Intralipid 20% Emul For Inj 250ml

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
Parenteral nutritional therapy
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Pharmacologic Class
Lipid emulsion; Source of calories and essential fatty acids
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Pregnancy Category
C
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FDA Approved
May 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 (IV) to provide your body with energy and essential fats it needs, especially when you can't eat normally or need extra nutrition. It helps your body get the calories and building blocks it requires to function properly.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. This drug is administered as an intravenous infusion over a specified period. If you are using this medication at home, your doctor or nurse will provide personalized instruction on its use.

Before administering, 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.

For storage and disposal instructions, consult with your doctor, nurse, or pharmacist to determine the best approach for your specific situation.

If you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Follow all instructions from your healthcare provider regarding your diet and other medications.
  • Report any discomfort or unusual symptoms immediately to your nurse or doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 1 to 2.5 g fat/kg/day, infused over 12-24 hours
Dose Range: 1 - 2.5 mg

Condition-Specific Dosing:

general_nutrition: Initial 1 g fat/kg/day, gradually increase to 2.5 g fat/kg/day based on metabolic tolerance. Max infusion rate: 0.125 g fat/kg/hour (0.625 mL/kg/hour for 20% emulsion).
essential_fatty_acid_deficiency: Minimum 0.5 to 1 g fat/kg/day
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Pediatric Dosing

Neonatal: Initial 0.5-1 g fat/kg/day, gradually increase to 3-4 g fat/kg/day. Max 4 g fat/kg/day. Infusion rate: 0.1-0.15 g fat/kg/hour (0.5-0.75 mL/kg/hour for 20% emulsion).
Infant: Initial 1 g fat/kg/day, gradually increase to 2-3 g fat/kg/day. Max 3 g fat/kg/day. Infusion rate: 0.1-0.15 g fat/kg/hour (0.5-0.75 mL/kg/hour for 20% emulsion).
Child: Initial 1 g fat/kg/day, gradually increase to 2-3 g fat/kg/day. Max 3 g fat/kg/day. Infusion rate: 0.1-0.15 g fat/kg/hour (0.5-0.75 mL/kg/hour for 20% emulsion).
Adolescent: Initial 1 g fat/kg/day, gradually increase to 2-3 g fat/kg/day. Max 3 g fat/kg/day. Infusion rate: 0.1-0.15 g fat/kg/hour (0.5-0.75 mL/kg/hour for 20% emulsion).
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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 and triglyceride levels closely.
Dialysis: No specific dose adjustment; monitor fluid and electrolyte balance and triglyceride levels closely.

Hepatic Impairment:

Mild: Use with caution; monitor liver function tests and triglyceride levels.
Moderate: Use with caution; monitor liver function tests and triglyceride levels. Consider dose reduction if hypertriglyceridemia or worsening liver function occurs.
Severe: Use with caution; monitor liver function tests and triglyceride levels. Consider dose reduction or temporary discontinuation if severe hypertriglyceridemia or worsening liver function 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, cell membrane integrity, and prevention/treatment of essential fatty acid deficiency (EFAD). It serves as a readily available energy source and a building block for various biological molecules.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Not precisely quantifiable for lipid emulsions; distributed throughout the body, primarily to adipose tissue, muscle, and liver.
ProteinBinding: Not applicable (emulsion particles)
CnssPenetration: Limited (large emulsion particles do not readily cross intact blood-brain barrier)

Elimination:

HalfLife: Variable, dependent on clearance rate (typically minutes to hours for triglyceride component)
Clearance: Rate-limited by lipoprotein lipase activity and tissue uptake; dose-dependent.
ExcretionRoute: Metabolites primarily eliminated via respiration (CO2) and urine.
Unchanged: Negligible (fully metabolized)
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Pharmacodynamics

OnsetOfAction: Immediate (upon infusion)
PeakEffect: Sustained during continuous infusion
DurationOfAction: Dependent on infusion duration and metabolic clearance

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Attention Immediately

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 or seek medical help right away:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of pancreatitis (pancreas problem), such as:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of gallbladder problems, such as:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Change in stools
+ Dark urine or yellow skin or eyes
+ Fever with chills
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased sputum or change in color of sputum
+ Pain with passing urine
+ Mouth sores
+ Wound that will not heal
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Shortness of breath
Chest pain or pressure, or a fast heartbeat
Dizziness or passing out
Blue or gray skin color
Headache
Excessive sweating
Feeling very tired or weak
Unexplained bruising or bleeding
Pain and irritation at the injection site

Other Possible Side Effects

Like all medications, this drug may cause side effects. However, many people experience no side effects or only mild ones. 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 all possible 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
  • Headache
  • Nausea or vomiting
  • Difficulty breathing or shortness of breath
  • Rash or hives
  • Unusual swelling
  • Pain, redness, or swelling at the IV 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 you experienced, including any symptoms that occurred.
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, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and medications.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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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. To ensure accurate results, inform your doctor and laboratory personnel that you are taking this drug.

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

This medication may contain aluminum, which can lead to aluminum toxicity with long-term use. The risk is increased if you have kidney problems or 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 excessive fatigue and weakness. 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, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to weigh the benefits and risks of this medication for both you and your baby. Your doctor will help you make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Fat overload syndrome (hyperlipidemia, fever, liver dysfunction, splenomegaly, coagulopathy, anemia, leukopenia, thrombocytopenia)
  • Abdominal pain
  • Nausea
  • Vomiting
  • Headache
  • Drowsiness
  • Dyspnea
  • Cyanosis

What to Do:

If overdose is suspected, stop the infusion immediately. Symptomatic and supportive measures should be initiated. Call 1-800-222-1222 (Poison Control) for further guidance.

