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Liposyn III 30

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Liposyn III 30

WARNINGS

Deaths in preterm infants after infusion of intravenous fat emulsions have been reported in the medical literature.1,2Autopsy 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 should not in any case exceed 1 g/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 infused fat from the circulation must be carefully monitored (such as triglyceride and/or plasma free fatty acid levels). The lipemia must clear between daily infusions.

Precipitation occurring in parenteral nutrition admixtures as a result of incorrect admixture practices has been reported. Precipitate formation may occur as a result of incompatibility of calcium and phosphate salts. Liposyn III 30 (liposyn iii 30 intravenous far emulsion) %, as a component of these admixtures, will obscure the presence of particulate matter (see DOSAGE AND ADMINISTRATION and Mixing Instructions For Combined Administration).

Caution should be exercised in administering Liposyn III (intravenous fat emulsion) to patients with severe liver damage, pulmonary disease, anemia or blood coagulation disorders or when there is danger of fat embolism. The too rapid administration of Liposyn III can cause fluid and/or fat overloading resulting in dilution of serum electrolyte concentrations, over-hydration, congested states, pulmonary edema, impaired pulmonary diffusion capacity or metabolic acidosis.

Caution should be exercised when admixing Liposyn III 30 (liposyn iii 30 intravenous far emulsion) % (Intravenous Fat Emulsion). Studies have documented the stability of Liposyn III 30 (liposyn iii 30 intravenous far emulsion) %, when admixed with Hospira electrolytes, Hospira trace metals, and Hospira Dextrose Injection, USP and Hospira Aminosyn II (amino acid) Injection. (Also see Mixing Instructions For Combined Administration under DOSAGE AND ADMINISTRATION). These compounded admixtures may be stored under refrigeration for up to 24 hours. Administration of admixtures should be completed within 24 hours after removal of refrigeration. Admixtures should be stored at room temperature (25°C) during this period. Reference should be made to the individual package inserts for detailed information on each component.

The prime destabilizers of emulsions are excessive acidity (low pH) and inappropriate electrolyte content. Careful consideration should be given to the dosage levels of the divalent cations (Ca++ and Mg++) and phosphates administered, as these have been shown to cause emulsion instability. Amino acid solutions exert a buffering effect, protecting the emulsion. NOTE: The TPN admixture containers used in the stability studies were formulated to minimize lipid/container interactions. The principal bag materials were a nonphthalate polyvinylchloride (PVC) or the CR3 co-polyester material of which the Nutrimix® dual-chamber flexible container is comprised. CR3 contains no plasticizers.

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

Because free fatty acids displace bilirubin bound to albumin, the use of lipid infusions in jaundiced or premature infants should be undertaken with caution.

During Liposyn III (intravenous fat emulsion) administration, the patient's hemogram, blood coagulation, liver function, platelet count and plasma lipid profile must be closely monitored. The lipemia must clear between daily infusions. Liposyn III should be discontinued should a significant abnormality in any one of these parameters be attributed to the infusion.

It is recommended that a 1.2 micron air-eliminating filter be used during administration of admixtures containing Liposyn III 30 (liposyn iii 30 intravenous far emulsion) %.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility of Liposyn III have not been conducted.

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

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in milk, caution should be exercised when Liposyn III 30 (liposyn iii 30 intravenous far emulsion) % is administered to a nursing mother.

Do not dispense the contents of any container in which the emulsion appears to be oiling out.

AVOID OVERDOSAGE ABSOLUTELY.

REFERENCES

1. Levene M, Wigglesworth J, Desai R. Pulmonary fat accumulation after Intralipid infusion in the preterm infant. Lancet II: 815-818, (Oct. 18), 1980.

2. Dahms B, Halpin T. Pulmonary arterial lipid deposit in newborn infants receiving intravenous lipid infusion. J. Pediatrics: 97:800-805, (Nov.), 1980.

Last reviewed on RxList: 2/2/2009
This monograph has been modified to include the generic and brand name in many instances.

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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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