Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/438
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Liposyn II (Injection, Emulsion)
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dailymed-instance:dosage |
Liposyn II (Intravenous Fat Emulsion) should be administered
as part of an intravenous total nutrition program via peripheral vein
or central venous catheter. Adult Patients Liposyn II can provide up to 60% of daily calories at
a dose not to exceed 3 g/kg of body weight per day. The other 40%
should be provided by carbohydrate and amino acids. For the prevention of essential fatty acid deficiency, the recommended
daily requirement is approximately 4% of the caloric intake as linoleate.
In most adult patients, this can be supplied as 500 mL of Liposyn
II 10% or 250 mL of Liposyn II 20% administered twice weekly. The initial infusion rate for the first 15 minutes should
be 1 mL/minute for Liposyn II 10% and 0.5 mL/minute for Liposyn II
20%. If no adverse effects are observed during this initial infusion,
the rate can be increased to allow no more than 500 mL of Liposyn
II 10% or 250 mL of Liposyn II 20% to be given over a period of four
to six hours. Pediatric Patients Liposyn II can provide up to 60% of daily calories at
a dose not to exceed 4 g/kg of body weight per day. The other 40%
should be provided by carbohydrate and amino acids. For the prevention of essential fatty acid deficiency, the recommended
daily requirement is approximately 4% of the caloric intake as linoleate.
The daily dosage of Liposyn II ranges from 5 mL to 10 mL per
kilogram for the 10% emulsion and 2.5 mL to 5 mL per kilogram for
the 20% emulsion, depending upon the size and maturity of the patient. The infusion should be started at a rate of 0.1 mL/minute
for the first 15 minutes. If no adverse effects are observed during
this initial infusion, the rate can be increased to allow no more
than 100 mL of Liposyn II 10% or 50 mL of Liposyn II 20% per
hour. Administration With
the exception of heparin at 1 to 2 units/mL of fat emulsion, additives
to the Liposyn II bottle are contraindicated. Partly used containers must not be stored for later use. Filters
of less than 1.2 micron porosity must not be used with Liposyn II.
Do not use any bottle in which there appears to be an oiling out of
the emulsion. See CONTRAINDICATIONS regarding
mixing this emulsion with other I.V. fluids or additives. Liposyn II can be infused into the same central or peripheral
vein as the carbohydrate/amino acid solutions by means of a short
Y-connector near the infusion site. This allows for mixing of the
solutions immediately before entering the vein or for alternation
of each solution. Flow rates of each solution should be controlled
separately by infusion pumps, if these are used. Fat emulsion may
also be infused through a separate peripheral site. If desired, heparin
may be added to Liposyn II at a concentration of 1 to 2 units per
mL prior to administration. Alternatively, studies have documented
the stability of Liposyn II 10% and 20%, necessary
Hospira electrolytes, Hospira trace metals, and Hospira 10% through
70% Dextrose Injection, USP ina TPN admixture container with the
following Hospira amino acid solutions: Admixtures were compounded in either a nonphthalate
polyvinylchloride (PVC) or an ethylene vinyl acetate (EVA) container.
(See NOTE). SEE MIXING INSTRUCTIONS FOR COMBINED ADMINISTRATION. Compounded
admixtures may be stored under refrigeration for up to 24 hours.
Administration of admixtures should be completed within 24 hours after
removal from refrigeration. Conventional administration
sets contain polyvinyl chloride (PVC) components that have DEHP (diethylhexyl
phthalate) as a plasticizer. Fat-containing fluids such as Liposyn
II extract DEHP from this PVC component, and it may be advisable to
consider infusion of Liposyn II or the 3-in-1 admixture through a
non-DEHP administration set. A 1.2 micron air-eliminating
filter can be used to deliver either a stable 3-in-1 admixture containing
Liposyn II or the emulsion alone. Parenteral drug products should
be inspected visually for particulate matter and discoloration prior
to administration, whenever solution and container permit. MIXING INSTRUCTIONS FOR COMBINED
ADMINISTRATION Caution should be exercised
when admixing Liposyn II (Intravenous Fat Emulsion). It is absolutely essential that the admixture be prepared using strict
aseptic techniques as this nutrient mixture is a good growth media
for microorganisms. Studies have documented
the stability of LiposynII 10% and 20% with necessary
Hospira electrolytes, Hospira trace metals, and Hospira 10% through
70% Dextrose Injection, USP in a TPN admixture container with the
following Hospira amino acid solutions: 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 ethylene vinyl acetate
(EVA). The only significant leachable from EVA is acetate. Acetate
is found in total parenteral nutrition (TPN) admixtures as acetic
acid, used for adjusting the pH of amino acid solutions, and as lysine
acetate. The level of leachable acetate from EVA is not sufficient
to alter the final acetate concentration significantly. Compounded
admixtures may be stored under refrigeration for up to 24 hours. Administration
of admixtures should be completed within 24 hours after removal from
refrigeration. 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 (Caand Mg) administered, as these have been shown to cause
emulsion instability. Amino acid solutions exert a buffering effect,
protecting the emulsion. The following proper
mixing sequence must be followed to minimize pH-related problems by
ensuring that typically acidic dextrose injections are not mixed with
lipid emulsion alone: Admixing should be accompanied by gentle agitation
to avoid localized concentration effects. Simultaneous or sequential
mixing of Liposyn II with other nutritional substrates using an automated,
gravimetric pumping system is considered an acceptable method for
admixture compounding, especially for institutions with a high volume
of 3-in-1 admixtures.