Drug Interactions

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Moderate Interactions

  • Heparin

Monitoring

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Baseline Monitoring

Serum Triglycerides

Rationale: To establish baseline lipid status and assess tolerance to lipid infusion.

Timing: Prior to initiation of therapy

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

Rationale: To assess baseline hepatic function and monitor for potential cholestasis or liver dysfunction.

Timing: Prior to initiation of therapy

Electrolytes (Na, K, Cl, HCO3, Ca, Mg, P)

Rationale: To assess baseline electrolyte balance.

Timing: Prior to initiation of therapy

Glucose

Rationale: To assess baseline glucose metabolism.

Timing: Prior to initiation of therapy

Complete Blood Count (CBC) with differential

Rationale: To assess baseline hematologic status.

Timing: Prior to initiation of therapy

Renal Function (BUN, Creatinine)

Rationale: To assess baseline renal function.

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) during infusion; < 200 mg/dL (neonates/children) during infusion

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

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

Frequency: Weekly

Target: Within normal limits or stable

Action Threshold: Significant elevation may require dose adjustment or investigation for fat overload syndrome or TPN-associated liver disease.

Electrolytes, Glucose, Renal Function

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

Target: Within normal physiological range

Action Threshold: Correct imbalances as needed; adjust TPN components.

Fluid Balance (Intake/Output, Weight)

Frequency: Daily

Target: Stable weight, appropriate fluid balance

Action Threshold: Adjust fluid intake to prevent overload or dehydration.

Complete Blood Count (CBC)

Frequency: Weekly

Target: Within normal limits

Action Threshold: Monitor for anemia, leukocytosis, or thrombocytopenia.

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Symptom Monitoring

  • Fever
  • Chills
  • Headache
  • Nausea
  • Vomiting
  • Dyspnea
  • Cyanosis
  • Hepatomegaly
  • Splenomegaly
  • Coagulopathy
  • Fat overload syndrome (hyperlipidemia, fever, liver dysfunction, splenomegaly, coagulopathy, anemia, leukopenia, thrombocytopenia)
  • Allergic reactions (rash, urticaria, dyspnea, hypotension)
  • Signs of infection at catheter site (redness, swelling, pain, pus)

Special Patient Groups

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Pregnancy

Intralipid 20% is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is often considered essential for nutritional support in pregnant women who cannot receive adequate nutrition orally or enterally.

Trimester-Specific Risks:

First Trimester: No specific adverse effects reported, but use only if clearly needed.
Second Trimester: No specific adverse effects reported, but use only if clearly needed.
Third Trimester: No specific adverse effects reported, but use only if clearly needed.
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Lactation

Intralipid 20% is considered compatible with breastfeeding (Lactation Risk L1). Lipids are a normal component of breast milk, and the components of Intralipid are metabolized and utilized by the body in a similar manner to dietary fats.

Infant Risk: Low risk to infant. No adverse effects expected.
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Pediatric Use

Widely used in pediatric patients, including neonates, infants, children, and adolescents, for parenteral nutrition. Dosing is weight-based and requires careful monitoring of triglyceride levels, especially in neonates and premature infants due to their immature lipid clearance mechanisms. Risk of fat overload syndrome is higher in this population.

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Geriatric Use

No specific dose adjustments are generally required for geriatric patients. However, elderly patients may have reduced metabolic capacity or comorbidities (e.g., renal or hepatic impairment, cardiovascular disease) that necessitate careful monitoring of fluid balance, electrolyte levels, and triglyceride clearance.

Clinical Information

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Clinical Pearls

  • Always inspect the emulsion for signs of separation (e.g., oil droplets, creaming) before administration. Do not use if separation is observed.
  • Administer via central or peripheral vein. For peripheral administration, ensure adequate dilution and monitor for phlebitis.
  • Intralipid is often administered as part of a total parenteral nutrition (TPN) admixture. Ensure proper mixing procedures and compatibility with other components (e.g., amino acids, dextrose, electrolytes, vitamins, trace elements) to prevent precipitation or emulsion instability.
  • Risk of fat overload syndrome, especially with rapid infusion rates or in patients with impaired lipid clearance (e.g., severe sepsis, renal failure, hepatic failure).
  • Monitor for essential fatty acid deficiency (EFAD) in patients on long-term parenteral nutrition without adequate lipid intake. Symptoms include dry scaly skin, hair loss, and impaired wound healing.
  • Blood samples for laboratory tests (e.g., bilirubin, hemoglobin, platelet count) should be drawn at least 6 hours after the cessation of lipid infusion to avoid interference from lipemia.
  • Use a 1.2 micron filter for administration of lipid emulsions or TPN admixtures containing lipids to remove particulate matter and prevent air embolism, but ensure the filter is compatible with lipid emulsions.
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Alternative Therapies

  • Other forms of parenteral nutrition (e.g., dextrose and amino acid solutions)
  • Enteral nutrition (tube feeding)
  • Oral nutrition
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Cost & Coverage

Average Cost: Price range per 250ml bottle
Generic Available: Yes
Insurance Coverage: Typically covered by medical insurance for medically necessary parenteral nutrition.
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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 guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to 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 or pharmacist, do not flush medications down the toilet or drain. If you are unsure about the correct disposal method, consult your pharmacist, as local drug take-back programs may be available. Some medications may come with an additional patient information leaflet, which can be obtained from your pharmacist. 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 amount, and the time it occurred.