Intralipid 20 g/100mL
I.V. Fat Emulsion · EMULSION · Fresenius Kabi USA, LLC
Intralipid is a emulsion containing i.v. fat emulsion at 20 g/100mL, taken intravenous. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- Intralipid
- Generic Name
- I.V. Fat Emulsion
- NDC Code (Product)
65219-531- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 20 g/100mL
- Dosage Form
- EMULSION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA018449
- Drug Class
- Lipid Emulsion [EPC]
- Marketing Start
- 04/01/2004
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Baxter Healthcare Corporation
Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Intralipid ® 10% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and as a source of essential fatty acids for prevention of EFAD.
Dosage & Administration
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. Not more than 500 mL of Intralipid 10% (A 10% I.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. The daily dosage should not exceed 2.5 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. 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 (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 b…
Contraindications
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%.
Adverse Reactions
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. These adverse reactions are inseparable from the hyperalimentation procedure with or without Intralipid 10% (A 10% I.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, hepatom…
Frequently Asked Questions
What is Intralipid used for?
Intralipid contains I.V. Fat Emulsion. It is a emulsion taken intravenous. Consult your doctor for specific uses.
Is Intralipid a controlled substance?
Intralipid is not classified as a controlled substance by the DEA.
What is the generic name for Intralipid?
The generic name for Intralipid is I.V. Fat Emulsion. There are no other listed brand versions of I.V. Fat Emulsion.
What is the NDC code for Intralipid 20 g/100mL?
The NDC (National Drug Code) for Intralipid 20 g/100mL is 65219-531, listed by Fresenius Kabi USA, LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)