Deaths in preterm infants after infusion of intravenous fat emulsion have been reported in the medical literature. Autopsy findings included intravascular fat accumulation in the lungs. Treatment of premature and low birth weight infants with intravenous fat emulsion must be based upon careful benefit-risk assessment. Strict adherence to the recommended total daily dose is mandatory; hourly infusion rate should be as slow as possible in each case and fat should not in any case exceed 1 g fat/kg in four hours. Premature and small for gestational age infants have poor clearance of intravenous fat emulsion and increased free fatty acid plasma levels following fat emulsion infusion; therefore, serious consideration must be given to administration of less than the maximum recommended doses in these patients in order to decrease the likelihood of intravenous fat overload. The infant's ability to eliminate the infused fat from the circulation must be carefully monitored (such as serum triglycerides and/or plasma free fatty acid levels). The lipemia must clear between daily infusions .
Deaths due to intravascular fat accumulation in the lungs in preterm infants after infusion of intravenous fat emulsion have been reported in the medical literature. Use caution when treating premature and low birth weight infants with intravenous fat emulsion and strictly adhere to the recommended total daily dose and hourly infusion rates. Hourly infusion rate should be as slow as possible in each case and fat should not in any case exceed 1 g fat/kg in four hours. Carefully monitor serum triglycerides and/or plasma free fatty acid levels in these patients .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Parenteral Lipids
Fat emulsions are used as dietary supplements for patients who are unable to get enough fat in their diet, usually because of certain illnesses or recent surgery. Fats are used by the body for energy and to form substances needed for normal body functions.
Fat emulsions are available by injection only with your doctor's prescription.
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 fat emulsion, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to fat emulsion 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.
Fat emulsions may cause or worsen lung problems or jaundice if given to premature infants. Although there is no specific information comparing use of fat emulsions in older children with use in other age groups, it is not expected to cause different side effects or problems in older children than it does in adults.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although there is no specific information comparing use of fat emulsions in the elderly with use in other age groups, fat emulsion is not expected to cause different side effects or problems in older people than it does in younger adults.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
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.
The presence of other medical problems may affect the use of fat emulsion. Make sure you tell your doctor if you have any other medical problems, especially:
The dose of fat emulsion will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of fat emulsion. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
It is very important that your doctor check your progress weekly while you are receiving fat emulsions to make sure that fat emulsion does not cause unwanted effects.
Fat emulsions can lower your ability to fight infection. If you think you are getting an infection, check with your doctor.
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 as soon as possible if any of the following side effects occur:More common
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:More common
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.
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