Intralipid

I.v. Fat Emulsion

Baxter Healthcare Corp
Human Prescription Drug
NDC 0338-0518

Intralipid also known as I.v. Fat Emulsion is a human prescription drug labeled by 'Baxter Healthcare Corp'. National Drug Code (NDC) number for Intralipid is 0338-0518. This drug is available in dosage form of Emulsion. The names of the active, medicinal ingredients in Intralipid drug includes Soybean Oil - 10 g/100mL . The currest status of Intralipid drug is Active.

Drug Information:

Drug NDC:	0338-0518
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Intralipid
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	I.v. Fat Emulsion
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Baxter Healthcare Corp
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Emulsion
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	SOYBEAN OIL - 10 g/100mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	INTRAVENOUS
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	NDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	12 Dec, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	25 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	NDA017643
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Baxter Healthcare CORP
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1859368 1859370 1859372 1859373 1859374 1859375
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000191261 M0012553
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	241ATL177A
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Lipid Emulsion [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:	Lipids [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Lipid Emulsion [EPC] Lipids [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
0338-0518-12	250 mL in 1 BAG (0338-0518-12)	12 Dec, 2014	N/A	No
0338-0518-13	500 mL in 1 BAG (0338-0518-13)	12 Dec, 2014	N/A	No
0338-0518-58	100 mL in 1 BAG (0338-0518-58)	12 Dec, 2014	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Intralipid

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NDC: 0338-0518

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Intralipid

I.v. Fat Emulsion

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NDC: 0338-0519

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I.v. Fat Emulsion

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Intralipid

I.v. Fat Emulsion

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NDC: 0338-0519

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Product Elements:

Intralipid i.v. fat emulsion egg phospholipids glycerin sodium hydroxide soybean oil soybean oil

Boxed Warning:

Warnings deaths in preterm infants after infusion of intravenous fat emulsion have been reported in the medical literature 2 . autopsy findings included intravascular fat accumulation in the lungs. treatment of premature and low birth weight infants with intravenous fat emulsion must be based upon careful benefit-risk assessment. strict adherence to the recommended total daily dose is mandatory; hourly infusion rate should be as slow as possible in each case and should not in any case exceed 1 g fat/kg in four hours. premature and small for gestational age infants have poor clearance of intravenous fat emulsion and increased free fatty acid plasma levels following fat emulsion infusion; therefore, serious consideration must be given to administration of less than the maximum recommended doses in these patients in order to decrease the likelihood of intravenous fat overload. the infant's ability to eliminate the infused fat from the circulation must be carefully monitored (such as serum triglycerides and/or plasma free fatty acid levels). the lipemia must clear between daily infusions.

Indications and Usage:

Indications and usage intralipid Â® 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 and 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/ Read more...

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. the initial rate of infusion in older pediatric patients should be no more than 0.1 ml/minute for the first 10 to 15 minutes. if no untoward reactions occur, the rate can be changed to permit infusion of 1 ml of intralipid 10%/kg/hour (equivalent to 0.1 g/kg/hour). the daily dosage should not exceed 3 g of fat/kg of body weight 3 . intralipid 10% (equivalent to 0.125 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. essential fatty acid deficiency when intralipid 10% (a 10% i.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. if infusion pumps are used, flow rates of each parenteral fluid should be controlled with a separate pump. fat emulsion may also be infused through a separate peripheral site. use a 1.2 micron filter with intralipid 10%. filters of less than 1.2 micron pore size must not be used. conventional administration sets and tpn pooling bags contain polyvinyl chloride (pvc) components that have dehp (di(2-ethylhexyl) phthalate) as a plasticizer. fatâcontaining fluids such as intralipid 10% extract dehp from these pvc components and it may be advisable to consider infusion of intralipid 10% through a non-dehp administration set. do not use any bag in which there appears to be an oiling out on the surface of the emulsion. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

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 hepatomeg Read more...

aly, 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 âintravenous fat pigment,â has been reported in patients infused with intralipid 10%. the causes and significance of this phenomenon are unknown.

Use in Pregnancy:

Pregnancy: animal reproduction studies have not been conducted with intralipid. it is also not known whether intralipid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. intralipid should be given to a pregnant woman only if clearly needed.

Pediatric Use:

Pediatric use: see dosage and administration .

Overdosage:

Overdosage in the event of fat overload during therapy, stop the infusion of intralipid 10% until visual inspection of the plasma, determination of triglyceride concentrations, or measurement of plasma light-scattering activity by nephelometry indicates the lipid has cleared. re- evaluate the patient and institute appropriate corrective measures. see warnings and precautions .

Description:

Description intralipid Â® 10% (a 10% intravenous fat emulsion) is a sterile, non-pyrogenic fat emulsion prepared for intravenous administration as a source of calories and essential fatty acids. it is made up of 10% soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection. in addition, sodium hydroxide has been added to adjust the ph so that the final product ph is 8. ph range is 6 to 8.9. the soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure: where are saturated and unsaturated fatty acid residues. the major component fatty acids are linoleic acid (44-62%), oleic acid (19-30%), palmitic acid (7-14%), Î±-linolenic acid (4-11%) and stearic acid (1.4-5.5%) 1 . these fatty acids have the following chemical and structural formulas: purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. these phospholipids have the following general structure: contain saturated and unsaturated fatty acids that abound in neutral fats. r 3 is primarily either the choline or ethanolamine ester of phosphoric acid. glycerin is chemically designated c 3 h 8 o 3 and is a clear colorless, hygroscopic syrupy liquid. it has the following structural formula: intralipid 10% (a 10% intravenous fat emulsion) has an osmolality of approximately 300 mosmol/kg water (which represents 260 mosmol/l of emulsion) and contains emulsified fat particles of approximately 0.5 micron size. the total caloric value, including fat, phospholipid and glycerin, is 1.1 kcal per ml of intralipid 10%. the phospholipids present contribute 47 milligrams or approximately 1.5 mmol of phosphorus per 100 ml of the emulsion. the primary plastic container (biofine tm ) is made from multilayered film specifically designed for parenteral nutrition drug products. the film is polypropylene based comprising three co-extruded layers. it contains no plasticizers and exhibits virtually no leachables. the container does not contain dehp (di(2-ethylhexyl) phthalate), pvc. the container is nontoxic and biologically inert. this product is not made with natural rubber latex. the container-emulsion unit is a closed system and is not dependent upon entry of external air during administration. the container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. figure figure figure figure figure figure figure

Clinical Pharmacology:

Clinical pharmacology intralipid 10% is metabolized and utilized as a source of energy causing an increase in heat production, decrease in respiratory quotient and increase in oxygen consumption. the infused fat particles are cleared from the blood stream in a manner thought to be comparable to the clearing of chylomicrons. intralipid 10% will prevent the biochemical lesions of essential fatty acid deficiency (efad) and correct the clinical manifestations of the efad syndrome.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility: studies with intralipid have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

How Supplied:

How supplied intralipid 10% is supplied as a sterile emulsion in the following fill sizes: 100 ml, 250 ml and 500 ml. 100 ml: 0338-0518-58 250 ml: 0338-0518-12 500 ml: 0338-0518-13

Package Label Principal Display Panel:

Package label - principal display - intralipid 250 ml container label ndc 0338-0518-12 intralipid Â® 1 0% a 10% i.v. fat emulsion 250 ml for intravenous use rx only bag 10

Comments/ Reviews:

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