Intralipid 30% Inj, 500ml

Manufacturer FRESENIUS KABI USA Active Ingredient Lipid Emulsion (Plant Based)(LIPid e MUL shun plant baste) Pronunciation IN-tra-lip-id
It is used to aid diet needs.It is used to give nutrition to the body.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Parenteral Nutrition, Caloric Agent
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Pharmacologic Class
Lipid Emulsion
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Pregnancy Category
Category C
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FDA Approved
Aug 1975
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Intralipid is a special type of fat solution given through a vein (intravenously) to people who cannot eat or absorb enough food. It provides important calories and fats that your body needs for energy and to stay healthy, especially when you are receiving nutrition through an IV.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an intravenous infusion over a specified period. If you are using this medication at home, your doctor or nurse will provide guidance on how to administer it properly.

Inspecting the Medication

Before using, inspect the medication to ensure it is white and free from discoloration, particles, oily droplets, or separation. Do not use the medication if the bag is leaking or if you notice any of these issues.

Storage and Disposal

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for instructions on proper storage.

Missed Dose

If you miss a dose, contact your doctor to determine the best course of action.
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Lifestyle & Tips

  • Report any discomfort or unusual symptoms during the infusion.
  • Maintain good hygiene around the IV site to prevent infection.

Dosing & Administration

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Adult Dosing

Standard Dose: Intralipid 30% is typically used as a component of a total parenteral nutrition (TPN) admixture, not for direct intravenous infusion. The dose of lipid emulsion for adults is generally 1 to 2.5 g fat/kg/day, not exceeding 2.5 g fat/kg/day. Infusion rate should not exceed 0.11 g fat/kg/hour.
Dose Range: 1 - 2.5 mg

Condition-Specific Dosing:

criticallyIll: Lower initial doses (e.g., 0.7-1 g fat/kg/day) may be considered, with careful monitoring of triglyceride levels.
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Pediatric Dosing

Neonatal: Initial dose: 0.5 to 1 g fat/kg/day, gradually increasing by 0.5 to 1 g fat/kg/day to a maximum of 3 g fat/kg/day. Infusion rate should not exceed 0.15 g fat/kg/hour.
Infant: Initial dose: 0.5 to 1 g fat/kg/day, gradually increasing by 0.5 to 1 g fat/kg/day to a maximum of 3 g fat/kg/day. Infusion rate should not exceed 0.15 g fat/kg/hour.
Child: Initial dose: 1 to 2 g fat/kg/day, gradually increasing to a maximum of 2.5 to 3 g fat/kg/day. Infusion rate should not exceed 0.15 g fat/kg/hour.
Adolescent: Similar to adult dosing, 1 to 2.5 g fat/kg/day, not exceeding 2.5 g fat/kg/day. Infusion rate should not exceed 0.11 g fat/kg/hour.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required, monitor triglyceride levels.
Moderate: No specific dose adjustment required, monitor triglyceride levels closely.
Severe: Use with caution, monitor triglyceride levels closely. Consider lower initial doses and slower infusion rates.
Dialysis: No specific dose adjustment required, monitor triglyceride levels closely. Lipid emulsions are not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific dose adjustment required, monitor liver function tests and triglyceride levels.
Moderate: Use with caution, monitor liver function tests and triglyceride levels closely. Consider lower initial doses and slower infusion rates if hypertriglyceridemia or liver dysfunction worsens.
Severe: Contraindicated in severe liver disease with impaired fat metabolism. Use with extreme caution and close monitoring if absolutely necessary.

Pharmacology

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Mechanism of Action

Intralipid provides a concentrated source of calories and essential fatty acids (linoleic acid and alpha-linolenic acid) for patients requiring parenteral nutrition. It serves as a substrate for energy production and as a component of cell membranes, prostaglandins, and other biologically active molecules. The fatty acids are incorporated into plasma lipoproteins and utilized by various tissues.
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Pharmacokinetics

Absorption:

Bioavailability: 100%
Tmax: Not applicable (IV administration)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: Approximately 0.05 L/kg (initial distribution space, similar to plasma volume)
ProteinBinding: Not applicable (lipids are transported as lipoproteins)
CnssPenetration: Limited (intact lipid particles do not readily cross the blood-brain barrier, but fatty acids can)

Elimination:

HalfLife: Variable, depending on the rate of infusion and metabolic clearance (e.g., for triglycerides, approximately 6-9 hours after infusion cessation, but clearance is continuous during infusion).
Clearance: Dependent on lipoprotein lipase activity and tissue uptake. Clearance capacity can be saturated at high infusion rates.
ExcretionRoute: Metabolized to carbon dioxide and water, excreted via lungs and kidneys.
Unchanged: Less than 1%
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Pharmacodynamics

