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Intralipid 10

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Intralipid 10%

WARNINGS

DEATHS IN PRETERM INFANTS AFTER INFUSION OF INTRAVENOUS FAT EMULSION HAVE BEEN REPORTED IN THE MEDICAL LITERATURE.2 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.

CAUTION SHOULD BE EXERCISED IN ADMINISTERING INTRALIPID® 10% (10% i.v fat emulsion) (A 10% INTRAVENOUS FAT EMULSION) TO PATIENTS WITH SEVERE LIVER DAMAGE, PULMONARY DISEASE, ANEMIA OR BLOOD COAGULATION DISORDERS, OR WHEN THERE IS DANGER OF FAT EMBOLISM.

WARNING: THIS PRODUCT CONTAINS ALUMINUM THAT MAY BE TOXIC. ALUMINUM MAY REACH TOXIC LEVELS WITH PROLONGED PARENTERAL ADMINISTRATION IF KIDNEY FUNCTION IS IMPAIRED. PREMATURE NEONATES ARE PARTICULARLY AT RISK BECAUSE THEIR KIDNEYS ARE IMMATURE, AND THEY REQUIRE LARGE AMOUNTS OF CALCIUM AND PHOSPHATE SOLUTIONS, WHICH CONTAIN ALUMINUM.

RESEARCH INDICATES THAT PATIENTS WITH IMPAIRED KIDNEY FUNCTION, INCLUDING PREMATURE NEONATES, WHO RECEIVE PARENTERAL LEVELS OF ALUMINUM AT GREATER THAN 4 TO 5 MCG/KG/DAY ACCUMULATE ALUMINUM AT LEVELS ASSOCIATED WITH CENTRAL NERVOUS SYSTEM AND BONE TOXICITY. TISSUE LOADING MAY OCCUR AT EVEN LOWER RATES OF ADMINISTRATION.

PRECAUTIONS

WHEN INTRALIPID® 10% (10% i.v fat emulsion) IS ADMINISTERED, THE PATIENTS CAPACITY TO ELIMINATE THE INFUSED FAT FROM THE CIRCULATION MUST BE MONITORED BY USE OF AN APPROPRIATE LABORATORY DETERMINATION OF SERUM TRIGLYCERIDES. OVERDOSAGE MUST BE AVOIDED.

DURING LONG TERM INTRAVENOUS NUTRITION WITH INTRALIPID® 10% (10% i.v fat emulsion) , LIVER FUNCTION TESTS SHOULD BE PERFORMED. IF THESE TESTS INDICATE THAT LIVER FUNCTION IS IMPAIRED, THE THERAPY SHOULD BE WITHDRAWN.

FREQUENT (SOME ADVISE DAILY) PLATELET COUNTS SHOULD BE DONE IN NEONATAL PATIENTS RECEIVING PARENTERAL NUTRITION WITH INTRALIPID® 10% (10% i.v fat emulsion) .

DRUG PRODUCT CONTAINS NO MORE THAN 25 MCG/L OF ALUMINUM.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Intralipid® have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy Category C: Animal reproduction studies have not been conducted with Intralipid®. It is also not known whether Intralipid® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Intralipid® should be given to a pregnant woman only if clearly needed.

Nursing Mothers: Caution should be exercised when Intralipid® is administered to a nursing woman.

Pediatric Use: See DOSAGE AND ADMINISTRATION.

AVOID OVERDOSAGE ABSOLUTELY.

2. LEVENE MI, WIGGLESWORTH JS, DESAI R: PULMONARY FAT ACCUMULATION AFTER INTRALIPID® INFUSION IN THE PRETERM INFANT. LANCET 1980; 2(8199):815-8.

Last reviewed on RxList: 7/30/2007
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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