May 25, 2017
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Perikabiven

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Perikabiven

PERIKABIVEN®
(amino acids, electrolytes, dextrose and lipid) Injectable Emulsion, for Intravenous Use

WARNING

DEATH IN PRETERM INFANTS

  • Deaths in preterm infants after infusion of intravenous lipid emulsions have been reported in the medical literature.
  • Autopsy findings included intravascular fat accumulation in the lungs.
  • Preterm infants and low birth weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion. [See WARNINGS AND PRECAUTIONS and Use in Specific Populations]

DRUG DESCRIPTION

PERIKABIVEN® is a sterile, hypertonic emulsion, for peripheral or central venous administration, in a Three Chamber Bag. The product contains no added sulfites.

Chamber 1 contains Dextrose solution for fluid replenishment and caloric supply.

Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes.

Chamber 3 contains Intralipid® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids.

See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of PERIKABIVEN® when all the chambers are mixed together.

Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6•H2O) and has the following structure:

KABIVEN® (amino acids, electrolytes, dextrose and lipid injectable emulsion) Figure 27 Illustration

Chamber 2: Contains a sterile solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows:

Electrolytes  
Sodium Acetate Trihydrate, USP CH3COONax3H2O
Potassium Chloride, USP KCl
Sodium Glycerophosphate C3H5(OH)2PO4Na2xH2O
Magnesium Sulfate Heptahydrate, USP MgSO4x7H2O
Calcium Chloride Dihydrate, USP CaCl2x2H2O
Essential Amino Acids
Lysine (added as the hydrochloride salt) H2N(CH2)4CH(NH2)COOH•HCl
Phenylalanine Phenylalanine- Structural formula IllustrationCH2CH(NH2)COOH
Leucine (CH3)2CHCH2CH(NH2)COOH
Valine (CH3)2CHCH(NH2)COOH
Threonine CH3CH(OH)CH(NH2)COOH
Methionine CH3S(CH2)2CH(NH2)COOH
Isoleucine CH3CH2CH(CH3)CH(NH2)COOH
Tryptophan Tryptophan - Structural formula IllustrationCH2CH(NH2)COOH
Nonessential Amino Acids
Alanine CH3CH(NH2)COOH
Arginine H2NC(NH)NH(CH2)3CH(NH2)COOH
Glycine H2NCH2COOH
Proline Proline - Structural formula Illustration
Histidine Histidine - Structural formula IllustrationCH2CH(NH2)COOH
Glutamic Acid HOOC(CH2)2CH(NH2)COOH
Serine HOCH2CH(NH2)COOH
Aspartic Acid HOOCCH2CH(NH2)COOH
Tyrosine Tyrosine - Structural formula Illustration

Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9.

The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:

Soybean - Illustration

whereFatty acid - Illustrationare saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas:

Linoleic acid C18H32O2

Linoleic acid - Structural Formula Illustration

Oleic acid C18H34O2

Oleic acid - Structural Formula Illustration

Palmitic acid C16H32O2

Palmitic acid - Structural Formula Illustration

Linolenic acid C18H30O2

Linolenic acid - Structural formula Illustration

Stearic acid C18H36O2

Stearic acid - Structural formula Illustration

Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:

Phospholipids - Structural formula Illustration

KABIVEN® (amino acids, electrolytes, dextrose and lipid injectable emulsion) Figure 41 Illustrationcontain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid.

Choline or ethanolamine ester of phosphoric acid- Structural formula Illustration

Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:

Glycerin - Structural formula Illustration

The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch.

The container is not made with natural rubber latex or polyvinyl chloride (PVC).

Last reviewed on RxList: 1/11/2017
This monograph has been modified to include the generic and brand name in many instances.

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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