Intralipid 20% Emul For 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, Fatty Acid Source
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Pregnancy Category
Category B
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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 provide your body with calories and essential fats it needs for energy and growth, especially when you can't eat normally. 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 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.

For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach for storing this medication at home.

If you miss a dose, contact your doctor to receive instructions on what to do next.
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Lifestyle & Tips

  • Report any signs of fever, chills, headache, nausea, or difficulty breathing immediately.
  • Inform healthcare providers about any new medications or supplements you are taking.
  • Maintain good hygiene around the IV site to prevent infection.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 1 g fat/kg/day, gradually increase to 2.5 g fat/kg/day. Max infusion rate: 0.15 g fat/kg/hour.
Dose Range: 1 - 2.5 mg

Condition-Specific Dosing:

maintenance: Up to 2.5 g fat/kg/day, adjusted based on metabolic needs and tolerance. Infusion rate should not exceed 0.15 g fat/kg/hour.
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Pediatric Dosing

Neonatal: Initial: 0.5 g fat/kg/day, gradually increase by 0.5-1 g fat/kg/day to a maximum of 3 g fat/kg/day. Max infusion rate: 0.15 g fat/kg/hour.
Infant: Initial: 0.5 g fat/kg/day, gradually increase by 0.5-1 g fat/kg/day to a maximum of 3 g fat/kg/day. Max infusion rate: 0.15 g fat/kg/hour.
Child: Initial: 1 g fat/kg/day, gradually increase to 2.5-3 g fat/kg/day. Max infusion rate: 0.15 g fat/kg/hour.
Adolescent: Initial: 1 g fat/kg/day, gradually increase to 2.5 g fat/kg/day. Max infusion rate: 0.15 g fat/kg/hour.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor triglycerides.
Moderate: No specific adjustment, monitor triglycerides closely.
Severe: Use with caution, monitor triglycerides and fluid balance closely. May require reduced dosage or slower infusion rate if hypertriglyceridemia occurs.
Dialysis: Use with caution, monitor triglycerides and fluid balance closely. May require reduced dosage or slower infusion rate if hypertriglyceridemia occurs.

Hepatic Impairment:

Mild: No specific adjustment, monitor liver function tests and triglycerides.
Moderate: Use with caution, monitor liver function tests and triglycerides closely. May require reduced dosage or slower infusion rate if hypertriglyceridemia or liver dysfunction worsens.
Severe: Use with caution, monitor liver function tests and triglycerides closely. May require reduced dosage or slower infusion rate if hypertriglyceridemia or liver dysfunction worsens.

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) for patients requiring parenteral nutrition. It is metabolized and utilized as a source of energy and for the synthesis of cell membranes and other biological molecules. The emulsion particles are similar in size to chylomicrons and are cleared from the bloodstream by lipoprotein lipase.
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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 a nutritional product; distributed throughout the body as a source of energy and structural components.
ProteinBinding: Not applicable (lipids are incorporated into lipoproteins)
CnssPenetration: Limited (primarily utilized peripherally, but fatty acids can cross blood-brain barrier)

Elimination:

HalfLife: Approximately 6-9 minutes (for triglyceride clearance from plasma, similar to chylomicrons)
Clearance: Dependent on lipoprotein lipase activity and metabolic demand.
ExcretionRoute: Metabolized to carbon dioxide and water, or incorporated into tissues; no direct renal or biliary excretion of intact emulsion.
Unchanged: Not applicable (metabolized)
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Pharmacodynamics

OnsetOfAction: Immediate (upon infusion)
PeakEffect: Continuous (during infusion, as lipids are constantly supplied and utilized)
DurationOfAction: Dependent on infusion rate and metabolic needs; effects cease shortly after infusion discontinuation.
Confidence: Medium

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 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, 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 a 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 concerned about 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, don't hesitate to reach out to 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
  • Abdominal pain
  • Difficulty breathing or shortness of breath
  • Rash or hives
  • Unusual bleeding or bruising
  • Yellowing of 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, 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, such as high triglycerides, pancreatitis caused by high triglycerides, or specific kidney problems (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 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 high 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.

A potential side effect of this medication is essential fatty acid deficiency (EFAD), which can cause symptoms such 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 immediately.

