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Liposyn III 30

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Liposyn III 30

INDICATIONS

Liposyn III 30 (liposyn iii 30 intravenous far emulsion) % Pharmacy Bulk Package is indicated for use in a pharmacy admixture program for the preparation of 3-in-1 or total nutrient admixtures (TNAs).

Liposyn III (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 III 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 III (intravenous fat emulsion) should be administered as part of 3-in-1 or total nutrient admixture via peripheral vein or central venous catheter.

Adult Patients

The initial infusion rate of the nutrient admixture in adults should be the equivalent of 0.1 g fat/minute for the first 15 to 30 minutes of infusion. If no untoward reactions occur (see ADVERSE REACTIONS section), the infusion rate of the nutrient admixture can be increased to be equivalent to 0.2 g fat/minute. For adults, the admixture should not contain more than 330 mL of Liposyn III 30% on the first day of therapy. If the patient has no untoward reactions, the dose can be increased on the following day. The daily dosage should not exceed 2.5 g of fat/kg of body weight (8.3 mL of Liposyn III 30 (liposyn iii 30 intravenous far emulsion) % per kg).Liposyn III 30% should make up no more than 60% of the total caloric input to the patient. Carbohydrate and a source of amino acids should comprise the remaining caloric input.

Pediatric Patients

The dosage for premature infants starts at 0.5 g fat/kg body weight/24 hours (1.7 mL Liposyn III 30 (liposyn iii 30 intravenous far emulsion) %) and may be increased in relation to the infant's ability to eliminate fat. The maximum dosage recommended by the American Academy of Pediatrics is 3 g fat/kg/24 hours.3

The initial rate of infusion of the nutrient admixture in older pediatric patients should be no more than 0.01 g fat/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.1 g of fat/kg/hour. The daily dosage should not exceed 3 g of fat/kg of body weight.3 Liposyn III 30 (liposyn iii 30 intravenous far emulsion) % should make up no more than 60% of the total caloric input to the patient. Carbohydrate and a source of amino acids should comprise the remaining caloric input.

Essential Fatty Acid Deficiency

When Liposyn III 30 (liposyn iii 30 intravenous far emulsion) % is administered to correct essential fatty acid deficiency, eight to ten percent of the caloric input should be supplied by Liposyn III 30 (liposyn iii 30 intravenous far emulsion) % in order to provide adequate amounts of linoleic acids. When EFAD occurs together with stress, the amount of LiposynIII 30% needed to correct the deficiency may be increased.

Administration

See Mixing Instructions For Combined Administration section for information regarding mixing this fat emulsion with other parenteral fluids.

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) %.

Admixtures were compounded in a nonphthalate polyvinylchloride (PVC) flexible container (see NOTE under WARNINGS). See Mixing Instructions For Combined Administration. Studies have documented the stability of Liposyn III 30 (liposyn iii 30 intravenous far emulsion) %, when admixed with Hospira electrolytes, Hospira trace metals, Hospira Dextrose Injection, USP and Hospira Aminosyn II (amino acid) Injection. 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.

Conventional administration sets contain polyvinylchloride (PVC) components that have DEHP (diethylhexyl phthalate) as a plasticizer. Fat-containing fluids such as Liposyn III extract DEHP from this PVC component, and it may be advisable to consider infusion of 3-in-1 admixtures containing Liposyn III 30 (liposyn iii 30 intravenous far emulsion) % through a non-DEHP administration set.

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 III (Intravenous Fat Emulsion).

It is absolutely essential that the admixture be prepared using strict aseptic technique, as this nutrient mixture is a good growth medium for microorganisms.

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.

Because warming parenteral nutrition admixtures may contribute to the formation of precipitates, once administration begins, care should be taken to avoid excessive warming of the admixture.

Because of the potential for life-threatening events, caution should be taken to ensure that precipitates do not form in any parenteral nutrition admixture. Precipitates can develop because of a number of factors such as: the concentration, pH and phosphate content of the amino acid solution, the calcium and phosphate additives or the order of mixing. The presence of a lipid emulsion in the TPN admixture will obscure the presence of any precipitate.

