Home › Drugs › Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine

Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine

FDA Drug Information • Also known as: Travasol

Brand Names
Travasol
Drug Class
Amino Acid [EPC]
Route
INTRAVENOUS
Dosage Form
INJECTION
Product Type
HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1) ] . TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4 . Table 4. Formulas for Amino Acids Essential Amino Acids Leucine (CH 3 ) 2 CHCH 2 CH (NH 2 ) COOH Isoleucine CH 3 CH 2 CH (CH 3 ) CH (NH 2 ) COOH Lysine (added as the hydrochloride salt) H 2 N (CH 2 ) 4 CH (NH 2 ) COOH Valine (CH 3 ) 2 CHCH (NH 2 ) COOH Phenylalanine (C 6 H 5 ) CH 2 CH (NH 2 ) COOH Histidine (C 3 H 3 N 2 ) CH 2 CH (NH 2 ) COOH Threonine CH 3 CH (OH) CH (NH 2 ) COO Methionine CH 3 S (CH 2 )2 CH (NH 2 ) COOH Tryptophan (C 8 H 6 N) CH 2 CH (NH 2 ) COOH Nonessential Amino Acids Alanine CH 3 CH (NH 2 ) COOH Arginine H 2 NC (NH) NH (CH 2 )3 CH (NH 2 ) COOH Glycine H 2 NCH 2 COOH Proline [(CH 2 ) 3 NH CH] COOH Serine HOCH 2 CH (NH 2 ) COOH Tyrosine [C 6 H 4 (OH)] CH 2 CH (NH 2 ) COOH TRAVASOL contains no more than 25 mcg/L of aluminum.

What Is Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine Used For?

1 INDICATIONS AND USAGE TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients. TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients. (1)

Dosage and Administration

2 DOSAGE AND ADMINISTRATION

  • Pharmacy Bulk Package. Not for direct intravenous infusion. (2.1)
  • 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 renal impairment. ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 )
  • Protect the admixed parenteral nutrition solution from light. ( 2.3 ) 2.1 Important Preparation Information TRAVASOL is supplied as a pharmacy bulk package for admixing only and is not for direct intravenous infusion . Prior to administration, TRAVASOL must be transferred to a separate parenteral nutrition container, diluted and used as an admixture with or without dextrose, electrolytes and/or lipid emulsion.
  • The key factor in preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients.
  • Do not remove container from overpouch until ready to use.
  • Tear protective overpouch across top at slit and remove solution container. Small amounts of moisture may be found on the solution container from water permeating from inside the container. The amount of permeated water is insufficient to affect the solution significantly. If larger amounts of water are found, the container should be checked for tears or leaks.
  • Inspect TRAVASOL prior to use. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Evaluate the following: o If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. o Check to ensure the solution is clear, colorless or slightly yellow. Discard if the solution is bright yellow or yellowish brown. o Check for minute leaks by squeezing inner container. If leaks are found, discard container.
  • TRAVASOL is intended for use in the preparation of sterile, intravenous admixtures. Because additives may be incompatible with TRAVASOL, evaluate all additions for compatibility. 2.2 Administration Instructions TRAVASOL is for admixing use only. It is not for direct intravenous infusion. Prior to administration, TRAVASOL must be diluted with other compatible intravenous fluids or used as an admixture with or without dextrose, electrolytes and/or lipid emulsion.
  • TRAVASOL is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). The key factor in the preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients.
  • TRAVASOL is for admixing with dextrose injection and/or lipid emulsions using a parenteral nutrition container.
  • When TRAVASOL is admixed with dextrose injection and/or lipid emulsion, the choice of a central or...

    • Side Effects (Adverse Reactions)

    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) ]
  • Aluminum toxicity [see Warnings and Precautions (5.8) ]
  • Parenteral Nutrition Associated Liver Disease [see Warnings and Precautions (5.9) ]
  • Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.10) ] The following adverse reactions from voluntary reports or clinical studies have been reported with TRAVASOL. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Metabolic acidosis
  • Alkalosis
  • Osmotic diuresis and dehydration,
  • Rebound hypoglycemia
  • Hypo- and hyper-vitaminosis Adverse reactions include pulmonary vascular emboli, hypersensitivity reactions infection, refeeding syndrome, hyperglycemia and hyperosmolar hyperglycemic state, vein thrombosis, elevated liver function tests, hyperammonemia, electrolyte imbalances, and hypervolemia. (6) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    • Contraindications

    4 CONTRAINDICATIONS The use of TRAVASOL is contraindicated in:

  • Patients with known hypersensitivity to one or more amino acids [see Warnings and Precautions (5.2) ] .
  • Patients with inborn errors of amino acid metabolism due to risk of severe metabolic or neurologic complications.
  • Patients with pulmonary edema or acidosis due to low cardiac output.
  • Known hypersensitivity to one or more amino acids. (4)
  • Inborn errors of amino acid metabolism. (4) Patients with pulmonary edema or acidosis due to low cardiac output. (4)

    • Pregnancy and Breastfeeding

    8.1 Pregnancy Risk Summary Limited published data with injectable amino acids solutions, including TRAVASOL in pregnant women are not sufficient to inform a drug associated risk for adverse developmental outcomes. However, malnutrition in pregnant women is associated with adverse maternal and fetal outcomes [see Clinical Considerations ]. Animal reproduction studies have not been conducted with injectable amino acids solutions, including TRAVASOL. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. However, the 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. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. Parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake.

    Overdosage

    10 OVERDOSAGE An increased infusion rate of parenteral nutrition can cause hypervolemia, electrolyte disturbances, acidosis and/or azotemia, hyperglycemia, hyperosmolality [see Warnings and Precautions (5.5 , 5.10) ] . Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal. Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to respiratory and cardiovascular systems. For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org .

    How Supplied

    16 HOW SUPPLIED/STORAGE AND HANDLING TRAVASOL 10% (amino acids) injection is available in plastic Pharmacy Bulk Package flexible containers in the following sizes as shown in Table 5 below. Table 5. TRAVASOL Dosage Forms Code Volume NDC Number 1B6623 500 mL NDC 0338-0644-03 1B6624 1000 mL NDC 0338-0644-04 1B6626P 2000 mL NDC 0338-0644-06 Minimize exposure of TRAVASOL to heat and avoid excessive heat. Protect from freezing. Store TRAVASOL at room temperature (25ºC/77ºF). Do not use if protective overpouch has been previously opened or damaged. For storage of admixed solutions [see Dosage and Administration (2.3) ] .

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.