Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine
Generic Name: dextrose, soybean oil, electrolytes, lysine, phenylalanine, leucine, valine, threonine, methionine, isoleucine, tryptophan, alanine, arginine, glycine, proline, histidine, glutamic acid, serine, aspartic acid and tyrosine
Brand Names:
Perikabiven
11 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 monohydrate 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.
Overview
11 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 monohydrate 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.
Uses
1 INDICATIONS AND USAGE PERIKABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PERIKABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients. PERIKABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PERIKABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.
Dosage
2 DOSAGE AND ADMINISTRATION • For intravenous infusion into a peripheral or central vein. ( 2.1 , 5.11 ) • See full prescribing information regarding preparation, administration, instructions for use, the recommended dosage in adults, and dosage modifications for patients with renal impairment. ( 2.1 , 2.2 , 2.3 , 2.4 ) 2.1 Administration • PERIKABIVEN is for intravenous infusion into a peripheral or central vein [see Warnings and Precautions ( 5.11 )]. • Use a 1.2 micron in-line filter. • Use of a vented intravenous administration set with the vent in the open position could result in air embolism. • Use a dedicated line without any connections.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information. • Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants [see Warnings and Precautions ( 5.1 )]. • Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders [see Warnings and Precautions ( 5.2 )]. • Pulmonary Embolism and Respiratory Distress due to Pulmonary Vascular Precipitates [see Warnings and Precautions ( 5.3 )]. • Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )]. • Precipitation with Ceftriaxone [see Warnings and Precautions ( 5.5 )]. • Infections [see Warnings and Precautions ( 5.6 )]. • Fat Overload Syndrome [see Warnings and Precautions ( 5.7 )].
Interactions
7 DRUG INTERACTIONS Coumarin and coumarin derivatives, including warfarin: Anticoagulant activity may be counteracted; monitor laboratory parameters. ( 7.1 ) 7.1 Ceftriaxone Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing parenteral nutrition solutions, such as PERIKABIVEN, in the same intravenous administration line. Do not administer ceftriaxone simultaneously with PERIKABIVEN, via a Y-site. However, ceftriaxone and PERIKABIVEN, may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid [see Dosage and Administration ( 2.1 )].
Warnings
5 WARNINGS AND PRECAUTIONS • Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants : Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported. ( 5.1 ) • Parenteral Nutrition-Associated Liver Disease : Increased risk in patients who receive parenteral nutrition for greater than 2 weeks. Monitor liver tests; if abnormalities occur, consider discontinuation or dosage reduction. ( 5.2 ) • Pulmonary Embolism and Respiratory Distress due to Pulmonary Vascular Precipitates : If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.3 ) • Hypersensitivity Reactions: Monitor for signs or symptoms and discontinue infusion if reactions occur. 4 CONTRAINDICATIONS The use of PERIKABIVEN is contraindicated in: • Neonates (28 days of age or younger) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone calcium salt precipitation in the neonate's bloodstream [see Limitations of Use ( 1 ), Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.4 )].
Pregnancy
8.1 Pregnancy Risk Summary The limited available data on the use of PERIKABIVEN in pregnant women are not sufficient to inform a drug-associated risk. However, there are clinical considerations if PERIKABIVEN is used in pregnant women [see Clinical Considerations ]. Animal reproduction studies have not been conducted with PERIKABIVEN. The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING PERIKABIVEN is a sterile emulsion available in the following 2 sizes: NDC Volume 63323-714-19 1,920 mL 63323-714-14 1,440 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. If accidentally frozen, discard the bag. It is recommended that the product be stored at 5°C to 25°C (41°F to 77°F).
Frequently Asked Questions
What is Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine used for?▼
1 INDICATIONS AND USAGE PERIKABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PERIKABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients. PERIKABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PERIKABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.
What are the side effects of Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine?▼
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information. • Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants [see Warnings and Precautions ( 5.1 )]. • Parenteral Nutrition-Associated Liver Disease and Other Hepatobiliary Disorders [see Warnings and Precautions ( 5.2 )]. • Pulmonary Embolism and Respiratory Distress due to Pulmonary Vascular Precipitates [see Warnings and Precautions ( 5.3 )]. • Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )]. • Precipitation with Ceftriaxone [see Warnings and Precautions ( 5.5 )]. • Infections [see Warnings and Precautions ( 5.6 )]. • Fat Overload Syndrome [see Warnings and Precautions ( 5.7 )].
Can I take Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine during pregnancy?▼
8.1 Pregnancy Risk Summary The limited available data on the use of PERIKABIVEN in pregnant women are not sufficient to inform a drug-associated risk. However, there are clinical considerations if PERIKABIVEN is used in pregnant women [see Clinical Considerations ]. Animal reproduction studies have not been conducted with PERIKABIVEN. The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S.
What are the important warnings for Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine?▼
5 WARNINGS AND PRECAUTIONS • Clinical Decompensation with Rapid Infusion of Intravenous Lipid Emulsion in Neonates and Infants : Acute respiratory distress, metabolic acidosis, and death after rapid infusion of intravenous lipid emulsions have been reported. ( 5.1 ) • Parenteral Nutrition-Associated Liver Disease : Increased risk in patients who receive parenteral nutrition for greater than 2 weeks. Monitor liver tests; if abnormalities occur, consider discontinuation or dosage reduction. ( 5.2 ) • Pulmonary Embolism and Respiratory Distress due to Pulmonary Vascular Precipitates : If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.3 ) • Hypersensitivity Reactions: Monitor for signs or symptoms and discontinue infusion if reactions occur. 4 CONTRAINDICATIONS The use of PERIKABIVEN is contraindicated in: • Neonates (28 days of age or younger) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone calcium salt precipitation in the neonate's bloodstream [see Limitations of Use ( 1 ), Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.4 )].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.