NutriLipid I.V. Fat Emulsion Soybean Oil 20 g/100mL Injection, Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Lipid Emulsion class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.2396 | $1,916.80 / 8000 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.1069 | $855.20 / 8000 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| NutriLipid I.V. Fat Emulsion 20 g/100mLthis 00264-4460-00 | B. | 1000 ml | — | AP | FDA listed | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
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🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00264-4460-00 You're viewing this | 8 CARTON in 1 CASE (0264-4460-00) / 1 CONTAINER in 1 CARTON / 1000 mL in 1 CONTAINER | 2014-06-30 | Active |
| 00264-4460-10 | 12 CARTON in 1 CASE (0264-4460-10) / 1 CONTAINER in 1 CARTON / 500 mL in 1 CONTAINER | 2014-06-30 | Active |
| 00264-4460-30 | 12 CARTON in 1 CASE (0264-4460-30) / 1 CONTAINER in 1 CARTON / 250 mL in 1 CONTAINER | 2014-06-30 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 88% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00264-4460-00?
What NDC number is used to bill for this package of NutriLipid I.V. Fat Emulsion Soybean Oil 20 g/100mL Injection, Solution?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
Why is there no price listed?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Nutrilipid ® 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated. Nutrilipid 20% is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated.
( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Nutrilipid 20% Pharmacy Bulk Package is not intended for direct intravenous administration. ( 2.1 ) For intravenous infusion through a peripheral or central line ( 2.1 ) Recommended dosage depends on age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize and consideration of additional energy given to the patient. ( 2.4 ) For information on the age-appropriate infusion rate, see the full prescribing information.
( 2.4 , 5.1 ) Age Nutritional Requirements Initial Recommended Dosage Maximum Dosage Preterm and term infants (<1 year) 1 to 2 g/kg/day 3 g/kg/day Pediatric patients 1 to 10 years Pediatric patients 11 to <17 years 1 g/kg/day 2.5 g/kg/day Adults 1 to 1.5 g/kg/day 2.5 g/kg/day
2.1Administration Instructions Nutrilipid 20% Pharmacy Bulk Package is not intended for direct intravenous administration. Nutrilipid 20% is for intravenous infusion through a peripheral or central line. When administered with dextrose and amino acids, the choice of a central or peripheral venous route should depend on the osmolarity of the final infusate.
Do not exceed the recommended maximum infusion rate in Table 1 [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ]. Use a non-vented infusion set or close the air vent on a vented set. Use of a vented intravenous administration set with the vent in the open position could result in air embolism.
Use a dedicated line without any connections. Multiple connections could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. Use a 1.2 micron in-line filter.
Nutrilipid 20% can be infused concurrently into the same vein as carbohydrate-amino acid solutions by means of a Y-connector located near the infusion site; flow rates of each solution should be controlled separately by infusion pumps. Do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). Conventional administration sets contain polyvinyl chloride (PVC) components that have DEHP as a plasticizer.
2.2Preparation Instructions for Nutrilipid 20% Bags for Direct Infusion Caution: Nutrilipid 20% Pharmacy Bulk Package is not intended for direct intravenous administration. Step 1: Inspect infusion bag overwrap and primary bag and do not use if damaged. Inspect oxygen indicator and do not use if oxygen indicator is pink or dark pink.
Use only if container and seals are intact. Step 2: To open, tear overwrap starting from the tear notches (Figure 1). Remove Nutrilipid 20% bag from overwrap and discard oxygen indicator, oxygen absorber and overwrap.
Step 3: Inspect Nutrilipid 20% bag visually (Figure 2). Nutrilipid 20% is a homogenous white and milky, sterile, nonpyrogenic lipid injectable emulsion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Inspect Nutrilipid 20% to ensure that the emulsion has not separated. Discard the bag if any particulates or discoloration are observed. Step 4: Remove aluminum foil of outlet port at the bottom of the bag (Figure 3a) and attach administration set (Figure 3b).
Do not use/penetrate blocked port. Step 5: Hang bag on IV Pole (Figure 4). If infusion pumps are used, flow rates of each parenteral fluid should be controlled with a separate pump.
Do not connect flexible bags in series to avoid air embolism due to possible residual gas contained in the primary bag. Air embolism can result if residual gas in the bag is not fully evacuated prior to administration if the flexible bag is pressurized to increase flow rates. If administration is controlled by a pumping device, discontinue pumping action before the bag runs dry to avoid air embolism.