Admixtures must be made using specific mixing protocols for 2-in-1 and 3-in-1 admixtures. Each pharmacy mixing protocol should be verified for compatibility of the resulting admixture. Admixtures should be verified at the final concentration used for amino acids, dextrose, lipid emulsion, the specific additives and the specific order of addition. Different manufacturers' components should not be substituted in a tested pharmacy admixture protocol without prior verification of compatibility.

When adding calcium and/or phosphate to parenteral nutrition solutions, the pharmacist must assess the impact of the following factors on the formation of a precipitate: 1) order of mixing, 2) salt form and concentration of electrolytes, 3) concentration of amino acids, 4) concentration of dextrose, 5) concentration of lipid emulsion, 6) temperature and pH and 7) presence of other additives.

The amounts of phosphate and of calcium added to the admixture are critical. The solubility of the added calcium should be calculated from the volume at the time the calcium is added. It should not be based upon the final volume. Any phosphate ions present in other constituents and the volume at the time the phosphate is added should be considered when calculating the amount of phosphate additives. Also, when adding calcium and phosphate to an admixture, the phosphate should be added first. The calcium should not be added consecutively or in close sequence to the phosphate addition.

Appropriate techniques should be used to ensure adequate mixing of all constituents. The admixture should be carefully inspected for the presence of precipitates.

The following proper mixing sequence must be followed for manual mixing to minimize pH-related problems by ensuring that typically acidic dextrose injections are not mixed with lipid emulsion alone:

  1. Transfer all of the aqueous components of the 3-in-1 admixture into the pooling container first, including the dextrose, amino acid solution, electrolytes and trace metals.
  2. Add the Liposyn III 30 (liposyn iii 30 intravenous far emulsion) %.
  3. Add the multivitamin supplement last, immediately prior to the start of patient infusion.

Admixing should be accompanied by gentle agitation to avoid localized concentration effects. NOTE: Simultaneous or sequential mixing of Liposyn III 30 (liposyn iii 30 intravenous far emulsion) % with other nutritional substrates using an automated pumping system is considered an acceptable method for admixture compounding 3-in-1 admixtures.

Recommended Directions for Use of the Pharmacy Bulk Package

Use aseptic technique

  1. Perform all manipulation in an appropriate laminar flow hood.
  2. Aseptically remove aluminum overseal.
  3. Insert piercing pin of sterile transfer set and suspend unit in a laminar flow hood. Insertion of a piercing pin into the outlet port should be performed only once in a Pharmacy Bulk Package solution. ONCE THE OUTLET SITE HAS BEEN ENTERED, THE WITHDRAWAL OF CONTAINER CONTENTS SHOULD BE COMPLETED PROMPTLY IN ONE CONTINUOUS OPERATION. Should this not be possible, a maximum time of 4 hours from transfer set pin or implement insertion is permitted to complete fluid transfer operations, i.e., discard container no later than 4 hours after initial closure puncture. Date and time of container entry should be noted on the area designated on the container label.
  4. Sequentially dispense aliquots of Liposyn III 30 (liposyn iii 30 intravenous far emulsion) % into I.V. containers using appropriate transfer set.

During fluid transfer operations, the Pharmacy Bulk Package should be maintained under the storage conditions recommended in the labeling.

HOW SUPPLIED

Liposyn III (intravenous fat emulsion) 30% is a white to slightly off-white emulsion with no evidence of oiling out of the emulsion.

Liposyn III 30 (liposyn iii 30 intravenous far emulsion) % in the Pharmacy Bulk Package (List No. 6892) is supplied in 500 mL glass bottles. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

REFERENCES

3. American Academy of Pediatrics: Use of intravenous fat emulsion in pediatric patients. Pediatrics 1981; 68:5 (Nov.):738-43.

Revised August 2005. Hospira, Inc., Lake Forest, IL 60045 USA. FDA Rev date: 3/12/2003

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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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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