Intralipid 20% Emul For Inj, 1000ml

Manufacturer FRESENIUS KABI USA Active Ingredient Lipid Emulsion (Plant Based)(LIPid e MUL shun plant baste) Pronunciation IN-tra-lih-pid
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
Nutritional products
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Pharmacologic Class
Lipid emulsion; Caloric agent; Essential fatty acid source
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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 sterile, intravenous (IV) solution that provides essential fats and calories. It's used when you can't get enough nutrition by eating, helping your body get the energy and building blocks it needs to function properly.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully read all the information provided to you and follow the instructions closely. This medication is administered as an intravenous infusion, which means it is given into a vein over a period of time.

If you are using this medication at home, your doctor or nurse will provide personalized instruction on how to administer it properly. 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.

Storing and Disposing of Your Medication

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

What to Do If You Miss a Dose

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

  • Follow all instructions from your healthcare provider regarding administration and monitoring.
  • Report any unusual symptoms or side effects immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: 1 to 2.5 g fat/kg/day
Dose Range: 1 - 2.5 mg

Condition-Specific Dosing:

Initial: 1 g fat/kg/day
Maintenance: Up to 2.5 g fat/kg/day
Maximum infusion rate: 0.125 g fat/kg/hour (equivalent to 0.625 mL/kg/hour of 20% emulsion)
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Pediatric Dosing

Neonatal: Initial: 0.5 to 1 g fat/kg/day, gradually increase to 3 to 4 g fat/kg/day. Maximum: 4 g fat/kg/day. Maximum infusion rate: 0.15 g fat/kg/hour.
Infant: Initial: 0.5 to 1 g fat/kg/day, gradually increase to 3 to 4 g fat/kg/day. Maximum: 4 g fat/kg/day. Maximum infusion rate: 0.15 g fat/kg/hour.
Child: Initial: 1 g fat/kg/day, gradually increase to 2 to 3 g fat/kg/day. Maximum: 3 g fat/kg/day. Maximum infusion rate: 0.15 g fat/kg/hour.
Adolescent: Initial: 1 g fat/kg/day, gradually increase to 2 to 3 g fat/kg/day. Maximum: 3 g fat/kg/day. Maximum infusion rate: 0.15 g fat/kg/hour.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment; monitor fluid and electrolyte balance.
Moderate: No specific dose adjustment; monitor fluid and electrolyte balance.
Severe: No specific dose adjustment; monitor fluid and electrolyte balance.
Dialysis: No specific dose adjustment; monitor fluid and electrolyte balance and serum triglycerides closely.

Hepatic Impairment:

Mild: Use with caution; monitor liver function tests and serum triglycerides.
Moderate: Use with caution; monitor liver function tests and serum triglycerides. Consider dose reduction if fat overload syndrome or significant hypertriglyceridemia occurs.
Severe: Use with caution; monitor liver function tests and serum triglycerides. Consider dose reduction or temporary discontinuation if fat overload syndrome or significant hypertriglyceridemia occurs.

Pharmacology

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Mechanism of Action

Intralipid 20% provides a concentrated source of calories and essential fatty acids (linoleic acid and alpha-linolenic acid) necessary for normal metabolism and cell membrane integrity. It is metabolized and utilized as energy, preventing essential fatty acid deficiency and providing a non-carbohydrate energy source.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Not available (rapidly metabolized)
ProteinBinding: Not applicable (lipids are transported by lipoproteins)
CnssPenetration: Limited (primarily utilized peripherally and in liver)

Elimination:

HalfLife: Variable (depends on metabolic rate and dose, generally rapid clearance from plasma)
Clearance: Rapidly cleared from plasma by LPL-mediated hydrolysis
ExcretionRoute: Metabolites excreted via respiration (CO2) and urine
Unchanged: 0%
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Pharmacodynamics

OnsetOfAction: Immediate (upon initiation of infusion)
PeakEffect: During continuous infusion
DurationOfAction: Dependent on infusion rate and metabolic clearance

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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, difficulty 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 nausea and vomiting
Signs of liver problems: dark urine, fatigue, decreased appetite, nausea or stomach pain, light-colored stools, vomiting, or yellow skin and eyes (jaundice)
Signs of gallbladder problems: pain in the upper right abdomen, right shoulder, or between the shoulder blades, changes in stool, dark urine, yellow skin and eyes, or fever with chills
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Shortness of breath
Chest pain or pressure, or rapid heartbeat
Dizziness or fainting
Blue or gray skin discoloration
Headache
Excessive sweating
Feeling extremely tired or weak
Unexplained bruising or bleeding
Pain or irritation at the injection site

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you're bothered by any of the following side effects or if they persist, contact your doctor:

Nausea or vomiting
* Other side effects not listed here

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
  • Headache
  • Nausea or vomiting
  • Difficulty breathing or shortness of breath
  • Yellowing of the skin or eyes (jaundice)
  • Unusual bleeding or bruising
  • Rash or hives
  • Swelling or pain at the injection site
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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 such as eggs, soybeans, or peanuts. Be sure to describe the allergic reaction and its symptoms.
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 alongside your other treatments 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 inform 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, be sure to notify your doctor.

This medication may contain aluminum, which can increase the risk of aluminum toxicity, particularly if you have kidney problems or are a premature infant. Your doctor will need to monitor you closely to minimize this risk.

While taking this medication, you may be at risk of developing essential fatty acid deficiency (EFAD). Signs of EFAD include a dry, scaly rash, hair loss, unhealed wounds, unexplained bruising or bleeding, or feelings of extreme tiredness or weakness. In children, poor growth may also be a sign of EFAD. If you or your child experience any of these symptoms, contact your doctor immediately.