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dailymed-instance:descripti... |
Liposyn II (Intravenous Fat Emulsion) is a sterile,
nonpyrogenic fat emulsion for intravenous administration. It is supplied
in both a 10% and 20% concentration. Liposyn
II 10% contains 5% safflower oil, 5% soybean oil, up to 1.2% egg phosphatides
added as an emulsifier and 2.5% glycerin in water for injection. May
contain sodium hydroxide for pH adjustment. pH 8.0 (6.0���9.0).
Liposyn II 10% has an osmolarity of 276 mOsmol/liter (actual). The
total caloric value of Liposyn II 10% including fat, phospholipid
and glycerol is 1.1 kcal/mL. Of this total, approximately 0.6 kcal/mL
is supplied by linoleic acid. Liposyn II 20%
contains 10% safflower oil, 10% soybean oil, 1.2% egg phosphatides
and 2.5% glycerin in water for injection. May contain sodium hydroxide
for pH adjustment. pH 8.3 (6.0���9.0). Liposyn II 20% has an
osmolarity of 258 mOsmol/liter (actual). The total caloric value of
Liposyn II 20% including fat, phospholipid and glycerol is 2 kcal/mL.
Of this total, approximately 1.2 kcal/mL are supplied by linoleic
acid. Both Liposyn II 10% and Liposyn II 20%
contain emulsified fat particles of approximately 0.4 micron
in diameter, similar to naturally occurring chylomicrons. Safflower oil and Soybean Oil, USP are mixtures of neutral
triglycerides with the following structure: ,andare saturated
and unsaturated fatty acid residues. The major component fatty acids
of the 50/50 safflower/soybean oil mixture are approximately 65.8%
linoleic, 17.7% oleic, 8.8% palmitic, 3.4% stearic, and 4.2% linolenic
acid. These fatty acids have the following chemical and structural
formulas: Egg phosphatides, purified, are primarily a mixture of naturally
occurring phospholipids which are isolated from the egg yolk. These
phospholipids have the following general structure: andare the same
saturated and unsaturated fatty acid residues that abound in neutral
fats. Ris primarily either the choline [HOCHCHN(CH)OH] ester or ethanolamine
(HOCHCHNH) ester of phosphoric
acid (HPO). Glycerin,
USP is chemically designated CHand is a clear colorless, hygroscopic syrupy liquid. It has the
following structural formula:
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dailymed-instance:clinicalP... |
Liposyn II (Intravenous Fat Emulsion) provides the
patient requiring parenteral nutrition with a source of calories and
the essential fatty acids normally obtained from a nutritionally complete
oral diet. The supplemental polyunsaturated fat prevents biochemical
changes of essential fatty acid deficiency (EFAD) and prevents and
reverses EFAD clinical manifestations (e.g., scaliness of skin, growth
retardation, poor wound healing and sparse hair growth). The infused fat particles are cleared from the bloodstream
in a manner thought to be similar to the clearing of chylomicrons.
Following infusion, there is a transient increase in plasma triglycerides.