Overwrap Illustration Figure 1 Tear Overwrap Figure 2 Inspect Bag Blocked port illustration Figure 3a and 3b Peel Foil and Insert Spike Do not use block…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Nutrilipid 20% is a homogenous white and milky, sterile, nonpyrogenic lipid injectable emulsion supplied as: 20% (50 g/250 mL) (0.2 g/mL) of lipid in 250 mL single-dose flexible bag 20% (100 g/500 mL) (0.2 g/mL) of lipid in 500 mL single-dose flexible bag 20% (200 g/1,000 mL) (0.2 g/mL) of lipid in 1,000 mL Pharmacy Bulk Package Injectable emulsion: 20% (50 g/250 mL)(0.2 g/mL) of lipid in 250 mL single-dose flexible bag ( 3 ) 20% (100 g/500 mL)(0.2 g/mL) of lipid in 500 mL single-dose flexible bag ( 3 ) 20% (200 g/1,000 mL)(0.2 g/mL) of lipid in 1,000 mL Pharmacy Bulk Package ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Nutrilipid 20% injection is contraindicated in patients who have: Known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients in Nutrilipid 20% [see Warnings and Precautions (5.3) ]. Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride >1,000 mg/dL) [see Warnings and Precautions (5.7) ]. Known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients.
( 4 ) Severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglycerides >1,000 mg/dL). ( 4, 5.7 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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. ( 5.1, 8.4 ) Parenteral Nutrition-Associated Liver Disease : Increased risk in patients who receive parenteral nutrition for greater than 2 weeks, especially preterm neonates. Monitor liver tests; if abnormalities occur, consider discontinuation or dosage reduction.
( 5.2, 8.4 ) Hypersensitivity reactions: Monitor for signs or symptoms. Discontinue infusion if reactions occur. ( 5.3 ) Infections, Fat Overload Syndrome, and Refeeding Syndrome, Hypertriglyceridemia: Monitor for signs and symptoms; monitor laboratory parameters.
( 5.4 , 5.5 , 5.6, 5.7 ) Aluminum Toxicity : Increased risk in patients with renal impairment, including preterm neonates. ( 5.8, 8.4 )
5.1Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants In the postmarketing setting, serious adverse reactions including acute respiratory distress, metabolic acidosis, and death have been reported in neonates and infants after rapid infusion of intravenous lipid emulsions. Hypertriglyceridemia was commonly reported. Strictly adhere to the recommended total daily dosage; the hourly infusion rate should not exceed 0.75 mL/kg/hour [see Dosage and Administration (2.4) ].
Preterm and small for gestational age infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion. Carefully monitor the infant’s ability to eliminate the infused lipids from the circulation (e.g., measure serum triglycerides and/or plasma free fatty acid levels). If signs of poor clearance of lipids from the circulation occur, stop the infusion and initiate a medical evaluation [see Warnings and Precautions (5.5, 5.7) and Overdosage (10) ].
5.2Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders Risk of Parenteral Nutrition-Associated Liver Disease Parenteral nutrition-associated liver disease (PNALD), also referred to as intestinal failure-associated liver disease (IFALD), can present as cholestasis or hepatic steatosis, and may progress to steatohepatitis with fibrosis and cirrhosis (possibly leading to chronic hepatic failure). The etiology of PNALD is multifactorial; however, intravenously administered phytosterols (plant sterols) contained in plant-derived lipid emulsions, including Nutrilipid 20%, have been associated with development of PNALD.
Monitor liver tests in patients treated with Nutrilipid 20% and consider discontinuation or dosage reduction if abnormalities occur. Other Hepatobiliary Disorders Hepatobiliary disorders including cholecystitis and cholelithiasis have developed in some PN-treated patients without preexisting liver disease. Monitor liver tests when administering Nutrilipid 20%.
Patients developing signs of hepatobiliary disorders should be assessed early to determine whether these conditions are related to Nutrilipid 20% use.
5.3Hypersensitivity Reactions Nutrilipid 20% contains soybean oil and egg phospholipids which may cause hypersensitivity reactions. Cross reactions have been observed between soybean and peanut. In postmarketing experience, anaphylaxis has been reported following Nutrilipid administration [see Adverse Reactions (6.2) ].
Nutrilipid 20% is contraindicated in patients with known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients in Nutrilipid 20% [see Contraindications (4)] . If a hypersensitivity reaction occurs, stop infusion of Nutrilipid 20% immediately and initiate appropriate treatment and supportive measures.
