Intralipid 20% Emul For Inj, 100ml

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 Component
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Pharmacologic Class
Lipid Emulsion; Source of Calories and Essential Fatty Acids
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Pregnancy Category
Category C
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FDA Approved
Aug 1977
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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). It provides your body with calories and essential fats that you need for energy and growth, especially when you can't eat enough or absorb nutrients properly through your digestive system. It's a key part of complete nutrition given through an IV.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and read all the information provided. 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 guidance on proper administration.

Before using, inspect the medication to ensure it is white and free of 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, consult with your doctor, nurse, or pharmacist for specific guidance on how to properly store this medication at home.

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

  • This medication is given intravenously, so no specific lifestyle modifications are typically required related to its administration, other than adherence to the overall parenteral nutrition regimen.
  • Maintain good hygiene around the IV access site to prevent infection.

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: 0.05 - 2.5 mg

Condition-Specific Dosing:

initial_dose: 0.5 to 1 g fat/kg/day
maximum_rate: 0.11 g fat/kg/hour (approximately 0.55 mL/kg/hour for 20% emulsion)
maximum_daily_dose: 2.5 g fat/kg/day
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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. Max 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. Max infusion rate: 0.15 g fat/kg/hour.
Child: Initial: 0.5 to 1 g fat/kg/day. Gradually increase to 2.5 to 3 g fat/kg/day. Max infusion rate: 0.15 g fat/kg/hour.
Adolescent: Similar to adult dosing: 1 to 2.5 g fat/kg/day. Max infusion rate: 0.11 g fat/kg/hour.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor fluid and electrolyte balance.
Moderate: No specific adjustment, monitor fluid and electrolyte balance, and triglyceride levels closely.
Severe: No specific adjustment, monitor fluid and electrolyte balance, and triglyceride levels closely. Consider reduced dose if hypertriglyceridemia occurs.
Dialysis: No specific adjustment, monitor fluid and electrolyte balance, and triglyceride levels closely. Lipids are not dialyzable.

Hepatic Impairment:

Mild: Use with caution, monitor liver function tests and triglyceride levels.
Moderate: Use with caution, monitor liver function tests and triglyceride levels closely. Consider reduced dose if hypertriglyceridemia or worsening liver function occurs.
Severe: Use with extreme caution. May be contraindicated in severe liver disease with impaired lipid clearance. Monitor liver function tests and triglyceride levels closely. Consider reduced dose or temporary discontinuation if 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 for patients requiring parenteral nutrition. It is composed of soybean oil, egg yolk phospholipids, glycerin, and water. The triglycerides in the emulsion are hydrolyzed by lipoprotein lipase (LPL) to free fatty acids and glycerol, which are then utilized by various tissues for energy or re-esterified for storage. It prevents and treats essential fatty acid deficiency (EFAD).
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Approximately 4-5 L (similar to plasma volume, as it remains largely in the intravascular compartment initially before metabolism)
ProteinBinding: Not applicable (lipids are transported by lipoproteins)
CnssPenetration: Limited (does not readily cross the blood-brain barrier as intact emulsion particles, but fatty acids can)

Elimination:

HalfLife: Approximately 6-9 minutes for the triglyceride component (initial rapid phase), but overall clearance depends on the rate of infusion and metabolic capacity.
Clearance: Variable, dependent on lipoprotein lipase activity and tissue uptake. Clearance rate is typically 0.11-0.15 g fat/kg/hour.
ExcretionRoute: Metabolized, not excreted unchanged in urine or feces.
Unchanged: 0%
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Pharmacodynamics

OnsetOfAction: Immediate (upon infusion)
PeakEffect: Dependent on infusion rate and metabolic clearance; steady-state plasma triglyceride levels are achieved during continuous infusion.
DurationOfAction: Plasma triglycerides return to baseline within hours after cessation of infusion, depending on the patient's metabolic rate.

