Multitrace-4
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FDA Labeling Changes
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Uses
This formulation is indicated for use as a supplement to intravenous solutions given for TPN. Administration of the solution in TPN solutions helps to maintain plasma levels of zinc, copper, manganese, and chromium and to prevent depletion of endogenous stores of these trace elements and subsequent deficiency symptoms.
History
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Other Information
MULTITRACE® - 4 (TRACE ELEMENTS INJECTION 4, USP) is a sterile, nonpyrogenic solution containing four Trace Elements for use as an additive for Total Parenteral Nutrition (TPN).
Each mL provides: Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg and Chromium 4 mcg. Each mL contains: Zinc Sulfate Heptahydrate 4.39 mg (equivalent to 1 mg Zinc); Cupric Sulfate Pentahydrate 1.57 mg (equivalent to 0.4 mg Copper); Manganese Sulfate Monohydrate 0.308 mg (equivalent to 0.1 mg Manganese); Chromic Chloride Hexahydrate 20.5 mcg (equivalent to 4 mcg Chromium); and Water for Injection, q.s. pH of the solution may be adjusted with sulfuric acid and/or sodium hydroxide. 0.9% Benzyl Alcohol is added as an antimicrobial preservative.
Sources
Multitrace-4 Manufacturers
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American Regent, Inc.
![Multitrace-4 (Trace Elements 4) Injection, Solution [American Regent, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Multitrace-4 | American Regent, Inc.
Each mL of the solution provides Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg, and Chromium 4 mcg. The suggested dosage ranges for the four trace elements are:
ZINC: For the metabolically stable adult receiving TPN, the suggested intravenous dosage level is 2.5 to 4 mg zinc/day. An additional 2 mg zinc/day is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost, or an additional 17.1 mg zinc/kg of stool or ileostomy output is recommended. Frequent monitoring of Zinc blood levels is suggested for patients receiving more than the usual maintenance dosage level of zinc. Normal plasma levels for zinc vary from approximately 88 to 112 mcg/100 mL.
For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day is suggested.
COPPER: For the metabolically stable adult receiving TPN, the suggested additive dosage level is 0.5 to 1.5 mg copper/day. For pediatric patients, the suggested additive dosage level is 20 mcg copper/kg/day. The normal plasma range for copper is approximately 80 to 160 mcg/100 mL.
MANGANESE: For the metabolically stable adult receiving TPN, the suggested additive dosage level for manganese is 0.15 to 0.8 mg/day. For pediatric patients, a dosage level of 2 to 10 mcg manganese/kg/day is recommended.
CHROMIUM: For the metabolically stable adult receiving TPN, the suggested additive dosage level is 10 to 15 mcg chromium/day. The metabolically stable adult with intestinal fluid loss may require 20 mcg chromium/day with frequent monitoring of blood levels as a guideline for subsequent administration. For pediatric patients, the suggested additive dosage level is 0.14 to 0.20 mcg/kg/day.
Periodic monitoring of plasma levels of Zinc, Copper, Manganese, and Chromium is suggested as a guideline for administration.
Aseptic addition of the solution to the TPN solution under a laminar flow hood is recommended. The trace elements present in the solution are physically compatible with the electrolytes and vitamins usually present in the amino acid/dextrose solution used for TPN.
Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).
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