Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Selenium Injection containing selenious acid 65.4 mcg/mL (equivalent to elemental selenium 40 mcg/mL). HOW SUPPLIED NDC NUMBER Pharmacy Bulk Package 5 x 10 mL vials per carton 81279-106-05 Pharmacy Bulk Package 10 mL Single-Use Vial 81279-106-01 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). Manufactured for: Pangea Pharmaceuticals, LLC Brielle, NJ 08730 Rev. 04/2024; PRINICIPAL DISPLAY PANEL - Vial Labeling NDC 81279-106-01 10 mL Single Use Vial Rx Only Selenious Acid Injection, USP 400 mcg*/10 mL (40 mcg*/mL) of selenium For intravenous use after dilution and admixing PRESERVATIVE FREE. 10 mL PHARMACY BULK PACKAGE 106-01; PRINICIPAL DISPLAY PANEL - Carton Labeling NDC 81279-106-05 Rx Only Selenious Acid Injection, USP 400 mcg*/10 mL (40 mcg*/mL) of selenium For intravenous use after dilution and admixing STERILE PRESERVATIVE FREE. 5x 10 mL VIALS PHARMACY BULK PACKAGE 106-05
- HOW SUPPLIED Selenium Injection containing selenious acid 65.4 mcg/mL (equivalent to elemental selenium 40 mcg/mL). HOW SUPPLIED NDC NUMBER Pharmacy Bulk Package 5 x 10 mL vials per carton 81279-106-05 Pharmacy Bulk Package 10 mL Single-Use Vial 81279-106-01 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). Manufactured for: Pangea Pharmaceuticals, LLC Brielle, NJ 08730 Rev. 04/2024
- PRINICIPAL DISPLAY PANEL - Vial Labeling NDC 81279-106-01 10 mL Single Use Vial Rx Only Selenious Acid Injection, USP 400 mcg*/10 mL (40 mcg*/mL) of selenium For intravenous use after dilution and admixing PRESERVATIVE FREE. 10 mL PHARMACY BULK PACKAGE 106-01
- PRINICIPAL DISPLAY PANEL - Carton Labeling NDC 81279-106-05 Rx Only Selenious Acid Injection, USP 400 mcg*/10 mL (40 mcg*/mL) of selenium For intravenous use after dilution and admixing STERILE PRESERVATIVE FREE. 5x 10 mL VIALS PHARMACY BULK PACKAGE 106-05
Overview
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.
Indications & Usage
Selenium Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration of selenium in TPN solutions helps to maintain plasma selenium levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
Dosage & Administration
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 parenteral nutrition solutions under laminar flow hood is recommended. Selenium is physically compatible with the electrolytes and other trace elements usually present in parenteral nutrition formulations. 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. Do not directly mix ascorbic acid injection with selenium containing parenteral products in the same syringe or vial, as this admixture may cause the formation of an insoluble precipitate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Warnings & Precautions
WARNING Selenium Injection can be toxic if given in excessive amounts. Supplementation of TPN solution with selenium should be immediately discontinued if toxicity symptoms are observed. Frequent determination of plasma selenium levels during TPN support and close medical supervision is recommended. Selenium Injection is a hypotonic solution and should be administered in admixtures only. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Contraindications
Selenium Injection should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.
Adverse Reactions
The amount of selenium present in Selenium Injection is small. Symptoms of toxicity from selenium are unlikely to occur at the recommended dosage level. To report SUSPECTED ADVERSE REACTIONS, contact Pangea Pharmaceuticals, LLC at 1-855-892-8224 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.