Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose
Generic Name: leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextrose
Brand Names:
Clinimix
11 DESCRIPTION CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8 .
Overview
11 DESCRIPTION CLINIMIX sulfite-free (amino acids in dextrose) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container. The outlet port chamber contains essential and nonessential amino acids. The formulas for the individual amino acids found in CLINIMIX sulfite-free (amino acids in dextrose) injections are provided in Table 8 .
Uses
1 INDICATIONS AND USAGE CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients. CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION See full prescribing information for information on preparation, administration, instructions for use, dosing considerations, including the recommended dosage in adults and pediatrics, and dosage modifications in patients with kidney disease. ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 ) 2.1 Preparation Prior to Administration • CLINIMIX is available in a three port container configuration and a two port container configuration. o Three Port Container : the ports consist of one medication port, one additive port and one outlet port. Additives can be introduced to the container through the medication port and lipids through the additive port on the three port container. o Two Port Container : the ports consist of one medication port and one outlet port.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information. • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1) ] • Hypersensitivity reactions [see Warnings and Precautions (5.2) ] • Risk of Infections [see Warnings and Precautions (5.3) ] • Refeeding syndrome [see Warnings and Precautions (5.4) ] • Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.5) ] • Vein damage and thrombosis [see Warnings and Precautions (5.6) ] • Hepatobiliary disorders [see Warnings and Precautions (5.7) ] • Parenteral Nutrition Associated Liver Disease [see Warnings and Precautions (5.9) ] • Electrolyte imbalance and fluid overload [see Warnings and Precaut...
Warnings
5 WARNINGS AND PRECAUTIONS • Pulmonary Embolism due to Pulmonary Vascular Precipitates : if signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.1 ) • Hypersensitivity Reactions : monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.2 ) • Risk of Infections, Refeeding Complications, and Hyperglycemia or Hyperosmolar Hyperglycemic State : monitor for signs and symptoms; monitor laboratory parameters. ( 5.3 , 5.4 , 5.5 ) • Vein Damage and Thrombosis : solutions with osmolarity of ≥ 900 mOsm/L must be infused through a central catheter. ( 2.2 , 5.6 ) • Hepatobiliary Disorders : monitor liver function parameters and ammonia levels. 4 CONTRAINDICATIONS The use of CLINIMIX is contraindicated in: • Patients with known hypersensitivity to one or more amino acids or dextrose [see Warnings and Precautions (5.2) ] . • Patients with inborn errors of amino acid metabolism due to risk of severe metabolic and neurologic complications. • Patients with pulmonary edema or acidosis due to low cardiac output.
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate or well-controlled studies in pregnant women with CLINIMIX. Additionally, animal reproduction studies have not been conducted with amino acids and electrolytes and dextrose. It is not known whether CLINIMIX can cause fetal harm when administered to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, the estimated background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING CLINIMIX (amino acids in dextrose) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See Table 9 ). Table 9: CLINIMIX Formulations (per 07-19-00-3604 and BE-30-03-648) After mixing, the product represents 1000 mL Code and NDC Number 2000 mL Code and NDC Number CLINIMIX 4.25/5 sulfite‑free (4.25% Amino Acid in 5% Dextrose) Injection Code 2B77...
Frequently Asked Questions
What is Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose used for?▼
1 INDICATIONS AND USAGE CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients. CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients. ( 1 )
What are the side effects of Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose?▼
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information. • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1) ] • Hypersensitivity reactions [see Warnings and Precautions (5.2) ] • Risk of Infections [see Warnings and Precautions (5.3) ] • Refeeding syndrome [see Warnings and Precautions (5.4) ] • Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.5) ] • Vein damage and thrombosis [see Warnings and Precautions (5.6) ] • Hepatobiliary disorders [see Warnings and Precautions (5.7) ] • Parenteral Nutrition Associated Liver Disease [see Warnings and Precautions (5.9) ] • Electrolyte imbalance and fluid overload [see Warnings and Precaut...
Can I take Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate or well-controlled studies in pregnant women with CLINIMIX. Additionally, animal reproduction studies have not been conducted with amino acids and electrolytes and dextrose. It is not known whether CLINIMIX can cause fetal harm when administered to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, the estimated background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.
What are the important warnings for Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose?▼
5 WARNINGS AND PRECAUTIONS • Pulmonary Embolism due to Pulmonary Vascular Precipitates : if signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.1 ) • Hypersensitivity Reactions : monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.2 ) • Risk of Infections, Refeeding Complications, and Hyperglycemia or Hyperosmolar Hyperglycemic State : monitor for signs and symptoms; monitor laboratory parameters. ( 5.3 , 5.4 , 5.5 ) • Vein Damage and Thrombosis : solutions with osmolarity of ≥ 900 mOsm/L must be infused through a central catheter. ( 2.2 , 5.6 ) • Hepatobiliary Disorders : monitor liver function parameters and ammonia levels. 4 CONTRAINDICATIONS The use of CLINIMIX is contraindicated in: • Patients with known hypersensitivity to one or more amino acids or dextrose [see Warnings and Precautions (5.2) ] . • Patients with inborn errors of amino acid metabolism due to risk of severe metabolic and neurologic complications. • Patients with pulmonary edema or acidosis due to low cardiac output.
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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.