Pronunciation:

fat e-MULL-shun, Soybean Oil

Dosage Forms:

• Emulsion

Classifications:

Therapeutic—

Parenteral Lipids

Uses of This Medicine:

Fat emulsion and soybean oil combination injection is used to provide nutritional support in patients who are unable to get enough fat in their diet. Fats are used by the body for energy and to form substances needed for normal body function.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Intralipid® 10% injection and Intralipid® 20% injection in children. However, children are more likely to have liver problems, which may require caution in patients receiving this medicine.

Appropriate studies have not been performed on the relationship of age to the effects of Clinolipid injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fat emulsion injection and soybean oil combination injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to egg, soybean, or peanut proteins or
• Hyperlipidemia (high cholesterol in the blood)—Should not be used in patients with these conditions.

• Infection—May decrease your body's ability to fight infections.

• Kidney disease—Giving this medicine for a long time in preterm babies may increase risk for aluminum toxicity.

• Undernourished patients, severely—May cause refeeding syndrome. Monitor and increase nutrient intake slowly for the patients.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given through a needle placed into one of your veins.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.

This medicine may cause parenteral nutrition-associated liver disease (PNALD). This usually occurs in patients who have been receiving parenteral nutrition for a long time, especially pre-term infants. Check with your doctor right away if you have chills, clay-colored stools, dark urine, diarrhea, dizziness, fever, headache, itching, loss of appetite, nausea, rash, unpleasant breath odor, unusual tiredness or weakness, vomiting of blood, or yellow eyes or skin.

This medicine may cause acute respiratory distress syndrome and metabolic acidosis in newborns and infants after rapid infusion. Check with your doctor right away if your child has blue lips, fingernails, or skin, difficult, confusion, drowsiness, fast breathing, muscle tremors, nausea, restlessness, stomach cramps, or unusual tiredness or weakness.

This medicine may cause a rare condition called fat overload syndrome. Tell your doctor right away if you or your child have a fever, chills, cough, sore throat, upper right abdominal or stomach pain and fullness, or unusual bleeding, bruising, or weakness.

This medicine may cause a serious allergic reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you or your child are receiving this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start receiving this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Call your doctor right away if you or your child start to have a cough that will not go away, weight loss, night sweats, fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs that you have an infection.

This medicine may cause aluminum toxicity (too much aluminum in the blood), which may damage the brain and can be life-threatening. Talk to your doctor if you have concerns.

Before you have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Blurred vision

changes in skin color

dry mouth

flushed, dry skin

fruit-like breath odor

increased hunger

increased thirst

increased urination

nausea

pain, tenderness, or swelling of the foot or leg

stomach pain

sweating

trouble breathing

unexplained weight loss

unusual tiredness or weakness

vomiting

Less common

Back pain

pain or discomfort in the legs, groin, or chest

swelling and redness in the lower leg

Rare

Black, tarry stools

bleeding gums

blood in the urine or stools

chills

clay-colored stools

dizziness

fever

headache

itching, rash

loss of appetite

painful or difficult urination

pinpoint red spots on the skin

sores throat

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

right upper abdominal or stomach pain and fullness

unpleasant breath odor

unusual bleeding or bruising

vomiting of blood

yellow eyes or skin

Incidence not known

Blue lips, fingernails, or skin

chest tightness

confusion

cough or hoarseness

difficulty in breathing or swallowing

drowsiness

fast heartbeat

lower back or side pain

muscle tremors

restlessness

stomach cramps

swelling of the face, throat, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Dry, red, hot, or irritated skin

feeling of warmth

redness of the face, neck, arms and occasionally, upper chest

sleepiness

Rare

Redness, swelling, or pain at the injection site

Incidence not known

Diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.