      Document 0164
 DOCN  DRG0164
 UNIQUE IDENTIFIER        DRG-0083
 NAME OF SUBSTANCE        Liposyn II [J of Parenteral and Enteral
                          Nutrition 1992;16(2)]
 REGISTRY NUMBER          112353-79-4
 STANDARD CHEMICAL NAME   Liposyn II [CHEMLINE]
 SYNONYMS                 Safflower oil and soybean oil [Abbott
                          Laboratories Drug Information Packet, Oct
                          1985]
 SYNONYMS                 Intravenous fat emulsion 20 percent [Abbott
                          Laboratories Drug Information Packet, Oct
                          1985]
 PROTOCOL ID NUMBERS      FDA 041A
 PROTOCOL ID NUMBERS      FDA 041B
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: Infused fat particles cause a
                          transient increase in plasma triglyceride
                          concentrations. The triglycerides are then
                          hydrolyzed to free fatty acids and glycerol
                          by the enzyme lipoprotein lipase. The free
                          fatty acids either enter the tissues (to be
                          oxidized or resynthesized to triglycerides
                          for storage) or circulate bound to albumin in
                          the plasma, and subsequently may undergo
                          hepatic oxidation or conversion to very
                          low-density lipoproteins that re-enter the
                          bloodstream. Fat emulsions also contain
                          phosphatides (a component of which is
                          choline) as an emulsifier, and glycerin to
                          adjust tonicity. Phosphatides are involved in
                          the formation of membrane structures; choline
                          prevents deposition of fat in the liver; and
                          glycerin is metabolized to carbon dioxide and
                          glycogen or is used in the synthesis of fats.
                          Study of the effects of lipid sources (such
                          as Liposyn II) in total parenteral nutrition
                          on whole body protein, kinetics and tumor
                          growth showed that the source of lipid can
                          influence tumor growth and host protein
                          metabolism. A structured lipid composed of
                          medium-chain triglycerides and fish oil seems
                          to improve protein metabolism in host tissue
                          without stimulating tumor growth. The effect
                          of lipid-based parenteral nutrition was
                          assessed in AIDS patients with weight loss of
                          10% or greater. In a 2 month period, weight
                          gain and improved well being were noted in
                          all patients. There was no change in T-cell
                          subsets; viral cultures and P24 serum levels
                          remained unchanged. Lipid-based parenteral
                          nutrition is safe and probably efficacious in
                          AIDS patients. [USP DI 1995] [J of Parenteral
                          and Enteral Nutrition 1992;16(6)] [J of
                          Parenteral and Enteral Nutrition 1992;16(2)]
 DISEASES STUDIED/TREATED Nutritional support [FDA 041A] [FDA 041B]
                          [AHFS Drug Information 1995]
 CLASSIFICATION CODE      Nutritional support [FDA 41A]
 OTHER MAJOR USES         Fatty acid deficiency (prophylaxis and
                          treatment); Intravenous fat emulsions are
                          used to prevent or reverse fatty acid
                          deficiency and provide a source of calories
                          for patients requiring parenteral nutrition
                          [USP DI 1995]
 SUBSTANCE INTERACTIONS   Drug stability and compatibility studies
                          should be performed for all medications added
                          to total nutrient admixtures (TNAs), before
                          adminstration to patients. Thus, some
                          histamine receptor antagonists such as
                          ranitidine are stable in TNAs containing
                          Liposyn II or Intralipid for 24 hours, but
                          beyond this time administration of ranitidine
                          may be unreliable because of poor stability.
                          [J of Parenteral and Enteral Nutrition
                          1994;18(4)]
 ADVERSE EFFECTS          Acute adverse effects include allergic
                          reactions, hyperlipemia, dyspnea, cyanosis,
                          flushing, dizziness, headache, sleepiness,
                          nausea, vomiting, hyperthermia, sweating,
                          chest and back pain, thrombocytopenia,
                          hypercoagulability and transient increases in
                          liver enzymes. Chronic side effects include
                          hepatomegaly, jaundice due to central lobular
                          cholestasis, splenomegaly, thrombocytopenia,
                          leucopenia, transient increases in liver
                          function test, overloading syndrome and
                          deposition of brown pigment (fat pigment)
                          in the reticuloendothelial tissue of the
                          liver. Warning: Death in preterm infants
                          after infusion of intravenous fat emulsions
                          has been reported. Caution should be
                          exercised in administering Liposyn II 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 concentration, overhydration,
                          congested states, pulmonary edema, impaired
                          pulmonary diffusion capacity or metabolic
                          acidosis. [Abbott Laboratories Drug
                          Information Packet, Oct 1985] [Lancet, Oct
                          18, 1980] [J Pediatrics, Nov 1980;97]
 CONTRAINDICATIONS        Risk-benefit should be considered when the
                          following medical problems exist: anemia;
                          blood coagulation disorders; conditions in
                          which there is disturbance in normal fat
                          metabolism such as: uncompendated diabetes,
                          or pathologic hyperlipidemia, or lipid
                          nephrosis, or acute pancreatitis if
                          accompanied by hyperlipemia, or renal
                          insufficiency; severe hepatic damage,
                          immunocompromised patient (fat emulsions have
                          been reported to alter immune response);
                          jaundice; platelet dysfunction disorders;
                          pulmonary disease; sensitivity to fat
                          emulsions; sepsis. [USP DI 1995]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Mixture of safflower oil
                          and soybean oil [AHFS Drug Information 1995]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: The major component fatty
                          acids of the 50/50 mixture are approximately
                          65.8% linoleic acid, 17.7% oleic acid, 8.8%
                          palmitic acid, 3.4% stearic acid, and 4.2%
                          linolenic acid [AHFS Drug Information 1995]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: It contains egg
                          phosphatides as an emulsifying agent and
                          glycerin to adjust tonicity [AHFS Drug
                          Information 1995]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: White to slightly
                          off-white emulsion [Abbott Laboratories Drug
                          Information Packet, Oct 1985]
 CHEMICAL/PHYSICAL DATA   STABILITY: Fat particle-size distribution in
                          and physical stability of Liposyn II and
                          Intralipid before and after their use in
                          total nutrient admixtures (TNAs) were studied
                          [AM J Hosp Pharm 1992;49(11)]
 CHEMICAL/PHYSICAL DATA   STABILITY: All the admixtures were stable in
                          terms of pH and visual appearance [Am J Hosp
                          Pharm 1992;49(11)]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: 10 and 20 % intravenous fat
                          emulsion [Abbott Laboratories Drug
                          Information Packet, Oct 1985]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Liposyn I 10 % is supplied in
                          100, 200, and 500 ml single dose containers.
