Intralipid 20%

Each 1000 mL of Intralipid 20% contains purified soybean oil 200 g. It also contains purified egg phospholipids, anhydrous glycerol, sodium hydroxide and water for injections.
Osmolality: 350 mOsmol/kg water.
pH: Approximately 8.
Energy Content: 8.4 MJ (2000 kcal)/1000 mL.
Organic Phosphate Content: 15 mmol/1000 mL.

Pharmacology: Pharmacodynamics: Intralipid 20% provides essential and non-essential long-chain fatty acids for energy metabolism and apposition in cell membranes.
Intralipid 20% in the recommended dosage does not cause any hemodynamic changes. No clinically significant changes in pulmonary function have been described when Intralipid 20% is used properly. The transient increase in liver enzymes seen in some patients on total parenteral nutrition (TPN) including Intralipid 20% is reversible and disappears when TPN is interrupted. Similar changes are also seen in parenteral nutrition without fat emulsions.
Pharmacokinetics: Intralipid 20% has biological properties similar to those of endogenous chylomicrons. Unlike chylomicrons, Intralipid 20% does not contain cholesterol esters or apolipoproteins, while its phospholipid content is significantly higher.
Intralipid 20% is eliminated from the circulation via the same pathway as endogenous chylomicrons, at least early-on in the catabolism. The exogenous fat particle is hydrolysed in the circulation and taken up by low-density lipoproteins (LDL) receptors peripherally and by the liver. The elimination rate is determined by the composition of the fat particles, nutritional status, disease and rate of infusion. In healthy volunteers, the maximum clearance rate of Intralipid 20% after fasting overnight is equivalent to 3.8±1.5 g triglycerides/kg body weight/24 hrs.
Both the elimination and the oxidation rates are dependent on the patient's clinical condition; elimination is faster and utilisation is increased in postoperative patients and in trauma, while patients with renal failure and hypertriglyceridemia show lower utilisation of exogenous fat emulsions.

Patients needing IV nutrition to supply energy and essential fatty acids. Patients with essential fatty acid deficiency (EFAD) who cannot maintain or restore a normal essential fatty acid pattern by oral intake.

The ability to eliminate Intralipid 20% should govern the dosage and infusion rate. See Fat elimination as follows:
Intralipid 20%, 1 g triglycerides corresponds to 5 mL.
Adults: Recommended Maximum Dosage: Three (3) g triglycerides/kg body weight/day. Within this upper limit, Intralipid 20% can be given to contribute up to 70% of the energy requirements, also in patients with highly increased energy requirements. The infusion rate for Intralipid 20% should not exceed 500 mL in 5 hrs.
Neonates and Infants: Recommended Dosage Range: 0.5-4 g triglycerides/kg body weight/day. The rate of infusion should not exceed 0.17 g triglycerides/kg body weight/hr (4 g in 24 hrs). In prematures and low birth weight neonates, Intralipid 20% should preferably be infused continuously over 24 hrs. The initial dosage should be 0.5-1 g/kg body weight/day followed by a successive increase by 0.5-1 g/kg body weight/day up to 2 g/kg body weight/day. Only with close monitoring of serum triglyceride concentration, liver tests and oxygen saturation may the dosage be increased to 4 g/kg body weight/day. The rates given are maximum rates and no attempt should be made to exceed these in order to compensate for missed doses.
Essential Fatty Acid Deficiency (EFAD): To prevent or correct EFAD, 4-8% of the nonprotein energy should be supplied as Intralipid 20% to provide sufficient amounts of linoleic and linolenic acid. When EFAD is associated with stress, the amount of Intralipid 20% needed to correct the deficiency may be substantially increased.
Fat Elimination: Adults: The ability to eliminate fat should be closely monitored in patients with conditions mentioned under Precautions and in patients given Intralipid 20% for >1 week. This is done by collecting a blood sample after a fat-free clearance period of 5-6 hrs. Blood cells are then separated from plasma by centrifugation. If the plasma is opalescent, the infusion should be postponed. The sensitivity of this method is such that hypertriglyceridemia can pass undetected. Therefore, it is recommended that serum triglyceride concentrations should be measured in patients who are likely to have impaired fat tolerance.
Neonates and Infants: The ability to eliminate fat should be tested regularly in neonates and infants. Measuring serum triglyceride levels is the only reliable method.

Severe overdose of fat emulsions containing triglycerides can, especially if carbohydrates are not administered simultaneously, lead to acidosis. (See Fat Overload Syndrome under Adverse Reactions.)

