Selenium Injection

Selenium Injection is a sterile, nonpyrogenic solution for use as an additive to solutions for Total Parenteral Nutrition (TPN).

Each mL contains Selenious Acid 65.4 mcg (equivalent to elemental selenium 40 mcg/mL) and Water for Injection q.s. pH may be adjusted with nitric acid to 1.8 to 2.4.

Selenium is part of glutathione peroxidase which protects cell components from oxidative damage due to peroxides produced in cellular metabolism.

Prolonged TPN support in humans has resulted in selenium deficiency symptoms which include muscle pain and tenderness. The symptoms have been reported to respond to supplementation of TPN solutions with selenium.

Pediatric conditions, Keshan disease, and Kwashiorkor, have been associated with low dietary intake of selenium. The conditions are endemic to geographical areas with low selenium soil content. Dietary supplementation with selenium salts has been reported to reduce the incidence of the conditions among affected children.

Normal blood levels of selenium in different human populations have been found to vary and depend on the selenium content of the food consumed. Results of surveys carried out in some countries are tabulated below:

Plasma selenium levels of 0.3 and 0.9 mcg/100 mL have been reported to produce deficiency symptoms in humans.

Selenium is eliminated primarily in urine. However, significant endogenous losses through feces also occur. The rate of excretion and the relative importance of two routes varies with the chemical form of selenium used in supplementation. Ancillary routes of elimination are lungs and skin.

Selenium Injection should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.

Selenium Injection provides 40 mcg selenium/mL. 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.

Aseptic addition of Selenium Injection to the TPN solution under laminar flow hood is recommended. Selenium is physically compatible with the electrolytes and other trace elements usually present in amino-acid/dextrose solution used for TPN. Frequent monitoring of plasma selenium levels is suggested as a guideline for subsequent administration. The normal whole blood range for selenium is approximately 10 to 37 mcg/100 mL.

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

Selenium Injection containing selenious acid 65.4 mcg/mL (equivalent to elemental selenium 40 mcg/mL).

NDC 0517-6510-25           10 mL Single Dose Vial           Packaged in boxes of 25

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

IN6510
Rev. 11/15

PRINCIPAL DISPLAY PANEL - Container 

NDC 0517-6510-25

SELENIUM INJECTION

Selenium 400 mcg/10 mL
(40 mcg/mL)

10 mL
SINGLE DOSE VIAL

Trace Element Additive

FOR IV USE AFTER DILUTION
PRESERVATIVE FREE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

PRINCIPAL DISPLAY PANEL - Carton

SELENIUM INJECTION

Selenium 400 mcg/10 mL
(40 mcg/mL)

Trace Element Additive

NDC 0517-6510-25
25 x 10 mL
SINGLE DOSE VIALS

FOR INTRAVENOUS USE AFTER DILUTION     PRESERVATIVE FREE      Rx Only

Each mL contains: Selenious Acid 65.4 mcg, Water for Injection q.s.
pH adjusted with Nitric Acid. Sterile, nonpyrogenic.
WARNING: DISCARD UNUSED PORTION. Store at 20°-25°C (68°-77°F); excursions
permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).
Directions for Use: See Package Insert.

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

Rev. 11/05