10%, 20% and 30%, respectively). In raised energy requirements, the supply of Intralipid can be increased but should not, without special precautions, exceed a quantity corresponding to 3 g fat (30 mL, 15 mL and 10 mL of Intralipid 10%, 20% and 30%, respectively)/kg body weight/day.

Prevention of Essential Fatty Acid Deficiency: The recommended minimum requirement is approximately 4% of the caloric intake. In most patients, this can be supplied as 500 mL of Intralipid 10% administered i.v. twice weekly.

The drip rate is adjusted to about 2 to 3 mL/minute for Intralipid 10% and about 1 to 2 mL/minute of Intralipid 20% at which rates 500 mL can be infused in 3 to 5 hours and 5 to 9 hours, respectively. The infusion time for 500 mL must not be shorter than 3 and 5 hours, respectively. The infusion should be started at half the infusion rate during the first 30 minutes, under supervision.

A daily supplement of 333 mL of Intralipid 30% (100 g fat) is regarded as sufficient to meet the basal metabolic requirements of a 70 kg patient on total parenteral nutrition. The drip rate is adjusted to 0.6 to 1 mL/minute at which rate 333 mL can be infused over a period of 5 to 10 hours. The rate of infusion should not exceed 333 mL of Intralipid 30% over a 5-hour period. The infusion should be started at half the infusion rate during the first 30 minutes, under supervision.

Children: The infant’s ability to eliminate fat should govern the dosage (see Contraindications and Precautions). Recommended dosage per 24 hours is 0.5 to 4 g fat/kg body weight equivalent to 2.5 to 20 mL Intralipid 20% and 5 to 40 mL Intralipid 10%/kg body weight, respectively. Recommended initial dose in very low birth weight infants and small for gestational age infants is 0.5 g fat/kg body weight per 24 hours. The dose should be increased in relation to the infant’s ability to eliminate fat, which should be checked daily (see Fat Elimination Test). The daily dose should preferably be administered continuously over 24 hours by infusion pump. Due to the lack of experience, Intralipid 30% is not recommended for use in infants.

Administration: Intralipid must not be mixed with electrolyte or nutrient solutions, nor must drugs or vitamins be added to the emulsion in the infusion bottle other than drugs or vitamins especially formulated for addition to fat emulsions. The simultaneous administration of Intralipid and amino acid solutions or carbohydrate can be achieved, using separate infusion sets where the two liquids are allowed to mix in a Y-tube just before the i.v. needle. Filters should not be used with i.v. fat emulsion. The remaining contents of a partly used bottle must be discarded and should not be stored for later use.

Availability And Storage: Intralipid 10%: 1 000 mL contain: purified soybean oil 100 g, purified egg phospholipids 12 g, glycerol anhydrous 22 g, water for injection q.s. ad 1 000 mL. pH is adjusted with sodium hydroxide to pH approximately 8. Energy content/L: 4.6 MJ (1 100 kcal). Osmolality (approx.): 300 mOsm/kg water. Bottles of 500 mL.

Intralipid 20%: 1 000 mL contain: purified soybean oil 200 g, purified egg phospholipids 12 g, glycerol anhydrous 22 g, water for injection q.s. ad 1 000 mL. pH is adjusted with sodium hydroxide to pH approximately 8. Energy content/L: 8.4 MJ (2 000 kcal). Osmolality (approx.): 350 mOsm/kg water. Bottles of 100, 250 and 500 mL.

Intralipid 30%: 1 000 mL contain: purified soybean oil 300 g, purified egg phospholipids 12 g, glycerol anhydrous 16.7 g, water for injection q.s. ad 1 000 mL. pH is adjusted with sodium hyroxide to pH approximately 7.5. Energy content/L: 12.6 MJ (3 000 kcal). Osmolality (approx.): 310 mOsm/kg water. Bottles of 333 mL.

Store at controlled room temperature below 25°C. Do not freeze.

INTRALIPID® 10% INTRALIPID® 20% INTRALIPID® 30% Pharmacia & Upjohn Fat Emulsions I.V. Nutrition

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