5.4Infections Lipid emulsions, such as Nutrilipid 20%, can support microbial growth and are an independent risk factor for the development of catheter-related bloodstream infections. To decrease the risk of inf…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Adverse Reactions described elsewhere in labeling: Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants [see Warnings and Precautions (5.1) ] Risk of Parenteral Nutrition Associated Liver Disease [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Infections [see Warnings and Precautions (5.4) ] Fat Overload Syndrome [see Warnings and Precautions (5.5) ] Refeeding Syndrome [see Warnings and Precautions (5.6)] Hypertriglyceridemia [see Warnings and Precautions (5.7) ] Aluminum Toxicity [see Warnings and Precautions (5.8) ] Adverse reactions include administration site reactions (e.g., erythema, extravasation, pain, phlebitis, pruritus, swelling), hyperlipidemia, hypercoagulability, thrombophlebitis, thrombocytopenia.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-833-425-1464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions reported with other intravenous lipid emulsions include hyperlipidemia, hypercoagulability, thrombophlebitis, and thrombocytopenia. Adverse reactions reported in long-term use with other intravenous lipid emulsions include hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leukopenia, abnormalities in liver function tests, brown pigmentation of the liver and overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly, splenomegaly and shock).
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of Nutrilipid 20%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General disorders and administration site conditions: extravasation, infusion site erythema, infusion site pain, infusion site phlebitis, infusion site pruritus, and infusion site swelling.
Immune system disorders: hypersensitivity reactions, including anaphylaxis [see Contraindications (4) , Warnings and Precautions (5.3) ].
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Coumarin and coumarin derivatives, including warfarin: Anticoagulant activity may be counteracted; monitor laboratory parameters (7.1)
7.1Coumarin and Coumarin Derivatives The soybean oil in Nutrilipid 20% contains vitamin K1. Vitamin K can reverse the anticoagulant activity of coumarin and coumarin derivatives, including warfarin, which work by blocking recycling of vitamin K. Monitor laboratory parameters for anticoagulant activity in patients who are on both Nutrilipid 20% and coumarin or coumarin derivatives.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no adequate or well controlled studies with Nutrilipid 20% in pregnant women. Additionally, animal reproduction studies have not been conducted with Nutrilipid 20%. It is not known whether Nutrilipid 20% can cause fetal harm when administered to a pregnant woman. Nutrilipid 20% should be given to a pregnant woman only if clearly needed.
8.3Nursing Mothers It is not known whether Nutrilipid 20% is present in human milk. Because many drugs are present in human milk, caution should be exercised when Nutrilipid 20% is administered to a nursing woman.
8.4Pediatric Use The evidence for safety and efficacy in pediatric patients of Nutrilipid 20% as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated is derived from the published literature and clinical experience with similar soybean oil-based intravenous lipid emulsions. In the postmarketing setting, clinical decompensation with rapid infusion of intravenous lipid emulsion in neonates and infants, sometimes fatal, has been reported [see Warnings and Precautions (5.1) ].
Patients, particularly preterm infants, are at risk for aluminum toxicity [see Warnings and Precautions (5.9) ] . Patients, including pediatric patients, may be at risk for PNALD [see Warnings and Precautions (5.2) ] . In clinical trials of a pure soybean oil based intravenous lipid emulsion product, thrombocytopenia in neonates occurred (less than 1%).
8.5Geriatric Use Clinical studies of Nutrilipid 20% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate or well controlled studies with Nutrilipid 20% in pregnant women. Additionally, animal reproduction studies have not been conducted with Nutrilipid 20%. It is not known whether Nutrilipid 20% can cause fetal harm when administered to a pregnant woman. Nutrilipid 20% should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
2.2Preparation Instructions for Nutrilipid 20% Bags for Direct Infusion Caution: Nutrilipid 20% Pharmacy Bulk Package is not intended for direct intravenous administration. Step 1: Inspect infusion bag overwrap and primary bag and do not use if damaged. Inspect oxygen indicator and do not use if oxygen indicator is pink or dark pink.
Use only if container and seals are intact. Step 2: To open, tear overwrap starting from the tear notches (Figure 1). Remove Nutrilipid 20% bag from overwrap and discard oxygen indicator, oxygen absorber and overwrap.
