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, selenium and chromium and to prevent
depletion of endogenous stores of these trace elements and subsequent deficiency
DOSAGE AND ADMINISTRATION
Each mL of the solution provides Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg,
Chromium 10 mcg, and Selenium 60 mcg. The suggested dosage ranges for the five
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 mg 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.
SELENIUM: For metabolically stable adults receiving TPN, the suggested
additive dosage level is 20 to 40 mcg selenium/day. For pediatric patients,
the suggested additive dosage level is 3 mcg/kg/day.
In adults, selenium deficiency states resulting from long term TPN support, selenium as selenomethionine or selenious acid, administered intravenously at 100 mcg/day for a period of 24 and 31 days, respectively, has been reported to reverse deficiency symptoms without toxicity. The normal whole blood range for selenium is approximately 10 to 37 mcg/100 mL.
Periodic monitoring of plasma levels of Zinc, Copper, Manganese, Chromium and Selenium is suggested as a guideline for administration.
Aseptic addition of the solution to the TPN solution under 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 controlled room temperature 15°-30°C (59°-86°F) (See USP).
MULTITRACE® - 5 CONCENTRATE (TRACE ELEMENTS INJECTION 5, USP)
Each mL provides: Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, Chromium 10 mcg, Selenium 60 mcg.
NDC 0517-8201-25 1 mL Single Dose Vial Packaged
in boxes of 25
NDC 0517-8210-25 10 mL Multiple Dose Vial* Packaged
in boxes of 25
*The 10 mL multiple dose vial contains 0.9% benzyl alcohol as an antimicrobial preservative.
Rev. 10/03. AMERICAN REGENT, INC., SHIRLEY, NY 11967. FDA rev date: n/a