OnsetOfAction: Immediate (upon infusion)
PeakEffect: Steady-state plasma triglyceride levels are typically reached within a few hours of continuous infusion.
DurationOfAction: Continuous as long as infusion is maintained; metabolic effects persist until cleared from circulation.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe upset stomach or vomiting
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; changes in stools; dark urine or yellow skin or eyes; or fever with chills
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased sputum or change in color of sputum, pain when passing urine, mouth sores, or a wound that will not heal
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or breath that smells like fruit
Shortness of breath
Chest pain or pressure, or a rapid heartbeat
Dizziness or fainting
Blue or gray skin color
Headache
Excessive sweating
Feeling extremely tired or weak
Unexplained bruising or bleeding
Pain and irritation at the injection site

Other Possible Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you are concerned about any of the following side effects or if they persist, contact your doctor:

Upset stomach or vomiting

This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Fever or chills (signs of infection or reaction)
  • Difficulty breathing or shortness of breath
  • Rash or hives
  • Swelling of the face, lips, or tongue
  • Severe headache
  • Nausea or vomiting
  • Unusual tiredness or weakness
  • Yellowing of the skin or eyes (jaundice)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances like eggs, soybeans, or peanuts. Be sure to describe the symptoms you experienced as a result of the allergy.
If you have conditions related to fat metabolism, such as high triglycerides, pancreatitis caused by high triglycerides, or specific kidney problems like lipoid nephrosis or minimal change disease.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.

Please note that this medication may interfere with certain laboratory tests, so it is crucial to notify your doctor and laboratory personnel that you are using this drug.

There is a risk of developing high triglyceride levels while taking this medication. If you have a history of elevated triglyceride levels, inform your doctor.

This medication may contain aluminum, which can lead to aluminum toxicity with long-term use. The risk is higher if you have kidney problems or if you are a premature infant. Discuss this potential risk with your doctor.

A condition called essential fatty acid deficiency (EFAD) may occur while taking this medication. Be aware of the following signs and symptoms: dry, scaly rash, hair loss, unhealed wounds, unexplained bruising or bleeding, or feeling extremely tired or weak. In children, poor growth may also be a sign of EFAD. If you or your child experiences any of these symptoms, contact your doctor promptly.

Premature and newborn infants require close monitoring while receiving this medication, as rapid administration can lead to severe and potentially life-threatening side effects. Consult with your doctor to discuss the best approach.

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. It is necessary to weigh the benefits and risks of this medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Fat overload syndrome (fever, chills, headache, nausea, vomiting, dyspnea, cyanosis, chest pain, back pain, fatigue, transient increase in LFTs, hepatomegaly, splenomegaly, thrombocytopenia, leukocytosis, hyperlipidemia)
  • Hypertriglyceridemia (very high fat levels in blood)

What to Do:

Stop the infusion immediately. Provide supportive care. Monitor vital signs and laboratory parameters (triglycerides, LFTs, CBC). Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

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Major Interactions

  • Heparin (may transiently increase lipoprotein lipase activity, leading to increased fatty acid release and potential for hypertriglyceridemia if not monitored)
  • Warfarin (Soybean oil in lipid emulsions contains Vitamin K1, which may antagonize the effects of warfarin. Monitor INR closely.)
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Moderate Interactions

  • Insulin (may affect lipid metabolism, requiring adjustment of insulin or lipid dose)
  • Corticosteroids (may affect lipid metabolism)

Monitoring

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Baseline Monitoring

Serum Triglycerides

Rationale: To establish baseline and ensure patient can metabolize lipids, and to prevent fat overload syndrome.

Timing: Before initiating therapy

Liver Function Tests (LFTs: AST, ALT, ALP, Bilirubin)

Rationale: To assess baseline hepatic function, as lipid emulsions are metabolized by the liver and can impact liver enzymes.

Timing: Before initiating therapy

Serum Electrolytes (Na, K, Cl, CO2, Mg, P, Ca)

Rationale: To establish baseline electrolyte status, as part of overall parenteral nutrition management.

Timing: Before initiating therapy

Blood Glucose

Rationale: To establish baseline glucose metabolism, as lipid emulsions can affect glucose utilization.

Timing: Before initiating therapy

Complete Blood Count (CBC) with differential

Rationale: To assess baseline hematologic status and monitor for potential adverse effects like thrombocytopenia.