Step 3: Inspect Nutrilipid 20% bag visually (Figure 2). Nutrilipid 20% is a homogenous white and milky, sterile, nonpyrogenic lipid injectable emulsion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Inspect Nutrilipid 20% to ensure that the emulsion has not separated. Discard the bag if any particulates or discoloration are observed. Step 4: Remove aluminum foil of outlet port at the bottom of the bag (Figure 3a) and attach administration set (Figure 3b).
Do not use/penetrate blocked port. Step 5: Hang bag on IV Pole (Figure 4). If infusion pumps are used, flow rates of each parenteral fluid should be controlled with a separate pump.
Do not connect flexible bags in series to avoid air embolism due to possible residual gas contained in the primary bag. Air embolism can result if residual gas in the bag is not fully evacuated prior to administration if the flexible bag is pressurized to increase flow rates. If administration is controlled by a pumping device, discontinue pumping action before the bag runs dry to avoid air embolism.
Overwrap Illustration Figure 1 Tear Overwrap Figure 2 Inspect Bag Blocked port illustration Figure 3a and 3b Peel Foil and Insert Spike Do not use blocked port illustration Figure 4 Hang Bag
8.4Pediatric Use The evidence for safety and efficacy in pediatric patients of Nutrilipid 20% as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated is derived from the published literature and clinical experience with similar soybean oil-based intravenous lipid emulsions. In the postmarketing setting, clinical decompensation with rapid infusion of intravenous lipid emulsion in neonates and infants, sometimes fatal, has been reported [see Warnings and Precautions (5.1) ].
Patients, particularly preterm infants, are at risk for aluminum toxicity [see Warnings and Precautions (5.9) ] . Patients, including pediatric patients, may be at risk for PNALD [see Warnings and Precautions (5.2) ] . In clinical trials of a pure soybean oil based intravenous lipid emulsion product, thrombocytopenia in neonates occurred (less than 1%).
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of Nutrilipid 20% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE In the event of overdose, serious adverse reactions may result [see Warnings and Precautions (5.1, 5.5) ]. Stop the infusion to allow lipids to clear from serum. The effects are usually reversible after the lipid infusion is stopped. If medically appropriate, further intervention may be indicated. The lipid administered and fatty acids produced are not dialyzable.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Nutrilipid 20% administered intravenously provides biologically utilizable source of calories and essential fatty acids. Fatty acids serve as an important substrate for energy production. The most common mechanism of action for energy production derived from fatty acid metabolism is beta oxidation.
Fatty acids are important for membrane structure and function, precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression. Nutrilipid 20% causes an increase in heat production, decrease in respiratory quotient, and increase in oxygen consumption following its administration.
12.3Pharmacokinetics The infused lipid particles are removed from the bloodstream in a manner generally thought to be similar to the enzymatic clearance of naturally produced chylomicrons formed after enteral fat intake. Following infusion, there is a transient increase in plasma triglycerides. The triglycerides are hydrolyzed to free fatty acids and glycerol by the enzyme lipoprotein lipase.
The free fatty acids either enter the tissues (where they may be oxidized or resynthesized into triglycerides and stored) or circulate in the plasma, bound to albumin. In the liver, circulating free fatty acids are oxidized or converted to very low-density lipoproteins that re-enter the bloodstream. Phosphatides are the hydrophobic components of membranes and provide electrically insulated layers.
They are involved in the formation of membrane structures. Choline prevents deposition of fat in the liver. Glycerol is metabolized to carbon dioxide and glycogen or is used in the synthesis of body fats.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Nutrilipid 20% administered intravenously provides biologically utilizable source of calories and essential fatty acids. Fatty acids serve as an important substrate for energy production. The most common mechanism of action for energy production derived from fatty acid metabolism is beta oxidation.
Fatty acids are important for membrane structure and function, precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression. Nutrilipid 20% causes an increase in heat production, decrease in respiratory quotient, and increase in oxygen consumption following its administration.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Nutrilipid 20% is supplied as a homogenous white and milky, sterile, nonpyrogenic, lipid injectable emulsion in the following strengths: Strengths REF Volume NDC Number 20% (50 g/250 mL) (0.2 g/mL) S4603 250 mL 0264-4460-30 20% (100 g/500 mL) (0.2 g/mL) S4601 500 mL 0264-4460-10 20% (200 g/1,000 mL) (0.2 g/mL) S4600 1,000 mL 0264-4460-00 (Pharmacy Bulk Container) Do not freeze. If accidentally frozen, discard the container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].
Use of the Pharmacy Bulk Package for admixing should be limited to up to four hours after opening. Admixtures should be used promptly with storage under refrigeration [2°C to 8°C (36°F to 46°F)] not to exceed 24 hours and must be completely used within 24 hours after removal from refrigeration.