When administering this medication to premature or newborn infants, it is crucial to monitor them closely, as rapid infusion can lead to severe and potentially life-threatening side effects. Discuss any concerns with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need 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, abdominal pain, dyspnea, hepatomegaly, splenomegaly, coagulopathy, jaundice)
  • Hyperlipidemia (very high triglyceride levels)
  • Metabolic acidosis

What to Do:

Stop the infusion immediately. Provide supportive care. Monitor serum triglycerides, blood gases, and coagulation parameters. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

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Moderate Interactions

  • Warfarin (potential for increased INR, monitor coagulation parameters)
  • Cyclosporine (may increase cyclosporine levels, monitor cyclosporine concentrations)

Monitoring

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Baseline Monitoring

Serum Triglycerides

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

Timing: Before initiation of therapy.

Liver Function Tests (LFTs)

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

Timing: Before initiation of therapy.

Electrolytes, Glucose, Renal Function

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

Timing: Before initiation of therapy.

Complete Blood Count (CBC)

Rationale: To assess baseline hematologic status.

Timing: Before initiation of therapy.

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Routine Monitoring

Serum Triglycerides

Frequency: Daily initially, then 2-3 times per week or as clinically indicated.

Target: < 400 mg/dL (fasting, before next infusion)

Action Threshold: > 400 mg/dL (consider reducing dose or holding infusion), > 1000 mg/dL (hold infusion, investigate cause)

Liver Function Tests (LFTs)

Frequency: Weekly or bi-weekly.

Target: Within normal limits or stable baseline.

Action Threshold: Significant elevation (investigate cause, consider dose adjustment or alternative lipid source).

Glucose

Frequency: Daily initially, then as clinically indicated.

Target: 70-180 mg/dL

Action Threshold: Persistent hyperglycemia or hypoglycemia (adjust glucose infusion rate, insulin).

Electrolytes, Renal Function

Frequency: Daily initially, then 2-3 times per week or as clinically indicated.

Target: Within normal limits.

Action Threshold: Abnormalities (adjust electrolyte supplementation, fluid management).

Fluid Balance and Weight

Frequency: Daily.

Target: Stable weight, appropriate fluid balance.

Action Threshold: Significant weight gain/loss, edema (adjust fluid intake).

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Symptom Monitoring

  • Signs of fat overload syndrome (fever, chills, headache, nausea, vomiting, abdominal pain, dyspnea, hepatomegaly, splenomegaly, coagulopathy, jaundice)
  • Signs of allergic reaction (rash, urticaria, dyspnea, hypotension)
  • Signs of infection at catheter site
  • Signs of essential fatty acid deficiency (dry scaly skin, sparse hair, poor wound healing, thrombocytopenia)

Special Patient Groups

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Pregnancy

Intralipid is considered safe and often necessary for nutritional support in pregnant women who cannot tolerate enteral feeding. It is classified as Pregnancy Category B.

Trimester-Specific Risks:

First Trimester: No known increased risk of congenital anomalies.
Second Trimester: No known adverse effects.
Third Trimester: No known adverse effects.
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Lactation

Lipid emulsions are compatible with breastfeeding (Lactation Risk L1). Components of lipid emulsions are normal constituents of human milk. It is generally considered safe for use in lactating women.

Infant Risk: Low risk to infant; components are naturally present in breast milk.
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Pediatric Use

Used extensively in pediatric patients, including neonates and infants, for parenteral nutrition. Dosing is weight-based and carefully titrated, with close monitoring of triglycerides due to potentially immature lipid clearance mechanisms in very young or critically ill infants.

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Geriatric Use

Generally well-tolerated in geriatric patients. Dosing should be individualized based on metabolic needs and tolerance. Close monitoring of triglycerides, liver function, and fluid balance is important, as elderly patients may have comorbidities affecting lipid metabolism or fluid status.

Clinical Information

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Clinical Pearls

  • Always check serum triglyceride levels before initiating and during therapy, especially in critically ill patients or those with impaired lipid clearance.
  • Intralipid 20% can be administered peripherally or centrally. For peripheral administration, ensure adequate venous access and monitor for phlebitis.
  • Do not use if the emulsion appears to be separating (oily layer on top) or if there are visible particles.
  • Lipid emulsions should be infused slowly, especially during the initial administration, to assess tolerance.
  • Intralipid can be used as a component of total parenteral nutrition (TPN) admixtures (3-in-1 or total nutrient admixtures), but compatibility with other components must be verified.
  • In cases of suspected fat overload syndrome, discontinue the infusion immediately and provide supportive care.
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Alternative Therapies

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

Average Cost: Not available (varies widely by supplier and contract) per 500ml bag
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 proper 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 call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time of the incident.