Timing: Before initiating therapy

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Routine Monitoring

Serum Triglycerides

Frequency: Daily or every other day initially, then weekly once stable

Target: < 400 mg/dL (adults), < 200 mg/dL (neonates/infants)

Action Threshold: > 400 mg/dL (adults) or > 200 mg/dL (neonates/infants) - reduce dose or temporarily discontinue

Liver Function Tests (LFTs)

Frequency: Weekly or bi-weekly

Target: Within normal limits or stable

Action Threshold: Significant elevation - investigate cause, consider dose adjustment

Blood Glucose

Frequency: Daily initially, then 2-3 times weekly once stable

Target: 70-180 mg/dL

Action Threshold: Persistent hyperglycemia or hypoglycemia - adjust glucose or insulin

Serum Electrolytes

Frequency: Daily initially, then 2-3 times weekly once stable

Target: Within normal limits

Action Threshold: Significant abnormalities - adjust electrolyte supplementation

Fluid Balance (Intake/Output, Weight)

Frequency: Daily

Target: Stable weight, appropriate fluid balance

Action Threshold: Significant fluid retention or dehydration - adjust fluid intake

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Symptom Monitoring

  • Fever
  • Chills
  • Nausea
  • Vomiting
  • Headache
  • Flushing
  • Dyspnea
  • Cyanosis
  • Chest pain
  • Back pain
  • Fatigue
  • Jaundice
  • Signs of infection at catheter site

Special Patient Groups

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Pregnancy

Intralipid is considered Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Parenteral nutrition, including lipid emulsions, may be essential for maternal and fetal well-being in certain conditions.

Trimester-Specific Risks:

First Trimester: No specific data on increased risk of congenital anomalies, but use only if clearly needed.
Second Trimester: Generally considered safe if clinically indicated for maternal nutritional support.
Third Trimester: Generally considered safe if clinically indicated for maternal nutritional support.
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Lactation

Lipid emulsions are components of normal human milk. While specific data on Intralipid excretion into breast milk are limited, the components (fatty acids) are naturally present. Use with caution, but generally considered compatible with breastfeeding when clinically indicated for the mother.

Infant Risk: L3 - Moderate risk. Monitor infant for any adverse effects, though unlikely given the natural presence of lipids in milk.
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Pediatric Use

Intralipid is widely used in pediatric patients, including neonates and infants, for parenteral nutrition. Dosing must be carefully calculated based on weight and age, with close monitoring of triglyceride levels, liver function, and fluid balance due to their immature metabolic systems and higher risk of fat overload syndrome.

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Geriatric Use

No specific dose adjustments are generally required for elderly patients, but they may have a higher incidence of underlying diseases (e.g., diabetes, renal/hepatic impairment) that could affect lipid metabolism. Close monitoring of triglyceride levels and overall clinical status is recommended.

Clinical Information

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Clinical Pearls

  • Intralipid 30% is a concentrated lipid emulsion primarily intended for compounding into total parenteral nutrition (TPN) admixtures, not for direct peripheral or central intravenous infusion due to its high osmolality and viscosity.
  • Always inspect the solution for particulate matter, discoloration, or phase separation before administration. Do not use if separation of the emulsion is observed.
  • Administer through a central venous catheter when used as part of a TPN admixture. If used in a peripheral line (typically lower concentrations like 10% or 20%), ensure proper dilution and monitor for phlebitis.
  • Use an in-line filter (1.2 micron or larger) for lipid-containing admixtures to prevent infusion of precipitates, but smaller filters (e.22 micron) should not be used as they will occlude.
  • Monitor serum triglyceride levels closely, especially during the initial phase of therapy and with dose adjustments, to prevent fat overload syndrome. If triglyceride levels exceed recommended limits, reduce the infusion rate or temporarily discontinue.
  • Patients with impaired lipid metabolism (e.g., severe liver disease, severe sepsis, pancreatitis with hypertriglyceridemia) may require lower doses or careful consideration of lipid emulsion use.
  • Intralipid contains soybean oil, egg phospholipids, and glycerol. Patients with known hypersensitivity to egg, soy, or any component should not receive this product.
  • Risk of infection is increased with parenteral nutrition. Strict aseptic technique is crucial during preparation and administration.
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Alternative Therapies

  • SMOFlipid (soybean oil, medium-chain triglycerides, olive oil, fish oil)
  • Clinolipid (soybean oil, olive oil)
  • Liposyn III (soybean oil)
  • Nutrilipid (soybean oil)
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Cost & Coverage

Average Cost: Varies widely per 500ml bag
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (often covered as part of TPN)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best disposal method, as some communities may have designated drug take-back programs.

Additionally, some medications may have a separate patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider for personalized guidance.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication, the amount taken, and the time of ingestion, to facilitate prompt and effective treatment.