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Liposyn

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Liposyn II

Indications
Dosage
How Supplied

INDICATIONS

Liposyn II (intravenous fat emulsion) 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 (intravenous fat emulsion) 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.

DOSAGE AND ADMINISTRATION

Liposyn II (intravenous fat emulsion) (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 (intravenous fat emulsion) 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 (intravenous fat emulsion) 10% or 250 mL of Liposyn II (intravenous fat emulsion) 20% administered twice weekly.

The initial infusion rate for the first 15 minutes should be 1 mL/minute for Liposyn II (intravenous fat emulsion) 10% and 0.5 mL/minute for Liposyn II (intravenous fat emulsion) 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 (intravenous fat emulsion) 10% or 250 mL of Liposyn II (intravenous fat emulsion) 20% to be given over a period of four to six hours.

Pediatric Patients

Liposyn II (intravenous fat emulsion) 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 (intravenous fat emulsion) 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 (intravenous fat emulsion) 10% or 50 mL of Liposyn II (intravenous fat emulsion) 20% per hour.

Administration

With the exception of heparin at 1 to 2 units/mL of fat emulsion, additives to the Liposyn II (intravenous fat emulsion) 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 (intravenous fat emulsion) .

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 (intravenous fat emulsion) 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 (intravenous fat emulsion) at a concentration of 1 to 2 units per mL prior to administration. Alternatively, studies have documented the stability of Liposyn® II (intravenous fat emulsion) 10% and 20%, 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:

Concentrations Aminosyn (pH 6) Aminosyn II Aminosyn II w/Electrolytes
7% X X X
8.5% X X X
10% X X X

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 (intravenous fat emulsion) extract DEHP from this PVC component, and it may be advisable to consider infusion of Liposyn II (intravenous fat emulsion) 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 (intravenous fat emulsion) 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 Liposyn®II 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:

Concentrations Aminosyn (pH 6) Aminosyn II Aminosyn II w/Electrolytes
7% X X X
8.5% X X X
10% X X X

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 (Ca++ and 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:

  1. Transfer Liposyn® II (Intravenous Fat Emulsion) to the TPN admixture container.
  2. Transfer Aminosyn® II (An Amino Acid Injection), Aminosyn II w/Electrolytes, or Aminosyn (pH 6).
  3. Transfer Hospira Dextrose Injection, USP.
  4. Perform addition of necessary Hospira electrolyte and Hospira trace metal additives.

Admixing should be accompanied by gentle agitation to avoid localized concentration effects. Simultaneous or sequential mixing of Liposyn II (intravenous fat emulsion) 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.

HOW SUPPLIED

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 (intravenous fat emulsion) 10% (List No. 9786) is supplied in 200, 250 and 500 mL single-dose containers.
Liposyn II (intravenous fat emulsion) 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.

Revised: August, 2005. Hospira, Inc., Lake Forest, IL 60045, USA. FDA Rev date: 4/14/2003

Last reviewed on RxList: 1/30/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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