Safety & Warnings

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Side Effects

Serious 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 or seek medical attention immediately:

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 or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wound that will not heal
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Shortness of breath
Chest pain or pressure, or a fast heartbeat
Dizziness or fainting
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 can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:

Upset stomach or vomiting

This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact 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 (may indicate infection or fat overload)
  • Difficulty breathing or shortness of breath
  • Rash, hives, or itching (signs of allergic reaction)
  • Swelling of the face, lips, or tongue
  • Unusual tiredness or weakness
  • Yellowing of the skin or eyes (jaundice)
  • Unexplained bleeding or bruising
  • Severe stomach pain
  • 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 foods (e.g., eggs, soybeans, or peanuts). Be sure to describe the allergic reaction and its symptoms.
If you have conditions related to fat metabolism, including 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 dose 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.

This medication may interfere with certain laboratory tests, so it is crucial to notify your doctor and laboratory personnel that you are taking this drug. Additionally, high triglyceride levels have been associated with this medication. If you have a history of elevated triglyceride levels, please inform your doctor.

Long-term use of this medication may pose a 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.

A potential side effect of this medication is essential fatty acid deficiency (EFAD), which can manifest as a dry, scaly rash, hair loss, unhealed wounds, unexplained bruising or bleeding, or excessive fatigue and weakness. In children, EFAD may also lead to poor growth. If you or your child experience any of these symptoms, contact your doctor promptly.

When administering this medication to premature or newborn infants, it is vital to do so with caution, as rapid infusion can lead to severe and potentially life-threatening side effects. Your doctor will provide guidance on the safe administration of this medication.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is essential 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, headache, nausea, vomiting, abdominal pain, hepatosplenomegaly, jaundice, coagulopathy, anemia, leukopenia, thrombocytopenia)
  • Hyperlipidemia (excessively high triglyceride levels in blood)
  • Respiratory distress
  • Cyanosis

What to Do:

Immediately discontinue the infusion. Provide supportive care. Monitor serum triglyceride levels, liver function, and blood counts. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

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Contraindicated Interactions

  • Patients with severe disorders of lipid metabolism (e.g., pathologic hyperlipidemia, lipoid nephrosis, acute pancreatitis with hyperlipidemia)
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Major Interactions

  • Not applicable (few direct drug-drug interactions, but physical incompatibility with other IV solutions is critical)
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Moderate Interactions

  • Heparin (transiently increases lipoprotein lipase activity, which may result in a transient decrease in plasma triglyceride levels followed by a rebound)
  • Warfarin (monitor INR, as some lipid emulsions may contain vitamin K, though Intralipid's content is low and unlikely to cause significant interaction)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Serum Triglycerides

Rationale: To establish baseline and ensure patient can clear infused lipids.

Timing: Prior to initiation of therapy

Liver Function Tests (LFTs)

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

Timing: Prior to initiation of therapy

Serum Electrolytes, Glucose, Renal Function (BUN, Creatinine)

Rationale: To assess overall metabolic status and guide complete parenteral nutrition formulation.

Timing: Prior to initiation of therapy

Complete Blood Count (CBC) with differential

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

Timing: Prior to initiation of therapy

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Routine Monitoring

Serum Triglycerides

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

Target: < 400 mg/dL (adults), < 200-250 mg/dL (neonates/infants) during infusion

Action Threshold: > 400 mg/dL (adults) or > 250 mg/dL (neonates/infants) during infusion; consider reducing rate or holding infusion

Liver Function Tests (LFTs)

Frequency: Weekly or bi-weekly

Target: Within normal limits or stable

Action Threshold: Significant elevation (e.g., >3x baseline or upper limit of normal); investigate cause, consider adjusting PN

Serum Glucose

Frequency: Daily initially, then every 2-3 days or as clinically indicated

Target: 70-180 mg/dL

Action Threshold: Persistent hyperglycemia or hypoglycemia; adjust dextrose/insulin

Serum Electrolytes, Renal Function

Frequency: Daily initially, then every 2-3 days or as clinically indicated

Target: Within normal limits

Action Threshold: Significant abnormalities; adjust PN or provide supplementation

Fluid Balance (Intake/Output), Weight

Frequency: Daily

Target: Stable weight, appropriate fluid balance

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

Signs of Infection (e.g., fever, chills, catheter site)