📋 Description ▾
11 DESCRIPTION Nutrilipid 20% is a homogenous white and milky sterile, nonpyrogenic lipid emulsion for intravenous administration. Each 100 mL of Nutrilipid 20% contains: Soybean Oil 20 g; Egg Yolk Phospholipid 1.2 g; Glycerin USP (glycerol) 2.5 g; Sodium Oleate 0.03 g; Water for Injection USP qs. pH adjusted with Sodium Hydroxide NF. pH: 6.8 (6.0-8.9); Osmolality: 390 mOsmol/kg (actual). Contains emulsified fat particles averaging approximately 0.26 micron in diameter, similar to naturally occurring chylomicrons.
The total caloric value, including fat, phospholipid, and glycerol is
2.0Kcal per mL. Soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure: are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48% - 58%), oleic (17% - 30%), palmitic (9% -13%), linolenic (4% - 11%), and stearic (2.5% - 5.0%).
These fatty acids have the folIowing chemical and structural formulas: Linoleic Acid C 18 H 32 O 2 Oleic Acid C 18 H 34 O 2 Palmitic Acid C 16 H 32 O 2 Linolenic Acid C 18 H 30 O 2 Stearic Acid C 18 H 36 O 2 Egg yolk phospholipids are a mixture of naturally occurring phospholipids isolated from egg yolk. Glycerol is chemically designated C 3 H 8 O 3 and is a clear colorless, hygroscopic syrupy liquid. It is added to adjust tonicity.
Not made with natural rubber latex, PVC or DEHP. Drug product contains no more than 25 mcg/L of aluminum. structural formula structural formula Linoleic Acid structural formula Oleic Acid structural formula Palmitic Acid structural formula Linolenic Acid structural formula Stearic Acid structural formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION When initiating Nutrilipid 20% administration, discuss the following information with the patient or caregiver: Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants Inform caregivers that acute respiratory distress and death may occur in neonates and infants after rapid infusion of intravenous lipid emulsions. If Nutrilipid is infused at home, instruct caregivers not to exceed maximum infusion rate [see Warnings and Precautions (5.1) ]. Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders Inform patients and caregivers that use of parenteral nutrition may result in parenteral nutrition-associated liver disease and/or other hepatobiliary disorders [see Warnings and Precautions (5.2) ].
Hypersensitivity Reactions Inform patients and caregivers that Nutrilipid 20% may cause hypersensitivity reactions, including anaphylaxis. If Nutrilipid 20% is infused at home, instruct patients and caregivers to stop the infusion of Nutrilipid 20% immediately and seek medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as rapid or weak heartbeat, feeling faint, difficulty in breathing or swallowing, vomiting, nausea, headache, sweating, dizziness, hives, rash, itching, flushing, dizziness, fever, or chills [see Warnings and Precautions (5.3) ].
Infections Inform patients and caregivers that patients who receive Nutrilipid 20% are at risk of infection. If Nutrilipid 20% is infused at home, instruct patients and caregivers to ensure aseptic techniques are used for the preparation and administration of Nutrilipid 20% and to monitor for signs and symptoms of infection [see Warnings and Precautions (5.4) ]. Fat Overload Syndrome Inform patients and caregivers that fat overload syndrome has been reported with the use of intravenous lipid emulsions.
If Nutrilipid 20% is infused at home, instruct patients and caregivers to stop Nutrilipid 20% if signs or symptoms of fat overload syndrome occur [see Warnings and Precautions (5.5) ]. Refeeding Syndrome If the patient is severely malnourished, inform patients and caregivers that administering parenteral nutrition including Nutrilipid 20% may result in refeeding syndrome [see Warnings and Precautions (5.6) ]. Hypertriglyceridemia Inform patients and caregivers about the risks of hypertriglyceridemia with Nutrilipid 20% use [see Warnings and Precautions (5.7) ].
Aluminum Toxicity Inform patients and caregivers that prolonged PN administration in patients with renal impairment, including preterm neonates, may result in aluminum reaching toxic levels associated with central nervous system and bone toxicity [see Warnings and Precautions (5.8) ]. Preparation and Administration Instructions If it is acceptable for a patient and caregiver to administer Nutrilipid 20% at home, then provide recommendations on how to prepare, administer, and store Nutrilipid 20% [see Dosage and Administration (2.1, 2.2) ].