. In addition, sufficient quantities of the major extracellular electrolytes sodium, calcium, and chloride, must be given. In patients with hyperchloremic or other metabolic acidoses, sodium and potassium may be added as the acetate salts to provide bicarbonate precursor. The electrolyte content of TrophAmine® must be considered when calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus, should be monitored frequently.
Appropriate vitamins, minerals and trace elements should also be provided.
Central Venous Nutrition. Hypertonic mixtures of amino acids and dextrose may be safely administered by continuous infusion through a central venous catheter with the tip located in the superior vena cava. Initial infusion rates should be slow, and gradually increased to the recommended 60–125 mL per kilogram body weight per day. If administration rate should fall behind schedule, no attempt to "catch up" to planned intake should be made. In addition to meeting protein needs, the rate of administration, particularly during the first few days of therapy, is governed by the patient's glucose tolerance. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of glucose levels in blood and urine.
Peripheral Parenteral Nutrition. For patients in whom the central venous route is not indicated and who can consume adequate calories enterally, TrophAmine® (Amino Acid Injections) may be administered by peripheral vein with or without parenteral carbohydrate calories. Such infusates can be prepared by dilution with B. Braun's Sterile Water for Injection or 5%–10% Dextrose Injection to prepare isotonic or slightly hypertonic solutions for peripheral infusion. It is essential that peripheral infusion be accompanied by adequate caloric intake. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
TrophAmine® may be admixed with solutions which contain phosphate or which have been supplemented with phosphate. The presence of calcium and magnesium ions in an additive solution should be considered when phosphate is also present, in order to avoid precipitation.
Care must be taken to avoid incompatible admixtures. Consult with pharmacist.
1 Suskind RM: Textbook of Pediatric Nutrition, Raven Press, New York, 1981. CLOSE
HOW SUPPLIED
TrophAmine® is supplied sterile and nonpyrogenic in 500 mL glass containers with solid stoppers.
NDC REF Units per Case
TrophAmine® (6% Amino Acid Injection)
0264-9361-55 S9361-SS 12
TrophAmine® (10% Amino Acid Injection)
0264-9341-55 S9341-SS 6
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.
Protect from light until use.
SPL UNCLASSIFIED SECTION
Rx only
Revised: November 2013
TrophAmine is a registered trademark of B. Braun Medical Inc.
DIRECTIONS FOR USE OF B. BRAUN GLASS CONTAINERS WITH SOLID STOPPERS
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