Frequency: Daily

Target: Absence of signs

Action Threshold: Presence of signs; investigate and treat

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Symptom Monitoring

  • Fever
  • Chills
  • Dyspnea
  • Cyanosis
  • Nausea
  • Vomiting
  • Headache
  • Flushing
  • Sweating
  • Chest pain
  • Back pain
  • Pressure over eyes
  • Drowsiness
  • Fatigue
  • Fat overload syndrome (fever, hepatosplenomegaly, jaundice, coagulopathy, anemia, leukopenia, thrombocytopenia)
  • Signs of hypersensitivity reaction (rash, urticaria, dyspnea)

Special Patient Groups

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Pregnancy

Category C. Intralipid is considered essential for providing nutritional support to pregnant women who cannot receive adequate nutrition orally or enterally. The benefits of adequate maternal nutrition generally outweigh potential risks. Monitor triglyceride levels closely.

Trimester-Specific Risks:

First Trimester: No specific risks identified beyond general PN considerations. Essential for fetal development.
Second Trimester: No specific risks identified. Continued nutritional support is crucial.
Third Trimester: No specific risks identified. Continued nutritional support is crucial for fetal growth and maternal well-being.
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Lactation

L3. Lipids are natural components of breast milk. While Intralipid is generally considered compatible with breastfeeding, caution is advised. Monitor the infant for any adverse effects, though unlikely. The benefits of adequate maternal nutrition for milk production and maternal health generally outweigh potential risks.

Infant Risk: Low risk. Components are natural dietary fats. High doses might theoretically alter milk composition, but unlikely to cause harm.
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Pediatric Use

Widely used and essential for pediatric parenteral nutrition, including neonates and infants. Dosing is weight-based and carefully titrated. Close monitoring of triglyceride levels, liver function, and fluid balance is crucial due to their immature metabolic systems and higher risk of fat overload syndrome.

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Geriatric Use

No specific dose adjustments are typically required, but geriatric patients may have reduced metabolic capacity or underlying comorbidities (e.g., diabetes, renal/hepatic impairment) that necessitate closer monitoring of triglyceride levels, glucose, and fluid balance. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Always inspect the emulsion for signs of cracking, oil separation, or particulate matter before administration. Do not use if observed.
  • Intralipid should be administered through a central or peripheral vein. For peripheral administration, ensure adequate dilution and monitor for phlebitis.
  • When used as part of a total parenteral nutrition (TPN) admixture, ensure proper mixing order (dextrose, amino acids, then lipids) and compatibility with other components to prevent emulsion instability ('cracking').
  • Monitor serum triglyceride levels closely, especially during the first few days of therapy and with dose adjustments. If levels exceed recommended thresholds, reduce the infusion rate or temporarily discontinue.
  • Be vigilant for signs of fat overload syndrome, particularly in neonates, infants, and patients with impaired lipid clearance.
  • Hypersensitivity reactions, though rare, can occur. Have appropriate resuscitation equipment readily available.
  • Intralipid can interfere with certain laboratory tests (e.g., bilirubin, hemoglobin, blood gases) if blood samples are drawn too soon after infusion. Allow adequate time (e.g., 4-6 hours) after stopping infusion before drawing samples for these tests if possible.
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Alternative Therapies

  • Oral/Enteral Nutrition (if gastrointestinal function permits)
  • Other sources of calories and essential fatty acids in parenteral nutrition (e.g., dextrose, amino acids, but these do not provide essential fatty acids)
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Cost & Coverage

Average Cost: $50 - $150 per 100ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (often covered under medical benefit for 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 your safety and the safety of others, never share your medication with anyone, and do not take medication prescribed to someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Properly dispose of any unused or expired medication. Unless instructed to do so by a healthcare professional or pharmacist, do not dispose of medications by flushing them down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult with your pharmacist, who can provide guidance on the best approach. Additionally, you may want to inquire about potential drug take-back programs available in your area.

Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist to see if this is the case. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for assistance.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the medication, including the amount taken and the time it was ingested, to ensure you receive the most effective treatment.