INDICATIONS AND USAGE
Intralipid 20% (A 20% Intravenous Fat Emulsion), is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition (PN) and as a source of essential fatty acids for prevention of essential fatty acid deficiency (EFAD).
Intralipid 20% Pharmacy Bulk Package and Intralipid 30% Pharmacy Bulk Package are intended for use in a pharmacy admixture program for the preparation of three-in-one or total nutrition admixtures (TNAs) to provide a source of calories and essential fatty acids for adult and pediatric patients requiring PN and a source of essential fatty acids for prevention of EFAD.
INTRALIPID 20% and 30% PHARMACY BULK PACKAGES ARE NOT INTENDED FOR DIRECT INTRAVENOUS ADMINISTRATION.
IMPORTANT SAFETY INFORMATION
INTRALIPID 20% (A 20% INTRAVENOUS FAT EMULSION) PHARMACY BULK PACKAGE AND INTRALIPID 30% (A 30% INTRAVENOUS FAT EMULSION) PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT INTRAVENOUS ADMINISTRATION. DILUTING INTRALIPID 20% TO A 10% CONCENTRATION OR 30% TO A 10% OR 20% CONCENTRATION WITH AN INTRAVENOUS FLUID SUCH AS NORMAL SALINE OR OTHER DILUENT DOES NOT PRODUCE A DILUTION THAT IS EQUIVALENT IN COMPOSITION TO INTRALIPID 10% OR 20% I.V. FAT EMULSIONS, AND SUCH A DILUTION SHOULD NOT BE GIVEN BY DIRECT INTRAVENOUS ADMINISTRATION.
Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize and eliminate lipids, and consideration of additional energy given to the patient. Protect the admixed PN solution from light. Use a 1.2 micron in-line filter during administration.
|Dosage for Intralipid 20%
|Initial Recommended Dosage
|Birth to 2 years of age (including preterm and term neonates)
|Pediatric patients 2 to <12 years of age
||1 to 2 g/kg/day
|Pediatric patients 12 to 17 years of age
||1 g/kg/day (stable)
≤1 g/kg/day (critically ill)
Dosage for Intralipid 30%
Premature infants: initial dose at 0.5 g/kg/24 hours, maximum recommended dosage is 3g fat/kg/24 hours.
Older pediatric patients: daily dose should not exceed 3 of g fat/kg/d.
Adults: The daily dosage should not exceed 2.5 g of fat/kg of body weight
Intralipid is contraindicated in patients with:
- Known hypersensitivity to egg, soybean, or peanut, or any of the active ingredients or excipients.
- Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride > 1,000 mg/dL).
- Disturbances of normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis or acute pancreatitis if accompanied by hyperlipidemia.
Risk of Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants: Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported.
Risk of Parenteral Nutrition-Associated Liver Disease (PNALD): Increased risk in patients who receive PN for extended periods of time, especially preterm neonates. Monitor liver function tests; if abnormalities occur consider discontinuation or dosage reduction.
Hypersensitivity Reactions: Monitor for signs or symptoms. Discontinue infusion if reactions occur.
Risk of Infections, Fat Overload Syndrome, Refeeding Syndrome, and Hypertriglyceridemia: Monitor for signs and symptoms; monitor laboratory parameters.
Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm neonates.
Most common adverse drug reactions (≥5%) from clinical trials in adults were nausea, vomiting, and pyrexia. Most common adverse drug reactions (≥5%) from clinical trials in pediatric patients were anemia, vomiting, increased gamma-glutamyltransferase, and cholestasis.
Vitamin K Antagonists (e.g., warfarin): Anticoagulant activity may be counteracted; increase monitoring of coagulation parameters.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This Important Safety Information does not include all the information needed to use Intralipid safely and effectively. Please see full prescribing information, for intravenous use at www.FreseniusKabiNutrition.com/IntralipidPI.