and bone toxicity. Tissue loading may occur at even lower rates of administration.
PRECAUTIONS
When Intralipid® 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®, 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 If these tests indicate that liver function is impaired, the therapy should be withdrawn.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®.
Drug product contains no more than 25 mcg/L of aluminum.
Carcinogenesis, Mutagenesis, Impairment of Fertility. Studies with Intralipid® have not been performed to eva luate 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.
ADVERSE REACTIONS
The adverse reactions observed can be separated into two classes:
Those more frequently encountered are due either to a) contamination of the intravenous catheter and result in sepsis, or to b) vein irritation by concurrently infused hypertonic solutions and may result in thrombophlebitis. These adverse reactions are inseparable from the hyperalimentation procedure with or without Intralipid®.
Less frequent reactions more directly related to Intralipid® are: a) immediate or early adverse reactions, each of which has been reported to occur in clinical trials, in an incidence of less than 1%: dyspnea, cyanosis, allergic reactions, hyperlipemia, hypercoagulability, nausea, vomiting, headache, flush-ing, increase in temperature, sweating, sleepiness, pain in the chest and back, slight pressure over the eyes, dizziness, and irritation at the site of infusion, and, rarely, thrombocytopenia in neonates; b) delayed adverse reactions such as hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leukopenia, transient increases in liver function tests, and overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly. splenomegaly and shock).
The deposition of a brown pigmentation in the reticuloendothelial system, the so-called “intravenous fat pigment,” has been reported in patients infused with Intralipid®. The causes and significance of this phenomenon are unknown.
OVERDOSAGE
In the event of fat overload during therapy, stop the infusion containing Intralipid® 20% (A 20% I.V. Fat Emulsion) until visual inspection of the plasma, determination of triglyceride concentrations, or measurement of plasma light-scattering activity by nephelometry indicates the lipid has cleared. Re-eva luate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS.
DOSAGE AND ADMINISTRATION
Intralipid® 20% (A 20% I.V. Fat Emulsion) Pharmacy Bulk Package should be administered only as a part of a three-in-one or t |
