A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Mte 5 Indications, Dosage, Storage, Stability - Trace Metal-5 Combination
Mte 5 Indications, Dosage, Storage, Stability - Trace Metal-5 Combination
INDICATIONS
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 symptoms.
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 loss, 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/10 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 wflow
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 between 15°- 30° C( 59°-
86° F). Avoid excessive heat.
HOW SUPPLIED
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 |
CAUTION: Federal (USA) law prohibits dispensing without prescription.
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