Nutrilipid 20% Emul For Inj, 500ml

Nutrilipid 20% provides a concentrated source of calories and essential fatty acids (linoleic acid and alpha-linolenic acid) for patients requiring parenteral nutrition. The fatty acids are incorporated into cell membranes, used for energy production via beta-oxidation, and serve as precursors for prostaglandins and other biologically active molecules. The emulsion also provides glycerol, which is metabolized to glucose or glycogen.

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 experience 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 when urinating
+ Mouth sores
+ Wounds that will not heal
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
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 no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that concern you, contact your doctor:

Upset stomach or vomiting

This is not an exhaustive list of 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.

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 certain kidney problems like lipoid nephrosis or minimal change disease.

This list is not exhaustive, and it is crucial to discuss all your medications, health issues, and concerns with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or allergies

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.

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, notify 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. Signs of EFAD include a 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 experience 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 breastfeeding, inform your doctor. It is necessary to weigh the benefits and risks of this medication for both you and your baby.

• Warfarin (due to Vitamin K content in soybean oil, may alter INR)
• Heparin (may transiently increase lipoprotein lipase activity, leading to increased fatty acid release and potential for hypertriglyceridemia if infusion rate is too high)

• Fever
• Chills
• Nausea
• Vomiting
• Headache
• Flushing
• Dyspnea
• Cyanosis
• Chest pain
• Back pain
• Fatigue
• Jaundice (long-term)
• Signs of allergic reaction (rash, itching, swelling)

Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Lipid emulsions are often a necessary component of parenteral nutrition for pregnant women who cannot maintain adequate oral intake.

L3 - Moderate risk. Components of lipid emulsions (fatty acids) are natural components of breast milk. While the amount transferred is likely small and unlikely to cause harm, caution is advised. The benefits of continued breastfeeding should be weighed against the potential risks. If parenteral nutrition is medically necessary for the mother, it is generally considered compatible with breastfeeding.

Nutrilipid 20% is indicated for pediatric patients requiring parenteral nutrition. Dosing must be carefully calculated based on weight, age, and metabolic capacity, with close monitoring of triglyceride levels to prevent fat overload syndrome. Neonates and premature infants have reduced capacity to clear exogenous lipids and require slower infusion rates and lower maximum doses.

No specific dose adjustments are typically required for elderly patients, but they may have a higher incidence of underlying diseases or polypharmacy. Monitor closely for fluid balance, electrolyte disturbances, and signs of fat overload syndrome, as metabolic clearance may be slightly reduced.

• Always inspect the emulsion for signs of phase separation, oil globulation, or particulate matter before administration. Do not use if abnormalities are observed.
• Administer via a central or peripheral vein using an in-line filter (1.2 micron or larger) to prevent particulate matter from entering the bloodstream.
• Do not add other medications directly to the lipid emulsion bag unless compatibility is confirmed, as this can destabilize the emulsion.
• Monitor serum triglyceride levels closely, especially during the initial days of therapy and with dose adjustments, to ensure adequate lipid clearance.
• Fat overload syndrome is a rare but serious complication; discontinue infusion immediately if symptoms occur.
• Long-term parenteral nutrition, including lipid emulsions, can be associated with PN-associated liver disease (PNALD) or intestinal failure-associated liver disease (IFALD). Monitor LFTs regularly.
• Nutrilipid 20% is a soy-based lipid emulsion. Patients with severe egg or soy allergies should be monitored closely or consider alternative lipid sources if available.

• Intralipid (soybean oil-based lipid emulsion)
• Liposyn III (soybean oil-based lipid emulsion)
• Clinolipid (soybean oil and olive oil-based lipid emulsion)
• SMOFlipid (soybean oil, medium-chain triglycerides, olive oil, and fish oil-based lipid emulsion)
• Omegaven (fish oil-based lipid emulsion, primarily for PNALD)

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 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.

Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs that provide a safe and environmentally friendly way to dispose of unused medications.

Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to 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 critical information, including the name of the medication, the amount taken, and the time it was taken, to ensure prompt and effective treatment.