                          [Abbott Laboratories Drug Information Packet,
                          Oct 1985]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Liposyn II 20 % is supplied in
                          200 and 500 ml single dose containers [Abbott
                          Laboratories Drug Information Packet, Oct
                          1985]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Intravenous [Abbott
                          Laboratories Drug Information Packet, Oct
                          1985] [AHFS Drug Information 1995]
 SUBSTANCE DELIVERY DATA  STORAGE: It is recommended that the product
                          be stored at room temperature (25 C). Protect
                          from freezing. [Abbott Laboratories Drug
                          Information Packet, Oct 1985]
 MANUFACTURERS            Abbott
 REFERENCES               Hatton J, Luer M, Hirsch J, Westrich T,
                          Holstad S. Histamine receptor antagonists and
                          lipid stability in total nutrient admixtures.
                          JPEN J Parenter Enteral Nutr. 1994
                          Jul-Aug;18(4):308-12.
 REFERENCES               Lennon C, Davidson KW, Sadowski JA, Mason JB.
                          The vitamin K content of intravenous lipid
                          emulsions. JPEN J Parenter Enteral Nutr. 1993
                          Mar-Apr;17(2):142-4.
 REFERENCES               Saladino CF, Kosacolsky-Singer C, Fox R,
                          Nethala V, Feffer SE, Jonas EA. The effect of
                          parenteral lipid emulsion-induced
                          hyperlipidemia on prostaglandin E1 modulation
                          of platelet function. Artery.
                          1993;20(6):303-13.
 REFERENCES               Singer P, Rubinstein A, Askanazi J, Calvelli
                          T, Lazarus T, Kirvela O, Katz DP. Clinical
                          and immunologic effects of lipid-based
                          parenteral nutrition in AIDS. JPEN J Parenter
                          Nutr. 1992 Mar-Apr;16(2):165-7.
 REFERENCES               Bullock L, Fitzgerald JF, Walter WV. Emulsion
                          stability in total nutrient admixtures
                          containing a pediatric amino acid
                          formulation. JPEN J Parenter Enteral Nutr
                          1992 Jan-Feb;16(1):64-8.
 REFERENCES               Mendez B, Ling PR, Istfan NW, Babayan VK,
                          Bistrian BR. Effects of different lipid
                          sources in total patenteral nutrition on
                          whole body protein kinetics and tumor growth.
                          JPEN J Parenter Enteral Nutr. 1992
                          Nov-Dec;16(6):545-51.
 REFERENCES               McLeod HL, McGuire TR, Yee GC. Stability of
                          cyclosporine in dextrose 5%, NaCl 0.9%,
                          dextrose/amino acid solution, and lipid
                          emulsion. Ann Pharmacother. 1992
                          Feb;26(2):172-5.
 REFERENCES               Nichoalds GE, Weinsier RL, Millikan WJ Jr,
                          Smith DK. Lipid and lipoprotein levels in
                          adults receiving Liposyn II. Nutrition. 1991
                          Sep-Oct;7(5):329-32; discussion 333-4.
 REFERENCES               Buchman AL, Ament ME. Comparative
                          hypersensitivity in intravenous lipid
                          emulsions. JPEN J Parenter Enteral Nutr 1991
                          May-Jun;15(3):345-6.
 REFERENCES               Update: October 1989 guidelines for nutrition
                          support in AIDS. Task Force on Nutrition in
                          AIDS. J Ark Med Soc. 1989 Nov;86(6):219-28.
 ENTRY MONTH              9003
 LAST REVISION DATE       960314
 

SOURCE: National Library of Medicine, Bethesda, MD.  Distributed by AEGIS.