Special caution is required when administering this medication to premature and newborn infants, as rapid infusion can lead to severe and potentially life-threatening side effects. Your doctor will need to closely monitor the infant's condition.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Fat overload syndrome: fever, chills, headache, nausea, vomiting, dyspnea, hepatomegaly (enlarged liver), jaundice, coagulopathy (blood clotting problems), hyperlipidemia (very high blood fat levels).

What to Do:

If you suspect an overdose or experience severe symptoms, stop the infusion immediately and seek emergency medical attention. Call 911 or your local emergency number. For general advice, call a poison control center at 1-800-222-1222.

Drug Interactions

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Moderate Interactions

  • Heparin (can transiently increase plasma free fatty acids by activating lipoprotein lipase, potentially affecting lipid clearance if given concurrently or in high doses)
  • Warfarin (theoretical interaction due to vitamin K content in soybean oil, but clinically insignificant with typical doses)

Monitoring

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Baseline Monitoring

Serum Triglycerides

Rationale: To establish baseline and assess risk of hypertriglyceridemia.

Timing: Prior to initiation of therapy.

Liver Function Tests (AST, ALT, Bilirubin, Alkaline Phosphatase)

Rationale: To assess baseline hepatic function and monitor for fat overload syndrome or cholestasis.

Timing: Prior to initiation of therapy.

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

Rationale: To establish baseline and monitor for imbalances.

Timing: Prior to initiation of therapy.

Glucose

Rationale: To establish baseline and monitor for hyperglycemia.

Timing: Prior to initiation of therapy.

Complete Blood Count (CBC) with differential

Rationale: To assess baseline hematologic status and monitor for signs of infection or fat overload syndrome.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Serum Triglycerides

Frequency: Daily initially, then 2-3 times per week once stable.

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

Action Threshold: If levels exceed target, reduce infusion rate or temporarily discontinue infusion. Investigate underlying causes.

Liver Function Tests (AST, ALT, Bilirubin, Alkaline Phosphatase)

Frequency: Weekly or as clinically indicated.

Target: Within normal limits or stable baseline.

Action Threshold: Significant elevation may indicate fat overload syndrome or parenteral nutrition-associated liver disease; investigate and consider dose adjustment.

Glucose

Frequency: Daily.

Target: Normal range (e.g., 70-180 mg/dL).

Action Threshold: Hyperglycemia may require insulin adjustment or reduction in dextrose infusion.

Electrolytes

Frequency: Daily initially, then 2-3 times per week once stable.

Target: Normal range.

Action Threshold: Correct imbalances as needed.

Fluid Balance (Intake/Output, Weight)

Frequency: Daily.

Target: Euvolemia, stable weight.

Action Threshold: Adjust fluid intake to maintain balance.

Complete Blood Count (CBC)

Frequency: Weekly.

Target: Normal range.

Action Threshold: Monitor for anemia, thrombocytopenia, or leukocytosis which can be associated with fat overload syndrome or infection.

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Symptom Monitoring

  • Fever
  • Chills
  • Headache
  • Nausea
  • Vomiting
  • Dyspnea
  • Hepatomegaly
  • Jaundice
  • Coagulopathy
  • Hyperlipidemia
  • Rash
  • Urticaria
  • Hypotension
  • Injection site pain or swelling

Special Patient Groups

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Pregnancy

Intralipid 20% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is generally considered safe when parenteral nutrition is clinically indicated.

Trimester-Specific Risks:

First Trimester: No specific increased risks identified beyond general risks of parenteral nutrition.
Second Trimester: No specific increased risks identified beyond general risks of parenteral nutrition.
Third Trimester: No specific increased risks identified beyond general risks of parenteral nutrition.
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Lactation

Lipid emulsions are compatible with breastfeeding. Lipids are a normal component of breast milk and are essential for infant development. Use is generally considered safe.

Infant Risk: Low risk to the infant.
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Pediatric Use

Widely used in pediatric parenteral nutrition, including neonates. Careful monitoring of serum triglycerides, liver function, and infusion rates is crucial due to immature metabolic pathways and higher risk of fat overload syndrome in this population.

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Geriatric Use

No specific dose adjustments are typically required for geriatric patients. However, monitor for comorbidities, fluid and electrolyte balance, and potential for impaired lipid clearance due to age-related physiological changes.

Clinical Information

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Clinical Pearls

  • Always inspect the emulsion for signs of phase separation (oily streaks or clear separation) before administration. Do not use if separation is observed.
  • Administer via central or peripheral vein. For peripheral administration, consider osmolarity of the total admixture to prevent phlebitis.
  • Use an in-line filter (1.2 micron) for lipid-containing admixtures to prevent particulate matter from entering the bloodstream.
  • Monitor serum triglycerides closely, especially in neonates, critically ill patients, and those with impaired lipid metabolism, to prevent fat overload syndrome.
  • Intralipid can be mixed with amino acids and dextrose in a total parenteral nutrition (TPN) admixture, but proper mixing procedures and stability checks are essential.
  • Risk of essential fatty acid deficiency (EFAD) if lipid emulsion is withheld for prolonged periods in patients on parenteral nutrition.
  • Discontinue or reduce infusion rate if signs of fat overload syndrome or significant hypertriglyceridemia occur.
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Alternative Therapies

  • Enteral nutrition (if gastrointestinal tract is functional)
  • Oral nutritional supplements (if patient can tolerate oral intake)
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Cost & Coverage

Average Cost: $100 - $300 per 1000mL bag (estimated)
Generic Available: Yes
Insurance Coverage: Usually covered by medical insurance when medically necessary for parenteral nutrition.
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.