Hypersensitivity to egg-, soya- or peanut protein or to any of the active substances or excipients of Intralipid 20%. Patients with acute shock and in patients with severe hyperlipemia. Severe liver insufficiency. Hemophagocytotic syndrome.

Intralipid 20% should be given with caution in conditions of impaired lipid metabolism as in renal insufficiency, uncompensated diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (if hypertriglyceridemic) and sepsis. If Intralipid 20% is given to patients with these conditions, close monitoring of the serum triglyceride concentration is obligatory.
Patients known to be allergic to soy or egg proteins should be given Intralipid 20% with great caution and only after hypersensitivity tests.
Intralipid 20% should be given with caution to neonates and prematures with hyperbilirubinemia and cases with suspected pulmonary hypertension. In neonates, particularly prematures on long-term parenteral nutrition, platelet count, liver test and serum triglyceride concentration should be monitored.
Intralipid 20% may interfere with certain laboratory measurements (bilirubin, lactate dehydrogenase, oxygen saturation, hemoglobin) if blood is sampled before fat has been adequately cleared from the bloodstream. Fat is cleared after a fat-free interval of 5-6 hrs in most patients.
Use in pregnancy & lactation: No adverse events during pregnancy and lactation has been reported.

No adverse events during pregnancy and lactation has been reported.

Intralipid 20% infusion may cause a rise in body temperature and less frequently, shivering, chills and nausea/vomiting (incidence <1%).
Reports of other adverse events in conjunction with Intralipid 20% infusion are extremely rare,  less than 1 adverse event per 1 million infusions. See table.

Click on icon to see table/diagram/image

Thrombocytopenia has been reported in association with prolonged treatment with Intralipid 20% in infants.
Transient increase in liver function tests after prolonged IV nutrition with or without Intralipid 20% have also been noted. Increased cholesterol has been observed with infants after long-term treatment with Intralipid 20%. The reasons are not clear at present.
Fat Overload Syndrome: An impaired capacity to eliminate Intralipid 20% may lead to the fat overload syndrome as a result of overdosage. However, this syndrome may also appear at recommended rates of infusion in association with a sudden change in the patient's clinical condition eg, renal function impairment or infection. The fat overload syndrome is characterised by hyperlipemia, fever, fat infiltration and disorders in various organs and coma. All symptoms are usually reversible if the infusion of Intralipid 20% is discontinued.

Some drugs, like insulin, may interfere with the body's lipase system. This kind of interaction seems, however, to be of only limited clinical importance.
Heparin in clinical doses causes a transient increase in lipolysis in plasma, resulting in a transient decrease in triglyceride clearance due to depletion of lipoprotein lipase.
Soybean oil has a natural content of vitamin K₁. This is considered important only for patients treated with coumarin derivatives, which interfere with vitamin K₁.
Incompatibilities: Intralipid 20% can only be mixed with other medicinal products for which compatibility has been documented.

Instructions for Use/Handling: Excel Bag: After inspection of the integrity indicator, the overpouch has to be removed.
Additions should be made aseptically. Single administration of electrolyte solutions to Intralipid 20% should not be made. Only medicinal, nutritional or electrolyte solutions for which compatibility has been documented may be added as directed. Compatibility data are available from the manufacturer for a number of mixtures. The leftover contents of opened bottles/bags should discarded and not saved for later use.
Excel Bag: The excel bag consists of an inner bag (primary package) with an overpouch. An oxygen absorber and an integrity indicator (Oxalert) are placed between the innerbag and the overpouch.
The innerbag consists of a poly (propylene/ethylene) copolymer, a thermoplastic elastomer and a co-polyester. The overpouch, the oxygen absorber and the integrity indicator should be discarded after opening of the overpouch. The integrity indicator (Oxalert) will react with free oxygen and change color in case of damage in the overpouch.

Store below 25°C. Do not freeze.
After Addition of Other Nutritional Elements: Mixing in Plastic Bag (Phthalate-Free Film): Mixtures aseptically prepared in a controlled and validated aseptic area should be used within 7 days after preparation. The mixtures can be stored up to 6 days in a refrigerator (2-8°C) followed by an infusion period of up to 24 hrs.
Shelf-Life: 24 months.
After First Opening the Container: The emulsion should be used directly due to the risk of microbiological contamination. Any unused emulsion should be discarded.
After Addition or Mixing According to Directions: When additions are made to infusion solution, the infusion should be completed within 24 hrs.

Parenteral Nutritional Products

B05BA02 - fat emulsions ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.

P₁S₁S₃