The triglycerides are hydrolyzed to free fatty acids and glycerol
by the enzyme, lipoprotein lipase. The free fatty acids either enter
the tissues (where they may be oxidized or resynthesized into triglycerides
and stored) or circulate in the plasma, bound to albumin. In the liver,
circulating free fatty acids are oxidized or converted to very low
density lipoproteins that re-enter the bloodstream. Phosphatides are the hydrophobic components of membranes and provide
electrically insulated layers. They are involved in the formation
of membrane structures. Choline prevents the deposition of fat in
the liver. Glycerol is metabolized to carbon
dioxide and glycogen or is used in the synthesis of body fats.
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The administration of Liposyn II (Intravenous Fat
Emulsion) is contraindicated in patients demonstrating disturbances
in normal fat metabolism such as pathologic hyperlipemia, lipoid nephrosis
or acute pancreatitis if accompanied by hyperlipemia.
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dailymed-instance:supply |
Liposyn II (Intravenous Fat Emulsion) 10% and 20%
is a white to slightly off-white emulsion with no evidence of oiling
out of the emulsion. Liposyn II 10% (List No.
9786) is supplied in 200, 250 and 500 mL single-dose containers. Liposyn II 20% (List No. 9789) is supplied in 200, 250
and 500 mL single-dose containers. Store at
20 to 25��C (68 to 77��F). [See USP Controlled Room Temperature.]
Protect from freezing.
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dailymed-instance:precautio... |
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
II 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
II should be discontinued should a significant abnormality in any
one of these parameters be attributed to the infusion.<br/>Pregnancy Category C.: Animal reproduction studies have not been conducted
with Liposyn II. It is also not known whether Liposyn II can cause
fetal harm when administered to a pregnant woman or can affect reproduction
capacity. Liposyn II should be given to a pregnant woman only if clearly
needed.<br/>Nursing Mothers.: It is not known whether the drug is excreted in human
milk. Because many drugs are excreted in human milk, caution should
be exercised when Liposyn II is administered to a nursing woman. Frequent (some advise daily) platelet counts should be
done in neonatal patients receiving parenteral nutrition with Liposyn
II. Liposyn II is supplied in single-dose containers.
Partially used containers must be discarded and should not be stored
or resterilized for later use. Do not administer the contents of any
container in which the emulsion appears to be oiling out. This product contains no more than 25 mcg/L of aluminum.
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In the event of fat overload during therapy, stop
the infusion of Liposyn II (Intravenous 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-evaluate the patient and institute
appropriate corrective measures. See WARNINGS and PRECAUTIONS.
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dailymed-instance:genericMe... |
Safflower oil, soybean oil, egg Phospholipids, and glycerin
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dailymed-instance:fullName |
Liposyn II (Injection, Emulsion)
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dailymed-instance:adverseRe... |
Sepsis due to contamination of administration equipment
and thrombophlebitis due to vein irritation from concurrently administered
hypertonic solutions have been encountered. These are attributable
to I.V. therapy in general or to the type of infusion administered. Adverse reactions directly related to fat emulsions are
of two types: (1) immediate (acute) and (2) long term (chronic). In
studies of lipid products in general, the following immediate reactions
have been noted: Allergic reactions, hyperlipemia, dyspnea, cyanosis,
flushing, dizziness, headache, sleepiness, nausea, vomiting, hyperthermia,
sweating, chest and back pain, thrombocytopenia (rarely in neonates),
hypercoagulability and transient increases in liver enzymes. The following reactions have been noted with long-term
therapy with lipid infusions in general: Hepatomegaly, jaundice due
to central lobular cholestasis, splenomegaly, thrombocytopenia, leucopenia,
transient increases in liver function tests, overloading syndrome
and deposition of brown pigment (���fat pigment���) in the
reticuloendothelial tissue of the liver. The significance of this
last occurrence and its cause are unknown.
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dailymed-instance:warning |
Deaths in preterm infants
after infusion of intravenous fat emulsions 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 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 lessthan 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. Caution
should be exercised in administering Liposyn II (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 II can cause fluid and/or
fat overloading resulting in dilution of serum electrolyte concentrations,
overhydration, congested states, pulmonary edema, impaired pulmonary
diffusion capacity or metabolic acidosis. Caution
should be exercised when admixing Liposyn II (Intravenous Fat Emulsion). 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.
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Liposyn II is indicated as a source of calories for
patients requiring parenteral nutrition. Where such nutrition is required
for extended periods of time (more than 5 days), Liposyn II is also
indicated as a source of essential fatty acids to prevent or reverse
biochemical changes in fatty acid composition of plasma lipids (elevated
triene/tetraene ratio) and the clinical manifestations of EFAD.
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Liposyn II
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